Express Pharma December 2017

CPhI & P-MEC INDIA 2017 SPECIAL

The three interviews in this page deal with varied issue. The first one is on the ensuring data
security through encryption. The second interview with Cipla’s Chief Medical officer is on the
growing incidence of respiratory disease and tackling it with a multi-pronged strategy involving
patient compliance, monitoring and raising awareness. The third interview is on Wockhardt
Pharma’s endeavour to tackle AMR with novel antibacterial therapies.

PHARMA TECHNOLOGY REVIEW

INTERVIEW

‘Pharma industry is heavily regulated
and HIPAA compliance mandates
that the industry encrypts its data’

Rahul Kumar, Country Manager,WinMagic throws light on the importance of data security solutions
and the need to adopt encryption by the pharma industry, in a tête-à-tête with Mansha Gagneja

What are the different data secure data is by encrypting regulated and HIPAA which creates a lot of IP and Pharma companies like the Quality. Speed. Simplicity.
security options available it. This ensures that the data compliance mandates that it is imperative that the fact that we bring in a
and why is encryption of is not accessible to the industry encrypts its customer is able to ensure solution which helps them
data becoming a more unauthorised users. data. The compliance is that their IP is secure and manage encryption, a
favoured option? aimed at securing the data at with them. perpetual pain area,
Securing data is the priority What will be the rest, thereby ensuring that better. The users are now
for Chief Information application of encryption in the research data is secure How widely is the pharma happy using this technology
Security Officer of an the pharma sector? and can’t be compromised. sector adopting these as it is simple and does not
organisation. The only way to Pharma industry is heavily This is one of the industries solutions as it is often interfere with their working.
labelled as a technology The bottom line is –
laggard? encryption was a word
The industry is fairly good in which used to push
adopting the technology customers away and now –
primarily because of customers know that a better
compliance. However, what world exists.
we have seen in the market is
that pharma customers have What is your market share?
troubles with encryption. Tell us about your major
Once they are aware about clientele.
solutions available for We have some of the key
managing encryption, it will enterprise customers in
be hassle-free. That is what India. Our clientele includes
we bring to the table and four big consulting houses,
customers are very happy three top pharma companies,
about it. three insurance companies
and three retail companies.
What are the encryption We have more than 110
challenges that exist in the customers in India now and
changing tech world? we are reaching a stage
The challenges have really where customers, when they
been the same for a couple of think about encryption, think
decades. User experience is about us.
one of the biggest challenge
when it comes to end-point Are there any other
encryption. Encryption solutions or upgrades in
industry has not seen a lot of the pipeline for the pharma
innovations in the space and industry?
we are the only company that We have recently come up
focuses on this area and we with a solution to help
bring a seamless user customers secure their cloud
experience for the customer. infrastructure. We are seeing
a lot of traction for this as
How are your solutions customers have been wary
helping pharma companies about the security of their
secure their data? How are virtualised environments.
they different from the
existing solutions? [email protected]

28 EXPRESS PHARMA

February 16-28, 2017

Express Pharma
(February 15 - 28, 2017)

RESEARCH

INTERVIEW

‘India has at least 60 million to 80 million
people with chronic respiratory disease’

As we mark World Asthma Day on May 2, Dr Jaideep A Gogtay, Chief Medical Officer, Cipla
explains to Viveka Roychowdhury why unlike the rest of the world, 70 per cent of COPD
patients in India are non-smokers and why increasing patient compliance, monitoring and
awareness are key to tackling chronic respiratory disease. Excerpts from the interaction

Why do we see an increase in are guesstimates. Asthma not seem to have lost their be amplified. wheezes, breathlessness For more than 90 years, you’ve known West as a packaging partner with a patient focus,
patients with chronic patients make up roughly 2-2.5 appeal. So, we need to track attacks, etc. The best drugs for quality products and global reach. Now get to know us for our speed and simplicity.
respiratory diseases (CRD)? per cent of the population, these changes on the smoking How will these factors impact controlling inflammation are
Globally, CRD are believed to which is 30 million people of front very carefully. treatment? corticosteroids. Steroids given West is pleased to introduce AccelTRATM - a new program designed to meet the needs of
affect one billion people. India’s 1.2 billion total You would see more severe by the oral route will always the generics injectable market.
Asthma and chronic population. An equal number Air pollution too adds to the asthma attacks, more difficult have problems, because they
obstructive pulmonary disease could have COPD. There are CRD burden. The Lancet has patients to deal with, etc. have systemic side effects. But • Meets Global Compendia
(COPD) are the two main CRD, some who believe it may be recently carried an article on Increasing urbanisation too will if you give them by the inhaled • Industry Leading Extractables and Leachables Profile
while there are several others, more than 2.3 per cent. Our the impact of air pollution in add to air pollution levels, with route, used in the standard • Functional Performance
like allergic rhinitis for guesstimate is that there are at various cities and India ranks increasing number of vehicles, therapeutic doses, they have
example. Asthma affects just least 60 million to 80 million second in terms of PM2.5, leading to increased incidence virtually no side effects in most
over 300 million, and for the people with CRD in India. following Bangladesh. This of CRDs. The recent Supreme patients. This is supported by
first time, this year, estimates data tells us that air pollution is Court ban on BS III vehicles is a data of almost 13-15 years of use
for COPD crossed asthma. The unique part of COPD in a big looming problem that will welcome step to reduce of inhaled corticosteroids, even
(One reason for the increase India is that 70 per cent, that’s add to our lung health vehicular pollution. in children aged five to six
could be that) we are now able almost two thirds of the COPD incidence. years.
to diagnose more COPD cases patients are non-smokers, Another source of air
in the last five to 10 years and whereas in most Western We don’t as yet know what is pollution is dust from roads, In many patients, you would
with this better data, COPD countries 90 per cent of COPD the exact contribution of construction site activities, need to add a long acting
incidence is today around 330 patients are smokers. The pollution to CRD but there is an industrial pollution. So all these bronchodilator. So this
million, up from the previous reason is that we have a huge interesting hypothesis put factors are unfortunately very combination is the standard
estimate of 210 million. These contribution (to COPD figures) forward around a decade back, conducive to creating more treatment of choice. There may
figures are as per the Global from biomass fuel, which that when air pollution, like respiratory problems for us. be 5 per cent patients who may
Initiative for Chronic women use for cooking in the diesel exhaust, combines with need more medication. But 88-
Obstructive Lung Disease rural communities. That is why allergies/allergens like dust Another hypothesis, called 90 per cent patients will do well
(GOLD) 2017 guidelines. we see the push to move to LPG mites, cockroach allergies, etc, the hygiene hypothesis, is that on this treatment protocol, with
for cooking. Biomass is also the lungs amplify the allergic as countries become more no symptoms, no nocturnal
So, while there is a focus on used for heating in the winter, response. So while air pollution prosperous, and the number of attacks and no loss of activities,
cardiovascular diseases which adds to the COPD may not directly cause asthma, infections and exposure to as long as they follow the
(CVDs), diabetes and cancer, burden among non-smokers in when combined with allergens, bacteria starts decreasing, the doctor’s orders and take their
CRD has now also been India. Of late, we realised that the symptoms of asthma may immune system develops a treatment regularly.
recognised as a big issue. In Africa, parts of Latin America stronger allergic response.
fact, COPD is included by the too have high numbers of non- Thus, the highest prevalence of What are the major
Government of India in the list smoker COPD patients. asthma is in New Zealand and challenges when addressing
of non-communicable diseases Australia. We don’t understand chronic long term
(NCDs). The challenge with Besides COPD, allergic everything right now because respiratory conditions like
some of the CRD is that in most rhinitis in India is quite high, the immunology (related to asthma, COPD?
countries, the ratio of patients estimated at around 15 per CRD) is quite complex. Patient compliance is a huge
diagnosed to undiagnosed is 1:8 cent, meaning it is several times challenge in treatment of
or 1:9. So, COPD is vastly under- more common than asthma. What are the basic asthma asthma. There is a huge drop of
diagnosed. For example, there India also has a fairly large treatment protocols? around six months of the year,
was a study in Latin America, population of smokers, Asthma treatment protocols especially during the summer
which showed that 90 per cent estimated around 15-18 per are quite clear. It was very well when it’s so hot that the
patients were undiagnosed, as cent. What’s worrying is that established in the early 90s that chances of asthma attacks goes
diagnosis requires a spirometry while smokers in their 40s are inflammation is the real down. Most patients stop
or a lung function test. giving up smoking, youngsters problem to deal with in asthma. treatment, for a variety of
seem to be picking it up earlier And if you can control the reasons. Some feel well, the
Where does India stand? than before. Also, more young inflammation, you can control symptoms disappear so they
In India, again, the estimates women seem to be picking up the symptoms of stop taking their medication.
(smoking) of late. And beedis do bronchospasm, coughs,

32 EXPRESS PHARMA

May 1-15, 2017

Express Pharma
(May 1-15, 2017)

MARKET

INTERVIEW

Wockhardt intends to acquire global
leadership in the field of antibiotics

Dr Murtaza Khorakiwala, MD, Wockhardt, shares the challenges faced with regards to AMR
and his vision to create a continual stream of novel antibacterial therapies in a conversation
with Mansha Gagneja

Why is antimicrobial earn good profits. On the other such challenges it is no wonder superdrug that introduces the Quality
resistance a global concern? hand, antibiotics which that in the past four to five first entirely new class of
Today, global mortality due to actually cure the disease are requires highly specialised skill years several Indian companies Gram-negative antibiotic • Optimized Lead Times • Single Next Generation Formulation 4031
anti-microbial resistance priced much lower. In order to sets and considerable insights that were engaged in this field treatment in 35 years. • As low as one week • Stoppers
(AMR) is more than seven preserve the effectiveness of in this therapeutic area, which have also given up discovery WCK5222 is expected to be a • Trial and Commercial quantities • 13 & 20 mm
lakhs, which is slated to antibiotics used in critical care, is developed through long- efforts. life-saving destination therapy • Serum and Lyo
increase up to 10 million by they are required to be used term commitment. Looking at for serious hospital acquired • Proactive Technical Support • Westar® RS & RU Certified
2050. Due to AMR, the judiciously for several years, What are the challenges infections (HAIs) such as
additional healthcare cost per thereby further curtailing their faced in formulation of hospital acquired bacterial For more information, contact West today. • Global Availability
year is more than $4 billion sales growth. This is unlikely antibiotics and anti-parasitic pneumonia, ventilator www.westpharma.com
globally. Moreover, there has for lifestyle disease products as drugs? associated pneumonia and
been collateral damage to their sales keep expanding on As antibiotics have a wide blood stream pneumonia and
healthcare settings across the yearly basis. As a result of Big range of uses besides treating blood stream infections.
globe, with compromised Pharma exodus from antibiotic infections, including pre and
ability to manage various discovery, internationally the post-surgical propylaxis for a It would be the first
surgeries, organ transplants, skill sets required for antibiotic range of surgical procedures, antibiotic moving ahead
deliveries etc. discovery have also sharply organ transplant, and in Phase III for five gram
declined. On the other hand, hip/knee/joint replacement, it negative superbugs -
AMR through various scientific challenges involved in is important that the Enterobacteriaceae,
multi-drug resistant superbugs discovering novel antibiotics formulations developed are Acinetobacter, ESBLs,
as Enterobacteriaceae, targeted towards multi-drug compatible with a wide range Salmonella, Pseudomonas.
Acinetobacter, ESBLs, resistant pathogens have of clinical conditions.
Salmonella, Pseudomonas, multiplied in view of a Development of injectable Wockhardt has five drugs
Staphylococcus and superbugs’ ability to deploy formulations throws up a which have entered
Streptococcus, is leading to multiple resistance significant challenge in phase II and phase III
loss of lives at a great extent mechanisms. Such a scenario managing injection site clinical trials. What is the
due to the uncontrolled deadly demands discovery of new tolerability. Similarly, oral progress on these drugs?
infections. Thus putting the agents that can tackle a broad formulations need to have good Our NCEs WCK 771, WCK
entire healthcare industry range of pathogens and GI tolerability and rapid 2349 and WCK 4873, are
under threat. resistance mechanisms. This absorption for quick onset of against multi-drug resistant
antibacterial action. gram positive infections, while
Why is research for new tools DEATHS ATTRIBUTABLE TO AMR EVERY YEAR WCK 4282 and WCK 5222 are
to combat drug resistance How much share is allotted against multi-drug resistant
declining? to research for AMR in gram negative infections. Speed licity
The research on new Wockhardt? Simp
antibacterial agents is Source: The Review on Antimicrobial Résistance, Jim O'Neill, 2016 Wockhardt has been engaged In addition to WCK5222,
declining due to its economic in drug discovery research for WCK 771 and WCK 2349 drugs
unattractiveness. Antibiotics the last 20 years and invested have received QIDP status.
which are prescribed for significantly during this period. Presently, this combination is
shorter courses of one or two Last year, our spend on R&D entering phase III clinical trials
weeks do not generate itself was approximately 15 per in India, post successful
sufficient return on cent of our sales of which our completion of its global phase I
investments to recoup the cost drug discovery portfolio is a and India-based phase II trials.
of research. Therefore, big critical component. It would cater to Indian and
pharma companies have emerging markets.
vacated the field to focus on Wockhardt has recently
more lucrative lifestyle received an approval for Further, WCK 4873 is
diseases requiring long-term phase III clinical trial from positioned against multi-drug
therapies. This is paradoxical the US FDA, could you brief resistant gram positive
since majority of such us about the new superdrug? superbug and has successfully
therapies do not cure the WCK 5222 is a novel class of completed its global phase I
disease but it helps companies trials and would be entering
global phase II trials.

WCK 4282 is a combination

14 EXPRESS PHARMA

May 16-31, 2017

Express Pharma
(May 15-31, 2017)

West and the diamond logo, AccelTRA and Westar are trademarks or registered trademarks of West Pharmaceutical Services, Inc., in the United States and other jurisdictions. 10166 0317
© 2017 West Pharmaceutical Services, Inc.

61EXPRESS PHARMA

December 1-15, 2017

CPhI & P-MEC INDIA 2017 SPECIAL

cover ) EXPRESS PHARMA (MARCH 1-15, 2017) NEW TECHNOLOGIES

28 EXPRESS PHARMA (T H E M A I N F O C U S This article analysed
electroceuticals, a new
March 1-15, 2017 ERA OF branch of medicine, which is
ELECTROCEUTICALS generating considerable interest
globally among medical
COMING SOON? researchers and entrepreneurs
Electroceuticals, hailed as the next frontier in medicine, is like GSK. It explored the potential
garnering considerable interest from medical researchers and of electroceuticals to treat a
entrepreneurs on the lookout for the next class of therapies wide range of illnesses by
BY LAKSHMIPRIYA NAIR altering electrical signals
diffused by nerves throughout
S ince time immemorial, the to treat a wide range of illnesses, is be- Research Projects Agency (DARPA) and neuromodulation. In October 2016, the body. The article also
idea of a miracle cure to rid ing touted as the next great frontier in National Institutes of Health (NIH) in NIH also announced $20 million in fund- covered the research done on
all the ailments afflicting medicine. the US have shown immense interest in ing for the field. The endeavour’s goal is to this field and reflected whether it
the human body have held the field of electroceuticals. understand more about the body’s elec- could replace pharmaceuticals
tremendous fascination for Gaining ground trical circuit – the peripheral nervous completely some day?
scientists, medical researchers, alterna- Also known as bioelectric medicine, it is DARPA, an agency of the US Depart- system.
tive medicine practitioners and even has generated considerable interest ment of Defense in charge of the devel- The story is an example
faith healers. Could it be that the globally among medical researchers and opment of emerging technologies for Catalysts of change of how Express Pharma captures
panacea the world’s looking for is noth- entrepreneurs. Leading medical device military use, has initiated a $79 million A MarketsandMarkets report predicts the pulse of the lifesciences
ing but electricity? The concept might manufacturers like Medtronics, Boston project called Electrical Prescriptions that the global electroceuticals/ industry. It is always
not have had too many takers a few Scientific Corporation, Cochlear and (ElectRx), in this field. NIH's Stimulat- bioelectric medicine market will reach on the look out for technological
decades earlier, but today ‘electroceuti- even pharma majors like GlaxoSmithK- ing Peripheral Activity to Relieve Condi- $25.20 billion by 2021 from $17.20 billion and therapeutic innovations and
cals’ a term used to describe miniature line (GSK) are making significant invest- tions (SPARC) programme is another in 2016, growing at a CAGR of 7.9 per disruptions to serve the sector
devices which can alter electrical signals ments for research in this arena. Even initiative that seeks to expand our cur- cent from 2016 to 2021. and keep it abreast of the latest
diffused by nerves throughout the body organisations like the Defense Advanced rent knowledge of nerve-organ interac- and future trends in the industry.
tions and propel progress in the field of The reports also reveal that North

To subscribe: [email protected] 29EXPRESS PHARMA

March 1-15, 2017

EXPRESS PHARMA (APRIL 1-15, 2017)

cover ) (T H E M A I N F O C U S DISEASE MANAGEMENT
STRATEGIES
ROOTING
OUT RUBELLA: The story covered the Union
Health Ministry’s efforts to
MAKING IT eliminate and control congenital
MISSION rubella syndrome (CRS) by
POSSIBLE 2020. It particularly focussed
on a concerted, nation-wide
The government needs to quash fears about safety of measles-rubella vaccination
the rubella vaccine and establish its efficacy to achieve its (MR-VAC) campaign for children
aged between nine months and
goal of eliminating the disease by 2020 15 years. It also highlighted that
the government needed to quash
BY PRATHIBA RAJU fears about safety of the rubella
vaccine and establish its efficacy
to achieve its goal of eliminating
the disease by 2020.

The objective of the article
was to review a public health
campaign and its effectiveness
in dealing with a disease which
afflicts many children in the
country.

22 EXPRESS PHARMA To subscribe: [email protected] 23EXPRESS PHARMA

April 1-15, 2017 April 1-15, 2017

62 EXPRESS PHARMA

December 1-15, 2017

CPhI & P-MEC INDIA 2017 SPECIAL

This page features three more interviews which cover various other aspects of the industry. The
first interview with Dr GN Singh and Dr V Kalaiselvan, reflected on the progress of PvPI in India and
its activities to strengthen pharmacovigilance in the country. The second interview with Merck,
covered the company’s plans for India in the next 18 months and its intent to reach out customers
directly through their consumer healthcare and bio-pharma segments. The interview with
Dr B Suresh from PCI reflected the state of pharmacy education in the country and the steps initiated
by PCI to bridge the industry-academia gap.

(T H E M A I N F O C U S www.glatt.com

INTERVIEW Process & Plant Engineering

Long-term goal of PvPI is to develop e-reporting and TECHNOLOGY – EQUIPMENT – ENGINEERING
reporting culture among HCPs

Dr GN Singh,
DCG(I) and
Secretary-
cum-Scientific
Director, IPC and
Dr V
Kalaiselvan,
Principal
Scientific
Officer, IPC, in an
interview with
Swati Rana
speak on PvPI’s
progress,
various skill
development
programmes
and steps taken
to spread
awareness in
rural areas on
ADR reporting

Pharmacovigilance
Programme of India (PvPI)
was initiated in July 2010
with an aim to monitor and
report ADR across the
country. Brief us on the
current status of PvPI and
PvPI's short term as well
long goals?
A robust and stable system of
PvPI has been established
under the aegis of Indian
Pharmacopoeia Commission
(IPC) to monitor, report,
collate and analyse adverse
drug reactions. In order to
ensure a stable PvPI system,
the guidance and support
from MoH&FW, commitment
and support from DCG(I) and
CDSCO officials is

25EXPRESS PHARMA

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(July 16-31, 2017)

cover )

overwhelming. Hence, the PvPI data is At present there are around monitor the safety of doctors and clinical
current pharmacovigilance effectively 250 Adverse drug medicines used in private pharmacists. Since nurses
system in India has reached utilised by the Monitoring Centre (AMC) sectors. and community pharmacists
an advanced stage. CDSCO for across the country. Explain Any further collaboration are important stakeholders of
taking the functioning of AMC and or MoU that will be signed pharmacovigilance, steps are
Our short-term goals are regulatory tell us about the number of globally? being taken to
to develop and implement decisions upcoming AMCs in 2017- IPC, NCC-PvPI is going to be motivate/empower them in
pharmacovigilance system in 2018. declared as WHO reporting ADRs.
India, recognising MCI- Dr GN Singh The AMCs are responsible in collaborative centre for
approved medical colleges as DCG(I) and monitoring and reporting pharmacovigilance in national What kind of training and
ADRs monitoring centres ADRs. They are routinely health programmes and skill development
and encourage healthcare Secretary-cum-Scientific- engaged in motivating HCPs regulatory capacity-building programmes are organised
professionals (HCPs) in Director, IPC to monitor adverse events. for pharmacovigilance in under PvPI?
reporting adverse events AMCs are the backbone of public health programmes As we mentioned, NCC and
associated wit the use of D&C Rules 1945 for PvPI in providing clinical- and regulatory services in the AMCs are jointly conducting
pharma products. Long-term establishment of oriented and India-specific WHO South-East Asia CMEs (pharmacovigilance)
goals are to expand the PvPI pharmacovigilance system at ADRs so that the meaningful Region. programme,
to all hospitals and centres of marketing authorisation information shall be used for orientation/induction-cum
public health programmes holders.This provides a huge protecting the safety of the IPC, NCC-PvPI training programme etc. for
located across the country, to opportunity to the industry to population. In the upcoming plans to better pharmacovigilance
develop electronic reporting participate in PvPI. Since year 2017-18, NCC plans to recognise 50 and harmonised
system and develop reporting quality management system recognise 50 more hospitals more hospitals pharmacovigilance practices.
culture among the HCPs. has been put in place to as AMCs. as AMCs In addition to this, to provide
manage the PvPI activities, an opportunity to the HCPs
It's being seven years since the completeness score of the What are the plans to Dr V Kalaiselvan and students across the
PvPI was launched in India. date generated from Indian expand pharmacovigilance Principal Scientific Officer, country, a nationwide 10-day
How was the journey so far patients is ahead of other programme to govt as well skill development
and what were the countries. SMS facility (drug as private hospitals? At IPC programme is conducted by
challenges? alert) is being well received present, how many the IPC. So far, four skill
Yes. PvPI is seven-year-old among the HCPs. hospitals report on ADR? How PvPI is planning to development programmes
and has become a flagship Interestingly, the PvPI data is IPC, NCC-PvPI is planning to expand its scope of have been successfully
programme in the country. effectively utilised by the enrol all government and activities to widen its reach conducted where 220
When we took charge as CDSCO for taking private hospitals to to other healthcare participants were benefited.
NCC, we realised that there is appropriate regulatory participate in PvPI. A professionals?
a huge need of capacity decisions. circular from MoH&FW has The current system of PvPI, What steps have been taken
building at NCC and also been sent to states and UTs engages with HCPs such as to spread awareness on
AMC. Therefore, efforts were to adopt pharmacovigilance ADR reporting in rural
taken to develop in the practice of HCPs. areas?
infrastructure, appointing AMCs in association with
manpower etc., both national In January 2017, IPC signed NCC are taking keen interest
and regional level - we an MoU with National to promote PvPI in rural
succeed! Also, there was a Accreditation Board for areas. To make public aware
great need of training and Hospitals (NABH). Tell us about the benefits of PvPI,
education needed on more on this initiative. the concept and importance
pharmacovigilance for those What are the numbers of of ADRs reporting is covered
working in PvPI. ADR reported from NABH in regional newspapers and
hospitals till date? also transmitted through
In addition to this, to After having an MoU with radio. IPC is working with
impart pharmacovigilance NABH, series of training Doordarshan to spread the
education and training, 10 programme for the NABH message of
zonal training centres have hospitals in reporting ADRs pharmacovigilance, which
been identified, which are is conducted across the will go a long way to educate
functioning under the country. In order to promote the public particularly in
umbrella of PvPI. PvPI also ease of doing rural areas.
integrates with various public pharmacovigilance by the
health programmes to hospitals, reporting of ADRs Road ahead for PvPI
monitor the safety of drugs to PvPI will only be a.Expansion of PvPI outreach
and vaccines used in their accountable during the to district and below level
respective programmes. NCC NABH accreditation or hospitals
has introduced various tools renewal (no need of duplicate b.Self sustainability of the
for ADR reporting by the reporting). Now NABH programme
HCPs and patients such as accredited hospitals begin c.IPC to become a centre of
reporting form in vernacular reporting to their nearby or excellence in
languages, mobile app and preferred AMCs. This pharmacovigilance
helpline (tool free). The arrangement will boost to
biggest achievement, is the [email protected]
amendment in Schedule Y of

26 EXPRESS PHARMA

July 16-31, 2017

Express Pharma
(July 16-31, 2017)

cover )

INTERVIEW

‘A contemporary and relevant pharmacy
curriculum is the need’

Dr B Suresh, President, Pharmacy Council of India, speaks on various issues related to
pharma education in India and elaborates on the initiative taken by Pharmacy Council of India
(PCI) to bridge the gap between industry and academia, in an interview with Swati Rana

Brief us on the current PCI has made it mandatory that pharma teachers attempt by PCI to bring Solutions for your investment projects in pharmaceutical, biotech and food industries.
scenario of pharma need to undergo continuing education complete pharma education
education in India. programmes and quality improvement under its roof. What is the » Consulting: project development + feasibility studies + technical due diligence + GMP audits + licenses.
The pharmacy education in programmes and get themselves updated both status? » Planning: conceptual design + basic engineering + detail engineering + execution engineering + general planning.
India is presently in a very with the pedagogy of teaching as well as the I would like to reiterate that » Implementation: procurement + delivery + building and consturction supervision + commissioning.
challenging phase. Due to an advances that has happened in the relevant fields dual regulation is greatly » Validation & qualification: comprehensive GMP compliance + integrated concept.
increase in the growth of the impacting the pharmacy » Project management.
pharma industry, there is a of pharmacy education, i.e. by strategies to harmonise their that can carry forward the education system. Efforts to We combine professional engineering with in-depth technology expertise. Worldwide! Benefit from reliable solutions from one source.
growing need for qualified and the PCI and All India Council regulations it still does vision of PCI in preparing a overcome this by the PCI are
highly knowledgeable human for Technical Education precipitate regulatory pharmacist workforce that is ongoing and has to be MEET THE EXPERTS @ CPhI & P-MEC India
resource. As a result, there is (AICTE). This dual regulation challenges that result in not competent, current and considered by the government Bombay Exhibition Center, Goregaon (East) Mumbai, India, 28.11. - 30.11.2017
now a sudden spurt of interest has led to institutions being able to bring about relevant. as changes require Stand No. J2
from the students to pursue exploiting structural and quality advancement. Besides amendment to various acts.
pharmacy programme in procedural mechanisms of this, the major challenge for Pharma education is Glatt. Integrated Process Solutions.
India. Further, job regulation to their advantage, pharmacy education in the regulated by two bodies, PCI The gap between academia
opportunities for engineering- resulting in a number of country relates to the and AICTE in India. How is it and industry is a major
based programmes are on the litigations. Though the PCI availability of qualified and impacting the education concern. How is PCI bridging
downslide, making it less and AICTE have worked out competent pharmacy teachers system? There was also an the gap?
attractive for students to There has been a steady
pursue engineering as a first change in the pharma sector
choice of career option. The approach to drug discovery
sudden influx of interest and and development. A
consequent increase of contemporary and relevant
demand has resulted in the pharmacy curriculum is the
rush to start new pharmacy need to address this gap.
colleges in India in an already Emerging and growing
overcrowded space. This scientific areas in pharma
sudden growth has sciences such as modelling and
precipitated issues relating to simulation training, clinical
the quality of education being and translational science as
delivered at these institutions. well as nano technology should
The Pharmacy Council of become available for both
India (PCI) has addressed this basic and advanced training.
challenge of quality in The faculty should be
pharmacy education through a developed and supported to
strategy involving three lead and contribute to fields
domains of action: quality such as cell and system
assurance, academic and biology, genomics, proteomics
institutional capacity building and nano technology. PCI has
and more emphasis on brought out five regulations
experiential education and and a national curriculum to
competency building. usher a paradigm shift in
pharma education, training
What are the issues faced and research. This will not
by PCI? only provide much needed
PCI faces a major challenge direction, growth and
with regards to dual regulation leadership for the cusrriculum

30 EXPRESS PHARMA

September 1-15, 2017

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(September 1-15, 2017)

63EXPRESS PHARMA

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CPhI & P-MEC INDIA 2017 SPECIAL

EXPRESS PHARMA (JUNE 1-15, 2017)

MARKET MARKET PUSH FOR
GENERICISATION
POST EVENT
Reviews, predictions and
Genericisation evokes fierce debate at feedback on the policies of
third edition ofVantage Point the government and laws of the
regulatory bodies are frequently
Panelists divided QualityPyramid for Quality Metrics ... covered in Express Pharma.Then
on the impact of Solution for the future how could it have not covered the
the push for government’s intent to push
generics, many genericisation?
laud the intent
but remain A fiery debate on
sceptical of ‘Genericisation: Panacea or
consequences Pandora’s Box?’ensued at the
third edition of Vantage Point,
Lakshmipriya Nair & Process capability APQR Interdependency risk assessment Process/Person vulnerability Express Pharma‘s platform to
Mansha Gagneja discuss and deliberate on Indian
Mumbai The product wise metrics can be integrated to form a comprehensive integrated Quality management suite to pharma sector’s most pressing
address each individual department's challenges and enterprise wide challenges of future- like quality metrics. and controversial topics, covered
A FIERY debate on ‘Generici- this issue in detail with the
sation: Panacea or Pandora’s CaliberLIMS Change Management Nichelon5 CMS Weighing and Dispensing CaliberDMS Drew out the pan- He said that if there He opined that He stated that She threw light on industry experts.
Box?’ ensued at the third edi- Deviation Management Master BMR and BPR elists to share was political will quality can be a though the intention how marketing and
tion of Vantage Point, Express Sample Tracking Annual Training Plans e-Process Instructions Pharma GMP compliance and collaboration concern in such a was to introduce a PR would change An eminent panel
Pharma‘s platform to discuss e-worksheets, 100% paperless lab Market Complaints Online exam and evaluation Integration with Balances Document publishing in pdf their views candid- scenario as the in times of generi- deliberated on the implications
and deliberate on Indian CAPA Short & long term evaluations Integration with SAP Configurable dossier format ly and discuss the between stakehold- industry and med- panacea to many and possibilities of the Centre’s
pharma sector’s most press- OOS, OOT ramifications of a ers, then generici- ical fraternity is ill- problems faced by cisation and its push towards genericisation of
ing and controversial topics. ERP, CDS & Instrument Interface Audit Management Trainers qualification CaliberBRM Task based workflow mandate to pre- sation could indeed equipped to deal healthcare industry effect on patients pharma brands, in a very
Partnered by Wellness For- Audit ready training records Configurable document security scribe only generic be a panacea and with genericisation today, inadvertently interesting and insightful
ever, the event was held at Inventory Management CaliberQAMS create significant opened a Pandora’s Priti Mohile session.
Sofitel in Mumbai. An emi- names of drugs positive impact for Dr Jayesh Lele Managing Director,
nent panel deliberated on the Innovative Solutions Holistic Support Superior Technology National Secretary – IMA Box
implications and possibilities Dr Milind Antani patients MediaMedic
of the Centre’s push towards Caliber nichelon Board of India Milind Mangle Communications
genericisation of pharma Head, Pharma and Life Dr Amar Jesani Internationally Certified
brands, in a very interesting Caliber0101 R Infosolutions Inc. Infotech Services Pvt. Ltd. Sciences, Nishith Desai Editor, IJME Coach and Consultant, Angle
and insightful session, moder- US & EUROPE ASIA PACIFIC Consultancy & Services
ated by Dr Milind Antani, C 0010 Tel: 1( 412) 499 3442 Ph: 91-40-30911555 Associates
Head, Pharma and Life TPL 00 Toll Free: 1 888 510 LIMS Sales: 91-40-30911552
Sciences, Nishith Desai www.caliberinfosolutions.com www.nichelon.com
Associates. Technologies Pvt. Ltd.

The panel comprised Dr ASIA PACIFIC 22 EXPRESS PHARMA
Amar Jesani, Editor, IJME; Dr Ph: 91-40-30911555
Jayesh Lele, National Secre- Sales: 91-40-30911552 June 1-15, 2017
tary – IMA Board of India; www.caliberindia.com
Milind Mangle, Internation-
ally Certified Coach and Con-
sultant, Angle Consultancy &
Services; Vaijanath Eknath
Jagushte, Treasurer, Chair-
man of Legal Affairs Commit-
tee —AIOCD & MSCDA and
Treasurer of MSCDA; Priti
Mohile, Managing Director,
MediaMedic Communica-
tions; Dr KS Sharma, PG
Committee Member, Medical
Council of India MCI and
Director Academic Tata

21EXPRESS PHARMA

June 1-15, 2017

EXPRESS PHARMA (JUNE 16 - 30, 2017)

cover ) SANJEEVANI FOR (T H E M A I N F O C U S ENCOURAGING AYUSH

16 EXPRESS PHARMA AYUSH { }OmSarveBhavantuSukhinah The patient-centric
Sarve Santu Nir-Aamayaah | approach of India’s
June 16-30, 2017 AYUSH could be the answer to India's Sarve Bhadraanni Pashyantu traditional systems of medicines
unmet medical needs but only if it is Maa Kashcid-Duhkha-Bhaag-Bhavet | has led the government to look
backed by scientific validation and May all become happy, may all be healthy (free from illness), at AYUSH as a panacea to India’s
may all see what is auspicious, may no one suffer in any way. public health challenges.This
credible evidence story covered the several
This Sanskrit prayer growth of AYUSH and prevent- Are clinical trials the unforetold harm. merits of the move. measures have been initiated by
BY LAKSHMIPRIYA NAIR is also a goal that ing its widespread acceptance? answer? Dr Ali Mehdi, Fellow & VK Dhawan, CEO, Planet the government to drive access
India has been In answer to this question, Fortunately, paying heed to affordable, reliable and easily
striving to ensure experts and industry veterans to the increasing clamour for Project Leader, Health Policy Herb Lifesciences also speaks accessible medical facilities to
for its citizens and cite various reasons on all evidence-based AYUSH, regu- Initiative from Indian Council in support of clinical trials. He the masses through AYUSH. It
enabling universal healthcare fronts: education, research, lators and the government for Research on International says, “It will certainly help also reflected on the ways and
access (UHC) is a pivotal step clinical practice, industry, and have been mulling over Economic Relations (ICRIER), to build trust and authenticity means to promote and
towards achieving this noble regulation. measures, systems, policies a leading policy research insti- amongst doctors and patients popularise alternative systems
objective. Yet, it remains a and processes to ensure better tution supports the intent to for herbal medicines. Today, of medicine.
distant dream due to unequal But, all of these are inter- documentation and validate mandate clinical trials for many doctors, mainly practic- It also covers examining the
health access, threat of existing connected and seems to be the drugs and practices of AYUSH drugs and states, “The ing in Western medicines several factors hindering the
and emerging diseases, lack of linked to one mammoth hurdle: these alternative systems of AYUSH industry cannot sus- doubts and do not trust on growth of AYUSH and preventing
trained medical professionals lack of scientific validation and medicine. Clinical trials for tainably thrive on faith! It has herbal medicines due to lack of its widespread acceptance, the
and rising costs of healthcare. evidence. AYUSH drugs is one of them. to be based on sound scientific clinical studies done on these story reveals how building trust
In 2016, Indian Council of Med- and management principles.” products. Once thorough stud- in the traditional medicine
The patient-centric ap- This has often led to the ical Research (ICMR) released ies are carried out it will help to systems through validated data
proach of India’s alternative rampant misuse of herbal and guidelines for conducting test- Opining that clinical trials support clinical claims about and irrefutable evidence has
and traditional systems of traditional medicines and ing medicines from AYUSH to are in the best interests of the the brand/products. It will emerged as an urgent need to
medicines that comprise thereby the negative outcomes provide more clarity on testing AYUSH industry, he believes certainly encourage those leverage the true potential of
Ayurveda, Yoga & Naturopathy, are often reported. Though ayurvedic formulations and that it would empower the organisations that are sincerely these systems.
Unani, Siddha & Sowa-Rigpa traditional medicines have other traditional medicines. practitioners to feel more con- involved in research-based
and Homoeopathy (AYUSH), been in use for a long time, fident - and probably incen- manufacturing activities and
has led the government to look there has been limited quality While there is unanimous tivised - to prescribe AYUSH ready to spend good amount
at them as a panacea to control and negligible docu- accord on the good intent of the medicines once they are con- on R&D activities to develop
India’s public health challenges. mented evidence of their government, the industry is vinced of their scientific value. quality product.”
Spurred by the belief in the safety and effectiveness. This, divided on its impact. Many He says, “Right now, they are
potential of AYUSH to alleviate in turn, has negatively im- believe that it would undoubt- unable to take ownership and He further states, “It will
the crises within Indian health- pacted the development of reg- edly lead to better safety and leave it to the patients to take help in manufacturing quality
care, the government has been ulations and legislation in this efficacy of AYUSH drugs, but them at their own risk.” medicines and to make clinical
trying to promote and popu- arena. Hence, building trust there are many dissenting claims for these products. Only
larise alternative systems in the traditional medicine voices who argue that such a However, he believes those manufacturers/brand
of medicine with an aim to systems through validated step, if implemented with that the move will meet with owners will stay in the field
integrate it with modern data and irrefutable evidence proper thought and planning, resistance from at least some who really have good research
systems of medicine. has emerged as an urgent need would not only curb the growth segments of the AYUSH based formulations available.
to leverage the true potential of the industry but also do it industry and recommends the Quality and efficacy of herbal
However, despite myriad of these systems. government to engage with the medicines will go high and reli-
actions to promote and popu- industry and clearly explain the ability of herbal medicines over
larise AYUSH, it hasn’t taken allopathic medicines will
off the way it was expected to. Paying heed to the increasing clamour for improve a lot. Additionally,
A health survey conducted by evidence-based AYUSH, regulators and the companies who really want to
National Sample Survey Office government have been mulling over stay in the market shall be
(NSSO) in 2015 revealed that measures, systems, policies and processes to forced to set up their own R&D
‘inclination towards allopathic ensure better document and validate the set up to deliver research
treatment was prevalent drugs and practices of these alternative based products. Copying of
(around 90 per cent in both systems of medicine. Clinical trials for branded formulation will stop.”
the sectors). Only five to seven AYUSH drugs is one of them
percent usage of ‘other’ includ- However, he is also aware of
ing AYUSH was reported both the challenges that need to be
in rural and urban area.’ tackled. He outlines, “Clinical
trials are quite expensive, they
Clarion call for evidence require huge investment. Only
So, what’s hindering the those companies who are really
sincere about conducting

To subscribe: [email protected] 17EXPRESS PHARMA

June 16-30, 2017

64 EXPRESS PHARMA

December 1-15, 2017

CPhI & P-MEC INDIA 2017 SPECIAL

EXCLUSIVE ARTICLES FROM INDUSTRY EXPERTS

In this retrospective issue, we bring to you some of the articles shared by domain experts on various
pertinent issues of the industry.Three experts from Khaitan and Co share their views on the FDC ban in the
first article of this page. The second one is from a representative of MSF Access Campaign who strongly
supports India’s strategy of providing affordable generics to the world. The third one reflected on the need
for a stringent regulatory authority to procure anti-TB medicines.

cover )

INSIGHT

Fixed dose combination drugs – to be

banned or not to be banned

Ajay Bhargava, Vanita Bhargava and Aseem Chaturvedi explain how the FDC ban notification
has adversely affected the pharma industry

With the advance- Ajay Bhargava, Partner, Vanita Bhargava, Partner, Aseem Chaturvedi, Principal The petitions were heard by Take control
ment of science and Khaitan & Co Khaitan & Co. Associate , Khaitan & Co. Justice Rajiv Sahai Endlaw, of sustained
technology, the over a period of nearly three drug release.
pharmaceutical Industry has drous caffeine, they formu- with immediate effect. The no- The pharma industry im- months, with several days of
also grown and evolved. Vari- lated an FDC to treat common tification purported to ban the mediately proceeded to chal- back to back hearings. Parteck® SRP 80
ous ailments, which could not cold, cough, throat pain and FDCs for the reason that they lenge the notification on vari-
be treated before, are easily di- fever, which in the common involved risk to human beings ous grounds. Although, The companies challenged the Solid oral formulations often rely on long-acting API efficacy. Our
agnosed and medication is market is known and available and that safer alternatives to several writ petitions were ban on, inter-alia, the following Parteck® SRP 80 offers superior reliability and consistency for your
available for its treatment. as D-Cold Total. Similar com- the same were available. Fur- filed before various High grounds: sustained release products. The evolved matrix technology of
There are boons and banes to binations are available in the ther, the notification was also Courts of the country – the ◗ Violation of Article 14 of the Parteck® SRP 80 helps you optimize the release profile of your API:
every field and science cer- market under different trade purported to be based on the Delhi High Court, having Constitution of India, in as
tainly is no exception . names such as Ascoril-D, findings and recommenda- passed the first interim order much as the notification was • Resistant to pH- and alcohol-induced dose dumping
Wickoryl etc. manufactured tions of an Expert Committee dated 14 March 2016 concern- issued in an arbitrary manner; • Suitable for direct compression processes
Earlier, the only medication by different companies. Some appointed by the Central Gov- ing the notification in WP (C) in violation of the principles of • Superior batch-to-batch consistency and robust performance
that was given as a cure for other popular examples of ernment, which stated that No. 2212 of 2016, directing that natural justice; was unreason- • Dependable sustained drug delivery
fever, cold, cough etc. was FDCs are Pfizer’s Corex, Pira- the FDCs in question were no coercive action will be able, harsh and unscientific.
paracetamol. Paracetamol, till mal Healthcare’s Saridon, found to have no ‘therapeutic taken by the government in ◗ Violation of Article 19(1)g, in To find out more about the new Parteck® SRP 80, visit
date, is considered a safe op- Merck India’s Nasivion, Glen- justification’. Lastly, the noti- furtherance of the notification, as much as the notification www.merckmillipore.com/partecksrp80
tion for treating fever and flu. mark’s Ascoril and Candibi- fication was, of course, touted till further orders – became was an unreasonable restric-
However, with the advance- otic, Lupin’s Gluconorm etc. as an exercise in ‘public inter- the hot-bed of the present liti- tion upon the business and
ment of science, various other est’. Hundreds of pharma gation. trade of the petitioners.
medicines were developed for The Government of India, companies were in for a shock ◗ Violation of the procedure
combating cold, flu, fever etc. however, sought to ban this when this notification was Soon, various other compa- prescribed under the Act, for
The pharma companies devel- mushroom growth of FDCs. published. nies followed and flooded the exercise of powers under Sec-
oped combination drugs also Exercising its powers under court room with petitions tion 26A, in as much as the No-
known as Fixed Dose Combi- Section 26A of the Drugs & Needless to say, the said no- challenging the ban; and a to- tification was issued without
nation Drugs (FDC). FDCs are Cosmetics Act, 1940 (the Act), tification adversely affected al- tal of 455 writ petitions were the mandatory consultation
combinations of two or more the Central Government, most the entire pharma indus- filed before the Delhi High with the Drugs Technical Ad-
active pharma ingredients in through its Department of try of the country; and had the Court. To maintain decorum visory Board (DTAB) and the
fixed ratios, given in the form Health & Family Welfare; is- notification gone unchallenged in such a circumstance the Drugs Consultative Commit-
of a single dose. sued a notification dated 10 – it would have amounted to a High Court, in an unprece- tee (DCC), as constituted by
March 2016, whereby 344 loss of revenue of approxi- dented measure, directed that virtue of sections 5 and 7 of
For example, a patient suf- Fixed Dose Combination mately `3,000 Crores, annu- only 1 lawyer per matter be al- the Act, respectively.
fering from fever, cold, cough (FDC) Drugs were banned ally. lowed to enter the court room. ◗ The primary ground of chal-
etc. would ideally have to take 3 lenge in most of the petitions
medicines i.e. for fever, the pa- was that there was a violation
tient is usually administered of the principles of natural jus-
500 mg of paracetamol and for tice, more particularly the
cold and cough the patient is principle of audi alteram
usually administered 10 mg of partem – in as much as no
Phenylephrine Hydrochloride. Show-Cause Notice was issued
However, Phenylephrine Hy- to the petitioners, enabling
drochloride is known to cause them to empirically justify
drowsiness. In order to get rid their production/ sale of the
of the side-effect of drowsi- banned FDCs. It may be noted
ness, caffeine is added which is that a Show-Cause Notice was,
known to keep people awake. in fact, duly issued to some of
the petitioners; and the said
Thus, when the companies petitioners, nonetheless, went
added 500 mg of paracetamol
+ 10 mg of phenylephrine hy-
drochloride + 32 mg of anhy-

34 EXPRESS PHARMA

January 1-15, 2017

Express Pharma
(January 1-15, 2017)

MANAGEMENT

INSIGHT

Don’t shut down the pharmacy

of the developing world

Shailly Gupta, Deputy Head, MSFAccess Campaign (India) emphaises the need to ensure
availability of affordable medicines within public health programmes, which is the need of the hour

One of the fastest-grow- even handed balance between lic health stakeholders. An on- However, what is largely being
ing economies in the providing patent protection on line leaked draft text of this ignored is that corporations are
world, our country is innovative medicines and the trade deal reveals that Japan utilising such trade deals to dis-
known globally as the home- necessity to protect public and South Korea have pro- guise their attack on public
land of the famed Taj Mahal health needs. India’s public posed several provisions that welfare sectors such as health-
and for its strong cultural her- health safeguards have guaran- go far beyond the World Trade care and access to essential
itage. However, and more sig- teed fewer patents in India, Organisation (WTO) require- medicines.
nificantly, India has had a far- more generic competition and ments and seek to extend
reaching positive global impact thus, more affordable medi- patent monopolies of pharma This attempt to surrepti-
through its supply of vast quan- cines for people and govern- corporations. This includes tiously convert public health-
tities of low-cost, good-quality ments in developing countries. provision for extending patent care into a commercial enter-
generic medicines, which have In contrast, countries like the terms for an additional five prise will allow medicine to be
saved or prolonged the lives of US have patent laws that years beyond the present 20- treated as any other profitable
millions of people. blindly favour pharma compa- year limit. Another proposed commodity, subject to monop-
nies over generic competition, harmful provision is introduc- olies and elevated product pric-
Amongst a handful of devel- tion of data exclusivity to defer ing. Consequentially, India’s
oping countries with a huge Source: MSF Access Campaign (India) the registration or marketing revolutionary low-cost generic
production capacity to manu- approval of generic versions of industry that stems from its
facture quality-assured generic allowing multiple and extended patent protections and restrict medicines by several years public health-oriented patent
medicines, India did not grant monopolies on the same medi- generic competition. which will effectively provide a policies will be shut down to
patents on medicines till 2005 cine, which, in turn, lead to ex- backdoor monopoly status to make space for profit-focussed
and thus, its generic companies orbitant prices for lengthy pe- One such trade deal is the pharma corporations – even for multinational corporations. El-
produce some of the cheapest riods of time. Regional Comprehensive Eco- older medicines that do not de- evated levels of intellectual
life-saving drugs in the world. nomic Partnership (RCEP). Big serve a patent. property rules in RCEP can
Known as the ‘pharmacy of the Multinational pharma cor- Pharma is attempting to re- dismantle the public health sys-
developing world’, the country porations view robust, afford- strict access to low-cost, life- If accepted, both provisions tem of many developing coun-
played a major role in scaling able generic medicines pro- saving medicines and jeopar- will delay the entry of afford- tries and restrict governments’
up treatment to 17 million peo- duced and marketed by Indian dise public- health via the able versions of medicines in capacities to protect public
ple across the world by lower- suppliers as an enormous RCEP negotiations that were the market and eventually, in health in not only India but in
ing the price of antiretrovirals threat to their profits. Pres- initiated in 2012 between 10 the absence of generic compe- other developing and least-de-
(HIV medicines) from $10,000 sured by these corporations, ASEAN countries and six trad- tition, keep prices high for veloped nations of Asia and
per patient per year in 2001 to foreign governments have ing partners – India, China, longer periods of time. In India, Africa.
less than $300. As a medical utilised various platforms—in- Australia, New Zealand, Japan where people pay nearly 70 per
treatment provider, Doctors cluding diplomatic talks, bilat- and South Korea. cent of health expenses out of So far, India has stood firm
Without Borders/Médecins eral and regional trade deals— pocket and rarely have health against the inclusion of these
Sans Frontières (MSF) relies to coerce the Indian Like several other free trade insurance, high prices of life- harmful patent provisions.
on affordable, quality generic government to amend its agreements, the RCEP, too, is saving medicines will keep With the next round of RCEP
medicines to treat a number of patent policies to offer more being negotiated behind closed them out of reach of the most negotiations set to take place in
diseases. In fact, 97 per cent of doors with no inputs from pub- vulnerable sections of society. Japan in March, MSF, as a
the medicines used by MSF to With emerging public health treatment provider that relies
treat HIV are generics sourced challenges and the increasing on affordable medicines
from India. burden of tuberculosis, hepati- sourced from India, hopes that
tis, and cancer in our country, India, along with other ASEAN
When the country amended the need to ensure the avail- countries, does not agree to a
its patent law to comply with ability of affordable medicines final text unless all provisions
international trade rules in within the public health pro- that go beyond international
2005 and started granting gramme is certainly the need of trade rules are removed. In its
patents for pharmaceuticals, the hour. place, the trade deal negotiat-
Indian parliamentarians en- ing text should ensure the pro-
sured the inclusion of public In the current economic tection of existing public health
health safeguards by granting landscape, the RCEP trade deal safeguards and enable develop-
patent monopoly rights only to has been lauded as it will bring ing countries like India to effec-
genuine inventions. India’s in huge investments, infra- tively balance its patent system
patent law strives to strike an structure and jobs to India. with public health needs.

32 EXPRESS PHARMA

March 1-15, 2017

Express Pharma
(March 1-15, 2017)

MANAGEMENT Visit us at CPHI
Date: 28th November - 30th November, 2017
INSIGHT Exhibition Venue BEC: Bombay Exhibition Centre.

Strict or stringent national regulatory authority The life science business of Merck operates as
for procurement of anti-tuberculosis medicines ? MilliporeSigma in the U.S. and Canada.

John F Loeber,Chief Procurement Officer,UN Stabilisation Mission in Haiti (MINUSTAH) Merck Millipore, the vibrant M, Parteck and Emprove are
Port-au-Prince,Haiti,in this article examines the requirement of strict or stringent National registered trademarks of Merck KGaA, Darmstadt, Germany.
RegulatoryAuthority (NRA) environments for procurement of anti-tuberculosis (TB) medicines,with © 2016 Merck KGaA, Darmstadt, Germany. All rights reserved.
specific focus on theWorld Health Organisation,United Nations Office for project services,StopTB
Partnership/Global Drug Facility andThe Global Fund to FightAids,TB and Malaria

The Global Drug Facility TABLE 1 ANTI-TB MEDICINES SOURCING ACCORDING C-9) procedure, or Art. 58 of
(GDF) operates as the TO GDF AND GFATM QA POLICIES
procurement arm of the European Union Regulation
Stop TB Partnership (TBP) Anti-TB Medicines Sourcing
Secretariat, hosted at the (EC9 No. 726/2004) or US FDA
World Health Organisation tentative approval”19, i.e. in-
(WHO), Geneva, Switzerland,
from 2001 until 2014 and forth- terim approvals have been
with at the United Nations Of-
fice for Project Services (UN- given by this set of
OPS). The Stop TB
Partnership is a network of countries/intergovernmental
some 1,300 governments,
donors, industry, NGOs, acade- organisation. A next to identi-
mia and other partners, joined
in the common fight against tu- cal regulation is found in the
berculosis (TB)2. The TBP i.a.
provides access for countries to WHO PQ Stringent ERP GFATM’s Quality Assurance
quality assured, affordable Programme NRA Process Policy20.
anti-TB medicines via GDF. As
of 2014 GDF has delivered med- In the event that none of the
icines for 24 mn TB patients to
133 countries3 in 13 years of op- above requirements are met,
eration, financed by bilateral
and multilateral donors such as GDF’s Quality Assurance pol-
USAID, The Global Fund to
Fight Aids, TB and Malaria Assurance Policy7. The same Member, Observer or Associate of the icy then allows that “Products
(GFATM) and UNITAID. standard is applied by the International Council for Harmonisation (ICH)
GDF’s annual purchases of TB GFATM8 as well as other fi- shall be found acceptable to the
medicines amounted to about nancing institutions and pro-
$200 mn in 20134, and the curement entities such as UNI- GDF through a quality
GFATM disbursed approxi- TAID9 and UNDP10.
mately $500 mn for TB in risk/benefit assessment
20155. On further examination,
GDF and the GFATM define in adjusting their pharma leg- to one individual authority, process involving an Expert
Stringent NRA the term “stringent” as being a islation to EU laws before moreover now an ICH “Stand- Review Panel (ERP)”21. While
requirement member, observer or associate recognising the approval by the ing regulatory member”17, it
A condition for procurement of of the International Council for national health authorities”14. cannot be deduced that the this specific, exceptional
anti-TB medicines by the GDF Harmonisation (ICH)11. The nine new ICH observers are
or its facilitation of direct pro- ICH, founded in 1990, is an as- From 2015, a range of Regu- currently recognised as repre- process was managed by the
curement is that medicines are sociation which helps in bring- latory Authorities joined the senting stringent regulatory
approved under the WHO Pre- ing together the regulatory au- ICH as observers, namely Aus- environments. The conclusion GDF itself until 2009/2010, the
qualification Programme6 or li- thorities and pharmaceutical tralia, Chinese Taipei, Cuba, In- must also be drawn in view of
censed for marketing by strin- industry to discuss scientific dia, Kazakhstan, Mexico, Rus- issuance of tenders for first- ERP assessment was forthwith
gent National Regulatory and technical aspects of drug sia, Singapore and South and second-line anti-TB medi-
Authorities (NRAs). This is es- registration12. Africa 15. Both GDF’s and the cines in October and February handled by the GFATM, in co-
tablished in the GDF Quality GFATM’s Quality Assurance 2016 with reference to the un-
Current ICH regulatory Policies, which antedate 2015, changed GDF Quality Assur- operation with GDF. The
members or associates are limit recognition to “an ICH ance Policy18. Hence apparent
Brazil, Canada, the EU, Japan, Observer, being the European lack of sourcing from those GFATM respectively refers to
South Korea, Switzerland and Free Trade Association countries on the basis of ICH
the US13. In regard to ICH (EFTA) as represented by observer status, as well as the this process on its website and
members having newly ac- Swiss Medic, Health Canada absence of media releases to linked material22. Under this
ceded to the EU such as and World Health Organisation the contrary or other forms of
Cyprus, Lithuania, Malta, (WHO) (as may be updated clarification by the two organi- backup process, for which ap-
Poland and Latvia, the GDF from time to time)”16. Despite sations since 2015 on these sig-
Quality Assurance Policy prin- the closing adjustment clause, nificant developments at ICH. provals are limited to a 12-
ciples additionally provide that given the significant develop- month period23, product sub-
“GDF will consult with relevant ment in ICH Observers and the As a further qualifying op-
WHO experts on the progress generally restrictive nature of tion, according to the GDF Pol- missions must be pending with
both organisations’ policies, in- icy it will be sufficient that
cluding the specific formula- products are “approved or sub- either the WHO Prequalifica-
tion of this provision, referring ject to a positive opinion under
mainly to associations and only the Canada S.C. 2004, c. 23 (Bill tion Programme or a stringent

NRA. Also, the product must

have been produced at a manu-

facturing site that was in-

spected and found acceptable

by either the WHO Prequalifi-

cation Programme, a stringent

NRA or a regulatory authority

participating in the Pharma-

ceutical Inspection Coopera-
tion Scheme (PIC/S)24.

PIC/S was established in

1995 as an extension to the

26 EXPRESS PHARMA

April 1-15, 2017

Express Pharma
(April 1-15, 2017)

65EXPRESS PHARMA

December 1-15, 2017

CPhI & P-MEC INDIA 2017 SPECIAL

EXPRESS PHARMA (JULY 1-15, 2017)

cover ) (T H E M A I N F O C U S FORMULATION
DEVELOPMENT
28 EXPRESS PHARMA FDD Conclave 2017
Experts predict an increase
July 1-15, 2017 A congregation of in formulation R&D spend,
as players try to
R&D leaders differentiate themselves by
investing heavily in R&D efforts
In an endeavour to encourage research and innovation in the and the development of new
rapidly evolving field of formulation development and drug drugs. Companies are looking at
tapping new patient segments,
delivery, Express Pharma and The Indian Express Group creating branding strategies
hosted the inaugural edition of FDD Conclave at Novotel around innovative drug delivery
approaches and meeting
Airport, Hyderabad. Held on 16-17 June, 2017, it saw evolving regulations.They have
attendance from over 100 leading scientists and R&D heads realised the need for executable
strategies and leading-edge
representing prominent pharma organisation and top technologies.
biotech companies
Therefore, in an endeavour to
To subscribe: [email protected] 29EXPRESS PHARMA encourage research and
innovation in the rapidly evolving
July 1-15, 2017 field of formulation development
and drug delivery, Express
Pharma hosted the inaugural
edition of FDD Conclave in
Hyderabad. It saw attendance
from over 100 leading scientists
and R&D heads of pharma
companies.This issue featured
exclusive coverage of the event.

EXPRESS PHARMA (JULY 16-31, 2017)

cover ) (T H E M A I N F O C U S PROGRESS OF PVPI

In 2010, Dr Surinder Singh, NEEDFOR In observance of
Former DCG(I), launched CONSTANT Pharmacovigilance Day, the
the Pharmacovigilance VIGILANCE story examined the progress of
Programme of India (PvPI) the PvPI programme so far.
with the objective of studying An analysis on the progress of India’s It empahsised on the growing
the adverse effects of drugs, to pharmacovigilance programme role of PvPI in India and pointed
strengthen the number of drug in- out that though PV is well
spectors and to maintain quality By Usha Sharma practiced in developed
parameters in countries from countries, multinational pharma
where India imported drugs. In companies operating in India
observance of Pharmacovigilance have realised that they too need
Day, let’s examine the progress of better understanding in this
the PvPI programme so far. arena.

Improved ADR reporting It also highlighted that both
Commenting on the progress the industry as well as regulatory
bodies are working towards
so far, Dr Renuka Munshi, Coordi- instrumenting a system which
nator, AMC, TN Medical College will work effectively. It reviewed
& BYL Nair Hospital says, “In the the steps taken to strengthen
last seven years, the programme pharmacovigilance in the
has been progressing in leaps and country as well.
bounds. Recently, PvPI has also
taken the responsibility of report- Thus, Express Pharma acts
ing adverse events due to medical as a watchdog of the industry
devices and has initiated the with such stories.
process of reporting adverse
events due to drugs used for vec- To subscribe: [email protected] 21EXPRESS PHARMA
tor-borne diseases like Kala-azar.
We have more than 250 ADR mon- July 16-31, 2017
itoring centres, which have been
involved in the activity. Pro-
grammes like Revised National
Tuberculosis Control Program
(RNTCP) and ART and their re-
spective centres have been roped
in to report ADRs.”

Enhanced Data Collection
PvPI has contributed numerous
data to the WHO-Uppsala Moni-
toring Centre (UMC) and Central
Drugs Standard Control Organi-
zation (CDSCO). Quality checks of
the submitted ADRs is done by
National Coordinating Centre
(NCC) and queries sent to respec-
tive ADR Monitoring Centre
(AMC). There has been a positive
impact on the quality of Indian

20 EXPRESS PHARMA

July 16-31, 2017

66 EXPRESS PHARMA

December 1-15, 2017

CPhI & P-MEC INDIA 2017 SPECIAL

Intellectual property and patents are very crucial topics in the pharma industry.The first two articles on
this page address this issue, with two renowned IP experts,Ashish Prasad and Dr Gopakumar Nair,
sharing their views. Both deal with encouraging innovation and creation of IP.The first deals with evolving
an effective IPR policy while the second one gives insights on how effective IP systems can create a
conducive environment to attract investments.The third article on this page deals with how the pharma
industry can drive innovation beyond core areas to minimise environmental impact.Thus, we do not only
cover issues which impact the pharma industry but also looks at how the sector impacts our world.

cover )

Abalancing act Patent
system only
Ashish Prasad, Partner, Economic Laws Practice Delhi, analyses IPR in way to...
India, elaborates on the need to evolve an effective IPR policy to encourage
innovation without compromising public interest Continued from Page 19

I nnovation is integral to the Ashish Prasad, Partner, patent laws of the developing Roche. With another battle for open and closed IP policies by
lives of individuals as it has Economic Laws Practice Delhi economies in the form of bevacizumab already in courts, being able to sustain revenues
over the years turned com- TRIPS-Plus provisions to curb it appears that we are about to within the total consumption
plications into progress, omists and policymakers re- the manufacture of generic see the same pattern that was bundle of platforms and com-
thereby improving standards. garding the development of the drugs. One of the most promi- seen during the rise of the plementary goods and serv-
It has found a cure to diseases Intellectual Property Rights nent examples is pushing for generic manufacturers. This ices. In his view, the markets
to which no cure was available, (IPRs) regime in order to bal- protection under Article 39.3 decision has a far reaching im- reward generosity where ‘to
made tasks easier, found sim- ance public interest and the re- on data exclusivity which disal- pact on the pharma industry of win a platform race, the clever
pler solutions to problems, im- wards to be accorded to the in- lows clinical trial data that is India as the generic drug/bio- host must leave a substantial
proved our knowledge, made novator. The pharma industry generated by the innovator similar manufacturers would portion of total revenues to
our lives healthier, safer and illustrates this conflict the best; company to be used by another be encouraged to innovate and third parties that provide
more comfortable by improv- need for the state to ensure company for obtaining ap- develop substitutable products complementary goods. Con-
ing availability of crops, drugs, that medicines are available provals to market the generic in the interest of public. On versely, the market punishes
medical procedures, appli- and affordable by all and the in- versions of the drug for which March 8, 2017 in the case of the selfish host that keeps too
ances etc. To put it generally, terest of the pharma industry the trial had been conducted. Bayer v. Union of India the large a portion of market rev-
innovation is developing a in engaging in continuous re- Acceding to this provision can Delhi High Court held that ex- enues for itself.’ Clearly, cali-
novel idea or concept to cause search and development for considerably delay the market port of drugs for the purposes brating firm’s IP policies de-
an improvement over existing the invention of new drugs and approval as well as availability of clinical trial was covered un- pending on the nature of the
knowledge or product to re- medicines. of generic versions of medi- der the exemption as provided market to self-maximise is ac-
solve problems faced by hu- cines for many years since this under Section 107 A of the tually an efficient market-
mans. In India, this conflict of in- would require generic manu- Patents Act, 1970. The Indian based outcome. How far these
terest is manifested in the tus- facturers to conduct clinical judiciary has by far been able conclusions support the pitch
The Agreement on Trade sle between innovated drug trials afresh. This would in- to set a well-reasoned stan- for substantial ‘reforms’ in the
Related Aspects of Intellectual manufacturers and manufac- crease the cost of production of dard, maintain equilibrium of patent system in an attempt
Property Rights (TRIPS) turers of generic/follow on generic medicines leading to a obligations under the TRIPS, to ‘fix it’ by analogising it with
which came into force on Jan- products. Indian law and policy higher price burden on the con- Patents Act and the social in- some imaginative ‘regulatory’
uary 1, 1995 sets the minimum is designed to encourage sumers. terest of the country. mechanism is anybody’s
standards for Intellectual generic drug manufacturers to guess!
Property Rights protection for develop and market follow-on As the tussle continues, It is now well known that
all members of the World drugs so that fruits of innova- multinational innovator com- the innovator pharma compa- Of course, this is not to sug-
Trade Organisation (WTO). It tion are available to the masses panies have often knocked the nies, in the interest of protect- gest that the patent system is
provides a framework for at lower costs. doors of the judiciary seeking ing their legitimate IP rights, perfect. In fact, it has miser-
granting legal protection to protection of their IPRs. The adopt various strategies in- ably failed to facilitate R&D in
new creations, innovations and It is but natural therefore, judiciary has in turn taken a cluding delaying of the intro- neglected diseases that dispro-
technological advancements, that developed countries are nuanced stand and walked the duction of bio-similar/generic portionately affect the devel-
thus incentivising innovators calling for stricter implemen- fine line between the interest of versions though litigation tac- oping world. We do need gov-
to invest in research and devel- tation of tougher and more re- the innovator and public inter- tics. They have now realised ernment interventions on a
opment of new products and strictive conditions in the est. Recently, the Delhi High the opportunity vesting with massive scale to support R&D
processes. Court, while dealing with the the generic market and have in such cases. Perhaps we
first case on bio-similar ap- now sought to enter the gener- shouldn’t stop trying non-mar-
The National IPR policy of provals in India, between ics’ market. ket based alternatives to the
India by promoting amongst Roche and The Drug Con- patent system like prizes, sub-
others, innovation, licensing, troller General of India and President Trump’s deci- sidies etc... Again, whether the
technology transfers, patent well known Indian drug manu- sions to withdraw the TPP may state-supported R&D will
pooling, cross sector partner- facturers (Mylan & Biocon) in have temporarily jolted the ex- replicate the success of the
ships, reducing API imports by its decision disallowed the isting negotiations undertaken market in innovation without
incentivising manufacture of right to question the approval during President Obama’s recourse to patents and mar-
API in India etc. follows the granted by the DCGI in an ap- regime. However, it may not be ket exchange is a difficult
TRIPS framework and at- peal before division bench. The long before when India will be question. However, it is impor-
tempts to provide for an en- interim decision by the single asked the same question again tant to note that these alterna-
abling structure for new inno- judge had earlier denied the In- i.e. to give its consent to incor- tive measures can only be in
vations. dian manufacturers to market porate the TRIPS-plus provi- addition to the patent system
their product as a bio-similar sions which would then affect and not by undermining it!
At the same time, over the to the drug innovated by the Indian pharma industry, es-
years there have been consid- pecially the generic segment. (Views are personal)
erable debates amongst econ-

20 EXPRESS PHARMA

April 16-30, 2017

Express Pharma
(April 16-30, 2017)

(T H E M A I N F O C U S

Techniques to enhance IP valuations

Dr Gopakumar G www.pharmalab.com
Nair, CEO,
Gopakumar Nair
Associates, gives
an insight on why
IP systems must
support
innovations by
creating a
conducive
environment to
attract
investments,
and must reward
inventions with IP
protection in
return for
disclosures

‘J allikattu’ controversy Pharmalab’s Pure Steam Generator are designed to deliver
can wait, IPR appears high quality, sterile steam, free of condensate, Pyrogens or
to be the new arena for Endotoxins.
the “bulls and bears.” These units are suitable to generate highest quality of steam according to the
Intellectual property right latest international Pharacopeia and rules (FDA, cGMP, etc), and is also
(IPR) has come a long way validated to meet the most exacting standards of EN285 & HTM 2010 for any
since Paris Convention and pharmaceutical applications such as:
other early treaties and conven- • Sterilization of storage tanks & solution tanks
tions. The fundamental ratio, • Sterilization of distribution loops
unanimously accepted, has al- • Sterilization of other pharmaceutical equipment or filter assemblies
ways been a fine balance of • Heating of autoclaves / sterilizers
rights (to inventors) and obliga- The unit is equipped with degasifying column for effective elimination of
tions (to users and the state). In non-condensable gases to meet the exacting standards of USP.
recent years, post 1980s in par- Fully automotic with programmable control system.
ticular, there has been intensive
efforts and initiatives to exploit Pharmalab India Pvt. Ltd.: Kasturi, 3rd Floor, Sanghvi Estate, Govandi Station Road, Govandi (E), Mumbai - 400 088.
IPR to the hilt in favour of in- Tel.: 6622 9900 • Fax: 6622 9800 • E-mail: [email protected] • CIN No. U29297MH2006PTC163141
ventors (or assignees) often to
the detriment of users.

Uruguay Round was con-
ceived by the developed nations
as an extension of this bull run,
to use IPR as a trade barrier to
rein in the trade growth poten-
tial of the third world countries.
The transformation of General
Agreement on Tariffs and

21EXPRESS PHARMA

April 16-30, 2017

Express Pharma
(April 16-30, 2017)

cover )

INSIGHT VIVEK P ADHIA,
Strategy Head – Climate,
Thinking beyond WRI India
medicines and products

Vivek P Adhia, Strategy Head – Climate, WRI India, Tanvi Bongale, Sr TANVI BONGALE,
Project Associate, Climate, WRI India, Shruti Karkhedkar, Air Quality Sr Project Associate, Climate,
Intern, WRI India, elaborate on how the pharma industry can drive WRI India
innovation beyond core areas to minimise environmental impact especially
on air quality, and in turn support improved human health

SHRUTI KARKHEDKAR,
Air Quality Intern,
WRI India

A ir pollution is increas- background, local air pollu- direct effect on human health. safe concentration levels of last few years, it is found that
ingly being recognised tants are those substances Typically, four major pollutants these pollutants have been es- more than 85 per cent of the
as a serious human when emitted in the atmos- are said to have maximum im- tablished based on various pub- global population lives in areas
health issue for India, and with phere – that continue to exist pact viz. sulphur dioxide (SOx), lic health studies, meant to pro- exceeding these safe guidelines
exponential growth in industri- over and above the natural nitrogen oxides (NOx) and par- vide a means to benchmark – which results in acute public
alisation, cities and infrastruc- physical diffusion, chemical ticulate matter (PM10 and and ascertain environmental health and livelihood impacts.
ture – this warrants immediate elimination and biological pu- PM2.5). Health related stan- impact on the local air quality For emerging economies, low
cohesive national action. As a rification to have a direct or in- dards providing guidelines on front. Consistently across the and middle income countries
and other groups that include
34 EXPRESS PHARMA India and China – about 99 per
cent of the population lives in
vulnerable areas. Further, as
per the outdoor air pollution in
cities database of World Health
Organization (WHO), 10 of the
20 most polluted cities (in
terms of PM2.5) are in India,
with most regions across the
Indo-Gangetic plains topping
the list as can be seen from the
adjoining chart.

Multiple causes, contribut-
ing to deteriorating air quality
including mobile sources
(transport), area sources
(waste burning, cook stoves,
suspended dust of construction
and industrial activity) and sta-
tionary sources such as power
plants, and diesel generators
have resulted in severe and
acute health impacts. Air pollu-
tion related deaths have in a
short time jumped into the top-
five causes within the country
(as seen in the chart titled, Acting
now is inevitable). This also re-
flects the broader situation
globally, with both indoor and

June 1-15, 2017

Express Pharma
(June 1-15, 2017)

67EXPRESS PHARMA

December 1-15, 2017

CPhI & P-MEC INDIA 2017 SPECIAL

EXPRESS PHARMA (AUGUST 1-15, 2017)

cover ) (T H E M A I N F O C U S CELEBRATING 70 YEARS
OF INDEPENDENCE
EVOLUTION OFTHE INDIAN PHARMA INDUSTRY THE GROWTH SAGA Rapidly growing healthcare sector
Indian healthcare sector, one of the fastest growing sectors, is Express Pharma, in its
1947 1950s 1960s 1970s 1980s 1990s 2000s 2010s Leading pharma producer expected to advance at a CAGR of 17% to reach $ 250 billion over Independence Special
Indian pharmaceutical sector accounts for about 2008–20 issues, chronicled the role of the
✦ Dominated by western ✦ Foreign companies held ✦ Import-dependent until ✦ Indian Patents Act 1970 ✦ Indian pharma ✦ Production and ✦ The pharma sector ✦ Indian pharma 2.4% of the global pharma industry in value terms pharma sector, which evolved
MNCs. Controlled 80 - the patent for 99% of all government policies and Drug Price Control companies developed R&D formulations of bulk drugs started attracting high companies take the M&A and 10% in volume terms Growing generics market from being an insignificant non-
90% of market, mainly pharma products under stressed self-reliance Order of 1970 gave a base and moved up the grew substantially. FDI inflows. route to increase product The generics market stood at $26.1 billion in 2016 from $21 billion in entity during the time
through importation. patent in India. through local production. big fillip to Indian value chain. ✦The Trade Related ✦ India became a major portfolios and market One of the highest exports 2015. India’sgenerics market has immense potential for growth we gained our independence
✦ Domestic Indian drug ✦ Five state-owned manufacturers. ✦The indigenous sector Intellectual Property Rights manufacturer of branded, footprint. India accounts for 20% of global exports in generics. In to the present day power house
prices were among the pharma companies were ✦ A generation of gained considerable (TRIPs) agreement brought generic and branded ✦ 100 % FDI in medical FY16, India exported pharmaceutical products worth Ranked 5th in terms of attracting FDI that produces and supplies high
highest in the world. set up to grow the scientist-entrepreneurs portion of the market. India's patent regime in generic medicines with a devices and New Drug $16.89 billion, with the number expected to reach Pharma sector in India attracted 5 % of the total FDIs into India from quality generic drugs to
domestic market took this opportunity to ✦ In late 1980s, Indian harmony with the WTO strong export pipeline. Pricing Control Order $40 billion by 2020 April 2000 to September 2016 markets across the world, in
set up companies which pharma firms started regulations. ✦Enactment of the Patent Cumulative FDI inflows worth $14.49 billion were made during April driving the progress of the
have emerged as eyeing overseas markets. ✦ Free imports, (Amendment) Act, 2005 Among fastest growing industries 2000 to September 2016 nation.
pharma giants foreign investment changed the protection The country’s pharmaceutical industry is expected to
and technological superiority regime in India. expand at a CAGR of 12.89 % over 2015–20 to reach Source: BEF Report 2017 www.ibef.org It showcased the struggle
became the buzzwords $55 billion and triumphs which led
to India’s rise as the‘Pharmacy
TURNOVER OFTHE INDIAN LAWS OF Drugs and Cosmetics Act, 1940 and of the world.’It acknowledged
PHARMA INDUSTRY THE LAND Drugs and Cosmetics Rules, 1945 people, companies and
Regulates import, manufacture, distribution and sales of drugs in institutions that have been part
1990 of India’s journey throughout its
$1 BILLION India. Ensures drugs and cosmetics sold in India are safe for existence as an independent
consumption and conform to standards set by Government nation through profiles, photo
features and guest articles.
DID YOU KNOW? The pharma industry in 2015 Indian Patent Act, Drugs and Magic Remedies
India meets around 70% of the $30 BILLION 1970 (Objectionable Advertisements) Act in 1954
country's demand for bulk drugs, drug Ensures adequate control over the advertising of drugs in India. Prohibits
intermediates, pharma formulations, Encourages the advertisements of drugs that claim to have magical properties.
chemicals, tablets, capsules, orals indigenous pharma
industry in India and Narcotic Drugs and
and injectables Psychotropic Substances Act, 1985
to ensure that the Provides stringent provisions to control and
Established in 1954, India had entered The first pharma company in citizens could afford Drug (Prices regulate operations of narcotics drug or
Hindustan Antibiotics Ltd (HAL) independence India, Bengal Chemicals was the drugs. Only process Control) Order, 2013 psychotropic substance. Prevents and combats abuse of
was the first public sector pharma patents were allowed illicit traffic in narcotic drugs.
company in India. It was set up with the patent system founded by Empowers the
of the British colonial masters, Acharya Prafulla Chandra Ray, until amendment National Pharmaceutical Pharmacy Act, 1948
with help from WHO, UNICEF the Father of Indian Chemistry, in 2005 to implement Regulates the profession and practice of pharmacy
enacted in 1911 product patent regime Pricing Authority (NPPA) to within the country. Provides provisions to constitute a
in 1901 regulate the prices of Central Pharmacy Council of India and State Pharmacy
in India essential drugs Councils

1952 1970
`32 `445
CRORES CRORES

Roche was the 1947
first company `10
in India to receive a patent CRORES
under the product patent regime.
It was granted for Pegasys
(peginterferon alfa-2a),
used in the treatment of
hepatitis C, in
March 2006

Sources:
http://www.jpsbr.org/
https://www.ibef.org
https://www.in.kpmg.com
http://pharmaceuticals.gov.in/document/annual-report-2016-17

24 EXPRESS PHARMA To subscribe: [email protected] 25EXPRESS PHARMA

August 1-15, 2017 August 1-15, 2017

EXPRESS PHARMA (AUG 16-31, 2017)

PHARMA TECHNOLOGY REVIEW MAKING SENSE OF
SERIALISATION
Making sense of serialisation It is always With more than 40 coun- follow. Even when they do de- ICRIER-RXGPS
advisable to stick tries already implementing cide on a global standard, RECOMMENDATIONS TO As serialisation mandates are
With more than 40 countries already implementing or set to enforce their serialisation mandates to the existing plan or set to enforce their seriali- (GS1 seems to be the most CDSCO ON SERIALISATION getting adopted in various
by 2018, are pharma exporters from India geared up to face this challenge? and implement it sation mandates, most im- common choice), there are countries, this article revealed
Viveka Roychowdhury portant export destinations differences in the interpreta- ◗ Recommendation 1: CDSCO and DGFT should delegate an how important it is to increase
as soon as will require some level of se- tions, which has turning out independent body to undertake (i) an economic impact assessment tracebility in pharma and
Imagine a world where all India has no (IBEF), India is the largest started in January 2011, when postponed by a year. The Eu- possible. This will rialisation/ traceability in to be a nightmare for manu- for domestic serialisation and traceability requirements under enhance the quality and safety of
medicines, from strips of choice but to supplier of generic medicines the Directorate General of ropean Union (EU), another place by 2018. How prepared facturers. “Since there is no consideration, and (ii) a regulatory impact assessment of existing drugs. It revealed that the
tablets to syrups to vac- be part of the globally, accounting for 20 per Foreign Trade (DGFT), important destination for allow the are pharma exporters from single global standard, every requirements for serialisation and traceability of exports. process of marking products
cines, in every chemist shop in global cent of the global export vol- launched the country's track pharma exports, has the Falsi- organisation to India to face this challenge? country has adopted their ◗ Recommendation 2: With regard to product exported to a country with unique identifiers, is already
the world, from Africa to mandate for ume. Pharma exports from In- and trace system for all fied Medicines Directive conduct some Will they lose out on their own regulations, which has that has its own serialisation requirements, the“tertiary package” a reality in most countries for a
America to India, has a unique serialisation, dia stood at $16.4 billion in pharma products exported (FMD), under which new trials and testing to competitive advantage to ex- made it difficult for manufac- should be considered the highest level of shipping container for variety of products, from FMCG
serial number with informa- followed by 2016-17, and is expected to from India. The US, the track and trace regulations avoid market porters from other coun- turers,” says Shivaji export. For example, the pallet will typically be the tertiary package to toys to medicines.
tion on the origin, shelf life and track and trace reach $20 billion by 2020, as biggest pharma market of the come into force from February complaint. Every tries? Chakraborty, Asst. GM, for exports to the United States or the European Union.The
batch number. If all these systems per estimates from the Phar- world, has its serialisation 2019. Countries like Belgium, country has their Packaging Development, homogenous case would be the tertiary package for markets where It also pointed out that
numbers can be stored, track- maceutical Export Promotion mandate, known as the Drug Greece and Italy have report- own regulations As usual, there are the Fresenius Kabi Oncology. He the case is the highest level of container exported.All levels of though serialisation has been
ing a substandard or counter- Council (Pharmexcil). India Supply Chain Security Act edly already made serialisa- which creates early birds and the laggards. also points out that the In- packaging below the tertiary package (as defined here) should then successfully implemented in
feit medicine to the exact loca- thus has no choice but to be (DSCSA), which was signed tion mandatory. Turkey is of- difficulty for the Shaunak Dave, VP, Asia and dian guideline is for products be exempt from unique identifier and labelling requirements under many other sectors, pharma
tion where it was produced part of the global mandate for into law on November 27, 2013. ten cited as an early bird manufacturers CEO and MD, India, Optel which are exported from In- the India serialisation and traceability regulations. serialisation has turned out to be
becomes much easier. serialisation, followed by track Though it is set to be imple- example of having one of the Shivaji Chakraborty Group, points out that out- dia, not for products which ◗ Recommendation 3: DGFT should grant exemptions on a more complicated. It concluded
and trace systems. mented by November 27 this longest standing track and side the US, the maximum are being sold in the domes- country-by-country basis, not a manufacturer-by-manufacturer or that all stakeholders will need to
Actually, serialisation, or year, enforcement of the prod- trace systems in place for all Asst GM, Packaging number of US FDA plants tic market. By this logic, product-by-product basis. work with, rather against, each
the process of marking prod- India's serialisation initia- uct identifier requirement was pharma products. Development, Fresenius are located in India and these manufacturers would need to ◗ Recommendation 4: Regulators should not define the GTIN other, to set common standards
ucts with unique identifiers, is tive for pharma products plants do not have any choice have different packaging indicator digit; it should be set by the manufacturer, as provided in and achieve the common goal of
already a reality in most coun- Kabi Oncology but to comply with US lines for export and domestic the GS1 GTIN General Specifications. increased patient safety through
tries for a variety of products, DSCSA regulations. He re- markets, adding to the capi- ◗ Recommendation 5: NIC should revise the DAVA database and more secure pharma supply
from FMCG to toys to medi- I personally believe veals that the Optel Group tal expenditure by way of portal to: chains.
cines. The next logical level of this is a little bit far started serialisation projects labour costs, separate stor- ❏ Segregate the portal interface for exports and domestic product.
security is to use these serial in India around 2011-12 and age areas, etc. ❏ Eliminate the primary package serial number field, or at a
numbers, which in most cases fetched but most big and medium size minimum, permit the field to be left blank.
is a unique number of al- technically pharma exporters are today Explaining further, Dave ❏ Eliminate the pricing information field, or at a minimum, permit
phanumeric code, most com- speaking, yes, the equipped with serialisation at says,“India's serialisation the field to be left blank.
monly encoded into a barcode, risk exists the secondary and tertiary guidelines are based on the ❏ Eliminate the requirement to upload product photos.
to track each pharma product packaging levels to meet In- GS1 standard which is ❏ Permit a single manufacturer to repeat serial numbers for
as it moves through the supply Jean-Pierre Allard dia's export regulations. adopted by a majority of different GTINs.
chain, from the time it leaves CTO, Optel Group “Many companies exporting countries who have an- ❏ Provide the option and interface for automatic upload of data via
the manufacturer's gate, to the to the US are ready with se- nounced this compliance. A web service.
stockist/distributor and finally rialisation but aggregation is few countries like China ❏ Prevent a company’s data from being visible to other companies.
to the chemist shelf. still a work in progress as it is mandated different stan- ◗ Recommendation 6: NIC should maintain development and
not a mandatory require- dards. Considering the im- simulation environments to support revisions to the DAVA portal.
A further level of security ment as of now. However, it is plementation issues, the reg- ◗ Recommendation 7: NIC should establish a clear, predictable
is to be able to trace back the the requirement from their ulations are under review in process for communicating revisions to the DAVA portal.
journey of each pharma prod- master distributors and busi- China and industry experts ◗ Recommendation 8: In the initial phase of requirements for
uct. Serialisation, combined ness partners.” believe that it will also be domestic product, CDSCO should require serialisation of the
with track and trace mecha- aligned with GS1 global stan- saleable unit.
nisms, are being seen as one Multiple standards, mul- dard.” ◗ Recommendation 9: CDSCO should not require manufacturers to
important solution to ensure tiple complications … capture, maintain, or report any information related to the
that substandard or counter- Serialisation has been suc- Differences in interpreta- movement of products by downstream trading partners.
feit medicines are discovered cessfully implemented in tion snowball into implemen- ◗ Recommendation 10: CDSCO should adopt a four-year, phased
before they do too much harm many other sectors, but tation challenges across the implementation timeframe for domestic requirements.
so that they can be recalled pharma serialisation has supply chain. For example, ◗ Recommendation 11: CDSCO and DGFT should consider
from global markets. turned out to be more com- Dave points out that while alternative approaches that limit data volumes.
plicated. Comparing the the Indian regulatory author- ◗ Recommendation 12: There should be a process for accrediting,
The case for serialisation mandates of various coun- ity's standards are based certifying, or otherwise auditing serialisation vendors.
The pharma sector thrives on tries, Pradeep Dhargalkar, purely on the definition of
exports and more so the com- Head of Packaging Develop- packaging (primary, second- 53EXPRESS PHARMA
panies from India, resulting in ment, Unichem Laboratories ary and tertiary) and there-
the country being often re- says, “The four basic data to fore considers primary pack- August 16-31, 2017
ferred to as the 'pharmacy of be serialised remains the aging as the first level of
the world'. According to India same across mandates: i.e. serialisation (although this is
Brand Equity Foundation batch number, expiry, GTIN, on hold), this view is not
and serial number. In the EU, aligned with global mandates
apart from serialisation, the from various countries. As
pack also needs to be tamper per US DSCSA, EU FMD
evident.” regulation, serialisation be-
gins with the unit saleable
But regulators of coun- pack, says Dave. He reckons
tries have not been able to that this is one of the biggest
agree on which standard to challenges as far as technical

52 EXPRESS PHARMA To subscribe: [email protected]

August 16-31, 2017

68 EXPRESS PHARMA

December 1-15, 2017

CPhI & P-MEC INDIA 2017 SPECIAL

This page features a very diverse mix of articles. The first one is a very strongly worded article from
Bharathi Ghanashyam of Journalists against TB, who talks about the story of MDR – TB control in India,
which seems to be stuck at the foreword and asks when does it move forward.The other article in this page
is from ACG’s CEO,Ajit Singh who traced the progress of the pharma industry over the past seven decades.
The third one is a very interesting piece on blending traditional medicine and modern science to develop a
holistic approach for cardiovascular healthcare.Thus, the readers of Express Pharma are spoilt for choice
in terms of information and content.

MANAGEMENT

INSIGHT

Let’s move this story forward

Bharathi Ghanashyam, Founder &Editor, Journalists against TB, talks about the story of (multi-
drug-resistant tuberculosis) MDR – TB control in India, which seems to be stuck at the foreword
and asks when does it move forward

For the first time in over nearly half of whom were in – TB and XDR – TB patients. Division of the Government of
125 years we have new China, India, and the Russian India on 25 May 2017 cau-
diagnostics, we have Federation. Worldwide, only 52 The drug was to be introduced tiously mentions, “For patients
two new drugs — bedaquiline, per cent of MDR-TB patients being treated outside the gov-
manufactured by Janssen and 28 per cent of XDR-TB are at six tertiary care centres ernment system, the manufac-
Pharmaceutica NV, and de- currently successfully treated. turers are providing this drug
laminid, manufactured by Ot- More alarming was the fact across India, which had ad- under Compassionate Use Pro-
suka Pharmaceuticals, after a that about 9.5 per cent of gramme free of cost to the doc-
wait of 50 years (this article MDR-TB cases had extremely vanced facilities for laboratory tors, provided they follow the
will talk only about be- drug-resistant TB (XDR-TB). recommended guidelines for
daquiline). We finally have testing and intensive care for starting the drug and its close
strong tools with which to fight As per the TB India 2017 re- monitoring.”
a disease that has been defeat- port of the Central TB Divi- patients. It was to also be in-
ing us down the centuries. And sion, India is home to the high- A lot of time has gone by
it seems like we are frittering est burden of MDR - TB. An troduced in 104 districts Implementation of the plans
away the opportunities, stuck estimated 1.3 lakh MDR - TB outlined by the Central TB Di-
as we are in red-tape and patients emerge annually in In- across five states. There is no vision for the use of BDQ has
seemingly needless delays in dia. Despite the grim situation, been something of a non-
effectively using these tools. instead of waging a full-scale data available on how many pa- starter. There has been no res-
war, we are still making our olution to concerns on whether
MDR – TB is a lethal form first weak battle cries. Let’s tients received BDQ during the the drug stands the danger of
of TB. As defined by World look at the history of what has being misused; whether it
Health Organisation (WHO), it been done. year. A year had passed with would end up being available
does not respond to at least over the counter without pre-
isoniazid and rifampicin, the The history of inaction little or no progress. scriptions and most of all
two most powerful anti-TB January 2015: The Govern- whether patients would be-
drugs. It currently requires the ment of India approved the use March 2017: The Government come resistant to the only re-
patient to be on treatment for of bedaquiline (BDQ) for about ally powerful weapon available
24 months or more, with six 500 patients under the na- However, no plans were an- of India announced that it for TB.
other drugs, including in- tional TB control programme. nounced to make the drug
jectibles for an intensive phase available to the private sector, would expand access to BDQ These fears might be un-
of six months and a continua- when in India, traditionally, founded. Prof Furin says,
tion phase with four drugs for more than half of those af- and make it available in 140 “While it is certainly true that
18 months or more. These flicted with TB, including MDR many antibiotics can be pur-
drugs are toxic and induce se- – TB seek treatment from the government-run centres by chased without prescriptions, it
vere side-effects. private sector. No data is avail- is highly unlikely that newer
able for how many patients ac- November. The Annual Status agents like BDQ and delamanid
The numbers are growing tually received BDQ that year. would be purchased on the open
Dr Jennifer Furin, an infec- March 2016: On the eve of Report of RNTCP reported market. They have no indica-
tious diseases specialist in World Tuberculosis Day, tions for use other than in the
Harvard Medical School has Health Minister JP Nadda that till December 2016, more treatment of serious mycobac-
observed in one of her papers launched BDQ as part of the terial disease, such as TB. So
that “…unless the management national programme for MDR than 207 drug resistant TB pa- the risk of them being sought af-
of MDR TB changes radically, ter for broad use is very low.”
it will be one of the main driv- tients had been initiated on
ers of antimicrobial resistance, That patients in need of the
which could kill more persons BDQ containing treatment new drug are running out of
than cancer by 2050…” patience is evident from the
(BDQ is given in combination case that was recently filed by
According to WHO, about the father of an 18-year old pa-
480 000 people worldwide de- with other drugs). tient of XDR –TB in the Delhi
veloped MDR-TB in 2015; High Court. He demanded that
Dr Sunil D Kharpade,

Deputy Director General,

Head, Central TB

Division,Project Director

RNTCP, responding to ques-

tions by e-mail responded,

“The yearly estimated number

of BDQ eligible patients in the

public sector as per existing

criteria is around 7000 –

8000.” He also revealed that

443 patients have been en-

rolled into the programme

across the sites.

Juxtaposed against the

number of people requiring the

drug, what has been achieved

does not even do justice to a pi-

lot-programme. These num-

bers also do not take into ac-

count patients in the private

sector who are eligible for the

drug. A press note uploaded on

the website of the Central TB

22 EXPRESS PHARMA

June 16-30, 2017

Express Pharma
(June 16-30, 2017)

cover )

Agrowth saga

Ajit Singh, Chairman, ACG Worldwide, speaks on the journey traversed by the Indian pharma
industry and predicts a bright future for it in the times to come

The amazing growth, ACG's factory at Shirwal, near Pune - One of India's largest factory making pharma machinery parts companies are generally headed
sophistication and with persons from Finance or
international reach tion to the industry when it was world’s cheapest prices and it of India. It’s a high-tech, high Marketing or similar back-
of the Indian pharma most needed. And left them to still makes a profit. This is value-added industry not grounds.
industry in the last few decades compete with the rest of the itself an indication of high tech- relying on cheap labour, and
has few parallels. It is now pro- world at the appropriate time, nology and competence, surely operating with ingenuity and The resilience of this indus-
moted as the ‘Pharmacy to the when it was felt to be strong more important than inventing high productivity. Due to its try in India is demonstrated by
World’. I prefer to use the enough. Pharmexcil, the export a couple of new molecules. No affordable prices, the industry its success and growth even
words ‘World’s Pharma Hub’ promotion council has also other country in the world has saves millions of lives globally though it has the strictest price
which would be more correct, played an important role in as- been able to match this per- each year. controls in the world. Like a
also in its grammar. sisting the globalisation of this formance, and India’s leadership champion weight-lifter chal-
industry, particularly in the last increases year-by-year. One of the noteworthy lenged with heavier and heavier
Our group, ACG Worldwide few years. aspects of the Indian pharma in- weights, every successive round
(formerly, the Associated Though the IT industry has dustry is that many of the of price control the industry has
Capsules Group), started its India has developed the received greater recognition largest companies in India are not succumbed, but has only
production of empty capsules in capacity to manufacture huge and its size is much bigger, the headed by pharmacists or tech- strengthened. And, interest-
the 1960s, along many of the quantities of formulations, of pharma industry should really nocrats. This is not so in ad- ingly, several heads of pharma
present leading companies of world quality standard, at the be recognised as the pride vanced countries where large companies are among the rich-
the Indian pharma industry. est in the country.
We grew side-by-side with the
Indian pharma industry. Alongside, Indian pharma,
its ancillary industry has also
Let me illustrate the per- developed the capabilities, the
formance of this industry based technology and competence to
on ACG’s actual experience as a compete globally.
leading supplier of equipment
and consumables. By the second For example, in the sophisti-
year of our production by when cated, high technology gelatin
the output had reasonably sta- capsule industry, ACG is the
bilised, we were producing second largest in the world
about 50 million capsules per and growing much faster than
year. We are now producing others.
about a 100 billion capsules a
year. This exponential growth is Several types of pharma
an indication of the growth of machines designed and made
the pharma industry in India. in India lead the world in
volume of production and in the
As the World’s Pharma Hub, value-for-money they offer to
India makes thousands of for- pharma customers worldwide.
mulations to meet all illnesses Major global pharma producers
and doctors’ prescriptions. and even MNCs, recognising
the strong competition they face
Some people say that, in from Indian pharma manufac-
spite of its other advancements, turers, have started importing
India has been largely unable to and using Indian-made machin-
develop any new pharma mole- ery and ancillaries, as histori-
cules that have become block- cally done by Indian competi-
busters. This may be so, but tors, so that their costs become
should India’s strategy be any more competitive.
different from what it is.
At the present time, various
The Government of India units of the Indian pharma
has played a strong supportive industry are facing rough
role even as it burdened the in- weather with inspection of their
dustry with a number of con- plants by some overseas FDA
trols. For example, in an almost agencies. Somewhat damaging
uncanny fashion it gave protec- is the focussed attention such

30 EXPRESS PHARMA

August 16-31, 2017

Express Pharma
(August 16-31, 2017)

MANAGEMENT

INSIGHT

Integrative cardiology:
Where canAyurveda contribute?

Dr M Vijayakumar, Clinical Professor,Adult Cardiology,Amrita Institute of
Medical Sciences, Kochi, Kerala and Dr P Ram Manohar, Research Director,
Amrita Centre for Advanced Research in Ayurveda,Amrita School of Ayurveda,
Kollam, Kerala, share insights on blending traditional medicine and modern
science to develop a holistic approach for cardiovascular healthcare

Dr M Vijayakumar,
Clinical Professor, Adult
Cardiology at Amrita Institute of
Medical Sciences, Kochi, Kerala

There is no question about cardiology. warranted. While the advance- beginning to consider alterna- Dr P Ram Manohar,
the miraculous impact of Cardiology has become in- ments in modern cardiology tives to conventional treatment Research Director, Amrita Centre
advanced medical cannot be undermined in any for management of a wide range for Advanced Research in
knowledge in saving millions of creasingly technology intensive way, complementing it with al- of conditions including angina, Ayurveda, Amrita School of
human lives. Specially so, when and while these advances are ternative approaches can per- arrhythmia and congestive Ayurveda, Kollam, Kerala
it comes to diseases that afflict life saving in many situations, haps reduce drug dependence, heart failure. Apart from sur-
a vital organ like the heart, there is growing concern that minimise surgical procedures gery and pharmaceutical drugs, be widely recognised.
which can create life and death such interventions are some- and improve quality of life Integrative Cardiologists are Ayurveda uses at least 1200
situations demanding complex times being used out of context where it is reasonably possible keen to prescribe diet and
interventions. New pharmaceu- and become the cause of eco- to do so. lifestyle modifications along medicinal plants and about
tical drugs, bypass surgery, nomic burden to the public. with standard care. 25,000 herbal formulations.
angioplasty, heart transplanta- In many parts of the first Many of these plants and formu-
tion, pacemakers and the list is Worldwide, there is growing world, Integrative Cardiology Integrative Cardiology is de- lations have been found to be po-
endless when it comes to dissatisfaction with conven- has emerged as a clinical disci- veloping around the world by in- tentially beneficial in the man-
discussing about the path tional treatments as they can at pline that attempts to integrate corporating many practices agement of cardiovascular
breaking developments that times be not effective or cause the best of both worlds in the bid from complementary and clter- diseases in preclinical and clini-
have revolutionised medical side effects or be prohibitively to provide the best care for the native Medicine. However, the cal studies. However, sufficient
interventions in the field of expensive. People are searching patient. role that Ayurveda can play in translational work has not been
for less invasive, cost effective Integrative Cardiology is yet to done to integrate Ayurveda into
and safer solutions where it is Many cardiologists are mainstream clinical practice for
management of cardiovascular
diseases.

26 EXPRESS PHARMA

October 1-15, 2017

Express Pharma
(October 1-15, 2017)

69EXPRESS PHARMA

December 1-15, 2017

CPhI & P-MEC INDIA 2017 SPECIAL

EXPRESS PHARMA (SEPTEMBER 1-15, 2017)

cover ) (T H E M A I N F O C U S ENHANCING PHARMA
EDUCATION
INSIDE 25 29 30 32 Pharma education: In need of a revamp
This story highlighted the
24 EXPRESS PHARMA PHARMA 'REVIVAL OF ‘A CONTEMPORARY HOMAGE TO An analysis of the current state of pharma
EDUCATION: IN NEED PHARMACY EDUCATION AND RELEVANT THE GURUS current state of education and traced the
September 1-15, 2017 OFA REVAMP IN INDIA IS THE NEED PHARMACY CURRICULUM pharma evolution of pharma education.
OFTHE HOUR' IS THE NEED’ education in Industry experts share their
India, its insights on the way forward to
successes and revamp the pharma education
shortcomings, as system within the country.A
well as measures multi-pronged strategy involving
needed to bridge three domains of action: quality
the gap between assurance, academic and
the industry and institutional capacity building
academia and more emphasis on
experiential education and
By Swati Rana competency building was also
discussed.
The pharmacy profession
in India began in the Industry veterans also
early 20th century and shared their views on the
since then, has undergone sev- upcoming trends in pharmacy
eral transformations. These education.The article
changes have had an impact on highlighted the urgent need to
pharmaceutical education as strengthen industry-academia
well. collaborations in terms of
education, training and research,
Tracing the beginnings through continuous interaction
The systematic implementation with the pharma industry leaders
of pharma education in and involving them in the
India commenced from 1948, framing of the pharmacy
with the enforcement of Phar- curriculum.
macy Act-1948, to set standards
and regulate pharmacy educa-
tion, profession and practice in
India. Provisions of the Phar-
macy Act are implemented
through the Pharmacy Council
of India (PCI), a statutory body
established in 1949. Thus, for-
mal pharma education in India
has been prevalent for several
decades. Since the late 1980s,
due to rapid industrialisation in
the pharma sector, privatisa-
tion, and economic growth,
pharmacy education has been
developing faster in India than
anywhere in the world. Yet,

25EXPRESS PHARMA

September 1-15, 2017

EXPRESS PHARMA (SEPTEMBER 16-30, 2017)

cover ) (T H E M A I N F O C U S MAKE IN INDIA REVIEW

INSIDE 30 33MAKE IN NORTH MAKE IN INDIA As India observed the third
EAST INDIA ACHIEVEMENT anniversary of the‘Make in
24 THE LIONAT REPORT India’initiative, Express Pharma
CROSSROADS reviewed its achievements and
shortcomings within the pharma
sector. It reflected on the vision
of the initiative to raise the
manufacturing sector’s
contribution to the GDP.
However, it also disclosed India’s
disproportionate dependency on
Chinese APIs which could
seriously derail the endeavour’s
progress.

The article recommended
the industry to tap the true
potential of pharma PSUs to rev
up API production.The article
drew attention towards the need
for significant investment and
efforts to make PSUs self-
sustainable and profitable.Thus,
it is an example of how Express
Pharma periodically reviews
policies of the government.

22 EXPRESS PHARMA To subscribe: [email protected] 23EXPRESS PHARMA

September 16-30, 2017 September 16-30, 2017

70 EXPRESS PHARMA

December 1-15, 2017

CPhI & P-MEC INDIA 2017 SPECIAL

A FORUM FOR KEY OPINION LEADERS

Express Pharma has always been the vehicle for the industry to convey its views and insights on
several topical issues. For instance, the first one is a post-budget analysis on the allocation for the
pharma sector.The next one is on the GST roll out.Though many were optimistic that it would prevent
the cascading effect of taxes, most of them had expressed concern on its effective implementation.A
very valid one, considering that it does seem to have adversely effected the sector’s growth.

cover )

All bluster and
no lustre?

With little or no financial incentives
in Union Budget 2017, the
pharmaceutical industry remains
deprived of a cure for its ailments

‘The budget has not specifically ‘The budget initiative of CUSTOMIZED With over 25 years of expertise in
addressed imminent challenges STRIVE would be of LAB FURNITURE designing and furnishing labs, we
directly affecting the sector’ great help for the Indian cater to some of the finest pharma
pharma industry’ INSTRUMENT TABLE labs in India
he life sciences sector rules for medical devices
UTKARSH are welcome, the Budget has HEMANT he budget has in- • R&D Lab . InstrumentationLab
PALNITKAR Thad great expectations not specifically addressed DESHPANDE • Wet Labs . Hot Room
NATIONAL HEAD – LIFE from the Budget not imminent challenges directly CEO, POLLUX T creased its allocation • QA/QC Labs . GC & LCMS lab
SCIENCES PRACTICE, only from a fiscal incentives affecting the sector. to `3016 crores, up by
KPMG INDIA perspective but also from a 67 per cent and 39 per cent over
regulatory angle; more so, In order to stay competi- the budgeted estimate and
given the government’s vision tive in the overseas market revised estimate of the last
of making India one of the and given the uncertain global budget. From a pharma indus-
top-three pharma markets climate, it was expected that try perspective, the budget
by 2020. specific impetus or incentives initiative of Skill Strengthening
would be given to innovation for Industrial Value Enhance-
However, this year, too, no in the form of weighted deduc- ment (STRIVE) to be launched
specific impetus was given to tion on R&D, incentives for in 2017-18 at a cost of `2,200
the sector. While the move to patents, exemptions of certain crores would be of great help
eradicate certain diseases; duties and taxes, etc. for the Indian pharma industry,
the proposal to set up two new which has already gone global
AIIMS; additional post-grad- These demands remained both in regulated and non-reg-
uate medical seats; proposed largely unaddressed, giving no ulated markets.
amendments in the Drugs and specific reason to cheer for the
Cosmetics Rules; and new sector as a whole in 2017–18.

‘The budget provides the necessary ‘We hoped for some

impetus to sustain GDP growth at reform announcements

over seven per cent’ on the regulatory front’

GLENN verall, the Union ing pharma. KANCHANA TK transforming 1.5 lakh health Why Modern Lab ENGINEERS?
SALDANHA The government has DIRECTOR GENERAL, sub-centres is encouraging. We • SEFA Tested Lab Furniture
CHAIRMAN AND MD, O Budget 2017 that OPPI also appreciate the Govern- • Pan – India network
GLENMARK PHARMA was presented ear- shown its clear intent to- ment’s intent to amend the • On – time Completion
lier today is a step in the wards fast-tracking inflow of PPI welcomes the com- Drugs and Cosmetics Act which • Durability
right direction. While it FDI, and the scrapping will be a step towards ensuring
has focussed on economic of FIPB is a notable step O mitment of the Govern- patient safety. We had some
reforms and liberalisation that would go a long way ment to - reduce infant expectations from the Union
of the economy, it has also in supporting the objective and maternal mortality rates; Budget 2017-18, given the
allocated funds to bring of ease of doing business. eliminate certain diseases like Government’s past stated inten-
more irrigation, roads, Additionally government’s TB, leprosy, measles and filaria tions of improving access to
electricity and sanitation to impetus to reduce the and make structural reforms in healthcare. Yesterday’s World
rural India. Even though the borrowing cost and increase medical practice and education. Economic Forum said that that
economic survey paints a access to credit will surely The Government’s intention of India’s public spending on
sober picture for 16-17 help businesses to grow. healthcare is much lower than
primarily due to a weaker We see the biggest ever the global average. It is unclear
second half, the budget pro- allocation to the infrastruc- whether the allocations will
vides the necessary impetus ture sector which would adequately address current
to sustain GDP growth at benefit all sectors, including healthcare challenges. We also
over seven per cent. Lower- the fast growing pharmas. hoped for some reform an-
ing tax on MSME’s is a The FM reiterates his com- nouncements on the regulatory
welcome step that would mitment to keep current ac- front in the form of weighted
provide a much needed fillip count deficit and fiscal deduction on R&D, incentives
– by creation of jobs and put- deficit under control GST for patents, exemptions of
ting more money in their implementation as soon as certain duties and taxes, etc.
pockets in all sectors includ- possible.

To subscribe: [email protected] 13EXPRESS PHARMA

February 16-28, 2017

Express Pharma
(February 16-28, 2017)

MARKET WALL TABLE

GST: Ushering new rules
to the game

Goods and service tax (GST), to be rolled-out from July 1 this year, is expected to
help bring in better efficiencies in the pharmaceutical industry’s supply chain management
and reduce the cost of manufacturing pharmac products. A few industry players and service

providers share their views on the impact of GST and getting ready for its roll-out
By USHA SHARMA

'GSTwill act as a bridge to create a seamless connection between ISLAND TABLE
manufacturers, distributors, regulators and customers'

G ST will have a positive chain management by bringing RAVI KANT SHARMA We may see sition phase. Recognising this
impact on the pharma- in enhanced transparency to FOUNDER AND CEO, the emergence threat and also our responsibil-
ceutical industry. It will the system with complete SASTASUNDAR of innovative ity, we at SastaSundar have
lead to an increase in compli- tracking of movement of the business decided to rework on our
ance and thereby enhanced product. It will be beneficial for no incentive for pharma com- models in near procurement strategy so that
transparency and better sup- all in the longer term. The panies to keep multiple ware- future in during this transition phase,
ply chain management which country will have a major relief houses across the country. The the pharma we can ensure the consistent
will not only be beneficial for from the threat of fake or coun- movement of goods from one supply chain availability of medicines.
the pharma industry but also terfeit medicines. We believe state to the other will not at- management
for all the intermediaries in that GST will act as a bridge to tract any differential taxation domain Preparedness
supply chain management and create a seamless connection and the pharma companies Regarding the preparedness
the customers. between the manufacturers, will rework on their distribu- Shortage of medicines for GST at Sastasundar, we
distributors, regulators and tion strategies. Eventually, it GST on most medicines have have an efficient supply chain
Enhanced transparency in customers. will result in the application of been kept at five per cent or 12 management model empow-
pharma distribution newer technologies in the sup- per cent and there will be no ered with technology. We have
There may be issues during the Innovative business ply chain management domain major impact on the price vari- already redesigned our system
initial phase of implementation models will come up with better inventory planning ation at all. However, due to in compliance with GST and
of GST, the reason being in The pharma distribution sys- and in turn, result in huge sav- concerns regarding the input tested it as well. For a majority
most of the states, medicines tem will undergo a major ings in the warehousing and lo- tax credit of 40 per cent (al- of the intermediaries in the
are currently being charged transformation. There will be gistics cost. We may see the lowed under the GST transi- pharma distribution, the
with VAT on MRP, i.e., single emergence of innovative busi- tion regime), realignment of GST regime will be a kind of
point taxation. It means the in- ness models in near future in production strategy by pharma transformation for their busi-
termediaries involved in the the pharma supply chain man- companies due to changes in ness models with enhanced
distribution of medicines are agement domain. tax rates and other factors, compliance load but with the
not required to pay any VAT. In there are fears related to medi- adoption of readily available
the current regime, maximum cine shortages during the tran- technology, we believe that
of intermediaries are not re- it can be managed. We under-
quired to take any registration stand that like us, all those
or pay VAT or file returns. But associated with the supply
in the GST arena, there will be chain management are also
no concept of taxation on MRP. geared up for GST.
Rather, all the intermediaries
will be required to take GST GST is one of the biggest
registration, pay monthly taxes reforms in the country and we
and file three returns per believe that the government's
month and in total, 37 returns mission to ensure affordable
annually. It will enhance com- healthcare to all Indians
pliance levels across the supply will get a major boost by the
GST regime.

'We need to embrace the new
reality and move away from
banal considerations'

G ST is finally upon us. Enough criticise or are negative about the devel-
has been spoken, and comprehen- opments and reforms pertaining to GST.
sively so, about GST’s form, While it’s true that these reforms have
structure, benefits and pitfalls by consult- been designed by administrators and bu-
ants, specialists, analysts and pundits. reaucrats and not by businessmen, hence
However, the unanimous sentiment is the flavour is more of compliance and reg-
that GST is an absolute game changer, ulation and not business friendliness,

GULSHAN BAKHTIANI
DIRECTOR, WELLNESS
FOREVER, WELLNESS

The undisputed consensus is that
this is a move in the right direction
for realising the vision of better
governance

not just for the pharma industry but for however, the bottom-line remains that MODERN LAB ENGINEERS
the country and its commerce as a whole. legal compliance is the fundamental
The undisputed consensus is that this is pre-requisite and should not be slotted as NO.10, 11TH AVENUE, ASHOKNAGAR, CHENNAI – 600 083
a move in the right direction for realising aspirational conformance. ‘What is Tele phone : 044-24744913, 24744912 Fax: 24744917
the vision of better governance. inevitable, needs to be embraced’.
Website : www.labinterior.co.in Email: [email protected], [email protected]
As responsible citizens and business With the roll-out of GST, two things
leaders, it is not only expected of us but will happen for sure:
it’s also our responsibility to be active
enablers for smooth implementation of a) The manner in which business will
the new GST reforms. Digitisation, be conducted will witness a paradigm
automation and the resultant trans- shift from how it was conducted in
parency is going to be a way of life rather the past.
than mere change management. There-
fore, we need to embrace the new reality b) Boys will be separated from men
and move away from banal considera- Confusion with regards to GST
tions such as impact on profit, deploy- taxation for online businesses will
ment of additional resources for book- continue to prevail. The industry itself
keeping, document filing compliance. In has given birth to myriad business
fact, the focus should be on reshaping the models and it’s imperative that clear
organisation to become more compliant, distinctions are made as to what consti-
efficient and, as a result, more scalable. tutes online commerce. This in turn will
lead to better clarity with respect to GST
I often meet leaders of small, medium taxation for online businesses.
and large businesses who partially owing Personally, I would like to believe that
to ‘change inertia’ and fear of the un- GST is a procedural, simple, tax-passing
known and partially due to hearsay and mechanism which is purely between busi-
incomplete information, indiscriminately nesses; the customer is merely the con-
sumer of tax.

To subscribe: [email protected] 25EXPRESS PHARMA

July 1-15, 2017

Express Pharma
(July 1-15, 2017)

71EXPRESS PHARMA

December 1-15, 2017

CPhI & P-MEC INDIA 2017 SPECIAL

EXPRESS PHARMA (OCTOBER 1-15, 2017)

cover ) (T H E M A I N F O C U S A MAJOR NEED

18 EXPRESS PHARMA Holistic and multi-disciplinary healthcare Areport released by the
approaches are an urgent need to tackle complex Ministry of Statistics reveals
October 1-15, 2017 that the number of citizens over
challenges posed by an increasing elderly the age of 60 jumped 35.5 per
population and ensure effective social and cent — from 7.6 crores in 2001 to
10.3 crores in 2011.Though many
economic development pharma companies are
operating in the global geriatric
To subscribe: [email protected] 19EXPRESS PHARMA medicines market for older
group of population, there is still
October 1-15, 2017 a void when it comes to providing
specific treatment options
suitable for geriatrics.

In this issue Express Pharma
focussed on the unique social,
economic, and clinical
challenges of geriatric care in
India and the solutions to tackle
them. It focussed on tackling
their medication needs for
complex health issues require
special attention to safeguard
their golden years and offer
them more independence and
mobility.Thus, it attempted to
identify and fulfil a growing need
in the country, which could
become a huge problem, if left
untackled.

cover ) EXPRESS PHARMA (OCTOBER 16-31, 2017) PROPELLING GROWTH

(T H E M A I N F O C U S This article highlighted a
growth opportunity for the
The global push for traceability to INSIDE 31 36OPPORTUNITIES INTV: PRAKASH CHANDRAJOSHI, pharma packaging
quell counterfeiting and raise quality CALLING SECRETARY GENERAL, PACE equipment market with the
28 PACKEDWITH global emphasis on the
standards have opened up myriad POTENTIAL implementation of traceability
growth avenues for India’s pharma solutions to reduce
counterfeiting of pharma
packaging equipment industry products. Serialisation
By Swati Rana mandates in many countries in
turn have created opportunities
26 EXPRESS PHARMA as well as challenges for the
pharma packaging industry.
72 EXPRESS PHARMA
This article analysed how
December 1-15, 2017 pharma packaging equipment
manufacturers are upping the
game to help the packaging
sector.

This story emphasised why it
is essential for the players in this
industry to spot opportunities
and take timely steps to leverage
them effectively to stay at the
top of the game.

To subscribe: [email protected] 27EXPRESS PHARMA

CPhI & P-MEC INDIA 2017 SPECIAL

We bring you three more instances of how Express Pharma acts as a forum for the industry to share
their observations.The first one on this page covered the debate over gelatin capsules vs plant-
based capsules. The next one was a special features where pharma experts expressed their respect
and gratitude towards their teachers.The last one discussed the impact that extended tax incentives to
industries in the North Eastern and Himalayan states till March 2027 albeit as a refund.Thus, we come
to an end of this compilation. We assure our readers that we will continue to offer timely, relevant and
informative content for our readers and subscribers.

MANAGEMENT MANAGEMENT cover ) (T H E M A I N F O C U S cover ) (T H E M A I N F O C U S

Veg meds: Yay or nay? QUESTION POSED TO MOHFW IN THE LOK SABHA 'IDMAWOULD NOT HOMAGE TO THE GURUS Continuityof taxincentiveswill not onlyboost
RECOMMEND CHANGE the industrybut also human health
Unstarred question no: 2081, Answered on: 28.07.2017, Jayadev Galla-TDP-Teleana FROM GELATINTO Isalute my great teacher, Dr G P Srivasatav. He moti-
CELLULOSE' vated all students, mentored and largely was re- DR SANJIT SINGH LAMBA
Will the Minister of Health and Family Min- pared from gelatin which is a purified pro- A person whose wisdom changed my life, in its own unless that person has the authority to say Yes. I had to sponsible for his students being gainfully engaged in MAKE IN NORTH EASTINDIA MD,
ister be pleased to state: tein obtained by partial hydrolysis of ani- DAARA B. PATEL way, was the late Nobel Laureate, Sir James really ponder over it, to understand this deep, original the pharma industry. His letter of recommendations in Eisai Pharmaceuticals
vs (a) whether the types of cellulose capsules mal collagen Secretary-General, IDMA Black, the Research Scientist at GSK, UK concept. Dr N Udupa 1970s were enough to fetch jobs in any place, in any in- Dr Arun Garg The government is making all efforts to uphold GST and claim the refund later. To bring a new tax regime based
that are presently available in the market (b) to (d): The Government has not re- whose work led to the development of Propranolol and Professor and Research dustry, in any city, even abroad. Dr G P Srivastav was a Make in India campaign as their progressive steps. This on exemption, the Department of Industrial Policy and The pharma sector is the
are different from animal based gelatin cap- ceived any such report that switching We have taken up the matter with the Health Ministry Ajit Singh Cimetidine. My other substantial learning was from the late Pro- Director (Health Sciences), popular teacher and always smiling, interacting with General Secretary – IPGA, Prof. & Dean, September, the Make in India campaign will be turning Promotion (DIPP) is working on preparing a scheme caretaker of national hu-
sules, if so, the details thereof; over to vegetarian cellulose capsules will and DCGI. We also had a meeting with Nripendra Chairman, ACG Worldwide fessor Arnold Beckett who was Professor at Chelsea Manipal University, Manipal students in laboratories, class rooms. Under his School of Medical & Allied Sciences three and the government has given many lucrative which will replace the current system. man resources of any country.
(b) whether switching over to vegetarian hit the ` 5000 crore gelatin capsules in- Misra, Principal Secretary to PMO on July 18, 2017 in New I learnt that a recognition by the Nobel Prize Commit- School of Pharmacy, London, U.K. mentorship, his students achieved great positions in na- KR Mangalam University, Gurgaon schemes to encourage industries to work in line with the Being a nation which has
cellulose capsules will hit the Rs 5000 dustry. However, some industry associa- Delhi and explained to him that change over from gelatin tee is not given only for expertise and new frontiers Kiran Mazumdar Shaw tional and international institutions in the pharma in- campaign. The government is trying to attract investors However, the new GST regime is critical for several more concern and care for hu-
crores gelatin capsule industry; tions have raised certain issues includ- capsules to cellulose capsules in no way would benefit our development in the narrow area of specialisation of the He visited India to lecture more than once. The pres- CMD, Biocon dustry. We were fortunate to learn a lot of talents and Prof B Suresh, the Honourable Vice-Chancellor and encourage them to setup their manufacturing industries like automobile, pharma and consumer man beings and which has a
(c) if so, the details thereof; and ing technical issues and economic Indian population. He asked us as to how much time industry award winner. It is also for a broad and humanitarian entation of his lectures were far ahead of his time, technologies relevant to the pharma industry in those of JSS University, Mysore, was my Ph.D super- facilities in the North Eastern region and Himalayan goods and companies must start units in backward huge population with hand to
(d) the action taken by the Government to viability for replacing gelatin capsules would require to change over, to which we put forth our log- view of our planet. illustrated with beautifully composed slides and deliv- days. He helped us to dispose the dog from the labora- visor and is my ideal teacher! Prof Suresh has states. Last year in May, PM Narendra Modi had said that areas, where the economic condition of the state is mouth means of earning, does
address the problem? with cellulose capsules. The government ical arguments as mentioned below. Finally, he was of the ered in a powerful tone of voice that engaged attention of tory after pharmacological experiment when technician been actively involved in uplifting the quality and stan- he will consider the North Eastern Region as the poor just by availing the advantage of area-based- necessarily require affordable
has, after examination of all pertinent is- opinion that both types of capsules should co-exist. We I learnt that one could talk to Sir James on almost and enthused the audience. He was like an actor on the was not available and the laboratory was stinking. dards of pharmacy education and profession in India Gateway to South-East Asia. And recently Arun Jaitley, programme. This is a major reason why the pricing of medicines to all. In
Answered by Faggan Singh Kulaste, the sues relating to use of gelatin capsules therefore request the government to continue to allow the every subject. For example, we even discussed about stage, and I learnt how active body movements and a He gave us a lesson and educated us that even if the for the past 30 years. Finance Minister announced that under the GST regime, government is extending tax incentives since 2003 to pursuit of that, providing tax
Minister of State in MoH&FW and its replacement by cellulose based use of gelatin capsules to ensure availability of safe, effica- marriage and divorce, right down to how to avoid bureau- varied modulation and tone of voice creates excitement technician is not available, we can go ahead with our the government has extended tax incentives to these regions. On January 7, 2003, the new industrial incentives to pharma compa-
(a): Yes. Presently, cellulose capsules are capsules, already constituted a Commit- cious and affordable drugs to the patients. cracy creeping into a growing organisation. in what could otherwise be a drab scientific lecture. experiment and research. Even during strikes and It was Prof B Suresh who gave me the opportunity industries in the North Eastern and Himalayan states policy and other concessions for these states were nies, irrespective of the zone
prepared from HydroxyPropylMethyl Cel- tee to consider all pertinent issues student unrest, he was the one allowing the students and encouraged me to indulge myself in pharma till March 2027 albeit as a refund. announced for 10 years. However, companies started or region is always a step in
lulose (HPMC), which is synthetic in ori- and make recommendations to the ◗ Gelatin capsules have been in use for over 100 years. It has He said that his recipe for attacking bureaucracy During one of his visits, Prof Arnold Beckett inaugu- like me to come and enter from the backdoor to work in research especially on drug utilisation to ensure and looking to exit the state as the concession period ends. the right direction to provide
gin, whereas Gelatin Capsules are pre- Government. been found to be very safe for human consumption and would not be found in any book on Management. It was rated a Scientific Pharmacy Museum that SciTech the laboratory and use the library. We will not get such improve the safety and quality of the life of diabetic Under the new GST regime, there is no provision for To retain companies, the government further extended affordable price of medicines
accordingly it has been accepted by regulators all over the world. simply that, within an organisation, authority should Centre/Associated Capsules set up at the Principal K.M. great teachers these days. patients. It was this humanitarian concern of my exemption but there is one section under the Act which the concession till March 2017. To those who set up to all. So, the continuity of tax
never be given to a person to say No to any proposal Kundnani College of Pharmacy, Mumbai. teacher that has made me become fully committed to permits refunds. their facilities before march 2017, now it has been incentives to pharma compa-
◗ Thousands of crores have been spent on establishing the However, he passed away in Varanasi in the year 1976 indulge in the issues and problems of diabetic patients further extended for 10 years which will help companies nies will not only boost the
T he debate over gelatin capsules vs plant-based capsules (Cellulose) has 'CONSUMPTION OF MEDICINE quality, viability and economics of gelatin capsules. M y favourite Teacher in Pharmacy is Dr JK Lala when I had just completed my M Pharm. I cannot forget around. On the very first day in JSS College of The industry experts are saying that the later move of to contribute to PM Modi's vision of Make in India. industry but also keep the
garnered a lot of attention from all stakeholders of the lifesciences IS MORE CURATIVE THAN OUT who was the Principal K.M.Kundanani College of my teacher of pharmacy, Dr Srivasatav who is responsi- Pharmacy, Ooty, Prof Suresh introduced Dr David the government is to implement indirect taxation well-being of human health.
industry. The discussion began almost a year back when Maneka OF PERSONAL CHOICE' ◗ There have been no adverse reports of gelatin capsules. Pharmacy Ulhasnagar. He was taking our subject ble for making me and shaping me as a pharmacy Kosh from Adelaide, Australia, to me and encouraged structure and give exemption to business enterprises By Usha Sharma
Gandhi, Union Minister for Women and Child Development made a ◗ We are totally self-sufficient with the raw materials for gelatin Drug Store Management. While taking this subject, without teacher and researcher. me to interact with him. With utmost care, Dr Kosh from paying sales tax.These businesses will be eligible to ‘Make in India’ is a major
‘representation' to the Health Ministry on completely replacing gelatin capsules capsules. any PPP during that time (1979), he was literally taking our went through my concepts and improved my national initiative designed to
with plant-based capsules following a request received from the Jain VIVEK SEIGELL Dr Mahesh Burande mind to the Drug Store by illustrating suitable examples, live Dr Dinesh Dua O n Teachers’ Day I always talk about my understanding of the drug utilisation studies. It is this Apart from taxincentives,there is a need facilitate investment, foster
community to create an option so that consumers can not be forced to use Director, PHD House ◗ We will be totally dependent on imports of raw materials for Director, Institute of Pharma situations, case studies,involving us and taking suggestions favourite teacher, Anne Warrior. She was a fas- generous and selfless attitude of my teacher that for dedicated pharma parks innovation and build best in
capsules made from animal tissues. cellulose capsules. Education and Research (IPER) from us and I think it was learning by participation and Vice Chairman, Pharmexcil, cinating person who taught me to think for my- enabled me to have a wider circle of pharmacy related class infrastructure that will
Gelatin capsules are consumed by people at cosmetics and hence even the red dots which are problem-based learning with command over language and Chairman,Higher Education, self, to excel in everything I do and to do things differ- academicians. Prof Suresh’s nurturing and encourage- further boost the economy
JP Nadda, Union Minister of Health and Family Welfare discussed the matter large as carriers of important medicines printed on non-veg products was not imple- ◗ The safety and efficacy of cellulose capsules cannot be Dr Mayur Yergeri humour. I am also inspired by the teaching style of Dr Chan- CII North India ently and creatively in order to make a ment has helped me a lot to enrich my professional and bring in more foreign in-
with the Drug Controller General of India (DCG(I)), Dr GN Singh and and then used to cure many terminal and lifestyle dis- mented for medicines. guaranteed. Members are concerned that even after approvals, Associate Dean and Professor, drakant Kokate, the first Pharmacy Teacher who became difference. Once, she got us to creatively spruce up a career. Last, but not the least, I would like to share with vestment in India. It should
Health Secretary, Bhanu Pratap Sharma to look into the matter on a priority eases. The consumption of medicine is more cur- few long term studies may show adverse reports and they may SPPSPTM Vice Chancellor of University. His lectures would be full of On Teacher’s Day on, I very fondly recall my wilting garden patch in school into a designer cactus you that Prof Suresh as a human being is very not be restricted as a concept
basis. However, the matter wasn’t taken up at the Drug Technical Advisory ative than out of personal choice. Looking at fun- In the meanwhile, soft gelatin capsules have not want to take the responsibility for that. information and statistics without any paper in front of him Dronacharya Guru, Dr Ahmed, HoD Pharma- garden over a weekend to win our class ‘The Garden supportive and always gives right guidance and and should be propagated to
Board (DTAB) and failed at the initial proposal itself. However, lately the debate damentals, it is not prudent to enter the been given a go-ahead, therefore there is no and wonderful quotes to start and end his speech. Currently, I cology. Early on in 1972, he saw a spark in me Patch of the Year’ award! Now when I look back, I real- suggestion with clear objectives and aims. the world that Make in India
has regained steam and now an expert committee set up by the Health Ministry vegetarian and non-vegetarian debate in this prima facie issue with the raw material and ◗ Today we manufacture 120 billion gelatin capsules compared am impressed with my friend Dr B Suresh, President, PCI, for from the chemistry perspective besides potential in ex- ize that her unconventionality rubbed off on me and led as a philosophy is a reality and
has asked all stakeholders to share their views on the matter. matter. It may further be noted, that gelatin used hence the replacement of hard gelatin capsules to only two billion cellulose capsules. the way he controls the crowd with humour and delivers new tracurricular activities and sports. With his continu- me later in life to break convention and do many of the this can happen when the
However, it is an issue with wide-ranging implications. Some of the major in the manufacture of empty capsules are de- because it is non-vegetarian is totally misplaced thoughts and concepts. Their styles of teaching inspired me to ous mentoring for five years of my academic career, things that were considered pioneering for young government is serious in giv-
questions that the situation throws up include: rived from an extraction process wherein no an- and uncalled for. ◗ Cellulose capsules are two to three times expensive compared become a teacher and I am trying to teach and talk like them I excelled in pharmacology. He encouraged me to women in the 1970s. ing incentives and tax breaks
◗ Gelatin-based capsules have been in use for over 185 years. How easy and imals are harmed or killed for this specific pur- to gelatin capsules.This would increase the cost of drugs to the as a teacher ,trainer and consultant who is appreciated today prepare and qualify for MBA from the Indian Institute to companies. This will boost
feasible would it be to replace them? pose. Only the leftover bones having Across the globe, over 95 per cent of capsule patients. by pharma industries and pharma profession. of Management, Ahmedabad during 1977-79 which The most important priority mulations manufactured using dozen large pharma companies turing plants. As regards to indigenous innovation and
◗ Is the issue about benefits or are we tinkering with long-established, hydroxide and collagen, which is a protein widely formulations are gelatin capsules and even gave a great fillip to my career. Dr Ahmed strongly for ‘Make in India’ cam- domestically produced APIs be have made plans for the same. GST, while the government is also compete with countries
scientifically-proven practices to pander to religious sentiments? found in animal bones (and is not more than two among the rest five per cent, Hydroxypropyl- ◗ Huge investment in plant and machinery would be required to Ihad some amazing teachers who taught me and some of ingrained in me a huge significance for culture and a paign from the pharma industry exempted from price control for periodically issuing clarifications like China for API manufac-
◗ Cellulose-based capsules are likely to be more expensive. Is it morally right to per cent of the total value of the dead animal) is methyl cellulose (HPMC) is primarily used for adopt cellulose capsules. these teachers went on to teach at universities in US. value system which I’m very proud of. Whatever I’m perspective should be domestic a period of five years as well as Apart from tax incentives, on 'frequently asked questions', turing.
make medicines more expensive in a country struggling to ensure healthcare extracted through sophisticated machineries in nutraceutical formulations. In India, only around As naming one teacher will be bias on my part, I will today, a huge credit goes to Dr Ahmed's mentoring. manufacturing of APIs, as we be given preference for govern- there is a need for dedicated many SMEs will require
access? a WHO-GMP approved extraction and manufac- two per cent capsules are HPMC-based and al- ◗ Several newspaper reports are harming the Industry’s take the some names of teachers who impacted my future are over dependent on China ment procurement. The finance pharma parks with subsidised guidance on interpretation on 31EXPRESS PHARMA
◗ What are the proven benefits, if we switch over from gelatin-based capsules turing plants. Accordingly it is misplaced to have most all of them are neutraceuticals. No cellu- reputation and needs to be countered. and career — Dr VN Sonar, Dr RH Udupi, my PhD DR AJIT DANGI and other countries for supply of minister’s announcement of tax water, electricity, common efflu- matters such as clearance of
to cellulose-based capsules? any notion that gelatin capsules are non-vegetar- lose capsules are used for products such as an- supervisor Dr KN Thimmaiah and Dr GJ Peters. One President & CEO, APIs as well as drug intermedi- incentives under GST for com- ent plant etc. Assistance in land physicians samples not for sale, September 16-30, 2017
◗ How will the industry be affected by the switchover, if cellulose-based ian in origin. tibiotics, oncology, anti-infectious, painkiller and teacher who did not teach me but inspired was Danssen Consulting ates. Any disruption in supply panies setting up manufacturing acquisition will help in attracting treatment of loan licence units,
capsules become the new reality? other medicinal categories. Nor have any tests Dr Yellapragada Subbarow, a pioneer who discovered chain due to any geopolitical facilities in North Eastern and industry. A proactive drug con- supplies made from erstwhile
Industry leaders and veterans share their views on these issues and highlight The Supreme Court, in its order dated March been carried out by the DCGI in India whether medicines like Tetracycline, Folic acid, Methotrexate, 30 EXPRESS PHARMA reasons could drastically impact Himalayan states till March trol administration and skill tax free zones etc. A GST Guid-
the different aspects of such a switchover. 07, 2013, Case No. 641, had ordered that there is such medicinal products would retain their sta- Aureomycin and Diethyl Carmabamzepine, we live longer our formulation industry. The 2027 is a positive move and cer- training centre in the these ance Cell, in collaboration with
no need for non-veg or veg labels on drugs or bility, bio-availability, bio-equivalence and other today because of these medicines. Our Late President September 16-30, 2017 new draft pharma policy has tainly encourage industry to set zones and good logistic as well as industry associations, in these
properties if filled in cellulose capsules. Dr Abdul Kalam’s Wings of Fire was inspiring for me and I taken cognizance of this prob- up their manufacturing plants in digital infrastructure will pro- zones will help clear many
brought and read this beautiful book five times. I also got lem and has proposed that for- this region. Already more than a vide necessary ecosystem for ef- such doubts.
an opportunity recently to be a Visiting Scientist with ficient running of such manufac-
Dr GJ Peters who is a pioneer in Preclinical studies in
cancer at the VU University Medical Center, Amsterdam,
Netherlands on a sabbatical for a year to keep abreast
the research happening in the field of cancer. It was a
rewarding experience and I was a Postdoc with him a few
years ago.

32 EXPRESS PHARMA To subscribe: [email protected] 33EXPRESS PHARMA

September 1-15, 2017 September 1-15, 2017

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August 16-31, 2017 August 16-31, 2017

Express Pharma Express Pharma Express Pharma
(August 16-31, 2017) (September 1-15, 2017) (September 15-30, 2017)

The Standard of Comparison

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Anhydrous, and Inhalation Lactose
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CPhI & P-MEC INDIA 2017 SPECIAL

EXPRESS PHARMA (NOVEMBER 1-15, 2017)

cover ) (T H E M A I N F O C U S THE TECH EFFECT

16 EXPRESS PHARMA India Pharma Inc has emerged as a note- til recently. As an Accenture report, released a Digital technology plays a key
worthy competitor and a significant part- few years ago, stated, “The net effect is that real, role in transforming a
November 1-15, 2017 ner in the global pharma arena. However, enduring success has become tougher for life business enterprise and an
with thinning product pipelines, lessen- sciences companies to attain. More than ever, industry at large.The pharma
ing blockbuster drugs, increasing regu- sustainable and profitable growth requires a sector is no exception. Every
latory scrutiny, pricing pressures, quality con- solid foundation built on longer term fundamen- segment of the pharma sector
cerns, increasing duration of clinical trials, tals. Interestingly, very few companies in this has been touched by technology
shifting disease profiles and patterns etc., chal- industry consider supply chain excellence to and pharma logistics too is
lenges and barriers to success too are mounting. be one of those fundamentals. Life sciences undergoing a metamorphosis,
fuelled by digital technology.
Emerging new technologies are creating strategic This article showcases various
opportunities for organisations to build competi- pharma logistic companies’
tive advantages in various functional areas of strategies to leverage digital
management including logistics and supply chain technology in their business.
management
Promising start-ups such as
Anjani Mandal, Co-founder and CEO, 4TiGO Locus, PharmaRack, 4TiGO, etc.,
share their vision to user better
Technology can be used to integrate functions efficiencies in the logistics
across the network, increase visibility of products sector through technology and
across the value chain and automate processes their efforts in this direction.The
to improve the supply chain’s responsiveness and article also highlights the
reliability significance of digital technology
in enhancing the supply chain
Nishith Rastogi, Founder, Locus.Sh within the pharma sector and
examines future trends.future.
Automated storage and distribution centres will
add to just-in-time delivery model, reducing
inventory and financial losses due to expiry of
medicines

Dinesh Agarwal, Executive Director, Khaitan & Co

We would see a lot new businesses flourishing
with a focus on pharma logistics which
has very different needs when compared to the
FMCG sector

Pradyumn Singh, Co-founder and CEO, Pharmarack

This, in turn, has led to pharma companies companies typically spend more time and effort
expanding their horizons to emerging markets, on the commercial and research sides of the
exploring untried strategies and revamping business and, conversely, place a lower priority
their product mix. In this scenario, the role of an on supply chain improvement.”
effective supply chain to become a major differ-
entiator in the value chain, as companies seek Thankfully, the pharma companies are grad-
the next phase of growth, cannot be under- ually waking up to the revenue building, cost-re-
mined. ducing potential of supply chain excellence.
They have also recognised that revamping the
Yet, the supply chain has often rated very low supply chain, of which logistics is a major
in the priority list of life sciences companies un- part, will enable pharma players to capitalise

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November 1-15, 2017

EXPRESS PHARMA (NOVEMBER 16-30, 2017)

cover ) (T H E M A I N F O C U S VIGILANCE FOR
QUALITY
By Swati Rana
Quality Assurance (QA) in
24 EXPRESS PHARMA pharma has been discussed and
deliberated several times within
November 16-30, 2017 the industry. Express Pharma
has been a part of this debate for
74 EXPRESS PHARMA a very long time.We have
brought to light many loopholes
December 1-15, 2017 within the sector and presented
many strategies to overcome
challenges.This article
reiterated the need for QA in
pharma and pharma-
covigilance’s role in ensuring it.

Moreover, the article gives an
update on the measures taken by
the government and the private
sector to put an effective QA
system in place for India. Finally,
it urged the industry to look at
measures that need to be taken
to strengthen QA in Indian
pharma.We are constantly
vigilant about the needs of the
pharma industry.

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November 16-30, 2017

CPhI & P-MEC INDIA 2017 SPECIAL

DEALTRACKER

Pharma industry witnesses
68 deals in October 2017

Deal value
decreases to
$7.1 billion when
compared five
months average
of $10.6 billion

THE pharmaceutical and
healthcare industry reported an
increase in volume terms
recording 68 deals in October
2017 when compared to five
months average, which stood at
56 deals per month. However,
deal value decreased to $7.1 bil-
lion when compared five months
average of $10.6 billion. Novartis’
acquisition of Advanced Accel-
erator Applications, a pharma
group specialised in the field of
nuclear medicine, for $3.9 billion
in cash, is one of the top deals re-
ported in October.

The acquisition will enable
Novartis to introduce a new
technology platform for cancer
treatment and strengthen its on-
cology portfolio. Other major
transactions reported in Octo-
ber 2017 include Amgen’s acquisi-
tion of remaining 50 per cent
stake in Kirin-Amgen, a biotech-
nology company, for approxi-
mately $780 million; and TPG
Capital’s acquisition of Exactech,
a producer of orthopaedic im-
plant devices and surgical in-
strumentation, for a price of $42
per share in cash or $625 million.

The venture capital market
recorded a decrease in the num-
ber of deals and deal values in
October 2017 with 59 deals
worth $1.1 billion when com-
pared to five months average of
82 deals worth $1.2 billion. No-
table fundings in October in-
clude: Cullinan Oncology raising
$150 million in series A financing
round; KSQ Therapeutics rais-
ing $76 million in financing
round; and Forty Seven raising
$75 million in series B financing
round.

75EXPRESS PHARMA

December 1-15, 2017

CPhI & P-MEC INDIA 2017 SPECIAL

Deal Date Acquirer (s) Target Deal value (US$ m)
30-Oct-17 Advanced Accelerator Applications SA (France) 3,900.0
30-Oct-17 Novartis AG (Switzerland) Kirin-Amgen, Inc (US) 780.0
22-Oct-17 Exactech Inc (US) 625.0
5-Oct-17 Amgen Inc (US) Harmony Biosciences LLC (US) 270.0

25-Oct-17 TPG Capital LP (US)
Deal Date
3-Oct-17 Fidelity Management & Research Company (US); Valor Equity Partners (US); HBM Healthcare
2-Oct-17 Investments AG (Switzerland); venBio LLC (US); Nan Fung Group (China); Novo Holding AS
17-Oct-17 (Denmark); Vivo Capital (US)

13-Oct-17 Ambu A/S (Denmark) invendo medical GmbH (Germany) 264.6
3-Oct-17 Deal value (US$ m)
Acquirer (s) Target 150.0
76.0
F2 Ventures Limited; MPM Capital, Inc Cullinan Oncology LLC (US) 75.0

Polaris Partners LLC; Flagship Pioneering Inc; ARCH Venture Partners LP; Alexandria Equities LLC KSQ Therapeutics Inc (US) 65.4
60.0
Wellington Management Company LLP; Clarus Ventures LLC; Sutter Hill Ventures LLC; Lightspeed Forty Seven Inc (US)
Venture Partners

Undisclosed Personal Genome Diagnostics Inc (US)
Recursion Pharmaceuticals Inc (US)
AME Cloud Ventures; Felicis Ventures; Two Sigma Investments LP; Epic Ventures; Advantage
Capital Partners; Lux Capital Management, LLC; Charles River Ventures; Menlo Ventures;
Data Collective Venture Capital LLC; Obvious Ventures; Mubadala Investment Company Limited;
Undisclosed

76 EXPRESS PHARMA

December 1-15, 2017

CPhI & P-MEC INDIA 2017 SPECIAL

New diabetes therapeutics to steal ground
from insulin therapies: GBI Research

Increased market diversification is expected due to patent expiries for major insulin products

THE INCIDENCE of diabetes
mellitus (DM), and most no-
tably type II diabetes mellitus
(T2DM), which accounts for
90–95 per cent of all DM cases,
is growing rapidly on a global
scale, according to business in-
telligence provider GBI Re-
search.

The company’s latest re-
port, ‘Global Diabetes Drugs
Market to 2023 - A Diversify-
ing Treatment Landscape as
GLP-1 Receptor Agonists and
SGLT-2 Inhibitors Gain
Ground Following Landmark
Cardiac Outcomes’ reveals
that the US is expected to ex-
perience the greatest rise in
T2DM prevalence, and inci-
dence rates are also expected
to increase from 2.5 per cent in
2016 to four per cent by 2023.

DM is a generalised term
used to define multiple dis-
eases with different etiologies
that are characterised by
chronic hyperglycemia (high
blood glucose levels) resulting
from insufficient synthesis, se-
cretion or signalling of insulin –
a hormone produced by the
pancreas. The main role of in-
sulin is to facilitate the absorp-
tion of glucose into skeletal
muscle and fat cells following
food digestion, which provides
these cells with a source of en-
ergy for metabolism, and also
reduces the concentration of
glucose in the blood. Insulin
signalling also has important
roles in many processes in-
cluding growth, development
and controlling inflammation.

The DM market has under-
gone a dynamic shift over the
past decade, primarily due to
the entry of three new non-in-
sulin drug classes for T2DM:
glucagon-like peptide-1 (GLP-
1) receptor agonists, dipeptidyl
peptidase 4 (DPP-4) inhibitors
and sodium–glucose linked
transporter 2 (SGLT-2) in-
hibitors.

EP News Bureau

77EXPRESS PHARMA

December 1-15, 2017

CPhI & P-MEC INDIA 2017 SPECIAL

Crohn’s Disease diagnosed incident cases
set to increase in the 7MM to 2026

The burden of diagnosed Crohn’s Disease (CD) is expected to grow between 2016 and 2026 in the
seven major markets

Epidemiologists from period, while Italy will have the data is based on a base forecast markets. However, we believe gastrointestinal tract. While any
GlobalData, a leading lowest. A spokesperson from that used literature values the lack of temporal data is a part of the gastrointestinal tract
data and analysis com- the GlobalData Pharma Ana- where there was lack of tempo- data gap, and that in reality, in- can be affected, inflammation is
pany, forecast an increase in the lysts team commented, “The ral data to trend for certain cidence would be likely to in- most commonly found at the
number of diagnosed incident crease based on findings from end of the small intestine
cases, most notably in the US primary research and from (ileum), and the start of the
and Japan. analysis of global trends.” large intestine (colon). The dis-
ease course of CD is charac-
The company’s latest report Therefore, an alternate fore- terised by periods of remission
‘EpiCast Report: Crohn’s Dis- cast of diagnosed incident cases followed by periods of relapse,
ease – Epidemiology Forecast to of CD is also provided for the US the length and severity of which
2026 and the EpiCast Model: and the 5EU markets to esti- differ from case to case. Inflam-
Crohn’s Disease – Epidemiology mate the patient size if trending mation in CD can result in se-
Forecast to 2026,’ confirms that was applied. The increase in inci- vere scarring and narrowing of
diagnosed incident cases of CD dent cases in the alternate fore- parts of the bowel. There is no
in the 7MM will increase from cast is even greater than the cure for CD, and treatment aims
70,985 cases in 2016 to 74,712 main forecast for each market to control symptoms and sus-
cases in 2026, at an Annual included. GlobalData epidemiol- tain remission; it is estimated
Growth Rate (AGR) of 0.53 per ogists estimate the US would that up to three quarters of
cent. In 2016, the US accounted see an increase of CD incident those with CD require surgery.
for 63.23 per cent of the diag- cases to 65,023 cases in 2026, The disease can lead to prema-
nosed incident cases of CD. The and the 5EU will see an increase ture mortality, disability, and de-
US is expected to have the high- to 35,992 cases in 2026. creased quality of life.
est number of diagnosed inci-
dent cases of CD among the CD is an inflammatory bowel EP News Bureau
7MM throughout the forecast disease (IBD) characterised by
chronic inflammation of the

Flexion’s Zilretta poised to shakeup knee osteoarthritis marketplace

The company anticipates a steady stream of novel therapies to enter the OA marketplace over the
next 10 years

FLEXION THERAPEUTICS eron’s fasinumab, as well as the preferred treatment option domised, parallel-group trial ex- in OA biomarker research have
recently announced the FDA DMOADs such as Samumed’s in the US.” amining blood glucose concen- led to the identification of poten-
approval of Zilretta, (triamci- SM04690 and TissueGene’s In- trations in patients with type II tial targets, which is reflected in
nolone acetonide [TA] ex- vossa. Zilretta will face compe- Zilretta is a sustained-re- diabetes, with peak plasma con- the current OA pipeline. The
tended-release injectable sus- tition upon launch of these ther- lease IA injection of TA deliv- centration of Zilretta decreased FDA approval of Zilretta offers
pension) for the treatment of apies; however, its significantly ered in a poly lactic-co-glycolic 40-fold relative to immediate-re- an important alternative ther-
pain associated with moderate- lower cost is likely to position acid matrix (PLGA), which re- lease TA. This is particularly im- apy option to OA patients and
to-severe knee osteoarthritis the therapy earlier in the treat- leases the drug’s active ingredi- portant for comorbid OA pa- marks an important milestone
(OA). This is a segment of the ment algorithm, ensuring a ent in the joint and is subse- tients with type II diabetes, as for the OA space.
patient population that Global- large patient share and peak quently metabolized into carbon conventional IA corticosteroid
Data, a leading data and analyt- sales of over $345m by 2026. dioxide and water. The signifi- injections can elevate blood glu- Sudhul added, ‘‘Even with
ics company, expects to signifi- cance of Flexion’s proprietary cose levels, causing significant the entry of Zilretta to the mar-
cantly drive the value of the Maria Sudul, Healthcare An- microsphere technology is two- distress for these patients and ket, the unmet need for im-
market over the next 10 years. alyst, Globaldata commented, fold. Localised and sustained re- potentially negatively impacting proved therapies remains
‘‘The OA space is largely generi- lease of Zilretta in the joint compliance. largely unfulfilled, with an abun-
The company anticipates a cised, so the entry of Zilretta at a space offers pain relief for over dance of opportunities existing
steady stream of novel therapies hypothetical cost of $500 per in- 12 weeks, which is up to four The OA space has been stag- for the development of novel
to enter the OA marketplace jection is likely to shift the treat- times longer than conventional nant for several decades, largely analgesics and disease-modify-
over the next 10 years including ment algorithm, with Flexion’s TA IA injections. due to the elusive nature of OA ing OA drugs (DMOADs) with
anti-nerve growth factor (anti- extended-release injection re- pathophysiology and conse- improved modes of action.”
NGFs) antibodies such as placing the conventional in- In addition, Zilretta’s prod- quent lack of suitable therapy
Pfizer’s tanezumab and Regen- traarticular (IA) TA injection as uct label includes positive data targets. Recent advancements EP News Bureau
from a double-blind, ran-

78 EXPRESS PHARMA

December 1-15, 2017

CPhI & P-MEC INDIA 2017 SPECIAL

Affluent market,medical tourism to steer best-in line
drug delivery devices in India

Trends indicate that medical tourism will also bolster the demand for sophisticated devices

AS THE GDP per capita in- mand for insulin delivery sys- gresses.” Interestingly, the over- almost swept by overseas play- figuring in the top 10 list.
creases, India’s affluent market tems will only grow as time pro- all drug delivery devices space is ers, with only one domestic firm EP News Bureau
will drive demand for best-in line
drug delivery devices and re-
ward innovations in the years to
come, says GlobalData.

According to the company’s
latest report, ‘India Drug Deliv-
ery Devices Market Outlook
to 2023, – Central Venous
Catheters, Infusion Systems,
Needle Free Injections and Me-
tered Dose Inhaler Devices,’ the
market, which was worth $411
million in 2016, is on course to
touch $510 million by 2023,
clocking a CAGR of 3.1 per cent
from 2016 to 2023.

Trends indicate that medical
tourism will also bolster the de-
mand for sophisticated devices
and emerge as an important
source of revenue for the Indian
medical industry. Relatively af-
fluent patients from more devel-
oped countries are opting India
to get a standard of care at a
fraction of the cost compared to
their home country. As health-
care prices in the developed
world continue to increase, so
too will the interest in medical
tourism in India.

Even as the demand for so-
phisticated products is set to
grow, Indian government is
ready and willing to take strong
measures to control the prices of
devices. This calls for devices
sold within its borders to be ef-
fective as well as cost efficient.

Aging population, prevalence
of chronic diseases, increasing
health awareness are among the
other key factors driving this
market. According to Global-
Data, the country’s aging popu-
lation will take care of volume
growth in future, if not necessar-
ily the quality of products. Cur-
rently, 1.9 per cent of the popula-
tion of India is 75 or above.

James Spencer, Medical De-
vices Analyst, GlobalData, says,
“India is the ‘diabetes capital’ of
the world, and the number of
people suffering from diabetes is
only expected to increase. As
more knowledge and awareness
is spread about diabetes, the de-

79EXPRESS PHARMA

December 1-15, 2017

CPhI & P-MEC INDIA 2017 SPECIAL

UPDATES

FDAapproves Roche drugs for
rare types of blood,lung cancers

The drug is already approved for patients who have been treated with Pfizer's lung cancer drugXalkori

ROCHE HOLDING won US Zelboraf is already ap- The drug is already ap-
approval to market its skin can- proved to treat melanoma, the proved for patients who have
cer drug Zelboraf for certain most serious type of skin can- been treated with Pfizer's lung
patients with Erdheim-Chester cer, in patients whose cancer cancer drug Xalkori whose dis-
Disease, a rare type of blood cells also contain a BRAF V600 ease had nonetheless pro-
cancer, and to market its drug mutation. Only 600 to 700 pa- gressed. Now patients can be
Alecensa as a first choice of tients world-wide suffer from given Alecensa without first be-
treatment for a subset of pa- Erdheim-Chester Disease, and ing treated with Xalkori.
tients with non-small cell lung about 54 per cent of those have
cancer. the BRAF V600 mutation, the Patients with ALK-positive
FDA said. non-small cell lung cancer ac-
The Food and Drug Admin- count for about 5 per cent of
istration approved Zelboraf to Separately, the FDA ap- patients with the condition.
treat patients with Erdheim- proved Roche’s drug Alecensa
Chester Disease whose cancer as initial treatment for patients Non-small cell lung cancer
cells have a genetic mutation with a rare form of non-small accounts for about 85 per cent
known as BRAF V600. It is the cell lung cancer caused by a of the more than 220,000 lung
first FDA-approved treatment mutation to a gene known cancer cases diagnosed in the
for the disease. as ALK. United States each year.

Reuters

Novartis seeks European approval for cell therapy Kymriah

The immunotherapy Kymriah is a key element of Novartis’s efforts to bolster its portfolio of
oncology drugs

SWISS DRUGMAKER No- adults with DLBCL last week. bodies, genetically re-engi-
vartis has submitted its cell The immunotherapy Kym- neered to fight their cancer and
therapy Kymriah for European then reinfused.
approval in two forms of blood riah is a key element of Novar-
cancer, seeking to expand the tis’s efforts to bolster its port- While Kymriah’s landmark
use of a new treatment it hopes folio of oncology drugs. It has approval in August in the US
will eventually become a $1 bil- been hit by the patent expiry of signalled a new era in cancer
lion-a-year seller. its once top-selling blood can- treatment, the drug now faces
cer medicine Gleevec, whose rivals in the DLBCL setting.
Novartis has applied to the market is quickly being eroded Last month, the US Food and
European Medicines Agency by generic rivals. Drug Administration approved
(EMA) for Kymriah to be used Gilead’s Yescarta for patients
in children and young adults “The submission to the with the disease who had failed
with acute lymphoblastic EMA is a major step toward other treatments.
leukemia (ALL) and adult pa- our goal of delivering it to more
tients with diffuse large B-cell critically ill cancer patients Novartis set the price for
lymphoma (DLBCL) who are around the world,” said Vas Kymriah at $475,000 per treat-
ineligible for autologous stem Narasimhan, Novartis’s drug ment for young patients with
cell transplant, the company development chief who will ALL that respond to the treat-
said. take over as chief executive ment, but the Basel-based com-
from Joe Jimenez on Feb. 1. pany has yet to announce the
The therapy has been ap- price for additional indications
proved in the US in paediatric Kymriah is a chimeric anti- and geographies.
ALL and was submitted in the gen receptor T cell (CAR-T)
world’s largest drug market for therapy in which patients’ im- Reuters
mune cells are taken from their

80 EXPRESS PHARMA

December 1-15, 2017

CPhI & P-MEC INDIA 2017 SPECIAL

GSK gets boost for early cancer hopes with
breakthrough status

The decision by the Food and Drug Administration paves the way for a speedy regulatory review of
the BCMA drug for multiple myeloma

GLAXOSMITHKLINE re-
ceived a boost for its oncology
research when an experimen-
tal drug for blood cancer re-
ceived a 'breakthrough' desig-
nation from US regulators.

The decision by the Food
and Drug Administration
paves the way for a speedy
regulatory review of the
BCMA drug for multiple
myeloma.

Although GSK sold its
marketed cancer drugs to No-
vartis in 2015, it continues to
invest in early-stage research

GSK planned
a rapid
programme of
clinical trials
with the new
drug, both
alone and in
combination
with other
therapies

and has said oncology could
become another pillar of its
pharmaceuticals business,
alongside HIV and respira-
tory medicine. The actions by
the US and European regula-
tors are based on promising
Phase I clinical trial results,
details of which will be an-
nounced on December 11 at
the annual meeting of the
American Society of Hema-
tology meeting in Atlanta.

GSK planned a rapid pro-
gramme of clinical trials with
the new drug, both alone and
in combination with other
therapies.

Reuters

81EXPRESS PHARMA

December 1-15, 2017

CPhI & P-MEC INDIA 2017 SPECIAL

Biotech firms race to recruit good bugs in war on cancer

Certain bacteria seem to help in cancer by priming immune cells and smoothing the path for
immunotherapy drugs known as PD-1 drugs

BIOTECH COMPANIES are sive option to license patent Co’s Keytruda or Bristol-Myers oncology in 2018, while Syn- gies - or ramp it up, which is
competing to develop medi- rights under the deal an- Squibb’s Opdivo, but Pomer- logic is also working on experi- needed for the body to fight
cines using 'bugs as drugs' to nounced recently. antz declined to say which mental cancer therapies. back against cancer.
fight cancer, building on the lat- would be used.
est scientific findings that pa- MD Anderson scientists French biotech company The first wave of micro-
tients with high levels of good were among two groups of can- Seres, which is backed by Enterome, meanwhile, is work- biome drugs rely on faecal mi-
gut bacteria are more likely to cer researchers who reported Swiss food giant Nestle, be- ing with Bristol-Myers on mi- crobiota transplantation
respond to modern im- on the benefits of good gut mi- came the first microbiome crobiome-derived diagnostic (FMT), or samples of microbes
munotherapy. crobes in the journal Science drug developer to go public in tests and potential drugs to use distilled from human faeces,
earlier this month. June 2015 but it suffered a set- with the US drugmaker’s im- delivered either as a capsule or
Certain bacteria seem to back last year when its leading munotherapy medicines. by enema. But companies are
help in cancer by priming im- The work underscores the drug candidate failed in a trial also working on synthetically
mune cells and smoothing the importance of the microbiome against C. difficile, a debilitat- “This shift makes sense,” fermented versions.
path for immunotherapy drugs - the vast community of mi- ing gut infection. said Bernat Olle, CEO,Vedanta
known as PD-1 drugs that work crobes living inside us - which of the latest focus on cancer. Seres boss Pomerantz be-
by taking the brakes off the im- has been linked to everything Other companies are com- lieves microbiome science will
mune system. from digestive disorders to de- peting hard. Like Seres, some “About 80 per cent of your open up a major new treatment
pression. are also eyeing the new oppor- immune system cells are in the field, like monoclonal antibod-
Seres Therapeutics hopes tunity in cancer, as microbiome intestine ... but cells that are ed- ies did when they were pio-
to become the first company to Roger Pomerantz, CEO, science moves beyond the ini- ucated in the gut don’t stay neered by Centocor, now part
leverage this discovery through Seres told Reuters the aim was tial focus on gastrointestinal there. Every day they cycle sev- of Johnson & Johnson, three
a collaboration with the MD to start the randomised, conditions like C difficile, ulcer- eral times throughout the body decades ago.
Anderson Cancer Center in placebo-controlled clinical trial ative colitis and inflammatory and some of them will go to tu-
Texas and the Parker Institute in metastatic melanoma in bowel disease. mours.” “Just as Centocor started
for Cancer Immunotherapy 2018, evaluating the impact of monoclonals back in the 1980s,
that will see its microbe medi- giving a newly developed Seres Vedanta Biosciences, an- Advocates argue that mi- we think we are the Centocor
cine tested in a clinical trial. microbiome drug alongside a other US biotech firm that is an crobiome medicine offers a of the microbiome - but of
PD-1 therapy. affiliate of PureTech Health, smart way to both tone down course there will be other com-
The Cambridge, Massachu- plans to file for approval to the immune system response - panies.”
setts-based firm has an exclu- There are currently two ap- start a clinical trial in immuno- useful for conditions like
proved PD-1 drugs, Merck & rheumatoid arthritis and aller- Reuters

Merck's drug gets US FDAapproval Sandoz says new

The drug is expected to be available from December, was clinical data support
approved both as a tablet and an injection
two biosimilars
MERCK'S DRUG to prevent While there are other drugs that
serious infection in patients who treat CMV once it occurs, The trials shows the efficacy and
undergo a type of stem cell attempts to find a safe drug that safety of biosimilar adalimumab
transplant was approved by the can prevent it had failed
US Food and Drug Administra- NOVARTIS’ GENERICS division, Sandoz, said new immunol-
tion, the drugmaker said re- vary based on the duration of the tients who have undergone a ogy data from four clinical studies supported its proposed
cently. Merck said the drug, treatment and individual health- transplant of hematopoietic biosimilars adalimumab for treating psoriasis and cancer drug
which is expected to be available care plans. stem cells, which are located in rituximab.
from December, was approved the bone marrow and derived
both as a tablet and an injection. Merck’s drug, Prevymis, was from a donor. While there are Adalimumab is a copy of AbbVie’s Humira, while rituximab
The list price for the tablets is approved to prevent cy- other drugs that treat CMV once copies MabThera/Rituxan by Roche and Biogen.
$195 per day, while it is $270 a tomegalovirus (CMV) infection - it occurs, attempts to find a safe
day for the injection. a complication associated with drug that can prevent it had The trials showed the efficacy and safety of biosimilar adal-
bone marrow transplants that failed. imumab and the safety of biosimilar rituximab matched their
The recommended dosing treat acute leukemias, other can- reference medicines in studies of multiple-switching and re-
for the drug is once everyday for cers and diseases of the bone Reuters treatment, Sandoz said.
100 days after the stem cell marrow. CMV can occur in pa-
transplant, bringing the effective Biosimilar adalimumab is under European regulatory re-
list price to $19,500 for the view, while biosimilar rituximab has already been approved in
tablets and $27,000 for the injec- Europe and is under review by the U.S. Food and Drug Admin-
tions. The list price of a drug is istration.
not necessarily what patients ac-
tually pay. ‘Out-of-pocket’ costs Reuters

82 EXPRESS PHARMA

December 1-15, 2017

CPhI & P-MEC INDIA 2017 SPECIAL

Novartis posts eye drug data amid play for Eylea’s turf

The Basel-based drugmaker hopes this latest analysis lends RTH258 additional muscle when
matched head-to-head with Eylea

NOVARTIS’S BID to move in tis, whose 2020 US patent expi- Moreover, Roche’s cancer because it costs a fraction of Lu- doctor groups aiming to switch
on Bayer’s and Regeneron’s eye- ration will expose it to cheaper drug Avastin is effective in off-la- centis and Eylea. In Britain, No- to Avastin.
drug turf was buoyed by data copies. bel AMD use and has won favour vartis and Bayer are fighting
showing patients on the Swiss Reuters
drugmaker’s new RTH258 drug
showed less disease activity than
those on its rivals’ drug Eylea.

Active disease was observed
in 23.5 per cent of RTH258 pa-
tients versus 33.5 percent of
Eylea patients at 16 weeks, No-
vartis said, of its investigational
treatment for wet age-related
macular degeneration (AMD),
where abnormal, leaky blood
vessels can cause blindness.

A second, similar study
found active disease in 21.9 per
cent of RTH258 patients versus
31.4 per cent of those on Eylea
for the condition affecting 20-25
million people worldwide.

Novartis in June touted ini-
tial data showing its drug may
require fewer injections directly
into the eye than Eylea, while
matching it on vision and safety
measures.

The Basel-based drugmaker
hopes this latest analysis lends
RTH258 additional muscle when
matched head-to-head with
Eylea as well as Lucentis, which
Roche sells in the United States.

“When you take all of that to-
gether ... we believe we have a
very compelling proposition,”
Vas Narasimhan, Chief Drug De-
veloper, Novartis who will be-
come CEO in 2018, said on a con-
ference call.

Novartis, which released the
data at the American Academy
of Opthalmology conference in
New Orleans, predicts RTH258
annual sales will top $1 billion
and aims to file for US approval
in late 2018.

Making it a success is by no
means clear sailing.

For one, Novartis owns Lu-
centis rights in Europe where it
has contractual obligations to
continue marketing that drug.
Analysts say cannibalisation
from RTH258 will be a chal-
lenge.

Competition abounds, too:
Eylea, with $5 billion in annual
sales, has made inroads against
the $3.2 billion-per-year Lucen-

83EXPRESS PHARMA

December 1-15, 2017

CPhI & P-MEC INDIA 2017 SPECIAL

J&J’s Stelara shows promise against lupus in study

J&J said the results were strong enough to advance Stelara into larger Phase III testing

JOHNSON & Johnson’s block- patients who received a placebo rheumatology meeting in San An estimated 1.5 million Ameri- ment, Stelara failed to achieve
buster psoriasis drug Stelara led on top of standard medicines, Diego. cans and five million people statistical significance over
to a significant reduction in dis- such as steroids or immunosup- worldwide have the disease placebo but showed a trend in
ease activity in patients with sys- pressive drugs, the company re- Lupus is a debilitating and which disproportionately affects the right direction, researchers
temic lupus compared with a ported. sometimes fatal chronic inflam- women. On some secondary reported. Stelara did lead to sig-
placebo in a midstage clinical matory autoimmune disorder measures of disease activity, nificantly fewer disease flare-
trial. Dr Ronald van Vollenhoven, that can affect the joints, skin, such as Physician Global Assess- ups. Van Vollenhoven said trials
the study’s lead investigator, heart, lungs, kidneys and brain. for potential new lupus treat-
Stelara, a biotech drug called the results 'pretty exciting ments were notoriously difficult
known chemically as ustek- and encouraging,' adding that because of the way disease activ-
inumab, is already approved for Stelara’s known safety profile ity tends to come and go and be-
psoriasis, psoriatic arthritis and provided added comfort. cause Stelara can affect patients
Crohn’s disease and had third- differently.
quarter sales of $1.12 billion. J&J said the results were
strong enough to advance Ste- The J&J drug was given in-
In the trial of 102 patients lara into larger Phase III testing. travenously at the start of the
with active lupus despite being There has only been one new trial and then by subcutaneous
on standard therapy, 60 per cent drug approved for lupus in the injections every eight weeks. It
of those who received Stelara ex- last 50 years, GSK’s Benlysta. works by blocking two proteins
perienced improvement on a believed to play an important
scale that measures disease ac- “Any new treatment for lupus role in the immune system’s in-
tivity after 24 weeks of treat- is going to be very welcomed by flammatory process.
ment. That compared with im- patients and physicians,” said
provement in 31 per cent of van Vollenhoven, who was sched- Reuters
uled to present the data at a

Time limit for stroke treatment may be longer in selected patients

The patients, all of whom had an occlusion of the intracranial internal carotid or proximal middle
cerebral artery, were treated at 26 centres in the US, Europe, Canada and Australia

REMOVING A stroke-causing lieve you can benefit beyond 6 to only about 2 per cent to 3 per awake or asleep. versible damage that’s severely
clot from a large blood vessel in hours,” coauthor Dr Tudor cent of the roughly 800,000 Delayed removal did not, undersupplied with blood and
the brain can improve outcomes Jovin, University of Pittsburgh strokes in the US each year, ac- not functioning well, but still
in some patients, even when ex- Medical Center Stroke Institute cording to Dr Jovin. however, reduce mortality, alive,” said Dr Jovin. “It’s not the
traction occurs six to 24 hours told Reuters Health. which occurred at rates of 19 time; it’s that mismatch.”
after symptoms develop, ac- The results of the study are per cent with clot extraction
cording to results of a large new But the results, presented at 'strikingly positive,' said Dr and 18 per cent without. If the clot isn’t removed, “the
test of the technique. the Society of Vascular and In- Werner Hacke, a neurologist at area that’s threatened but not
terventional Neurology’s annual the University of Heidelberg in The patients, all of whom dead will eventually become
Until now, studies have sug- meeting in Boston and online by a Journal editorial. had an occlusion of the intracra- dead,” he explained.
gested that the extraction needs the New England Journal of nial internal carotid or proximal
to be performed within six Medicine, are not going to apply At 90 days, 49 per cent of the middle cerebral artery, were Dr Hacke cautioned that the
hours of the stroke. to all stroke patients. 107 patients who received a treated at 26 centres in the US, findings do not mean doctors
thrombectomy along with stan- Europe, Canada and Australia. can relax the six-hour treatment
The old time limit may still The DAWN study only con- dard care were functionally in- The trial was stopped after the window.
provide the best outcome, but sidered testing the technique, dependent versus 13 per cent of first interim analysis because
the new findings of the DAWN known as thrombectomy, on the 99 who received standard the benefit was so dramatic. “Reducing the time from the
trial open the door to clot re- people with a blockage in a large care alone. onset of stroke to treatment re-
moval for other patients, partic- blood vessel of the brain that The median time between in- mains essential and results in
ularly people who don’t discover had produced symptoms six to The rate of neurological de- clusion in the trial and when the the best outcomes,” he said. “It
their symptoms until they wake 24 hours earlier. terioration was 14% in the clot- patient was last known to be is likely that a limited propor-
up, making the precise time of extraction group versus 26% free of new stroke symptoms tion of patients with occlusion of
onset unknown. In about one third of those with standard care. was 12.2 hours in the thrombec- a large vessel who present late
cases, symptoms were far more tomy group and 13.3 hours in the after the onset of stroke will
The study was financed by severe than a CT scan or an “For every 2.8 patients who control group. It typically took have a small infarct core and a
Michigan-based Stryker Neu- MRI of the brain might suggest, underwent thrombectomy, one another 1.4 hours to remove the large volume of tissue at risk, as
rovascular, which made the clot- and that mismatch made them additional patient had func- clot and restore blood flow to did the patients in the DAWN
removal device used in the trial, candidates for clot extraction, tional independence at 90 days,” the brain. trial. For those patients, late
maintained the database for the said Dr Jovin. That meant some the researchers concluded. The thrombectomy works — but as
study, and analysed the data. degree of blood was still getting benefits were seen regardless of But the key element in decid- of now, as far as we know, it
to the affected areas of the age, stroke severity, time to ing whether to go ahead with works only for them.”
“The stroke community is brain. treatment, the site of the block- clot removal once more than six
going to embrace these results age and whether the stroke hap- hours has expired is whether Reuters
very easily because many be- Those criteria would apply pened when the person was there is a sizable “area of re-

84 EXPRESS PHARMA

December 1-15, 2017

CPhI & P-MEC INDIA 2017 SPECIAL

Trial data suggests new typhoid shot could halve infection rate

The vaccine developed by Bharat Biotech could also be used safely in babies

A NEW typhoid vaccine devel- said in The Lancet that the demic areas. jugate vaccines to prevent ty- fund vaccines at lower prices
oped by privately-held Bharat trial’s results had been The World Health Organiza- phoid. Once the WHO’s recom- for poor countries, will decide
Biotech proved safe and highly “awaited with much anticipa- mendations have been made, whether or not it can finance
immunogenic in a study and tion” by global health experts tion’s expert panel on vaccines the Global Alliance for Vaccines the shots.
could be used to prevent mil- keen to tackle typhoid in en- is due next month to consider and Immunisation, which helps
lions of infections if it succeeds whether to recommend Vi-con- Reuters
in final-stage clinical trials, re-
searchers said.

Typhoid fever affects be-
tween 12 and 20 million people
worldwide in regions where the
quality of water and sanitation
is low, particularly in south
Asia and sub-Saharan Africa.

Around one in 100 cases is
deadly, and about 3 per cent of
those infected become chronic
carriers of the disease.

Results of a mid-stage trial
of the vaccine, a so-called Vi-
conjugate shot which, its devel-
opers say, could also be used
safely in babies, showed it was
able to prevent half of those
vaccinated from developing ty-
phoid when they were exposed
to it.

“Our study provides further
evidence to support the devel-
opment of Vi-conjugate vac-
cines as a control measure to
reduce the burden of typhoid
fever,” said Andrew Pollard of
Oxford University’s vaccine
group, who co-led the trial.

Experts say that while chil-
dren are particularly suscepti-
ble to typhoid, no vaccine has
yet been licensed for worldwide
use in babies under 24 months
old. This study, published in
The Lancet medical journal, was
conducted in 112 adult volun-
teers and used a ‘controlled hu-
man infection model.’ Volun-
teers are randomly assigned to
be given either the experimen-
tal vaccine or a control one, and
then deliberately exposed to
the pathogen. Participants are
closely monitored and treated
for infection afterwards.

Studies like this have been
used in the development of var-
ious vaccines, including shots
against cholera, since they are
a fast and clear way to assess
whether a vaccine works.

Nicholas Feasted, an expert
at the Liverpool School of
Tropical Medicine in Britain,
and Myron Levine of the Uni-
versity of Maryland in the US,

85EXPRESS PHARMA

December 1-15, 2017

CPhI & P-MEC INDIA 2017 SPECIAL

‘We received an excellent reaction
from the European market’

Suresh Pareek, MD, Ideal Cures, in an interaction with Express Pharma,
talks about the uniqueness of INSTACOAT 4G, which was recently
displayed at CPhI Worldwide

What are the major to equipment, from company to 4G may reduce energy system). shown to maximise the
advantages of INSTACOAT company and by geographic consumption since it has ◗ INSTACOAT 4G allows for potential of batch and
4G over other coating location. Typical values are shorter coating process time high solids reconstitution level continuous coating machines –
technologies? used and it is used as a and may in turn reduce of 35 per cent at low viscosity A poster detailing the
INSTACOAT 4G stands today representative analysis. Under equivalent CO2emissions by values and increased spray INSTACOAT 4G trial
as one of those rare coating the assumptions provided in 79.2 per cent per year rates conducted on continuous
formulations that can maximise this article, using INSTACOAT (compared to HPMC coating ◗ INSTACOAT 4G trials have coaters, was presented at
the potential of advanced AAPS 2016 as well as AAPS
continuous and batch coaters. NSTACOAT 4G - CO2 EMISSION 2017
Our team has also presented ◗ AAPS 2017 Posters include:
papers on this innovation at Reconstitution levels Energy Equivalent CO2 CO2 emission CO2 saving
AAPS 2017, held in San Diego consumption emission (kg/year)** per year (%)*** T5047: Coating
this year. (KWhr/batch*) Performance Evaluation of
(kg/batch)# INSTACOAT 4G in a
Some of the major features Bectochem Lodige Coater
of INSTACOAT 4G include but Reference (11 per cent) Approx. 610 (1) 328 1,97,000
are not limited to: T5050: Evaluation of
◗ High production output with Reference (20 per cent) Approx. 340 183.3 1,09,000 44.7 INSTACOAT 4G High
approximately 60 per cent Productivity Coating System
reduction in the coating INSTACOAT 4G (35 per cent) Approx. 126 67.8 41000 79.2 using O’Hara Technologies
process time compared to Continuous Coater
HPMC-based film coating Parameters Traditional HPMC Batch Coater (60 inch pan) INSTACOAT 4G
systems Based Aqueous System PVA Based System T5051: Coating
◗ Reduced energy consumption Performance Study of
by virtue of reduced coating Batch size (kg) 11 300 35 INSTACOAT 4G using various
time results in reduced carbon % Solids 6.8 20 spray guns and nozzles
emissions and carbon footprint 2.10
making INSTACOAT 4G a Target Weight Gain ( % ) 3 60% w.r.t HPMC, 40% w.r.t PVA W1031: Evaluation of
best-in-class eco-friendly No. of Guns 5 Coating Performance of
coating system 200 INSTACOAT 4G in the
◗ There is an approximate Spray Rate (g/min) 3.8 Bectochem Perforated Pan
reduction of 80 per cent in Process Time (Hr.) ◗ Innate moisture barrier
carbon emissions/ year with % Time Reduction properties as the Polymer is
INSTACOAT 4G compared to PVA and the absence of
traditional coating systems (11 Parameters Traditional HPMC PVA Based System INSTACOAT 4G plasticizers like PEG
per cent) Based
◗ *Batch size = 300 kg, There is no gun blockage,
◗ ** 2 batches of 300 kg/day in a Aqueous System tablet sticking and picking,
year (300 working days in a giving the end product a
year) Process Time (Hr.) for 1 batch of 300 kg 6.8 3.8 2.10 smooth finish with excellent
◗ *** With respect to 11 per cent Process Time (Hr.) /Year (Assuming 2 4080 2280 1260 uniformity
reconstitution levels batches of 300kg for 300 working days) ◗ Cost saving
◗ # 0.5377(CO2 conversion Approx. 60 per cent
factor used for calculations, Time Saving time saving w.r.t HPMC Cost-savings by virtue of
Ref: Carbon Trust, “Conversion and 40 per cent w.r.t PVA high production output,
factors: Energy and Carbon reduced energy consumption,
Conversions” 2011) shorter process times,
Assumptions: All the decreased labour cost and
parameters are based on reduced machine-free time.
assumptions. These More than 60 per cent
assumptions were used to
quantify both the (Table 3) Parameters Reference (11 per cent) Reference (20 per cent) INSTACOAT 4G
aforementioned energy
consumption and the Energy Consumption (KWhr/batch*) Batch size – 300kg 610 340 126
production capacity of a single 3,66,000 2,04,000 75600
coater. These numbers may Energy Consumption (KWhr/year) Assuming 2 batches of
obviously vary from equipment 300 kg, 300 working days ` 25,87,620 ` 14,42,280 ` 5,34,492

Cost spent on energy (Rs 7.07/ unit of KWhr, Palgarh Approx. 80 per cent cost saving w.r.t
District) 11 per cent and 60 per cent w.r.t 20

Cost-saving w.r.t traditional systems per cent solids

86 EXPRESS PHARMA

December 1-15, 2017

CPhI & P-MEC INDIA 2017 SPECIAL

reduction in process time is Products launched (Type and size Range (#)) greatly reduce transportation have received at least six
seen with respect to (w.r.t) time, cost and labour. months of training at our Vasai
traditional HPMC-based film MCC Spheres #20 - #30, #30 - #40 and #40 - #60 or Jammu facility. We take
coating systems. Reduced The second phase of our pride in being preferred
energy consumption (Kwhr) Sucrose Spheres #20 - #30 facility will be commissioned suppliers for excipients and this
allows for approx. 70 per cent soon, allowing for the new facility is another floret
reduction in costs: Tartaric Acid #20 - #30 and #30 - #40 production of coloured coating added to our blossoming
material. Manufacturing of bouquet of services. We are
How was your experience at Silicon Dioxide Spheres #30 - #40 and #40 - #60 white coating material has assured that our clients will
CPhI Worldwide? Did you already begun and will continue welcome this new venture and
launch any new products? 40 pharmaceutical customers and close to the new with exponential speed. will continue to give us
An avid participant of this manufacturing plants in North- airport, we are in a position to opportunities to serve them!
prestigious exhibition, our East out of which 32 are in deliver our coating materials We have specifically
booth was well received and Sikkim. With our new facility, within the shortest time recruited locals for this facility EP News Bureau
saw continuous interaction. we are the first excipient possible, sometimes even on and have ensured that they
Some great opportunities provider in the vicinity. Being the same day post
presented themselves and we centrally located to our manufacturing. This will
were eager to showcase our
new innovation – InstaSpheres. Visit us at CPhI India P-MEC 2017
We received an excellent
reaction from the European /// November 28 - 30, 2017
market and are assured that
InstaSpheres will be welcomed MUMBAI
in India as well. Hall: 7A | Stall No: V1

To give a little introduction, FEATURES OF THE ElectraSyn flow basic |
InstaSpheres is our take on seal ELECTRASYN FLOW BASIC AT A GLANCE ElectraSyn flow eco
coated spheres, available in › complete system
MCC, Sucrose, Tartaric Acid › nine combinable half cells Ident No. 0020014266 |
and Silicon Dioxide at various › product recirculation capability 0020014267
commercial sizes. › cell splitting by means of proton / cation INR 8,03,712.00 |
INR 5,85,321.00
These ready-to-drug layer exchange membrane
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that you do not waste your time 814/475, Survey No.129/1 Mysuru Road,
doing it. Kengeri Bengaluru 560060, Karnataka, India
Phone: +91 80 26253 900, Fax: +91 80 26253 901
Being available for eMail: [email protected], web: www.ika.com
immediate drug layering they
eliminate initial coating time.
Reduction in overall processing
time brings about massive time
and cost saving. These spheres
are robust with zero friability
and negligible dust generation.
Product consistency is
maintained with uniform drug
loading. There is tight particle
size distribution with batch to
batch consistency.

We are very excited about
these 'Next Generation'
spheres and look forward to
introducing our customers to
them at CPhI India.

Tell us more about the Sikkim
facility. What was the reason
behind choosing the state?
A state-of-the-art, +7500 sq mt
facility with an average
capacity of 75 MT/month, our
newly commissioned Sikkim
facility opened doors in March
2017. The main idea behind
setting up manufacturing at a
remote location was to provide
ease of business for our
customers. There are around

87EXPRESS PHARMA

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Risk-based monitoring: Gaining ground

Risk-based monitoring (RBM) adoption is building momentum as pharma companies and CROs
are shifting focus and are developing strategies to develop processes. An insight by
Dr Bina Naik, Chief Operations Officer, CBCC Global Research

Clinical trial sponsor’s man subject protection and not only resource-intensive, central repository it is easier which involves identifying
regulatory obligation is data integrity. The new GCP but limited in its ability to to identify outliers and trends risks, analysing risks and de-
to ensure proper moni- takes evolution of technology identify and prevent issues in the data. Access to the cen- termining whether risk can be
toring of investigation at each into consideration and en- proactively. The TransCeler- tralised data also makes is modified by implementing
enrolling site. In order to ful- courages sponsors to pursue ate BioPharma consortium possible to compare data be- control. Assessments of pa-
fill this requirement, frequent innovative approaches for member companies con- tween sites to assess perform- rameters to identify risks that
onsite monitoring visits, i.e., conducting clinical trials. QbD ducted a retrospective analy- ance and identify potentially could affect the collection of
100 per cent source data veri- and risk-based quality man- sis to assess queries identified fraudulent data. Centralised critical data or the perform-
fication (SDV) with regularly agement are now recom- via SDV to find the percent- data analysis enables cross ance of critical processes is of
scheduled monitoring visits mended as approaches of age of SDVgenerated queries functional team approach utmost importance ,to list a
has been industry’s long choice to sponsors of clinical in critical data. The total was with coordination between few – site characteristics, site
standing practice. These mon- trials. only 2.4 per cent, suggesting monitors, data managers, performance metrics, (e.g.,
itoring activities include en- that SDV has little impact on statisticians, medical moni- high screen failure or with-
suring that rights and well be- Beyond the regulatory the quality of the data. tors, and site staff. drawal rates, high frequency
ing of trial subjects are guidance, the TransCelerate ◗ RBM provides greater com- of eligibility violations, delays
protected, compliance with BioPharma consortium (a Risk-based monitoring pliance with GCP and relevant in reporting data), complexity
protocol, proper IP handling non-profit organisation fo- aims to more efficiently de- regulatory requirements3 of the study design, types of
and management and verifica- cussed on advancing innova- ploy resources across studies study endpoints, and clinical
tion of accuracy of data en- tion in research and develop- based on their specific levels Integrating QbD and RBM complexity of the study popu-
tered into the database ment) has published a of risk, with the goal of reduc- lation; geography, and other
against the primary source of position paper with opera- ing total monitoring resource QbD concept is based on the factors such as the experience
the data. tional analysis, best practices, requirements while maintain- premise that quality should be of partners working with each
and practical tools for imple- ing patient safety and data part of the project planning other, use of electronic data
This thinking was changed menting risk-based monitor- quality. process. In clinical research capture systems, the stage of
in August 2013, when the FDA ing. TransCelerate’s method- the protocol identifies the the trial .This assessment as-
introduced the final guidance ology focusses on building Some of the benefits are: quality requirements and de- sists in appropriate resource
for a risk-based approach to quality and risk management tailed plans and activities allocation to areas of greatest
monitoring in clinical investi- approaches into the scientific ◗ Cost efficiency: Out of the complement what is in the need.
gations. This guidance sup- design and operational con- total cost of bringing drug to protocol. Key factors to QbD
ports selective monitoring, duct of clinical trials to miti- market, approximately 30 per methodologies include a well- No single approach to
provided that the selective ap- gate risk and detect issues cent of the cost is site moni- designed protocol, proper exe- monitoring is apt or neces-
proach is justified in a risk- early. toring cost. RBM is the way to cution of the protocol, steps to sary for every clinical trial.
based monitoring plan linked improve clinical trial quality assure protocol compliance, FDA recommends that each
to sponsor’s assessment of op- While FDA guidelines and and increase efficiencies by corrective and preventative sponsor design a monitoring
erational and patient safety new Good Clinical Practice reducing low value on site action methodologies, clear plan that is tailored to the
risks. The FDA believes that (GCP) guidance provide the monitoring and concise communication subject protection and data
targeted risk-based monitor- foundation to RBM processes ◗ Better quality: As compared strategies, a well designed integrity risks of the trial.
ing ( RBM) that focus on criti- and methodologies, RBM to on-site monitoring, ongoing case report form (CRF) to RBM, by building quality and
cal data elements will result in adoption is gradually building remote monitoring identifies capture critical data accu- risk management approaches
more effective monitoring and momentum as pharma com- issues earlier, enabling quick rately and to ensure uniform into clinical trial design and
help to overcome many of the panies and CROs are shifting resolution and creating data collection across investi- management integrates early
limitations of on-site monitor- focus and are developing strategies to prevent recur- gator sites. and ongoing risk identifica-
ing. There is a growing con- strategies to develop 2 rence thereby providing im- tion and mitigates risks early
sensus that risk-based ap- processes and deploy appro- proved quality of analysis. A good way to integrate or even prevents them en-
proach is more likely to priate technology to adopt With all data flowing into a improved protocol quality is tirely.
ensure subject protection and risk-based monitoring of clini- to have initial cross-functional
overall study quality while im- cal trials to improve data discussions to incorporate The monitoring process
proving efficiency. quality, trial efficiency and pa- QbD, review of protocol for with RBM
tient safety. clinical trial quality, risk iden-
ICH GCP E6 R2 is an im- tification, risk mitigation and ◗ Data collection and submis-
portant milestone in driving Why adopt risk-based prioritisation. sion.
adoption of Quality-by-Design monitoring?
(QbD) and quality risk man- TransCelerate methodol- A centralised approach re-
agement principles and Clinical trials are becoming ogy for risk-based monitoring quires a steady and reliable
methodologies in clinical de- more complex and costly. Var- includes risk assessment, de- flow of data from each study
velopment. The revision pro- ious studies have estimated termination of critical data site to the central monitoring
motes implementation of effi- monitoring costs at around 30 and processes and mitigation system. This will take place
cient approaches to clinical per cent of the total study of the risks through inte- through entry of relevant data
trial design, conduct, over- budget. The traditional ap- grated quality and monitoring into an electronic database.
sight, recording and reporting proach, heavily reliant on ex- plan. The sponsors are en- ◗ Back office /centralised
while continuing to ensure hu- haustive on site source data couraged to carry out early monitoring
verification has proven to be and ongoing risk assessment
Centralised monitoring

88 EXPRESS PHARMA

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CPhI & P-MEC INDIA 2017 SPECIAL

processes provide additional safety measures. However it is Step 4. EMA, 2013. Reflection Paper Trials, Oct 20, 2015.
monitoring capabilities that some time before industry to 4 version dated 9 November on Risk Based Quality Man- 7. FDA Guidance for Industry:
can complement and reduce adopt RBM and for the onsite 2016 agement in Clinical Trials Q9 QRM, June 2006.
the extent and/or frequency of visits to decrease. ICH GCP 2. FDA, August 2013. Guidance (EMA/INS/GCP/394194/2011) 8. Quality by Design: Concepts
on-site monitoring and help E6 (R2) will propel the adop- for Industry - Oversight of 5. Position Paper: Risk-Based for ANDAs ,Robert A. Lion-
distinguish between reliable tion of RBM. Clinical Investigations - A Monitoring Methodology, 2013 berger, Sau Lawrence Lee,
data and potentially unreli- RiskBased TransCelerate Biopharm Inc LaiMing
able data. References Approach to Monitoring 6. Andrianov A, Wilder B, Lee, Andre Raw, and Lawrence
◗ Identify missing data, incon- 3.European Medical Agency. Proupin-Perez M. ICH GCP X. Yu, AAPS J. 2008 Jun;
sistent data, data outliers, un- 1. Integrated Addendum to ICH (2015) Guideline for good clini- Goes Risk Based. Applied Clin- 10(2): 268–276.Published on-
expected lack of variability E6 (R1): Guideline for Good cal practice E6(R2) 4 - Step 2b ical line 2008 May 9.
and protocol deviations. Clinical Practice (R2) Current
◗ Examine data trends such
as the range, consistency, and PHARMACEUTICAL
variability of data within and
across sites. Solutions
◗ Evaluate for systematic or
significant errors in data col-
lection and reporting at a site
or across sites; or potential
data manipulation or data in-
tegrity problems.
◗ Analyse site characteristics
and performance metrics.
◗ Select sites and/or
processes for targeted on-site
monitoring.
◗ Targeted on-site investiga-
tion

Centralised monitoring
and further analysis will rec-
ommend further require-
ments of monitoring, recom-
mending traditional onsite
visits for source data verifica-
tion in certain cases.

Challenges to Lubrizol LifeSciences is your pharmaceutical solution partner.
implementation of RBM We provide support from idea to execution.

Some of the challenges that How we do it:
have prevented companies
from moving to RBM include • Polymers: high performance pharmaceutical ingredients
the level of change manage- for applications including sustained release oral solids,
ment required to adopt an semisolid and liquid, transdermal applications and drug
RBM approach, lack of expe- eluting devices
rience with and ability to feel
confident in data quality if not • Formulation: advanced drug delivery solutions, including
performing 100 per cent SDV, drug-eluting devices
and lack of industry experi-
ence with approval of new • Manufacturing: contract manufacturing for complex
drug applications that moved pharmaceutical drug delivery systems
away from the old 100 per
cent SDV model. The spon- To learn more, visit www.lubrizol.com/lifesciences
sors will have to take a sys- or email [email protected]
tematic approach and plan
steps towards implementa- © 2017 The Lubrizol Corporation, all rights reserved.
tion of quality management All marks are the property of The Lubrizol Corporation.
framework ensuring overall The Lubrizol Corporation is a Berkshire Hathaway company. 17-80600
risk management. Lubrizol Advanced Materials India Pv.t Ltd., 5th, 6th & 7th Floor, Jaswant Landmark, LBS Marg, Vikhroli (W), Mumbai- 400079, India
Ph.: +91 22 6607800 Email id : [email protected]
Conclusion

Compared to earlier monitor-
ing methods, like 100 per cent
source data verification, RBM
clearly demonstrates advan-
tages. Beyond cost saving the
obvious benefits of RBM are
better quality data, improved
timelines and robust patient

89EXPRESS PHARMA

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Beyond just a filler – application of calcium
phosphates in direct compression formulations

Daniel Zakowiecki, Marek Lachmann and Tobias Heß Chemische Fabrik Budenheim, in this
article outlines the most important properties of various grades of calcium salts of
orthophosphoric acid

CALCIUM PHOSPHATES are hard, inorganic compounds well as fine materials for granula-
have been used in the pharma- which during compression un-
ceutical technology for many dergo mainly brittle fracture. Be- tion processes. This article out-
years. They have many physical cause of that property they show
and chemical properties that very good compaction proper- lines the most important prop-
make them ideal candidates for ties allowing preparation of hard
the production of solid oral tablets. In addition to that erties of various DC grades of
dosage forms. They are mainly tablets made with calcium phos-
used as fillers in order to bulk up phates do not expand in volume calcium salts of
formulations [1] however, the upon ejection from the die. A
function of calcium phosphates phenomenon commonly ob- orthophosphoric acid:
goes far beyond mere filler and served after decompression of
the adequate utilisation of their elastic or plastic-elastic materi- ◗ dibasic calcium phosphate an-
full functionality can support als. Another essential feature of
achieving the intended formula- calcium phosphates is their low hydrous: DI-CAFOS® A150 and
tion goals. lubricant sensitivity. Increased
DI-CAFOS® A60
Calcium phosphates are in- amounts of lubricants or longer
organic substances of mineral mixing time do not significantly ◗ dibasic calcium phosphate di-
origin and therefore are charac- affect the compaction properties
terised by exceptional chemical of powder mixtures containing hydrate: DI-CAFOS® D160
stability. For the same reason, calcium phosphates.
they are compatible with most ◗ tribasic calcium phosphate:
of known drug substances. The There are many different
few exceptions include in- types of calcium phosphates TRI-CAFOS 500 manufactured
domethacin and tetracycline available in the pharma market
antibiotics which form with the including coarse DC grades as by the German company
calcium ions hardly absorbable
complexes. Tribasic calcium Chemische Fabrik Budenheim
phosphate (USP) shows incom-
patibility with the tocopheryl Daniel Zakowiecki Marek Lachmann (called further Budenheim) and
acetate which is related to the
large number of hydroxyl sion process. Due to their granulation. Very high density of intended for direct compression
groups on the surface of the favourable particle size and calcium salts of orthophosphoric
substance. [1,2] shape calcium phosphates ex- acid allows either using of larger processes. Furthermore, it pres-
hibit excellent flowability. Fur- amounts of excipients without
Calcium salts of orthophos- thermore, they enable to govern increasing the size of the dosage ents the properties of tablets ob-
phoric acid do not interact with the flow pattern of poorly flow- form or decreasing it when the
water and therefore can be suc- able powders, which allows for same quantity of excipient is tained from these products
cessfully used in any technolog- relatively easy preparation of used.
ical operations involving water tableting mixtures without the showing how many different for-
as a completely inert densifier. Dibasic calcium phosphates
Due to the very high content of mulation purposes they help to
calcium and phosphorus they
are very often used in dietary achieve.
supplements. Especially hydrox-
yapatite finds wide spread use Functional properties of
due to its calcium to phospho- calcium phosphates
rous ratio which is identical to
the one present in human bones. Grains of dibasic calcium phos-
phate (DI-CAFOS® A150,
Calcium phosphate based ex- DI-CAFOS® A60 and DI-
cipients possess many functional CAFOS® D160) are aggregates
properties making them ideal of fine primary particles of vari-
candidates for direct compres- ous shapes and sizes. The SEM
pictures show the almost spher-
ical shape of the calcium phos-
phate particles (Fig 1 - 3). At the
same time the surface is uneven
and well-developed which facili-
tates uniform blending with
other ingredients.

The surface of tribasic cal-
cium phosphate (TRI-CAFOS®
500) is vast and its structure re-
sembles a sponge (Fig. 4). Owing
to this very special structure
during mixing fine particles of
other substances, including API,
can easily adhere to the larger
particles of phosphates and im-
prove the efficiency of mixing
processes.

Calcium phosphates are
characterised by very high

90 EXPRESS PHARMA

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CPhI & P-MEC INDIA 2017 SPECIAL

volumetric mass density which, hydrates even if mixed with wa- and thus the amount of potential binding capacity results from porosity and size expressed as
in conjunction with the ter for a long time. binding sites between powder the extensive specific surface tablet volume. The tablets con-
favourable shape of the particles, particles is elevated. Enhanced area and consequently a large tained 99.5 per cent of the se-
provides excellent flow proper- Tableting properties of bonding capacity allows produc- number of potential binding lected calcium phosphate and
ties. On top of that, the elevated calcium phosphate DC tion of tablets of high hardness sites. [3,5] 0.5 per cent lubricant (magne-
density allows a significant re- excipients even at relatively low compres- sium stearate). Powder mixtures
duction of tablet or capsule size sion forces. [3,4] Tribasic calcium Fig 5 - 7 show a comparison of were compressed into tablets
without changing their weight. Dibasic calcium phosphates un- phosphate (TRI-CAFOS® 500) some physical properties of the using the Fette 102i rotary tablet
Alternatively it allows using dergo fragmentation by brittle behaves differently and during tablets obtained using four DC press (Fette Compacting ,
larger quantities of the sub- fracture. Due to this deformation compression undergoes mainly calcium phosphates which are Schwarzenbek, Germany) at
stance without increasing the mechanism the specific surface plastic deformations. Its high manufactured by Budenheim - three compaction forces: 10 kN,
size of the dosage form. This is of area of the particles is increased tablet hardness (breaking force),
significant importance when
working with drug substances
characterised by poor flowabil-
ity or/and compactibility and al-
lows overcoming these chal-
lenges.

A very important aspect is
the behaviour of calcium phos-
phates in aqueous environment
since it can impact on drug effi-
cacy. Generally, these substances
are insoluble in aqueous media
at neutral or alkaline pH. How-
ever they are soluble in diluted
acids, e.g. 0.1 M hydrochloric
acid. That means that in acidic
environment prevailing in the
stomach they dissolve com-
pletely without causing the dan-
ger of retaining the drug in the
tablet matrix. Consequently
there is no perturbation in disso-
lution behaviour and absorption
from the gastrointestinal tract.
Furthermore, in contact with
water or aqueous solutions cal-
cium phosphates do not swell or
form hydrogels. They do not dis-
integrate easily themselves,
however, the application of small
amounts of commonly used dis-
integrants (eg. croscarmellose
sodium or cross-linked
polyvinylpyrrolidone) allows
producing tablets with a very
short disintegration time (Fig.6).

Dibasic calcium phosphates
are not hygroscopic and under
conditions normally prevailing
in laboratory or manufacturing
area are chemically and physi-
cally stable. [1,4] Tablets contain-
ing these substances do not tend
to undergo changes in tablet
hardness if properly stored. [6]

The tendency of the anhy-
drous organic excipients to form
hydrates in contact even with
small amounts of water vapour
being present in the air is well
known. Such negative effect is
not observed in the case of cal-
cium phosphates. It should also
be mentioned that the anhy-
drous dibasic calcium phosphate
(DI-CAFOS® A60 and DI-
CAFOS® A150) does not form

91EXPRESS PHARMA

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20 kN and 30 kN. The results ity make them ideal candidates successfully applied in the References 4. Zebrowska W, Sawicki W. Excipi-
shown in Fig 5 indicate that both for direct compression processes of wet or dry granula- ents. The applied pharmacy (ed. Jan-
dibasic calcium phosphate anhy- processes. Since the main defor- tion. The advantage of using 1. Rowe CR, Sheskey PJ, Quinn ME. icki S, Fiebig A, Sznitowska M).
drous (DI-CAFOS® A150) and mation mechanism that occurs them is ease of handling. In addi- Handbook of Pharmaceutical Ex- PZWL,Warsaw2008,pp.652-6935.
dihydrate (DI-CAFOS® D160) during compression of calcium tion to high bulk density, they cipients (6th ed.). Pharmaceutical 5. Patel NK, Patel BR, Plakogian-
have very good tableting proper- phosphates is brittle fracture, contain a smaller fraction of fine Press, London 2009 nis FM, Reier GE. An evaluation of
ties. Even at relatively low com- these materials are less sensitive particles. Therefore dust gener- 2. Khan MA, Reddy IK. Calcium tricalcium phosphate excipients
paction forces tablets of high to differences in production ated during weighing and siev- phosphate in pharmaceutical prod- particularly using instrumented ro-
hardness (breaking force) can be equipment, speed of tableting or ing is minimal. Until recently, the uct development. Calcium phos- tary and single station tablet
obtained. It should be also noted lubricant addition. Such robust- excipients were considered phates in biological and industrial presses. Drug Dev. Ind. Pharm.
that in the case of Di-CAFOS® ness can prove to be helpful dur- solely as inactive ingredients systems (ed. Zahid Amjad). Kluwer 1987; 13: 2693-2718
A150 the compaction force has a ing scaling-up of technological used only in order to bulk-up Academic Publishers, Boston 1998, 6. Ahlneck C, Alderborn G. Mois-
very significant impact on tablet processes. Although this article powders and facilitate their fur- pp. 303–323 ture absorption and tableting II.
hardness. focuses on the functional prop- ther processing. Nowadays how- 3. Bolhuis GK, Chowhan ZT. Mate- The effect on tensile strength and
erties of phosphate for direct ever it is well known that they rials for direct compaction. Phar- air permeability of the relative hu-
DI-CAFOS® A60 is a mate- compression it should not be for- may also have a crucial impact maceutical Powder Compaction midity during storage of tablets of
rial of exceptionally high density gotten that the coarse grades of on a long-term stability of drugs Technology (ed. Alderborn G, Nys- 3 crystalline materials. Int J Pharm
and very low porosity. These calcium phosphates can also be as well as their efficacy. tröm C). Marcel Dekker Inc., New 1989; 56: 143-150
properties can be employed to York 1996, pp. 419–478
obtain tablets or capsules of re-
duced size (Fig 6). Dosage forms
of smaller size increase the com-
fort of intake and thereby en-
hance patient compliance, espe-
cially for pediatric or geriatric
applications. Moreover, DI-
CAFOS® A60 can be used to de-
sign dosage forms with high den-
sity, greater than a density of
gastric fluid, which settle in the
lower part of the antrum and
thus affect gastric retention
time. On the other hand, it
should be kept in mind that the
low specific surface area of DI-
CAFOS® A60 necessitates
higher compaction forces to be
employed to yield tablets of suffi-
cient hardness.

TRI-CAFOS® 500 is mostly
not used as the sole filler in DC
mixtures but can be successfully
used as additive to commonly
used filler materials. When used
in tablet formulations in a con-
centration of 10 – 30 per cent its
large specific surface area in-
creases the bonding capacity of
the powder mixtures and facili-
tates an increase of tablet hard-
ness and porosity at the same
time (Fig. 8 - 9). Apart from cal-
cium phosphates (DI-CAFOS®
A150 and TRI-CAFOS® 500) the
tablets contained 2 per cent of
croscarmellose sodium as a disin-
tegrant and 0.5 per cent of a lu-
bricant (magnesium stearate). It
should also be noted that apart
from increasing the tablet hard-
ness, admixture of TRI-CAFOS®
500 can increase tablet matrix
porosity and consequently sig-
nificantly shorten disintegration
time (Fig 10).

Summary

Many properties of calcium
phosphates such as excellent
flowability or high compactibil-

92 EXPRESS PHARMA

December 1-15, 2017

CPhI & P-MEC INDIA 2017 SPECIAL

Coating performance evaluation of INSTACOAT
4G using various spray guns

Suresh Pareek, MD, Ideal Cures and Sanjay Negi, DGM Film Coatings, Ideal Cures, give an insight
the coating performance of IDEAL CURES revolutionary product INSTACOAT 4G with high solids
capability, in combination with different spray guns

THE PHARMACEUTICAL in- Suresh Pareek, MD, Sanjay Negi, DGM Film Coatings, and product quality. In a coating process it is very
dustry is witnessing a transfor- Ideal Cures Ideal Cures The present study evaluates important that the coating sus-
mation from conventional batch pension must be distributed
to automated continuous pro- the coating performance of evenly on the tablet bed. Spray-
cessing in response to changing IDEAL CURES revolutionary ing guns are used to achieve the
requirements. There have also product INSTACOAT 4G with desired distribution. Most often
been many improvements in the high solids capability (35 per these are atomisers that use
design of spray guns with the cent solids), in combination compressed air to atomise the
aims of improving coating with different spray guns (Gan- coating suspension. There are
process efficiency and the qual- sons GHPN-III, Spraying Sys- three common gun types: 2-port,
ity of appearance of the finished tems, RAU & Schlick 930 ABC). 3-port and 4-port. The simple 2-
product. With similar aims, there High Solids and low viscosity port spray gun has one port for
have been parallel developments capability of INSTACOAT 4G the liquid coating suspension and
in the coating formulations that makes it the preferred choice the other is for the atomising air.
enhance the coating efficiency for all types of spray guns and In a 3-port spray gun, the atomi-
coating equipment.

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sation and spray activation pres- blockage issues. Coating trials due to its low viscosity capabili- TABLE NO. 1: COATING PROCESS PARAMETERS
sures can be controlled inde- were performed using optimised ties. (Ref. Figure No. 2).
pendently which allows the spray coating conditions at the Ideal Batch Size (kg.) 10
width to be controlled. In a 4-port Cures laboratory facility in a Evaluation of coating
spray gun, three ports are for air Gansons Autocoater Model process Inlet Air Temperature (°C) 60-70 65-70 65-70
and one for liquid, and these al- GAC-600 fitted with a 24-inch di-
low for the independent control ameter pan. Refer Table No. 1 for An approximate 60 per cent re- Product Bed Temperature (°C) 42-45 42-45 42-45
of activation pressure, atomisa- process Parameters. duction in the coating process
tion pressure and spray width. time was seen, in comparison to Inlet CFM 350 350 350
Spray Guns from Schlick, traditional coating formulations.
Process summary Spray Systems (RAU) and Gan- This time saving advantage can Atomizing Air Pressure (kg/cm2) 2.2 2.2 2.2
sons (GHPN-III) were used for be attributed to the ability of
INSTACOAT 4G was reconsti- the experiments. Spray patterns INSTACOAT 4G of reconstitut- Fan Air Pressure (kg/cm2) 3 3 1.8
tuted at 35 per cent solids and were visualised on paper sur- ing at a high solid level of 35 per
applied at a target weight gain of faces using each nozzle at a dis- cent, while maintaining low vis- Pan Differential Pressure (bar) 5-6 5-6 5-6
2.5 per cent w/w. High Solids and tance of approximately 12 to 15 cosity value. (Ref. Figure No. 1)
low viscosity capability of IN- cm inches’ distance from the Coating suspension was agglom- Pan Speed (rpm) 11-13 11-13 11-13
STACOAT 4G allows quick dry- gun. Fine spray mist could be erate free and easily sprayable.
ing of the tablets without any gun achieved with INSTACOAT 4G No gun blockage was observed Spray Rate (g/min.) 23.62 22.76 27.7

FIGURE NO. 1: COATING PROCESS TIME COMPARISON Spray Time (min.) 47 28 33
Weight gain (%) 3 33

FIGURE NO. 2: SPRAY PATTERNS OF DIFFERENT SPRAY NOZZLES during the entire coating process. vides precise, simplified solutions
There were no coating defects, no uniquely shaped to meet a cus-
1) Gansons GHPN-III color uniformity concerns tomer’s requirements.
(DE<1.5) and coated tablets ex-
2) Spraying Systems RAU hibited good surface smoothness IC provides its customers
and logo clarity. (100 coated with a complete range of coating
3) Schlick 930 ABC tablets samples were evaluated). products and excipients comple-
mented by technical and regula-
Conclusion tory services. IC’s product port-
folio includes INSTACOAT
Coating trials were carried out ready-to-use film coating sys-
successfully in a 24 inch Gansons tems, ECOPOL range of Pharma
Autocoater 600 using predeter- Acrylic Polymer’s, ECOCOOL
mined coating parameters with brand of cooling compounds, ES-
three spray gun/nozzle combina- PHERES range of microcrys-
tions at Ideal Cures Goregaon talline cellulose, silicon dioxide,
Laboratory using INSTACOAT calcium carbonate, tartaric acid
4G. It was found that the spheres, new generation of sugar
INSTACOAT 4G – a high solid, spheres and INSTANUTE coat-
low viscosity coating formulation ing technology for nutraceuticals
could be rapidly applied at 35 per and dietary supplements.
cent solids. The coating process
time was significantly lowered IC is the first film coating
and the suspension exhibited low company to have all its cGMP
viscosity in spite of very high compliant manufacturing plants
solids (35 per cent). Fine spray EXCiPACT certified. IC’s latest
mist was achieved during spray- manufacturing facility in Sikkim
ing with different gun designs. will be certified in due course. An
The coated tablets had a smooth ISO 9001:2015 certified company
surface at the end of the coating with a US DMF for all its manu-
process. facturing facilities, IC is one of
the most innovative film-coating
About Ideal Cures companies. IC has 11 granted
patents and 8 pending grants for
Ideal Cures (IC) is one of India’s its film-coating products, spe-
leading manufacturer and ex- cialised excipients and R&D
porter of pharma excipients and coating machines.
ready-to-use coating systems for
solid oral dosage forms. IC pro- The above study was success-
vides tailor-made solutions and fully presented at AAPS (Ameri-
products for the pharma and al- can Associates of Pharmaceuti-
lied industries, through a net- cal Scientists) 2017, Nov 12-15,
work of customers and partners San Diego
across more than 40 countries
around the world. Leveraging Experiment protocol de-
over three decades of coating ex- signed by: Sanjay Negi
perience, technical know-how
and expertise Ideal Cures’ pro- Experiments executed by:
Sanjay Negi
Contact details
Email: info@ idealcures.co.in

94 EXPRESS PHARMA

December 1-15, 2017

CPhI & P-MEC INDIA 2017 SPECIAL

‘We are able to make many advances
in XRPD to address industry needs’

Dr Michael Caves, India Business Development Manager, Malvern Instruments, in an
interaction with Express Pharma, talks about the benefits of XRPD systems and its usage for
multiple applications

Why is X-ray powder Proving that a new chemical the sample intact for further improved the performance for
diffraction (XRPD) so entity (NCE) is indeed a novel investigation by other even routine types of
important to the structure is critical to patent techniques. measurements. For example,
pharmaceutical industry? positioning. Additionally, new XRPD optics, such as
XRPD is a powerful tool in the powder diffraction What advances in XRPD in PANalytical’s
pharma industry because of measurements can be made recent times have been most BraggBrentanoHD optic
its capability to help under non-ambient significant for pharma delivers 40 per cent improved
researchers identify conditions (temperature, analysis? sensitivity for ultra low-level
crystalline structure of humidity, etc) such that In the past five years, new polymorph screening. New
materials, identify phases material stability can be optics, stages and detectors applications possible on an
that are present, distinguish tested under extreme have allowed more XRPD system include small
between polymorphs, and conditions. And most application capability to be angle X-ray scattering
even elucidate structure in applications of XRPD are non- added to a multi-purpose (SAXS) for nano-sized
amorphous materials. destructive in nature, leaving diffraction system, as well as materials, which can

PREMIUM QUALITY Acc. to ISO, ASTM and
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To subscribe: [email protected]
Test Sieves for perfect quality control

The well-proven RETSCH sieves consist of a solid stainless steel
sieve frame of high stability for reliable sieving results. RETSCH
test sieves are available in many sizes and varieties, primarily in
the four frame sizes most widely used in laboratory analytics:
n 200 x 50 mm, 200 x 25 mm
n 8“x 2“ (203 x 50 mm), 8“x 1“ (203 x 25 mm)

[email protected]
www.verder-scientific.co.in

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determine size distribution beam path SAXS chambers
and shape of materials has also allowed for bioSAXS
including micelles, proteins, experiments on a
and nano-particles for drug multipurpose XRPD platform,
delivery; with new detector to study for example the
technology and easy overall size, compactness and
conversion of an XRPD aggregation behaviour of
system to hard radiation protein molecules in their
(such as Silver X-ray tube native state (crystallisation
anodes), pair distribution not required), and even to
function (PDF) for determine the 3D envelope
investigating the structure of structure at a resolution of 1-2
nano- and amorphous nm. And a very new addition
materials has brought this to capabilities on an XRPD
traditionally synchrotron system is in situ protein
beam-line application to a crystallisation with our new
laboratory system; and these computer-controlled
same advanced detectors for transmission humidity
hard radiation lend chamber.
themselves nicely to
computed tomography (CT) What are up and coming
on an XRPD system, to XRPD techniques or
analyze non-destructively the applications that would be
inner structures of coatings of interest to pharma?
on tablets, evaluate porosity One application that we see
and distribution of significant interest from
components within tablets, pharma researchers is pair
and even investigate tablets distribution function (PDF)
within packaging. analysis, which can be used to
discriminate between
What are the recent trends different amorphous or
in XRPD that you have seen crystalline pharmaceutical
from the pharma industry? structures. Protein screening
We are seeing a trend toward and indexing for researchers
centralised research labs in the area of protein
when mergers have occurred. crystallography, which is
This in turn has caused an typically done on single
increased interest in XRPD crystal instruments or at
systems that can be used for beam lines, is another area we
multiple applications versus see as a growth area for
dedicated systems for a XRPD.
specific application. So
systems combining Finally, we have advanced
combinatorial screening, software capability now,
environmental chambers which includes using a
(heat and humidity), SAXS, method known as partial least
and transmission capability squares regression (PLSR) to
are routinely being supplied analyse XRPD data for things
to this industry. like % crystallinity without
the use of an internal
What other techniques XRPD data. X-ray How can a powder X-ray proteins for size and shape standard, keeping the method
complement XRPD? Fluorescence (XRF) diffraction system assist determination. Screening non-destructive. More
XRPD analysis for polymorph spectroscopy determines researchers doing protein samples headed for a developments are in the
identification, structural elemental composition, and crystallography? beamline can show the quality works, and it is through close
analysis, and nano-particle data can be used in an The two main applications of the sample, whether it is a collaboration with pharma
size and shape is automated fashion within that come to mind are powder single phase, and can also companies that we are able to
complementary to many XRPD phase analysis to diffraction for screening allow indexing to determine make many advances in
techniques available in restrict the search to only samples that will be taken to a lattice type and lattice XRPD to address the needs of
today’s analytical phases chemically possible. beamline for structure parameters of the material. the industry.
laboratories, not only for the determination, and SAXS of The advent of evacuated Contact details
information provided but also Malvern Aimil Instruments
because it is non-destructive. Naimex House,
Solid state NMR, A-8 Mohan Co-operative
spectroscopies such as near Industrial Estate,
infrared (NIR) and Raman, Mathura Road
and single crystal diffraction New Delhi – 110044
all provide molecular and Tel : 011-3081024
crystalline structure Fax : 011-26950011
information that compliments Email : [email protected]

EP News Bureau

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CPhI & P-MEC INDIA 2017 SPECIAL

Coating performance evaluation of
INSTACOAT4G in a batch coater

Suresh Pareek,MD,Ideal Cures and Sanjay Negi,DGM Film Coatings,Ideal Cures,evaluates coating
uniformity and appearance of tablets coated with Ideal Cures’revolutionary product INSTACOAT4G,a
high solids aqueous coating system of 35 per cent solids capability,in a batch coater

THE PHARMACEUTICAL in- Suresh Pareek Sanjay Negi ity – INSTACOAT 4G. of 35 per cent solids capability,
dustry is continuously improv- Achieving good colour uni- in a batch coater.
ing manufacturing efficiency
and product quality by adopting formity at higher reconstitution Process summary
innovative technologies. Coat- levels is a big challenge at com-
ing systems with high solids are mercial scale and it has been INSTACOAT 4G was reconsti-
used to significantly save both evaluated in our trial conducted tuted at 35 per cent solids con-
process time and overall energy using a batch coater. centration in water and applied
consumption. Ideal Cures un- at a target weight gain of 3 per
derstands the needs of pharma The present study evaluates cent. The coating dispersion
companies and has developed a the coating uniformity and ap- was evaluated for appearance
revolutionary coating formula- pearance of tablets coated with and viscosity.
tion having high solids capabil- Ideal Cures’ revolutionary prod-
uct INSTACOAT 4G, a high Coating trials were per-
solids aqueous coating system formed in a batch coater using

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predetermined optimised coat- TABLE NO. 1 COATING PROCESS PARAMETERS making INSTACOAT 4G a best- tors: Energy and Carbon Con-
ing conditions. in-class eco-friendly coating sys- versions”2011)
Desired Weight Gain (%) 3 tem
Round shaped placebo Assumptions
tablets were used for the coat- Batch Size (kg) 600 There is an approximate re-
ing trials. duction of 80 per cent in carbon All the parameters are based on
Product Bed Temp (?C) 40-45 emissions/ year with INSTA- assumptions. These assump-
The viscosity of the coating COAT 4G compared to tradi- tions were used to quantify both
suspension was found to be 209 Gun to tablet bed distance (cm) 20-22 tional coating systems (11 per the aforementioned energy con-
cps which is too low and very cent) sumption and the production
spray able considering 35 per Atomising air pressure (kg/cm2) 3 ◗ *Batch size = 300 kg, capacity of a single coater.
cent solid. Coating process eval- ◗ ** 2 batches of 300 kg/day in a These numbers may obviously
uation was carried out in terms Pan speed (rpm) 2-7 year (300 working days in a vary from equipment to equip-
of coating process time, finished year) ment, from company to com-
tablet appearance, coating de- Spray rate (g/min) 90-100 ◗ *** With respect to 11 per cent pany and by geographic loca-
fects and disintegration time. reconstitution levels tion. Typical values are used
Refer Table 1. for coating Actual Spraying Time taken (mins.) 140 ◗ # 0.5377(CO2 conversion fac- and it is used as a representa-
process parameters. Coated tor used for calculations, Ref: tive analysis. Under the as-
tablet samples were collected Carbon Trust, “Conversion fac- sumptions provided in this arti-
from the coating pan at different cle, using INSTACOAT™ 4G
time intervals (15 minutes) until FIGURE NO.1: COLOUR DEVELOPMENT AT DIFFERENT COATING PROCESS TIME POINTS may reduce energy consump-
the completion of the coating tion since it has shorter coating
process. Colour difference of the FIGURENO.2:COATINGPROCESSTIMECOMPARISONWITHTRADITIONALCOATINGFORMULATIONS process time and may in turn re-
coated tablets was measured duce equivalent CO2 emissions
using a reflectance spectropho- by 79.2 per cent per year (com-
tometer. Coated tablets pared to HPMC coating sys-
achieved very low colour differ- tem).
ence values after 120 minutes of
coating. (Figure No.1) which is Conclusion
remarkable.
A need for innovative technolo-
Evaluation of coating gies to improve product quality
process: Massive reduction in and process efficiency with re-
coating time with ability to tention or enhancement of prod-
triple production output! uct safety within commercially
acceptable cost constraints was
Coating process could be identified, leading to the devel-
completed very quickly as com- opment of the most advanced
pared to traditional coating for- aqueous coating formulation –
mulations (Ref. Figure No. 2) INSTACOAT 4G.
due to high solids and low vis-
cosity capabilities of INSTA- INSTACOAT 4G, innovated
COAT 4G. by Ideal Cures is the most ad-
vanced immediate release film
Coating of a batch (300 Kg) coating system, designed for
in a 60-inch pan generally takes rapid film coating. It brings
around four hours and hence in about large-scale reduction in
one entire shift, an approximate the overall coating process time,
of 1.5 batches is possible. reduces total cost of coating op-
erations and most importantly,
INSTACOAT 4G due to its will save energy and help reduce
high solids capabilities will re- carbon footprints. It offers ex-
duce the process time by more cellent film adhesion properties,
than 60 per cent. It allows coat- smooth product finish along
ing of three batches instead of with moisture barrier proper-
1.5 batches and almost triples ties. Launched globally in 2016,
production output. this one-of-a-kind firm coating
system offers 35 per cent recon-
Further, coating suspension stitution – seen in no other coat-
was agglomerate free and easily ing formulation.
sprayable. No gun blockage was
observed during the entire coat- The coating trial of INSTA-
ing process. COAT 4G was successfully per-
formed in a 60-inch Batch
There were no coating de- Coater and coated tablets were
fects and colour uniformity con- evaluated for appearance,
cerns. (DE<1.5) Coated tablets colour difference, coating de-
exhibited good surface smooth- fects and disintegration time at
ness and logo clarity (100 coated various intervals of the coating
tablets samples were evaluated) process. INSTACOAT 4G
achieved acceptable results.
Reduce carbon emission, The product under test was suc-
gain carbon credits cessfully applied and achieved

Reduced energy consumption
by virtue of reduced coating
time results in reduced carbon
emissions and carbon footprint

98 EXPRESS PHARMA

December 1-15, 2017

CPhI & P-MEC INDIA 2017 SPECIAL

good colour uniformity within a INSTACOAT 4G - CO2 EMISSION
short coating process time.
Reconstitution Energy Consumption Equivalent CO2 CO2 Emission CO2 Saving
Over 60 per cent coating Levels (KWhr/batch*) Emission (kg/batch)# (kg/year)** per year (%)***
process time savings can be
achieved by using INSTA- Reference (11%) Approx. 610 (1) 328 1,97,000 -
COAT 4G as compared with Reference (20%)
traditional film coating formu- INSTACOAT 4G (35%) Approx. 340 183.3 1,09,000 44.7
lations. INSTACOAT 4G is well
suited for all coating equip- Approx. 126 67.8 41,000 79.2
ment i.e. conventional, batch
coaters to the most advanced forms. IC provides tailor-made regulatory services. IC’s prod- pliant manufacturing plants tical Scientists) 2017, Nov 12-15,
continuous coaters being used solutions and products for the uct portfolio includes INSTA- EXCiPACT certified. IC’s latest San Diego.
in the pharma industry pharma and allied industries, COAT ready-to-use film coat- manufacturing facility in
worldwide. through a network of customers ing systems, ECOPOL range of Sikkim will be certified in due Experiment Protocol Designed
and partners across more than Pharma Acrylic Polymer’s, course. An ISO 9001:2015 certi- by: Sanjay Negi
Ref: 40 countries around the world. ECOCOOL brand of cooling fied company with a US DMF Experiments Executed by:
Leveraging over three decades compounds, ESPHERES for all its manufacturing facili- Sanjay Negi
(1) Coating Economics – How very of coating experience, technical range of microcrystalline cel- ties, IC is one of the most inno-
low viscosity coatings reduce the know-how and expertise Ideal lulose, silicon dioxide, calcium vative film-coating companies. (Note: All figures/graphs derived
total cost of ownership of coating Cures’ provides precise, simpli- carbonate, tartaric acid IC has 11 granted patents and are based on the assumptions
operations, DOW WOLFF Celu- fied solutions uniquely shaped spheres, new generation of eight pending grants for its given in this article. The actual
losics to meet a customer’s require- sugar spheres and IN- film-coating products, spe- performance in a manufacturing
About Ideal Cures ments. STANUTE coating technology cialised excipients and R&D operation may vary depending on
Ideal Cures (IC) is one of India’s IC provides its customers with for nutraceuticals and dietary coating machines. various factors, but the fundamen-
leading manufacturer and ex- a complete range of coating supplements. The above study was success- tal efficiency advantage of using
porter of pharmaceutical excip- products and excipients com- IC is the first film coating com- fully presented at AAPS (Amer- INSTACOAT 4G coating still
ients and ready-to-use coating plemented by technical and pany to have all its cGMP com- ican Associates of Pharmaceu- holds)
systems for solid oral dosage

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India is an important market for
Shin-Etsu in the global business

Hiroshi Watanabe, GM, Shin-Etsu Chemical Company, Japan, Shungo Fujii, Sales Manager,
Shin-Etsu Chemical Company, Japan and Nitin Bhusane, Director, Shin-Etsu Chemcial
Tylose India, in an interaction with Express Pharma, inform about the company’s growth
prospects in India

How has Shin-Etsu Chemi- HIROSHI WATANABE, SHUNGO FUJII, NITIN BHUSANE, technical seminars, and
cal evolved over the years? GM, Shin-Etsu Chemical Sales Manager, Shin-Etsu Director, Shin-Etsu Chemcial providing problem based
Where are your facilities Company, Japan Chemical Company, Japan Tylose India solutions to pharma
located? customers.
Shin-Etsu Chemical began global business. Indian applications like binder, name Shin-Etsu Chemical
producing cellulose pharma companies mainly disintegrant, film coating, Tylose India. This is another As per current R&D
derivatives in 1962. Since target generic business for enteric coating, solid extension of Shin-Etsu trends in Indian pharma
then, thanks to feedback regulated markets like the dispersion etc., which are application lab global companies, beside
from our customers, we have US and Europe, who require well known in the pharma network. conventional projects of
been improved our quality good quality excipients to industry. Sometime immediate release tablets
and manufacturing system. make high quality pharma customers require special Shin-Etsu Chemical ,sustained release tablets or
We are confident in our products. Shin-Etsu is well guidance related to use of Tylose India lab will focus on delayed release tablets,
quality control which is in known in the industry for these products. Therefore providing support to more focus has been given
accordance with IPEC/PQG high quality excipients, our new application lab will pharma customers and on solubility enhancement of
GMP guideline,. Shin-Etsu which gives a valuable play a very crucial role to coordinate with other Shin- poorly soluble drugs.
Chemical’s cellulose contribution between Indian provide technical support to Etsu labs worldwide to Generally, Shin-Etsu
excipients can make a pharma companies and Indian pharma scientists. generate more application AQOAT (HPMC AS) is well
valuable contribution in Shin-Etsu. data using Shin-Etsu known for its application in
various areas of You have recently products for pharma solid dispersion and enteric
pharmaceutical technology. It has been observed that launched Thane facility. customers worldwide. coating. Shin-Etsu lab in
the domestic Indian market Throw some light on the Thane will explore Shin-
Currently, Shin-Etsu has has become more and more same. This application lab is Etsu AQOAT and other
two production plants for quality conscious, and Shin-Etsu is proud to being set up for solid oral Shin-Etsu products like L-
pharma excipients. One plant majority of the branded announce the opening of a dosage formulation HPC, METOLOSE,
is located in Naoetsu Japan generic products maintain new pharma application lab developments. The offerings PHARMACOAT, HPMCP in
and the other in Wiesbaden high quality standards. in the Thane area, Mumbai, from the India lab will their formulation.
Germany. Shin-Etsu is India, under the company involve preformulation and
continuously expanding its Shin-Etsu cellulose formulation development Shin-Etsu believes in
global presence. excipients are used for studies, workshops and continuous research and
development of its products,
Shin-Etsu understands so that it can launch new
the importance of products in the market,
continuous technical which meets customer
support to pharma requirements. Recently
customers. Therefore, Shin- Shin-Etsu has added Smart
Etsu has developed global Ex, HME Cleaner Plus and
network of application Polyvinyl Alcohol (PVA) to
laboratories. We have its portfolio. Smart Ex can
application labs in Naoetsu, be used as directly
Yokohama, Japan; compressible grade for
Wiesbaden, Germany and orally disintegrating tablets
New Jersey, US. We have or for MUPS application.
also opened a new HME Cleaner Plus is a
application lab in Thane unique cleaner, which can be
near Mumbai, India used to clean the screw of
hot melt extruder. PVA can
What is your say about the be used in moisture barrier
Indian pharma market? coating and has an
India is a very important advantage to use as a binder.
market for Shin-Etsu in the
EP News Bureau

100 EXPRESS PHARMA

December 1-15, 2017

CPhI & P-MEC INDIA 2017 SPECIAL

NEOMACHINE MFG CO:Aleader in automatic coating technology

KOLKATA-BASED NEOMA- During the last three During the last service to the clients. constructional features for vali-
CHINE MFG CO was started in decades, NEOMACHINE man- three decades, The in-house R&D facility is dation and qualification. The
1973 with an objective of manu- ufactured and marketed more Neomachine equipment are supplied with all
facturing quality pharmaceuti- than 600 machines, out of which manufactured abreast with latest technology the necessary documents for
cal machinery. 100 machines were exported to and marketed upgradation and developments proper validation during installa-
the different countries like the more than 600 in ‘coating technology. This tion and commissioning as well
For a decade, the company US, Australia, China, Jordan, machines helps in continuous improve- as trial production.
catered to the requirements of Yemen, UAE, Uganda, Kenya, ment of the product.
the Indian pharma companies Sudan, Cyprus, Saudi Arabia, strictly following all the quality Inspired by this opportunity,
in injectable, liquid, tablet, cap- Austria, Brazil, Bangladesh and control guidelines during man- NEOMACHINE also pro- NEOMACHINE started the
sule and ointment sections ma- Bolivia, Nepal, Myanmar, Nige- ufacturing. The boughtout items vides DQ/IQ /OQ/ documents process of developing an Auto-
chinery. ria etc. are inspected at the manufac- for automatic coating system matic Coating Machine for
turers’ works periodically. and are in the process of getting tablets. After, two years of re-
While catering to this mar- NEOMACHINE, a profes- CE certification. Neomachine search and development, the
ket segment, NEOMACHINE sionally managed organisation The company has a dedi- being a single product company first NEOCOTA Automatic
happened to come across a now has two manufacturing cated team of engineers for pro- manufacturing only automatic Coating System was manufac-
Kolkata-based pharmaceutical During the last three decades, viding erection and commis- coating system for coating of tured in 1984.
producer, who were envisaging NEOMACHINE manufactured sioning and prompt aftersales Pharma Tablets, Pellets & Gems
problems in solvent-based film and marketed more than 600 Products has gained vast expe- Over the years, the company
coating of tablets. Till then, the machines units in Kolkata, riences in latest coating technol- has gained vast experiences in
tablets were being coated in which are equipped with state- ogy as well as validation and manufacturing 'Automatic
conventional pans, which were of-the-art equipment like fabri- qualification of coating equip- Coating System' by interacting
not only causing health hazards cation, machining, assembling, ment to qualify for audit of vari- with various Indian & multina-
to the coating personnel, but finishing and other related jobs. ous national and international tional pharma and confec-
was also a time consuming- agencies. The latest models of tionery units based in India and
process. The company has been NEOCOTA are having all the abroad.

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December 1-15, 2017

CPhI & P-MEC INDIA 2017 SPECIAL

Growth will be driven by targeting
non-traditional markets

Mitul Shah, CEO, LabGuard India, in an interaction with Express Pharma talks about
LabGuard’s future growth prospects

Labguard India is in the reckon with and has built an We are looking service to leading research workmen that we employ at our
market since the last 30+ enviable national and global at forging institutes, educational factory are from local farming
years. How has the journey reputation. Prakash Sansare collaborations institutes, standards and community who have been
been so far? has been the driving force and tie-ups with certification agencies. trained in their respective
Prakash Sansare took behind the tremendous equity local trades
voluntary retirement from for product quality and representatives What will be your growth
Mazagon Docks to fulfill his LabGuard's reputation built in target strategy in the next three ◗ Investment does not stop
dream of addressing the over the years. markets years? at internal stakeholders alone.
engineering industry's most Growth will be driven by We go extra mile to support
challenging problems. The Tell us about your new furniture with available and targeting non-traditional community around us and have
journey has been nothing short product launches. How are easy to maintain technology markets/ end user applications set up labs in schools in
of an adventure. What started the products unique from has been our contribution for and embedding more Aadivasi cluster through social
as an opportunity to design and your competitors? the Indian industry. technology in our products for organisations as part of our
make import substitute has Research and development is safer and more productive social responsibility. We take
now become an industry in always a work in process for Who are your major pharma work environments. pride in supporting clients for
itself. ever evolving target audience clients? Investment would be in their social commitments in
that we cater to. Continuous Difficult to choose a few in this sourcing technology and their respective
Prakash Sansare was joined engagement with research limited space. Suffice to say augmenting manufacturing neighbourhoods for setting up
by his elder son Salil after fraternity, end users and others that all major pharma capability. labs for schools and colleges.
graduation (VJTI Production) in the ecosystem gives us companies have been our
and contributed towards insights into product design. It clients. Not just pharma Investment is not just about Do you plan to launch new
establishing market reach as is our endeavour to offer new companies, we also service creating physical assets; facilities?
well as customer interface. The designs and work concepts to industries such as chemical We have already commissioned
younger son Swapnil, an the end user keeping safety, (petroleum, speciality, agro, ◗ We are targeting to create new assembly shops and are
electronics engineer soon functionality and productivity etc), FMCG, Flavours & brand loyalty through actively working on enhancing sheet
joined with the focus on in mind all the time. During the fragrances, paints and dyestuff, engaging with key stakeholders metal processing capacity at
automation and product last two years, we have engineering, energy, to offer solutions for day-to-day existing facility. We have
design. Soon thereafter, Ajay successfully launched and manufacturing, mines and problems through product launched modern training-
Kanekar joined to lead the scaled up some key products. minerals, healthcare design, servicing and offering cum-conference facility at our
overall operations as the (hospitals). We also provide one-stop solution for factory for our staff as well as
business was growing. Salil and 1. Adventa helps optimise establishing labs like civil customers. For further facility
Swapnil eventually moved on to space and aids ease of interior, MEP and design and expansion, we are going for
pursue their own career maintenance of the fume hood. consulting services. hybrid model in the short term;
aspirations in respective areas wherein we have tied up with
of interests. 2. PP storage cabinets not ◗ We are investing in our partners for optimising supply
only add to performance but future users by conducting free chain and improving lead time
The current leadership increase aesthetics of the sessions at various universities, as we scale up operations
team has been with the workspace. schools for good lab practices. across geographies.
organisation in thick and thin
for almost a decade. I joined 3. Custom made furniture to ◗ Investing in human capital Are there any plans to
eight months back as the CEO suit individual lab and end user by skill building and employee venture into foreign shores?
after spending 13 years with culture has been our engagement are our focus We are already present across
organisations like Aditya Birla specialisation and therefore, areas. It is noteworthy that geographies and our products
Group and Prince Piping each solution is unique in itself. have been our brand
System. It was a home coming ambassadors as most orders
for me as I had started my Customers today want one have been through referrals.
professional career as the stop shop for their needs and However, we are looking at
Production Engineer at this we have successfully completed forging collaborations and tie-
organisation after passing out lab sets ups for prestigious ups with local representatives
from VJTI and then moved on clients. in target markets. We are very
to pursue higher studies (MBA conscious about compatibility
from JBIMS). Sans family has We are always on the of culture while exploring such
been my local guardian during lookout for adopting collaborations.
engineering and MBA days. technological advances to meet
latent customer needs; EP News Bureau
Today, LabGuard has adopting auto fire-
metamorphosed into a force to extinguishers, auto work area
in fume hood closures as well as
maximising flexibility in

102 EXPRESS PHARMA

December 1-15, 2017

CPhI & P-MEC INDIA 2017 SPECIAL 28-B3o0mbNaoyMvEVeuximhmsiEibbbt-iat6eUiio,6rsIn,N2aHCD0teaI1SAnll7ttraNen,od. 6 TEKNOPAK

Save time and Engineered Solutions for Airborne Contamination Control
protect data integrity
with fingerprint Sterilizing & Depyrogenating
authentication Tunnels for Glass Vials and
Ampoules

Aditya Marfatia, Director, Electrolab and
Dr Neelam Sayed, Application Scientist,
Electrolab give an insight about how Electrolab
with a technological collaboration has
introduced a convenient 21 CFR part 11
compliant operating system, integrOS

Unidirectional Air Flow Systems (LAFs)

Mobile Unidirectional
Air Flow Systems

Reverse Air Flow Containment Stations
for Dispensing & Sampling

Pass Boxes Garment Storage Cabinets

Dr Neelam Sayed Aditya Marfatia

EACH CONSUMER expects the drugs are attributable, legible, contemporane- Our Specialization CLEANROOM EQUIPMENT & ACCESSORIES
they consume to be safe and effective. ously recorded, original or a true copy
To ensure safety, efficacy and quality of and accurate (ALCOA). It refers to STERILIZING & DEPYROGENATING TUNNELS
drugs, regulatory bodies such as US maintaining and assuring the accuracy
FDA, UK MHRA and Indian FDA have and consistency of data over its entire MODULAR CLEANROOM PARTITION SYSTEMS
set regulatory standards, typically re- life-cycle, including the usage of any sys-
ferred to as Good Manufacturing Prac- tem which stores, processes, or re- TURNKEY PROJECTS FOR CLEANROOMS
tices (GMP). GMP assures proper de- trieves data. Ensuring data integrity & ASSOCIATED CONTROLLED ENVIRONS
sign, monitoring and control of means protecting original data from ac-
manufacturing processes and facilities cidental or intentional modification, fal- CUSTOMIZED HEPA FILTERED DEVICES TO
for various systems. This is supported sification, malicious intent (fraud), or MEET ANY SPECIFIC APPLICATION
by underlying data records to trace even deletion (data loss). Considering
manufacturing processes, which can that raw data acts as an evidence that suntec teknopak
prove evidence that the drugs have been drugs are safe, efficacious and manufac- cleanrooms & containments
manufactured as per agreed protocols. tured as per appropriate quality stan-
dards required, violation of data in- suntec techno centre, E-50, midc, [email protected]
Data integrity affirms that complete, tegrity is considered to be grave by ambernath (east) – 421 506, [email protected]
consistent and accurate data records dist. thane, maharashtra, india. tel. : +91 251 2620811

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December 1-15, 2017

CPhI & P-MEC INDIA 2017 SPECIAL

leading regulators such as the FIG.1: THE KEY PILLARS OF 21 CFR PART 11 COMPLIANCE led to numerous regulatory ac-
US FDA, UK MHRA, Health FIG.2: INTEGRATION OF INSTRUMENTS WITH KLOUDFACE WITH INTEGROS tions, including warning letters,
Canada, Therapeutic Drugs drug recalls, import alerts and
Administration (TGA) and In- consent decrees. These regula-
dian FDA, all of which mandate tory actions not only impact the
data integrity. existing revenue stream of the
company, but also affect the
In recent years, FDA has in- drug maker’s ability to get ap-
creasingly observed CGMP vi- proval for new drug applica-
olations involving data integrity tions. In addition, it also causes
during inspections. FDA in- reputational damage, competi-
spections cite a range of serious tive disadvantage and lengthy
deficiencies in how employees remediation process that tend
handle important data records to consume time, money and of-
and documents. FDA cites re- ten loss of talent. Data integrity
ports of records found in trash is critical to regulatory compli-
bins, data that do not match ance and hence the fundamen-
test results, unauthorised ma- tal reason for formation of Code
nipulation of electronic raw of Federal Regulations (CFR).
data, sample retesting to
achieve desired results, deletion A company’s SOP describes
of undesirable results, practice how processes are to be per-
of performing trial injections formed while manufacturing a
for HPLC analyses prior to run- particular drug or formulation.
ning the release and stability During implementation of
tests etc. Some of the key root these processes, the US FDA
causes for these violations are registered company needs to
lack of awareness, shortage of comply with Title 21 of CFR –
manpower, quantity over qual- Part 11, commonly known as '21
ity approach and ineffective CFR 11'. 21 CFR Part 11 estab-
training. These data integrity- lishes the criteria under which
related CGMP violations have electronic records and signa-

FINGERPRINT SCAN
KLOUDFACE WITH BIOMETRICS

104 EXPRESS PHARMA

December 1-15, 2017

CPhI & P-MEC INDIA 2017 SPECIAL

FDAWarning Letter Excerpt, 2015 states“Access to production equipment used in parenteral
manufacturing and solid (b)(4) dosage forms used a password shared by four or five
individuals to gain access to each individual piece of equipment and access level. During our
inspection, your Executive Production and QA manager confirmed that the password was
shared. Neither your operators nor your supervisors had individual passwords.”

Why is FDA concerned with the use of shared login accounts for computer systems?
US FDA in its draft guidance states“You must exercise appropriate controls to assure that only
authorised personnel make changes to computerized MPCRs (master production and control
records), or other records, or input laboratory data into computerised records and you must
implement documentation controls that ensure actions are attributable to a specific
individual.When login credentials are shared, a unique individual cannot be identified through
the login and the system would thus not conform to the CGMP requirements in parts 211 and
212. FDA requires that systems controls, including documentation controls, be designed to
follow CGMP to assure product quality”.

tures are stored and is considered trust- minimise the time personnel are spend-
worthy, reliable and equivalent to paper ing on compliance activities while ensur-
records by the US FDA. Part 11 has a to- ing that they are still in compliance. To
tal of 19 requirements, some of them are ensure complete 21 CFR part 11 compli-
specific to Part 11 and others are more ance and to overcome all the hassles
generic requirements of some or all listed above while also better securing
FDA regulations. The key pillars of 21 the organisation, Electrolab with a tech-
CFR part 11 compliance is depicted in nological collaboration has introduced a
Fig.1. convenient 21 CFR part 11 compliant op-
erating system, integrOS. integrOS has a
It is crucial to pay particular atten- secure authentication method that
tion to all these requirements when ad- utilises fingerprint authentication to
dressing data integrity. Due to lack of register a user on the system. Biomet-
thorough understanding of 21 CFR as- rics is usually a quicker process than en-
pects, pharmacists and even instru- tering a username and password and far
ment manufacturers may believe a sys- more secure than using login creden-
tem is 21 CFR part 11 compliant tials. Biometric technology eliminates
however; gaps may still exist which employee downtime due to forgotten
when highlighted by auditors can lead passwords and also reduces the amount
to detrimental effects. of IT support required to reset accounts.
An audit trail with classification of
Some of the commonly observed is- events based on user, date,
sues that lead to breaches in data creation/modification status in integrOS
integrity include no correct administra- aids with compliance and assures that
tor rights for laboratory system (72 per no alterations have been made post ap-
cent users in QC department have IT proval. Managing paper and complying
administration rights), sharing of login with regulatory policies can be tedious,
IDs and passwords for laboratory sys- while integrOS allows more efficient use
tems (33 per cent), audit or reviews not of time in the lab or on the plant floor.
being conducted to assess potential kloudface is an interface which allows
gaps in assurance of data integrity existing installed base of instruments to
(33 per cent), unawareness about 21 use integrOS and achieve convenient
CFR Part 11 compliance requirements compliance, hence optimising capital in-
(25 per cent), disabled audit trails on lab vestment. Instruments that can be inte-
equipment (21 per cent) and no clearly grated with kloudface with integrOS are
documented SOP on backup and dele- depicted in Fig.2.
tion of laboratory data (13 per cent)
(Analysing the state of data integrity Data integrity software integrOS,
compliance in the Indian pharmaceutical fulfills CFR requirements in terms of
industry, EY). Amongst all the above multi-level security, unlimited users,
concerns, sharing of login credentials user defined privileges, audit trails, accu-
for laboratory systems is a common is- rate and complete copies of records, au-
sue cited by FDA in its observations. thority and device checks, linking of
electronic signatures etc. Utilising inte-
Primarily, sharing of login creden- grOS with biometrics in the manufac-
tials are done to streamline remember- turing process and laboratories can
ing multiple passwords for multiple in- help to remain compliant, operate more
struments and for cost saving reasons efficiently and receive faster approvals.
when softwares are licensed on a named Contact details:
user model. Electrolab
Email: [email protected]
In a convenience focussed world, Website: www.electrolabgroup.com
making compliance convenient would Tel: +91–22–4041 3131/ +91–22–41613122
minimise deviations from good labora-
tory practices. Users, especially in reg-
ulated industries need solutions that

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December 1-15, 2017

CPhI & P-MEC INDIA 2017 SPECIAL

‘We are known for quick, prompt
and reliable service in the market’

Dr Kiran Badgujar, Founder and Director, Mack Pharmatech, talks about Mack
Pharmatech’s services to the pharma industry and its growth prospects in an
interaction with Express Pharma

How has Mack contributed to 'Fire Proof Chambers' recently. We are in a (upto -40 Deg. Cel.), competitors?
the growth of the Indian We are in a constant process of constant bacteriological incubator, photo Being a very young player in
pharma industry? developing and upgrading our process of stability chamber, hot air oven, the market, we are giving the
Mack Pharmatech is and state-of-the-art and pioneer developing vacuum oven, duel zone leaders a good run for their
always has been an 'innovator' software DAAS with- newer and upgrading chamber, seed germinator etc. money as we are committed to
of novel technologies which features making it more user our pioneer Our state-of-the-art machines manufacture and supply the
helps the user of our chamber friendly. Recently, we have software DAAS are carefully handcrafted with best and latest equipment and
to concentrate more on his/her launched our DAAS 3.0 edition with- newer utmost care in our fully services. We are known for
core work rather than looking & its been welcomed by the features equipped plant in Malegaon, quick, prompt and reliable
at and/or attending the industry. We, MPPL, DO NOT making it more Sinnar plant in Nashik district service in the market, which
equipment. charge any fees (license &/or up user friendly of Maharashtra, India. sets us in a different league
gradation) to our client if they altogether.
Mack Pharmatech has want to upgrade their software standard models as well as we Which are your pharma
pioneered and launched the from an earlier version to the can 'customise' them as per the specific products? Do you How much revenue did your
European certified 'CE' latest one, and there are no need of our customers- Stand- cater to any other industry as company generate in the last
approved environmental hidden costs whatsoever. Alone or Walk-in type. Apart we well? fiscal? What percentage of
chambers first time in India. It from these, we also All the products are specific to your revenue came from the
has received a grand welcome What are the different types manufacture deep freezers the pharma sector. However, Indian market?
by the Indian pharmaceutical of products you these are also used in food, MPPL has consistently been
industry and pharma fraternity manufacture? cosmetic, chemical, health showing a double digit growth
in general. Mack Pharmatech industry. Also, used in colleges in the last few fiscals. This year
manufactures all types of and universities for educational was no exception where we
Also, Mack Pharmatech environmental chambers, such purpose. clocked an impressive more
pioneered and launched a as Humidity Chambers than 30 per cent growth
'PLC'-based control system in (Stability Chambers), Cold What are the advantages of beating the industry growth
India. We have developed a Chambers, BOD Incubators- all your products? How good are rate by a huge margin. We are
'software' which is 21CFR Part the three. We have our they in comparison with your confident that we will continue
11 compliant and certified and to do so this year and years to
one of the best in industry, as come, thanks to our innovative
the PLC & Software: D.A.A.S., products and top notch after
performs all the important sales service.
functions- automation,
controlling, communication and Whom do you consider your
database, giving user complete major client and why?
freedom. We have a strong presence in
the West & South markets.
After the advent of the PLC- Most of the big names in the
based machines our users are industry are our valued and
facing the audits more regular clients.
confidently and completing
them even more successfully. Tell us more about your
expansion plans?
This has gone down in Recently, Mack has acquired
history books that all our peers a second plant dedicated for
and contemporaries followed our 'Walk in Chambers.' We
our footsteps. We launched a have shifted our R&D
new HMI last year (Make: department in the same plant
ASEM from Italy), wherein the giving them more room and
HMI itself has a inbuilt memory freedom to experiment on the
of 4GB: so it can store roughly novel ideas and technologies.
about five years of data in itself,
more over the user can take EP News Bureau
print outs directly from HMI by
connecting a printer to it.

We also have successfully
designed and launched our

106 EXPRESS PHARMA

December 1-15, 2017

CPhI & P-MEC INDIA 2017 SPECIAL COMPLIANCE MEETS CONVENIENCE

‘Our products are Dissolution Tester Hardness Tester
widely accepted and
used across India’

Sunil Saraf, Director, REMI Group, in an
interaction with Express Pharma, talks
about the company’s offerings for the
pharma sector and its growth plans

Brief us about your company. Disintegration Tester Fingerprint Tap Density Tester
REMI, founded in 1960, is a reputed and Authentication
huge group of multiple manufacturing
units. We at REMI LAB are primarily Electromagnetic Sieve Friability Tester
into manufacturing of laboratory and Shaker
blood bank equipment catering to the
medical and healthcare industries. Over creation of this motor which revolved in Weighing Balance
the last six decades, we have established circular motion further gave birth to
ourselves as market leaders in India for different manufacturing units which Introducing
centrifuges and other laboratory and used this motor technology as their
blood bank products. Along with all primary product to create products like integrOSTM
major hospitals, medical colleges, path fans, mixies, centrifuges, stirrers etc,
labs diagnostic centres in India, our which now function as independent Data Integrity Operating System
clientele spans across 50 plus other business units respectively.
countries. We have a strong sales and Paper instrument
support team network spreading across Which products will be showcased at log book
14 different cities in India. CPHI/P-MEC 2017?
For P-MEC 2017, we will showcase some 21 Limited System Access
What is your company’s USP? of our best products. There will be a CFR Audit Trail
We are market leaders in centrifuges. wide range of centrifuges accompanied Authority and Device Checks
Our products are widely accepted and with stirrers, shakers, mixers, Metadata Storage
incubators, freezer and walk in Electronic Signatures
Technological chamber.
upgradation and
global market What is the company's road map for
expansion will next five years?
constantly We at REMI, are focussing on a two-
sophisticate our pronged approach for the next five
existing range of years. Technological upgradation and
products global market expansion will constantly
sophisticate our existing range of
used across India and various other products for our home market
European, African, Asian and Middle customers. Market expansion will
Eastern markets. We are known to bring ensure a global reach to strengthen and
the latest in technology of centrifuges grow our market in the world and
from time to time for our customers optimise on the rich technology
with our new models and variants to suit exchange in order to serve our home
their changing and increasing demand market and extended market with the
for various purposes of centrifugation. best products.
The master technology in centrifugation
can be attributed to the company's EP News Bureau
history of developing motors way back
in 1960 as their first product. The

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December 1-15, 2017 E-mail : [email protected] l Website : www.electrolabgroup.com

Tel : +91-22-4041 3131 / +91 - 22-4161 3122

CPhI & P-MEC INDIA 2017 SPECIAL

HiMedia in collaboration with premier academic
institutes is exploring key projects with BIRAC

Dr GM Warke, Founder, CMD, HiMedia Laboratories, in an exclusive interview with
Swati Rana, spoke about the company’s journey and its upcoming project with DBT

HiMedia is almost four to immediately provide `120 crores in the past five faced by the company? 'Excellent Quality', HiMedia
decades old. How has the replacement instead of years for such cutting-edge In pursuit of the Make in India presently caters esteemed
journey been so far? wasting time in sequential equipment facility. We are dream, obtaining a license and patrons globally with a
The journey of Make in India analysis. Of course constantly updating and recognition of our products in comprehensive range of
biosciences products was simultaneously, we begin root upgrading our manufacturing the domestic and global sophisticated, word-class
started by us about 42 years cause analysis of the issues units so as to satisfy the needs market was a very difficult quality products at
ago. The expedition was very faced by the customers. of global demand. To achieve task in the beginning, as these competitive prices, for
challenging, inspiring and HiMedia is always focussed on this, we are increasing our per products were imported from excellent and accurate results.
satisfying as well. We have our the common man needs and day manufacturing capacity of other countries such as the Today, HiMedia is a leading
state-of-art R&D set up; on how they can benefit from ready prepared cultured US and the UK. Very few biosciences company and have
strong, enthusiastic research our knowledge and media plates by about five manufacturing units were a 90 per cent market share in
team with innovative ideas and experience. folds by 2018. For this, our new present in India at that India.Which countries do you
high-end technology. The production unit for ready time.They were unable to export to and how much does
company, which was started Tell us about your prepared cultured media compete with the foreign export contributes to your
with barely five to six products manufacturing capacity and plates is being set up near companies then especially in annual turnover?
in microbiology, now has capabilities. Mumbai. Apart from this, we terms of quality and cost of
diversified and flourished with At present, we have six WHO- are expanding and upgrading the products. Urge for cost- We are an aggressively
other wings of biosciences, GMP certified manufacturing our Nashik plant with new effective quality products and growing industry and at
animal cell culture, plant facilities in Maharashtra technology to produce 10-12 market scenario were the present, we are exporting to
tissue culture, molecular spread across Nashik, fold greater amount of dry major motivations for us, more than 150 countries,
biology, agro industry and so Ambernath and Dombivali, powder over our existing which led to the foundation of including Japan, the US,
on. HiMedia currently has a where in hi-tech and advanced capacity. indigenous manufacturing European countries, Russia,
strong portfolio of 4500 machines have been installed. unit of HiMedia in India in other Asian Countries, Brazil
supplying products to many We have invested around What are the challenges 1976. Keeping the promise of and Argentina. We have our
industries such as own warehouses in the US and
pharmaceutical, agriculture, Germany to quickly deliver the
clinical and health sector, products to the US, Canada,
brewery and fermentation, Europe and other neighbouring
environmental and sanitary, countries. We also have our
textile, petroleum, cosmetics, presence in strategically
food, dairy, veterinary and located centre, Dubai, which
biotechnology segments of can cater to the Middle East
biosciences. HiMedia has and African countries. There is
consistently provided a massive demand for HiMedia
exemplary services to all the products worldwide.
biosciences segments at Understanding this global
reasonable prices. demand, we would like to open
our warehouses in Thailand
How do you assure the and Philippines to cater to the
quality, sustainability and nearby countries. Currently,
affordability of your product HiMedia is generating sales
in the Indian market? revenue of over ` 500 crore of
Over the past four decades, we which 35 per cent revenue is
faced intense competition generated through exports
from more than 40 companies.
However, we have been able to According to you, what steps
sustain due to the should the government take
unchallenged quality of our to ease exports?
products, prompt technical We truly appreciate the efforts
services and moreover, wide taken by Government of India
range of products including for encouraging, Make in India
microbiology, cell culture and concept and its development.
molecular biology. To provide Moreover, there is further
quick solution to our esteemed scope to encourage indigenous
customers, if they feel they are companies, to export more
facing certain challenges in Make in India products by
our products, we try our best reconsidering certain rules so
as to speed up the delivery of

108 EXPRESS PHARMA

December 1-15, 2017

CPhI & P-MEC INDIA 2017 SPECIAL

the products. This will help us Strength of HiMedia is R&D, due to which the of varieties of ready prepared
to increase foreign revenues. company could flourish and possess broad series media. Recently, HiMedia has
Concerned officials perhaps of products in all the segments of biosciences. ventured into hydroponics
need to work more closely with Henceforth, we will keep launching numerous new business and working
medium to large Indian origin products persistently in the future aggressively in this sector.
companies to understand
these challenges which would our sales revenue is devoted to Department of Biotechnology proposed projects are under What is the company's road
definitely increase the export, R&D. We also plan to surge it (DBT) has developed very the scheme of affordable map for the next three
generating more foreign beyond that, to upgrade our strong benches for basic and product development. years?
currency. technology for inventing novel applied research in modern With the mission of
products. We have gone to the biology. Moreover, several Which products are in the “BioSciences in the service of
Tell us about the USP of next level with respect to biotech parks and incubation pipeline? Humankind” and vision
HiMedia. innovations. We have invented centres have been established Strength of HiMedia is R&D, “Quality First” HiMedia is
Urge for innovative products, many synthetic media by DBT and are fully due to which the company working dedicatedly to
supplying excellent quality and wherein raw materials from operational. DBT is really a could flourish and possess provide unique, cost-effective,
exclusive products at vegetable or animal sources back-bone for broad series of products in all unchallenged quality products
reasonable price has been the are not used, which is scientists/industrial R&D’s the segments of biosciences. and excellent service to our
main USP of HiMedia, ever supporting to the green like ours and others in India Henceforth, we will keep customers worldwide.
since its inception. Our R&D revolution. who are willing to develop new launching numerous new
team is always on the toes and technologies for the mankind. products persistently in the At present, HiMedia is
is driven for constant Tell us about your project HiMedia in collaboration with future. As India is the second one of the leading brands in
innovations and quality with DBT. a couple of premier academic hub for FDA approved the world. My directors,
enhancement. Hence, we have It has been revealed by several institutes have been exploring products, we understand fellow scientists, marketing
successfully invented many experts that innovation in certain key projects with enormous opportunities in team and other colleagues
unique products which are not biosciences can make it a Biotechnology Industry pharmaceutical/healthcare are striving strategically to
available with our competitors. bigger industry and also it’s Research Assistance Council industry. As pharma industry make HiMedia the top brand
We are the first manufacturer envisaged that without basic (BIRAC), which is a not-for- is expanding at almost 18-20 in the world within a span of
of certain unique products such research the country will profit set up by Department of per cent CAGR, we are also 5 years. To attain this goal,
as HiVeg, having highest purity. always remain knowledge Biotechnology (DBT), expanding our portfolio in this enhancing quality of
deficient. Therefore, the Government of India. The segment, especially the supply products, inventing unique
What is the annual turnover products and supplying these
of the company and how at reasonable prices is
much do you invest in R & D? always going to be our first
As R&D is our core strength, priority.
approximately 10 per cent of
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To subscribe: [email protected] EXPRESS PHARMA 109

December 1-15, 2017

CPhI & P-MEC INDIA 2017 SPECIAL

Emerging trends in pharmaceutical industry

Manu Grover, Product Manager – Pharma, Waters India, gives an insight about the concepts of
reverse innovation in LC Detector Technology drawing instances from a case study

THE PHARMACEUTICAL FIGURE-1: COMPARISON OF PEAKS IN MULTIPLE BRANDS/DIFFERENT FORMULATIONS
industry’s steady growth
curve is beginning to taper in major ingredients/impurities.
2017, thanks to a few unique
challenges that have unfolded This is often used to verify la-
recently. Pharma R&D pro-
ductivity has also diminished bel claims or give guidance to
and the pharma landscape is
changing. the formulation/analytical

The US is the largest chemist, and in next level we
pharma market globally and
for India too, hence the per- need to identify and quantify
formance of the US market is
crucial for the industry. Sin- all impurities, process mark-
gle-digit spending growth is
forecast for the US market. ers etc. in the system which is
The US market growth rate
declined from 12 per cent in needed to ensure that the
2015 to 7 per cent to 8 per cent
in 2016 with a 6 per cent to 9 ANDA will meet approval
per cent growth forecasted
through 2021. Despite the with consideration to ICH
slowing growth, the US will
account for 53 per cent of Q3B (R2), impurities in NDA.
forecasted global pharma in-
dustry growth of $367 billion There are analytical tools
through 2021.
available in the industry today
In these times of rapid
changes, it is not enough for which can help in
pharma companies to focus
solely on selling drugs and innovator/generic drug
medications. Today, the indus-
try aims for more holistic ap- screening like liquid chro-
proach with integrated serv-
ices. There are upcoming matography equipped with
trends in the industry to which
pharma companies have to re- Acquity QDa, Evaporative
spond to. One such innovative
trend is 'reverse innovation or Light Scattering Detectors,
reverse engineering.'
Refractive Index Detectors &
Reverse innovation is any
innovation, which is likely to UV/PDA detectors. Other
be adopted first in the devel-
oping world. Upon adoption of than conventional liquid chro-
the reverse innovation in
emerging world, the product matography techniques, we
gets distributed globally. Re-
verse innovation is a response have technologies available
to numerous challenges,
which the industry is facing like FTIR, DSC/TGA, SEM,
now, such as a slowdown in
successful new drug launch, Microscopy, XRD, LC-MS etc.
increasing research costs, de-
creasing revenues due to Let us explore here
patent expirations and huge
expense to bring a drug to the through a case study the ad-
market as a result of en-
hanced regulatory hurdles. vantage of Waters 'Acquity

There are different levels QDa' w.r.t reverse innovation
of reverse innovation, for e.g.
in first level, we identify the process.

Acquity QDa is an orthog-

onal mass detector, that com-

plements UV/PDA detector

and gives mass information

about the peak of interest.

This detector has been de-

signed for chromatographers

who lack mass spectrometer

(LC-MS) handling expertise.

In this case study, to study

110 EXPRESS PHARMA

December 1-15, 2017