BioSpectrum India December 2019

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4 BIO CONTENT BIOSPECTRUM | DECEMBER 2019 | www.biospectrumindia.com

COVERSTORY 29.............................................................................................. COVER
DESIGN BY:
INDIGENOUS MEDICAL DOMINIX STRATEGIC
DEVICE AND DIAGNOSTICS DESIGN PVT. LTD.
MARKET GROWING AT 6%
CROSSES RS 36,000 CRORE

The market of indigenous medical device and diagnostics is worth Rs 36,400 crore
growing at 6 per cent for 2018-19. Indian medical device and diagnostics market
comprises of over 800 companies. The domestic medical devices market is highly
fragmented with less than 100 companies generating a revenue of over Rs 50 crore per
year. The growing demand for quality healthcare and the absence of matching delivery
mechanisms pose a challenge and certainly a great opportunity.

EXPERT SAYS / COVER STORY

18 19

Indian IVD industry - A robust regulatory framework

A global manufacturing & fair policy can spur Indian

hub in the making Diagnostics Sector

Suresh Vazirani, Nadeem Anam,

Chairman & Managing Director, Executive Officer, Medical Technology
Transasia-Erba group, Mumbai association of India (MTaI), Gurgaon

20 22

Medical devices need Trends in medical devices

separate regulatory framework distribution: 2019 and beyond

Rajiv Nath, Sanjay Jha,

Forum Coordinator of Association of Indian Director,
Medical Devices Industry (AiMeD), New Delhi Collateral Medical, Mumbai

24 25

Affordability is key for Indian IVDs – The next

home medical devices industry big story after pharma

Saurabh Goyal, Abhinav Thakur,

Executive Director, Managing Director,
Nureca, Chandigarh Accurex Biomedical, Mumbai

26 28

Diagnostic services in India: AI will transform the way we

an untapped potential diagnose and treat diseases

Rahul Rastogi, Zoya Brar,

Co-Founder and CEO, Founder and CEO,
Agatsa, Noida CORE Diagnostic, New Delhi

BIOSPECTRUM | DECEMBER 2019 | www.biospectrumindia.com BIO CONTENT 5

ANALYSIS TOPVIDEO

16 Dr VG Somani,
DCGI, CDSCO
Government’s Nano talks about the
approach for pharma industry initiatives taken by
the government
EVENTREPORT for the medical
devices industry
39
Scan the QR Code »
2019 WORLD CONFERENCE ON ACCESS TO MEDICAL PRODUCTS
Prof Nirmal K.
“Let us develop robust Ganguly, Advisor,
system of knowledge sharing” Translational
Health Science
40 and Technology
Institute highlights
BENGALURU TECH SUMMIT 2019 the efforts
being taken to
Hand-holding start-ups has been a cornerstone treat Lymphatic
of the state policy: Dr Ashwath Narayan filariasis in India

50 Scan the QR Code »

6TH NATIONAL NHM SUMMIT Dr GSK Velu,
CMD, Trivitron
“Let us take back new ideas, innovations Healthcare shares
and knowledge, & ensure that we details on its new
implement these in our states” license agreement
with C-CAMP
REGULARS for a multiplex
microfluidics
BioEdit ........................................................................06 fluorescent
BioMail .......................................................................08 analyser
Policy and Regulatory News.....................................10
Company News..........................................................11 Scan the QR Code »
Finance News.............................................................12
Start-up News............................................................14
WHO News.................................................................15
Science News............................................................41
Academic News.........................................................42
Supplier News............................................................44
People News..............................................................49

6 BIO EDIT BIOSPECTRUM | DECEMBER 2019 | www.biospectrumindia.com

Pharma Sector:
To Up its Game

One of every three pills prescribed in the from western regulators. The letters cause delayed
US is produced by Indian companies and approval leading to delay in introduction of new
nearly 25 per cent of UK medicines in products, affecting the exports adversely. A sector
2015 were made in India as per the note taken which is among the top five in the Indian economy
by Indian Pharmaceutical Alliance in its June contributing the reduction of India’s trade deficit
2019 report. As is known to all, Indian pharma with $11 billion trade surplus cannot afford to lose
accounted for 40 per cent of generic drug or even delay the exports. Particularly, when more
approvals in the US in 2017. Indian drugs are opportunities are likely to open up due to US-
important in the US market due to their low cost. China trade war and further spurred by China’s
As per one estimate, Indian companies’ affordable decision of stopping low value-added chemicals,
generic medicines have helped US to save $80 which is a major source for pharma companies of
billion in healthcare cost. low-cost APIs and other raw materials.

But there is another side to this. The growing As Indian companies were dependent
export of Indian generics to the US has naturally on Chinese companies for the supply of
attracted increased attention from the US FDA these materials, now they will have to look
and other European regulators. Several Indian for alternative sources. There will be a new
pharma companies have received warning letters opportunity as Indian pharma companies will
from the USFDA in the last few months. Poor have to look for the alternative sources within
quality control, Active Pharmaceutical Ingredient the country in order to buy ingredients at lower
(API) contamination, lack of cleanliness and prices to maintain the drug prices at an affordable
maintenance of equipment and lack of proper level. If such sources are not available then they
record maintenance are the reasons for the will have to be brought in. Not only for Indian
warning letters. Apparently, there is a rise in the companies but also for western companies who
US FDA’s activities again for Indian companies were buying from China till now will also turn to
as out of 38 warning letters issued till August this new sources. That will open up an opportunity
year, 13 were to Indian companies. Similarly, out for exports of APIs and raw materials. That is
of the total foreign inspections by the US FDA, where Prasad’s point of backward and forward
one third are conducted in India. Just recently, US integration by Indian pharma sector becomes
FDA observed several violations and shortcomings important and as he has rightly said that it is the
in Aurobindo Pharma’s sterile injection facility need for the hour.
near Hyderabad.
This all will be in addition to the capturing
At the background of these two facts one space created by the reduced Chinese export of
needs to read the recent speech by G V Prasad, medicines to US due the escalating trade war. But
co-chairman and MD, Dr Reddy’s Laboratories all this is possible with improved standards of
and Chairman, Confederation of Indian Industry’s productions by the Indian companies.
(CII) national committee of pharmaceuticals.
On one hand he has projected a rosy picture of For that Prasad’s reported message to the
growing opportunities for Indian pharma as a industry of everybody should up their games in
result of ongoing US-China trade war, but on the terms of quality, systems, discipline and integrity
other, he has rightly cautioned the companies on of data becomes very important. If that is not
the issue of quality. done it will be an important opportunity lost for
India.
Alleged lack of standards of different types at
the production facilities of various Indian pharma Milind Kokje
companies has obiviously attracted more vigil Chief Editor

[email protected]



8 BIO MAIL BIOSPECTRUM | DECEMBER 2019 | www.biospectrumindia.com

Vol 17; Issue 11; November 2019 Thank you for the interaction with
Omar Sherief Mohammad, General
Acknowledgments Manager, Roche Diabetes Care India,
in the November edition. The message
The cover story titled ‘Digitization has been put across very well.
improves lab supply chain
management’ has come out really well. - Koeyli Jaluka, Mumbai
Congratulations.

- Dr Ved P Dwivedi, New Delhi

The article ‘Improving laboratory Thanks a lot for the coverage and
management’ in the November interview feature with Swapan
issue looks great. Thank you for the Bhattacharya, MD, TCG Lifesciences,
feature. in the November issue.

- Shabir Ahmad, UK - Sreetama Ghosh, Kolkata

Vol 17; Issue 12; December 2019 MM Activ Sci-Tech Communications

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proper enquires before



10 POLICY AND REGULATORY NEWS BIOSPECTRUM | DECEMBER 2019 | www.biospectrumindia.com

Health Ministry India takes a step forward
launches in nanopharmaceuticals
IMI 2.0
portal for full The Union Minister for Science & Technology, Earth Sciences and Health &
immunization Family Welfare, Dr Harsh Vardhan has released “Guidelines for Evaluation
of Nanopharmaceuticals in India”. Dr Harsh Vardhan has informed that
A new initiative being this is one of the most important steps for delineating quality, safety and
taken by the Ministry of efficacy assessment of the novel nanoformulations. These guidelines are
Health and Family Welfare intended to provide transparent, consistent and predictable regulatory
to achieve the target of pathways for nanopharmaceuticals in India. The guidelines apply to the
full immunization is the nanopharmaceuticals in the form of finished formulation as well as Active
launch of Intensified Pharmaceutical Ingredient (API) of a new molecule or an already approved
Mission Indradhanush molecule with altered nanoscale dimensions, properties or phenomenon
(IMI) 2.0 from December associated with the application of nanotechnology intended to be used for
2019 to March 2020, treatment, in vivo diagnosis, mitigation, cure or prevention of diseases and
wherein several ministries disorders in humans. The Guidelines are developed by the Department
are coming forward to of Biotechnology (DBT), Ministry of Science and Technology, Indian
join hands in taking Council of Medical Research (ICMR) and Central Drugs Standard Control
the mission forward. Organization (CDSCO), Ministry of Health and Family Welfare and is an
The IMI 2.0 portal outcome of all concerned Inter-Ministerial efforts coordinated by DBT.
has been designed to
capture information on Government targets Lymphatic
the blockwise target of Filariasis elimination by 2021
children and pregnant
women to be vaccinated Union Health & Family Welfare India. According to the Health
during the IMI drive Minister, Dr Harsh Vardhan, Minister, elimination by 2021 is
and also the coverage has announced an aggressive possible if greater collaboration and
data during the rounds strategy to address and eliminate commitment by all stakeholders
of activity. The data will Lymphatic Filariasis by 2021. At is fostered including global
be entered at the district the national symposium on ‘United public health experts, national
level. This will help the to Eliminate Lymphatic Filariasis’ & state representatives, partners
programme officers and organized by the National Vector & donors. Strategies like Triple
administrators at the Borne Disease Control Programme Drug Therapy or IDA [Ivermectin,
block, district, state and (NVBDCP) in New Delhi during diethylcarbamazine (DEC) and
national level to have real October 2019, he stressed upon Albendazole] with strengthened
time information on the the importance of building a mass programme delivery and robust
progress of the campaign movement or ‘Jan Andolan’ to community engagement are
and also take timely action address this preventable vector required to improve the quality of
on slow progress in any borne disease which affects is still Mass Drug Administration (MDA)
particular area. endemic in 160 districts across rounds.

BIOSPECTRUM | DECEMBER 2019 | www.biospectrumindia.com COMPANY NEWS 11

Macleods inks drug license Morepen Labs
agreement with TB Alliance
adds 3 new drugs
Non-profit drug developer 140 countries and territories.
TB Alliance has granted TB Alliance has previously to API portfolio
Mumbai based firm collaborated with Macleods
Macleods Pharmaceuticals on the introduction of child- New Delhi based Morepen
Limited a non-exclusive friendly formulations of first- Laboratories has developed
license to manufacture the line TB medicines. Since and added three blockbuster
anti-TB drug pretomanid as launched in 2015, more drugs to its portfolio of Active
part of the three-drug “BPaL” than one million treatment Pharmaceutical Ingredients (APis)
regimen. Pending regulatory courses have been ordered for sale in domestic and global
approvals, Macleods has by 94 countries, which markets. The three bulk drugs
agreed to commercialize represent approximately / APis are Rivaroxaban (trade
the anti-tuberculosis (TB) 95 per cent of the global name - Xarelto), Vildagliptin (trade
medicine in approximately childhood TB burden. name- Galvus, Zomelis) and UDCA
(Ursodeoxycholic Acid). While
two products - Rivaroxaban and
Yildagliptin will augment Morepen’s
presence in the Cardiac and Diabetic
segments respectively, the third
product UDCA will cater to the Liver
segment. The current global market
size for Rivaroxaban, a powerful
anticoagulant (blood thinner), is $7.1
9 billion and that of Vildagliptin,
which is a strong oral Anti-diabetic
drug used for the treatment of type 2
diabetes, is $1.28 billion.

Cipla acquires Elores in its bid to fight AMR

Cipla has announced the Sulbactam (a beta-lactamase
inhibitor) and Disodium EDTA
acquisition of a novel and (an Antibiotic Resistance
Breaker) indicated for the
patented anti-infective treatment of life threatening
infections caused by gram-
product, Elores, from Venus negative bacteria. It preserves
the efficacy of the antibiotic
Remedies Limited (VRL) for using appropriate Antibiotic
Resistance Breakers (ARBs).
the Indian market to further The product was launched in
India across select tertiary care
strengthen its presence in hospitals in the country in 2013
after approval from the Drug
the branded Indian critical Controller General of India.

care space and as a part of its

agenda to contribute to the

fight against Anti-Microbial

Resistance (AMR). Elores

is a novel combination of

Ceftriaxone (a third generation

beta-lactam cephalosporin),

12 FINANCE NEWS BIOSPECTRUM | DECEMBER 2019 | www.biospectrumindia.com

Stryker acquires Wright Medical for $5.4B

Stryker, one of the extremities (shoulder,

world’s leading medical elbow, wrist and hand),

technology companies, lower extremities

has announced a (foot and ankle) and

definitive agreement to biologics markets, which

acquire all of the issued are among the fastest

and outstanding ordinary growing segments in

shares of Wright Medical orthopaedics. Wright

Group N.V. for $30.75 Medical’s leading upper

per share, or a total equity extremity portfolio and

value of approximately advanced preoperative

$4.0 billion and a total planning technology

enterprise value of will significantly add

approximately $5.4 to Stryker’s offering.

billion (including convertible complementary product portfolio Additionally, Wright Medical’s
and customer base to Stryker’s
notes). Wright Medical, which trauma and extremities business. lower extremity and biologics will
With global sales approaching
was founded in 1950, is a global $1 billion, Wright Medical is a complement Stryker’s portfolio
recognized leader in the upper
medical device company focused and strengthen the company’s

on extremities and biologics. position in this high-growth

Wright Medical brings a highly segment.

Granules India Piramal Enterprises raises
to exit from China capital of Rs 5,400Cr
Joint Venture
Piramal Enterprises Limited has announced
Granules India will divest its entire equity that its Board has approved fresh capital raise of
shareholding in its Chinese joint venture Granules Rs 5,400 crore ($770 million) through a Rights
Biocause Pharmaceuticals. The latter is an equal joint Issue and preferential allotment of Compulsory
venture between Granules India and Hubei Biocause Convertible Debentures (CCDs). The Rights Issue
Heilen Pharmaceutical with manufacturing facility at of Rs 3,650 crore ($ 520 million) at Rs 1,300 per
Jingmen in China. In 2007, Granules formed the joint share, is intended to give an opportunity to all its
venture to ensure a regular supply of Ibuprofen active existing shareholders to participate in the capital
pharma ingredient (API) to support its requirements raise at an attractive price. The Promoters will
for manufacturing pharma formulation intermediates participate in and are committed to the success
and finished dosages. The environmental issues have of the Rights Issue. In addition, the company
created an atmosphere of business uncertainty in plans to raise Rs 1,750 crore ($ 250 million)
China. To comply with regulatory issues on pollution, through the preferential allotment of CCDs
Granules Biocause Pharmaceuticals production facility (at a conversion price of Rs 1,510 per share) to
had invested and will continue to invest substantial Canadian institutional investor, Caisse de dépôt
capital expenditure (capex), which is contrary to et placement du Québec (CDPQ). The preferential
Granules India’s strategy of reducing capex outflow allotment will take place by end November 2019
and free cash flow generation. and the Rights Issue is expected to be completed
by end February 2020.



14 START UP NEWS BIOSPECTRUM | DECEMBER 2019 | www.biospectrumindia.com

Neuroleap raises Karnataka opens
funds for growth BioIncubator at MAHE

Neuroleap, a Mumbai-based brain enhancement Manipal Academy of Higher Education
and mental health startup, has raised an undisclosed (MAHE) and Government of Karnataka
amount of funding from Rajashree Birla, Chairperson, (GoK) have established a BioIncubator centre
Aditya Birla Centre for Community Initiatives and at Manipal. The new Technology Business
Rural Development, and Sminu Jindal, MD, Jindal Incubator has been set up to facilitate
Saw, and Founder Chairperson, Svayam. NeuroLeap incubation of start-ups. The centre aims to
uses advanced Brain Computer Interface (BCI) upscale innovations specialized in technology
technology to understand brain activity and help it and propel innovative ideas towards product
perform at optimum potential. The latest investments commercialization. This world class bio-
would encourage the applied neuroscience startup to incubation space with cutting edge access to
grow its presence across India. So far, the startup has expertise and infrastructure is for start-ups,
successfully delivered brain enhancement for various entrepreneurs, innovators, entrepreneurship
areas like attention, executive function, calmness, ventures of researchers, faculty and students.
sleep, memory, and emotional health for people from Manipal-GOK BioIncubator also focuses on the
all walks of life and across age groups, who may or translational activities dedicated to promoting
may not have any mental disorders. technology based early stage ideas, through
mentorship, investment readiness support,
technical assistance, business validation and
networking opportunities.

C-CAMP to build rapid prototyping facility for medtech startups

Bengaluru based Centre for Cellular and Molecular Platforms
(C-CAMP) with support from National BioPharma Mission
(NBM), Biotechnology Industry Research Assistance Council
(BIRAC) and Department of Biotechnology (DBT), has
announced a first-of-its-kind national medtech rapid prototyping
facility with a focus on Microfluidics technologies. The facility
is envisaged to provide design and prototyping support to
medtech startups in developing low-cost, rapid and point-of-care
Microfluidic Device solutions with applicability in healthcare,
both human and animal health. Through this Rapid Prototyping
facility, C-CAMP will throw open its doors to researchers from
across academia, industry and startups for fabricating plastic
microfluidic devices from design to pilot scale bolstered also by
basic testing capabilities. The prototyping facility will comprise
of a Class 10000 clean room with capabilities for prototyping as
well as pilot scale. It is expected that the facility will be launched
formally in 2020.

BIOSPECTRUM | DECEMBER 2019 | www.biospectrumindia.com WHO NEWS 15

WHO WHO signs MoU with IGBA
announces to promote access of medicines
eradication of
wild poliovirus Full access to medicines is hampered by a variety of factors. Two important
type 3 barriers are high prices and regulatory issues such as long lag times in
bringing medicines to market. To address these issues, Dr Tedros Adhanom
In a historic announcement Ghebreyesus, WHO (World Health Organisaiton) Director-General, and
on World Polio Day on Jim Keon, Chair of the International Generic and Biosimilar Medicines
October 24, an independent Association (IGBA) have signed a memorandum of understanding
commission of experts (MoU). The new agreement is an important step in WHO’s drive towards
concluded that wild universal health coverage by underscoring the importance of generic and
poliovirus type 3 (WPV3) biosimilar medicines to increasing access to affordable, quality treatment.
has been eradicated WHO is an active supporter of expanding use of generic medicines: The
worldwide. Following the vast majority of the products in the WHO Essential Medicines List are
eradication of smallpox generic. The new agreement between WHO and IGBA highlights the role
and wild poliovirus type of the pharmaceutical industry in helping WHO maintain tools that can
2, this news represents facilitate registration of generic and biosimilar medicines. It will facilitate
a historic achievement cooperation between the two organizations to reduce the burden of clinical
for humanity. WPV3 is trials for biosimilars, speeding up registration and increasing access.
the second strain of the
poliovirus to be wiped out, WHO expert panel on digital
following the certification of health meets for first time
the eradication of WPV2 in
2015. The last case of WPV3 WHO is convening global experts included: Developing a global
was detected in northern to help shape the organization’s framework for WHO to validate,
Nigeria in 2012. Since then, roadmap to advance the digital implement and scale up digital
the strength and reach of the health ecosystem. The WHO health technology and solutions;
eradication programme’s Digital Health Technical Recommendations for safe and
global surveillance system Advisory Group met for the first ethical use of digital technologies
has been critical to verify time during the last week of to strengthen national health
that this strain is truly October 2019 to discuss topics systems by improving quality and
gone. Investments in ranging from data governance, coverage of care, increasing access
skilled workers, innovative to ethical and equitable use of to health information; Advice on
tools and a global network digital technologies, to helping advocacy and partnership models
of laboratories have communities benefit from to accelerate use of digital health
helped determine that no proven and cost-effective digital capabilities in countries to achieve
WPV3 exists anywhere health solutions. The meeting better health outcomes; and
in the world, apart from focused on better defining advice on emerging digital health
specimens locked in secure WHO’s role in supporting global technologies with global reach and
containment. The polio digital transformation. Topics impact, so no one is left behind.
eradication efforts have
saved the world more than
$27 billion in health costs
since 1988.

16 ANALYSIS BIOSPECTRUM | DECEMBER 2019 | www.biospectrumindia.com

Government’s Nano

approach for pharma industry

Nanotechnology is now known to be the Dr Harsh Vardhan, Union Minister for Science & Technology,
game changer when it comes dealing Earth Sciences and Health & Family Welfare releasing the
with the rising burden of various life guideline along with dignitaries.
threatening diseases such as cancer, diabetes,
cardiovascular diseases along with others. There delivery of drugs and therapeutic molecules
are no specific guidelines for development and minimizing off target effects and toxicity. There
evaluation of nanopharmaceuticals in India. is a considerate scope of innovation in the area
There is a need to formulate comprehensive of nanoscience and Nanobiotechnology which
guideline focusing on the quality, safety and can develop new generations of nanomaterials
efficacy of nanopharmaceuticals for their with novel functions. We have made considerable
therapeutics use. progress in knowledge generation and innovation
capabilities in this area. However, translation
Keeping this in mind and with an aim of these novel concepts to commercially viable
of supporting, coordinating and advancing products for clinical applications needs regulatory
the nanotechnology based research in India, approvals assessing the quality, safety and efficacy
Department of Biotechnology (DBT), Ministry of of the formulations. In this respect, the present
Science and Technology, Indian Council of Medical guidelines in this multidisciplinary complex
Research (ICMR) and Central Drugs Standard domain will be of great help for the innovators
Control Organization (CDSCO), Ministry of Health and industries to optimize their research on
and Family Welfare have rolled out the first developing the product based on the regulatory
guidelines for the sector ‘Guidelines for Evaluation requirements.”
of Nanopharmaceuticals in India’ on October 24.
It is an outcome of all concerned Inter-Ministerial Commenting of the
efforts coordinated by DBT. guidelines Zarine Khety-
Head of the department,
Releasing the document Pharmacy, Saifee
Dr Harsh Vardhan, Hospital, Mumbai
Union Minister for said “Nanotechnology is
Science & Technology, highly applicable to treat
Earth Sciences and humans especially for
Health & Family Welfare diseases like cancer and as
informed that these immunomodulators. The
“Guidelines for Evaluation guidelines will provide transparent, consistent
of Nanopharmaceuticals and predictable regulatory pathways for
in India” is one of the most nanopharmaceuticals in India. The intervention
important steps for delineating quality, safety and
efficacy assessment of the novel nanoformulations.
These guidelines are intended to provide
transparent, consistent and predictable regulatory
pathways for nanopharmaceuticals in India.”

Dr Renu Swarup,
Secretary, Department
of Biotechnology
said, “Applications of
nanotechnology in medical
therapeutics has the potential
to revolutionize the current
treatment strategies in near
future. Nano Pharmaceuticals
can enable target specific

BIOSPECTRUM | DECEMBER 2019 | www.biospectrumindia.com ANALYSIS 17

shall also witness significant procession towards wide range, hence it has an overlap with medical
cutting edge technology and quick clearances to diagnostics business. Mostly safety has been given
newer products on nanotechnology.” a priority and its structure and function has been
taken into consideration. These guidelines are
Reacting to the release of useful for manufacturers of Active Pharmaceutical
the guidelines, Mahendra Ingredient (API) and formulations, and other
Patel, Managing research and development organizations.
Director, Lincoln It’s inclusion in detailed lifecycle plan for
Pharmaceuticals, pharmacovigilance and marketing authorization
Ahmedabad said “Every application is required.”
year several new nano-
pharmaceuticals are being Sharing his views Dr
developed and marketed Vikram A Munshi,
across the world. However, Founder, WhiteSpace
regulatory approvals is the most important Consulting & Capability
factor for translating laboratory research into Building, Gurugram said
new products, the new set of guidelines is “This framework is expected
designed to facilitate this process. The move is to expedite the decision-
an important steps and intended to aid research making of regulators and
towards development of new nano-formulations researchers during the launch
that are more effective, safer than conventional of quality assured, anticipated
medicines, less toxic while also affordable for the products in the market which will benefit the end-
masses. These guidelines are intended to provide users and the manufacturers.”
transparent, consistent and predictable regulatory
pathways for nanopharmaceuticals in India and Way Forward
will be applicable to finished formulations as well
as API of a new molecule.” A report by Grand View Research, Inc. observed
that the global nanomedicine market is anticipated
Patel further said “Nanocarrier-based to reach $ 350.8 billion by 2025. Development of
targeted drug delivery is an emerging field novel nanotechnology-based drugs and therapies
with introduction of nanopharmaceuticals is driven by the need to develop therapies that
in the market. Nano-formulations are not have fewer side effects and that are more cost-
entirely new drugs but medicines that have effective than traditional therapies, in particular
better quality because of the technology-led for cancer.
delivery mechanisms that are used to make its
administration in the body more effective and site India is already has a huge and developed
specific. The guidelines articulate that all nano- pharmaceutical market. There is a good
pharmaceutical products will have to comply synchrony between the industry players and the
with the new drug and clinical trial rules, 2019 R&D industry in India when it comes to picking
for seeking approval for manufacturing or import up the right product at various stages of the
of any drug or to undertake clinical trial. To sum research and converting them into a full-fledged
up, Nano-pharmaceuticals derived by application product available in the market for various
of nanotechnology in medical therapeutics are stakeholders. The guidelines will facilitate the
expected to bring about a revolution in treatment movement.
strategies as they would enable target specific
delivery of drugs and therapeutic molecules and There is a considerate scope of innovation in
thus offer higher efficacy and lower toxicity in the area of nanoscience and nanobiotechnology
many disease conditions.” which can develop new generations of
nanomaterials with novel functions. This
Sharing his views Dr document will give impetus to initiate activities
RB Smarta, Chairman for developing safety guidelines for other domains
& Managing Director, like agri-inputs and agri-products, cosmetics,
Interlink Marketing implantable devices, through interventions of
Consultancy, Mumbai nanotechnology. Besides, the guidelines will pave
said “The guidelines are useful the way for significant benefits through such
for diagnosis, mitigation or cutting edge technology and contribute to the
cure, prevention of diseases mission on “Affordable Health Care for All”.
or disorders. It covers a
Kalyani Sharma
[email protected]

18 COVER STORY OPINION BIOSPECTRUM | DECEMBER 2019 | www.biospectrumindia.com

Indian IVD industry - A global
manufacturing hub in the making

« ‘priority’ diseases such as HIV, tuberculosis, malaria,
hepatitis B and C, human papillomavirus and syphilis.
Suresh Vazirani,
Chairman & Managing Streamlining of government procurement
Director, Transasia-Erba pathway: Government e-marketplace (GeM) can be a
group, Mumbai game changer to make public procurement of diagnostic
equipment transparent, inclusive and efficient.
The Indian In-vitro Diagnostic (IVD) industry
is growing at a steady pace within the country, Digitally enabled diagnostics are the future:
emerging as a global manufacturing hub in the Internet of Things (IoT) is making strong inroads in
medical devices space. Government initiatives such as the medical device industry that is seriously exploring
Ayushman Bharat, Essential Diagnostics List and Make its short and long-term benefits. Established IVD
in India are also playing a key role in promoting the companies and manufacturers are investing in
Indian IVD industry. digitization for consumer-friendly devices, embedded
remote connectivity for real-time access to data, and to
Encouraging the setting-up of medical simplify sample collection processes. While we seem to
device parks: The Centre has recently given be heading in the right direction, there are still some
approval to set up medtech parks in Andhra Pradesh, challenges that require immediate attention:
Telangana, Tamil Nadu and Kerala with Uttarakhand
and Gujarat also showing keen interests. The various Medical devices are not drugs: To start with,
device manufacturing clusters in the country, along the declassification of devices from drugs is something
with medical device and medtech parks in the vicinity that needs to be urgently looked into. It is also critical
of these clusters, have the potential to create a large to address gaps in regulatory framework. Policymakers
ecosystem of manufacturers, suppliers and developers. need to consider structuring a Medical Device Law that
separates drugs from devices. By rejecting the health
Quality paves the way: Introduced in 2018, ministry’s proposal to bring medical devices under
Indian Certification for Medical Devices (ICMED) is the Central Drugs Standard Control Organization
the country’s first indigenous quality assurance system (CDSCO), NITI Aayog has given a new ray of hope.
for India manufactured medical devices. It is proving
to be a boon for IVD manufacturers, in bringing down Lack of lab infrastructure and trained
the substantial time and monetary investment to obtain manpower: Unfortunately, the number of diagnostic
globally accepted quality certifications. It is also giving labs outnumber certified pathologists in the country. In
a boost to the ‘make in India’ focus on this industry. such a scenario, misdiagnosis is not uncommon and most
From the customer’s perspective, it helps in assuring of the medical errors are triggered due to lack of skills and
standardized products. We are proud to be India’s first proper training. As a direct result of this skill gap, most
IVD company to receive this certification. laboratories are functioning illegally and are the ones
responsible for the misdiagnosis and wrong treatment.
India - first to chalk out an Essential The Government needs to devise stringent policies to
Diagnostics List: Considering the indispensability prohibit path labs managed by unqualified professionals
of medical diagnosis, World Health Organization and non-calibrated or non-validated equipment.
(WHO) finally woke up to the fact that just like the
Essential Medicines List, there is a need for the Essential Rationalizing trade margins: The issue of
Diagnostics List (EDL), which outlines essential unreasonably high trade margins in medical devices
diagnostic tests that each country should provide at has been adversely affecting both the industry as
affordable costs for timely disease management. It is well consumer interest. An approach to trade margin
noteworthy, that India has taken the lead in setting up its rationalization that focuses on encouraging market
own National EDL, comprising in-vitro tests to diagnosis development, manufacturing and ease of doing
business in India, would provide the right environment
for ensuring quality and affordable access to medical
technologies in India.

With a little more government intervention, India
stands a very good chance at becoming a global hub
of innovation and manufacturing of next-gen medical
devices.

BIOSPECTRUM | DECEMBER 2019 | www.biospectrumindia.com COVER STORY OPINION 19

A robust regulatory framework
& fair policy can spur Indian
Diagnostics Sector

« However, only 11 states including Arunachal
Pradesh, Himachal Pradesh, Rajasthan,
Nadeem Anam, Jharkhand, Mizoram, UP and Uttarakhand have
Executive Officer, adopted the Act so far with several of them yet to
Medical Technology implement it.
association of India
(MTaI), Gurgaon With plans to set up the Clinical
Establishment (Central Government) Rules,
Emerging as one of the bright spots of 2019, to specify norms in terms of infrastructure,
India’s healthcare, the diagnostic industry manpower, equipment, drugs, support
at present is a $9 billion market, growing service and records for registration of clinical
at 15- 20 per cent in the last 5 years. The sector establishments, the government is looking to
is expected to exceed $12 billion by financial year provide a comprehensive regulatory mechanism
2020-21 with most of the growth expected in Tier for the industry. A more robust implementation
2 and 3 cities. and monitoring framework is also needed for the
Rules to be effective.
The diagnostics space in India is largely
unorganized and fragmented comprising of The Indian patient should have the access
about 100,000 diagnostic labs, 90 per cent of to the best available tests at the right value
which comprise of unorganized players that irrespective of where the reagents, equipment
lack specialized clinical expertise to move away or instrument are manufactured. The three-
from routine diagnostics . Furthermore, only fold increase from 10 per cent to 30 per cent in
1 per cent of these laboratories are accredited. custom duty of IVD reagents (imported from
Lack of poor resources and scarcity of qualified US) is contrary to the government’s vision of
technicians restrict the use of latest diagnostic providing affordable and quality healthcare for
equipment that is otherwise available in the Indian patients. Additionally, the government
market. Compounding the complexities, there must facilitate the adoption of global standards
are collection centres, whose role is limited to in its regulatory policy, which will not only
collecting samples and sending them to the help patients in accessing best possible care at
central laboratories for diagnostic tests. The par with global best practices but also enable
diagnostic industry in India is therefore in need domestic manufacturers to qualify their products
of guidelines on collection of samples, storage in global markets.
and transportation and also a structure to ensure
basic training in phlebotomy to the staff of these The impetus provided by several Government
centres. Companies such as Becton Dickinson, Insurance Schemes have fuelled the recent
B Braun and Vygon offer cutting edge training pace and speed of growth of healthcare. To
programmes in phlebotomy- a fundamental spur it even further, government should look at
technique which needs excellence. including diagnostics spends under the ambit of
insurance/ aided pay, to help reduce financial
The Clinical Establishments (Registration and burden for the Indian consumer.
Regulation) Act 2010 has been enacted by the
Central Government to provide for registration For the Indian diagnostics industry to
and regulation of all clinical establishments. achieve its growth potential, a robust regulatory
framework is needed. Adoption of internationally
harmonized principles and technical guidance in
legislation will create a coherent ecosystem and
help the industry thrive by keeping healthcare
costs low and encourage introduction of newer
and innovative technologies in India.

20 COVER STORY OPINION BIOSPECTRUM | DECEMBER 2019 | www.biospectrumindia.com

Medical devices need
separate regulatory framework

« on October 18 , has indicated notifying all medical
devices that are engineering products as ‘medicines’
Rajiv Nath, under the Drugs & Cosmetics Act from December
Forum Coordinator of 2019 but the roadmap being defined in cover note
Association of Indian from the Under Secretary does not entail migrating
Medical Devices these to a separate ‘Medical Devices Act in due course
Industry (AiMeD), (as being drafted by NITI Aayog) and seems to be
New Delhi an independent parallel action .This uncoordinated
announcement is causing huge confusion and
The vast majority of India’s medical devices apprehensions amongst domestic manufacturers
of which is nearly 80 per cent import especially of Medical Electronics as while one
dependent, are unregulated for quality notification talks about a reasonable transition
and safety. While many of these products may period of 3 to 4 years another notification to regulate
have regulatory certifications in other countries, ultrasound equipment gives only one year and there’s
the reality is that a considerable number of them no mention of a separate Act. At present only 24 out
are being exported from countries that do not of over 6,000 medical devices are regulated by being
regulate their exports. The medical devices market notified as drugs
in India is over $15 billion (Rs 105,000 crore) and
projected to grow to $50 billion by 2025 and is the Devices are Engineering
fourth-largest in Asia. items and not drugs

Thirty years have gone by since the 1st It’s imperative to have a separate law as devices
medical device was regulated as a drug in 1989. A are engineering items and not medicines — a
comprehensive regulatory framework is nearly in MRI or CT Scan machine by no stretch of the
sight with the Draft MEDICAL DEVICES (Safety, imagination can be called a drug, and, so, continued
Effectiveness & Innovation) Bill from NITI Aayog to attempts to regulate devices as drugs is illogical
be shortly proposed as a Separate Law. and incorrect unless assured that it is a temporary
measure. A beginning was made to correct the
Our policymakers in Health Ministry were anomalous situation with the introduction of the
surprisingly undecided and seemed to be in no Medical Device Rules in 2018.These Rules have
urgency to usher in a ‘Patient Safety Medical Devices risk proportionate controls correlating to the risk
Law to protect patients, even after the recent ICIJ
implant files or J&J incident, or the most recent
ban on Trans-vaginal Pelvic Mesh by US Food and
Drug (FDA). As Ministry of Health & Family Welfare
(MoHFW) had been surprisingly very reluctant to
draft a separate law preferring to attempt to amend
the Drugs Act and Central Drugs Standard Control
Organization (CDSCO) has a conflict of interest to
empower itself the industry watchers are waiting
with anxiety the details of the Draft Medical Devices
Bill that NITI Aayog is reportedly working upon in
consultation with other stakeholder departments and
ministries to address the regulatory vacuum & the
national patient safety concerns.

Devices do need to be regulated but the two drafts
and two final notifications recently issued by MoHFW

BIOSPECTRUM | DECEMBER 2019 | www.biospectrumindia.com COVER STORY OPINION 21

classification of devices. Similarly, the law and Medical Devices need a
penal provisions need to be risk-proportional as you Competent Regulatory Body
can’t have the same penalty for a manufacturing
failure of a pair of spectacles as for a contact Policymakers while beginning to view devices and
lens or for an intra-ocular lens. Patient safety is drugs differently, need to ensure these are of high
more complex with devices where the same are a quality and are safe, must consider regulating devices
shared responsibility of the manufacturer, medical under the ministry of health as done for food. Food
practitioners, product user and the regulator. is not regulated under the Drugs Act or under Drugs
The Drugs Act itself needs reforms as it does not Controller General of India (DCGI), or the CDSCO, but
uniformly and equitably regulate quality from has a Food Safety and Standards Authority of India
state-to-state in the absence of a national singular (FSSAI) with a Secretary level chairman and CEO.
regulatory authority and there is no point of While many of the manufacturers of the 24 categories
replicating this limitation for devices too. The recent of already notified devices are ok to be regulated
J&J episode showed the limitations of the Drugs under a familiar CDSCO but wish it to revamped with
Act and the Drugs Controller was initially seen to be a medical devices specific division and appropriately
handicapped to discipline overseas manufacturers. needed competent staffing by engineers and scientists,
a vast majority of the manufacturers of devices that
Medical Devices has failed to attract investors to are currently not regulated prefer to seek a separate
put up factories. Why? Can a competent builder from national regulatory body which will not view Devices
Mumbai, experienced enough to make a 90-storey from the prism of Drugs , as reportedly envisioned in
building, risk starting the construction of a 70-storey the NITI Aayog draft Bill.
one in Gurgaon if the building by-laws there don’t
permit construction of over 36 floors only under The government should stick to earlier assurance
hearsay that said by-laws are under amendment or given to the industry by the MoHFW in 2016 of four
will he wait? steps—starting with the Medical Devices Rules (MDR),
initially experimenting with a few electronic devices
Similarly, medical devices manufacturers need under the MDR, the MDR to be amended as per
to know the legal requirements, in a predictable experience gained after six months of introduction and
manner. This will attract overseas and Indian the simultaneous drafting of a Medical Device Bill to be
investments. Presently, investors shy away from an reviewed by us and other stakeholders and passed by
unpredictable, incomplete and incorrect regulatory Parliament and the MDR to accordingly be tweaked in
environment. This will also attract investments order for it to migrate to an eventual Medical Devices
not only in manufacturing but in the much needed Law.
supportive eco system of Testing Laboratories
and Certification Bodies and competent Quality The National Accreditation Board of Certification
Assurance personnel and Regulatory experts. In Bodies is already accrediting certification bodies for
the absence of regulations, domestic manufacturing voluntary quality assurance (the Indian Certification
suffers as a surgeon is unsure of trying an for Medical Devices (ICMED) scheme) under the
unregulated device from a start-up on a live patient. QCI (Quality Council of India). Incentivizing ICMED
certification by the QCI will help Indian manufacturers
in capacity building for voluntary compliance to quality
standards, thereby ensuring global competitiveness and
enabling the smooth transition to mandatory compliance
under the proposed draft Medical Devices Bill from
NITI Aayog. A strong and fair regulatory environment
will help the Make in India campaign by encouraging
the growth of this industry. Right from trade margin
rationalization to ensuring a separate set of legislations
and regulatory frameworks to govern the medical device
sector and everything in between needs to be looked at
afresh to galvanize domestic manufacturing.

If we are serious about placing India as a top global
medical devices manufacturing hub, then one needs to
understand that piecemeal reforms will not work and
continuing to attempt to regulate Devices as Drugs
under Drugs Act without an assurance of migrating to
a separate legislation will do more harm than good to
Make in India campaign.

22 COVER STORY OPINION BIOSPECTRUM | DECEMBER 2019 | www.biospectrumindia.com

Trends in medical devices
distribution: 2019 and beyond

« the complete Distribution model is outsourced to a
few National Distributors, commonly referred to as
Sanjay Jha, Group Purchasing Organizations (GPO), who through
Director, their expertise and established tiers of distribution,
Collateral Medical, make available the medical products to Healthcare
Mumbai Professionals. ColMed is one such Indian company,
which has been at the forefront of this revolution in
Much like drugs, medical devices and India. The GPO’s big-dollar investment in quality
equipment is today a key input in manpower and sophisticated inventory control
the healthcare sector. Widespread systems, help local distributors in Tier 2 & Tier 3 cities
availability and easy accessibility of quality medical in catering to health centers, by enabling them to
devices is critical to the realization of our goal of procure quality products at affordable price.
universal healthcare. India is currently the 4th
largest medical devices market in Asia after Japan, It is a win-win model for all, since OEM’s can focus
China and South Korea and the medical devices on enhancing Product Awareness, GPOs can use their
market in the country is expected to grow to $50 expertise of distribution, Tier 2 & Tier 3 distributors
billion by 2025. The growth is humongous across can purchase products at low price in spite of limited
the world and the global medical devices market buying volumes, and customers get access to a wide
size is likely to grow by a whopping $ 119.98 billion array of products at reasonable price.
during 2018-2022, according to a report by market
research firm Technavio. 2) Pricing Regulations by Government and
its implication on distribution: Recognizing the
With a rapidly expanding healthcare sector, India need to improve regulatory standards for medical
is today a lucrative market for all global companies devices, the government has initiated measures to set
manufacturing and selling medical devices and
equipment. Most global companies are already selling
products in India or are planning to enter the market.
Even as the diversity and complexity of the Indian
market remains a challenge for distributors, a series
of new developments and trends are laying ground
for improved regulatory standards, cost effective
interventions as well as improved supply chain
management.

Here are some prominent new trends that are
expected to impact the medical devices distribution in
recent years:

1) Distribution Rationalization: For original
equipment manufacturer (OEMs), managing
distribution networks and sales channels effectively
has always been a significant area of concern. Today,
many OEM’s have devised a strategy in which they
focus on their core job of developing products,
leaving the distribution conundrum to specialist
group purchasing organizations. As seen in the USA,

BIOSPECTRUM | DECEMBER 2019 | www.biospectrumindia.com COVER STORY OPINION 23

up a separate regulatory authority for this sector that technology products, a few domestic companies and
hitherto came under the domain of drug regulator MNCs with manufacturing facilities in India have
Central Drugs Control Standard Organization successfully developed low cost products that are on
(CDSCO). The government is planning to set up a par in terms of quality with existing products that
Medical Devices Authority (MDA) that will devise require complex technical know-how to manufacture.
Indian regulatory norms for the entire spectrum in the These products have succeeded in developing a niche
medical devices sector that till now adheres to Food market in many regions globally. For example, Indian
and Drug Administration (FDA) regulations. The manufactured heart valves have found new export
government is also working on rules for rationalizing markets in Myanmar, Kenya and Thailand. This has
the trade margins for medical devices that have been helped the medical devices exports register strong
categorized as drugs. In fact, price caps have already growth.
been introduced on devices such as stents, reducing
the profit margins of hospitals as well as distributors. 4) Improved supply chain management
using Artificial Intelligence & Machine
All these measures are set to make regulations learning: Supply chain management is often highly
more stringent for devices, even as price regulations under-rated part of an efficient distribution network.
will have an impact on trade margins. Distributors are A report by an American healthcare supply chain
now trying to work on finding innovative distribution management company concluded that improving
strategies that are more cost effective. supply chain management can enable health systems
to reduce their supply expenses by an average of
3) Reducing Quality Differentiation: A 17.7 per cent, equivalent to $11 million annually per
number of factors have helped bridge the brand hospital.
differentiation between the products of multinational
companies (MNCs) and local manufacturers. These Growing realization about the need to institute
factors include improvement in quality of Indian efficacious supply chain management practices have
manufacturing and wide scale acceptability of Indian led distributors to turn to sophisticated technologies
manufacturer products which offer good results at like artificial intelligence (AI) and machine learning
lower costs. The wide brand choices have reduced that can leverage big data and help standardize
brand differentiation, which has helped local OEMs processes. This in turn results in better predictability,
to compete with International MNCs. Though optimization of supplies and reduction of wastage and
manufacturing remains limited to producing low expenses. AI based algorithms that use vast data for
predictive analysis proves to be particularly useful
in supply chain applications. Similarly, a McKinsey
study found that using AI to enhance supply chain
management could cut forecasting errors by 20 per
cent to 50 per cent.

As Medical Device & Consumable distribution
moves towards optimization of resources, AI based
applications are set to become a norm in supply chain
management practices.

5) Greater consolidation of businesses and
growing role of private equity players: A rapidly
growing healthcare distribution business is fast
catching the attention of private equity players who
have turned towards investing in medical distribution
businesses. This will result in greater standardization
of practices and inflow of more expertise in the sector.
Apart from entrance of more private equity players, a
greater consolidation of businesses also seems to be
on the cards. Globally, pharmaceutical and devices
distribution have consolidated to a large extent.
However, in India it is still largely fragmented. A series
of acquisitions and mergers are already underway in
the sector and the trend is likely to continue. As we
move towards greater consolidation, this will also
result in better supply chain management practices
and improved technological prowess.

24 COVER STORY OPINION BIOSPECTRUM | DECEMBER 2019 | www.biospectrumindia.com

Affordability is key for Indian
home medical devices industry

« three considerations without compromising on cost-
effectiveness remains a formidable challenge which
Saurabh Goyal, not every company can meet.
Executive Director,
Nureca, Chandigarh Accurate readings right up to the third decimal
point, advanced yet easy to use features, cutting-edge
The alarming increase in the incidence of lifestyle solutions and adherence to international quality and
diseases in India is leading to rising awareness safety standards like USFDA, CE and ROHS, apart
about the importance of early detection of from ISO, can make all the difference in setting
health complications, making the age-old adage the pace for the medical devices industry in India.
“Prevention is better than cure” more relevant than Innovative solutions and cutting-edge technologies
ever before. The pressures of fast-paced modern living like patent designs, Hindi voice instructions and the
have brought the focus on preventive healthcare with flow control-enabled feature in nebulisers which
home health monitoring devices enabling people who regulates the flow of medicine, reduces wastage
cannot visit clinics on a frequent basis to regularly and enhance the efficacy of the drug, can be a game
monitor vital health parameters in the comfort of their changer. Companies which adopt these value-added
homes, and that too at affordable prices. features without bargaining on affordability will have
a definite edge, which will eventually reflect in higher
Though the Indian market for medical devices is market shares.
expected to grow from $4.46 billion in 2018 to $6.21
billion by 2020, home healthcare adoption is still at There are immense opportunities waiting to be
a nascent stage in the country. Poised to grow at a tapped owing to many favourable factors like more
Compounded Annual Growth Rate of 30 per cent, demand due to rise in incidence of lifestyle diseases,
the market is still constrained by the price factor with increase in disposable incomes, especially the
steep prices confining the use of medical devices largely incomes of the middle class, large market size and
to affluent sections of the society. Common people increase in digital penetration. While the demand
still cannot afford them. While they are reluctant to for quality value-added products has increased with
compromise on quality for a lower price, high-quality digital penetration with people seeking better quality
devices come at a price they simply cannot afford. products in the same price range, a right mix of on-
ground retail and online selling models is the way
The focus on low pricing with little consideration forward. Nureca, for instance, enjoys considerable
for quality has been the bane of the home medical presence online through all major e-commerce
devices market in India. So, even in an impressively platforms, but it has also joined hands with Croma,
growing market, there is a wide gap between the India’s first Omni-channel electronics retailer from
need for and availability of affordable yet world-class the Tata Group, to emerge as the very first company
medical devices. Nonetheless, there are companies to sell healthcare and wellness products through
looking to fill this gap by making products with the Croma stores. The idea behind this collaboration is to
latest technology and features readily available at ensure the availability of high-quality yet affordable
competitive prices. healthcare and wellness technologies among people
who want to physically explore a product before
Apart from affordability, what people look for purchasing it.
in medical devices can largely be classified in three
categories—exceptional accuracy, high quality and However, there are challenges, too. The real
advanced value-added features. However, coming challenge lies in allaying the doubts of people
up to the expectations of consumers on all these regarding the products and their efficacy, and this
is what we primarily need to address. Changes in
government regulations for medical devices can also
be a challenge, but this does not hold true in every
case. It is rather an opportunity for companies which
conform to global quality and safety standards like
USFDA and CE.

BIOSPECTRUM | DECEMBER 2019 | www.biospectrumindia.com COVER STORY OPINION 25

IVDs – The next
big story after pharma

« also aim to promote a culture of self-compliance by
manufacturers of medical devices.
Abhinav Thakur,
Managing Director, However, these falls short of a promise since they
Accurex Biomedical, regulate only IVDs reagents and not instruments.
Mumbai This leads to imports of a lot of rebranding, re-
labeling and condemned pre-owned equipment that
The Indian In Vitro Diagnostics (IVDs) sector, finds their way into the country.
included under the Make-in-India initiative
of the Government of India, has huge market Industry Players
potential and is witnessing double digit growth.
It is estimated there are 70 IVDs reagent
The IVDs market in India is estimated to be $1 manufacturer’s in the country.
billion currently and experiencing an annual growth
of 15 per cent and has the potential to be a $1.8  Roche captures maximum share of the India
billion industry by 2025 as per industry estimates. IVDs market.
India is the fourth largest market for IVDs devices in
Asia after China, Japan and South Korea.  Siemens and Transasia held the 2nd and 3rd
position in Indian IVDs market.
India being an emerging market is also evolving as
a potential manufacturing hub for key global medical  TransAsia the largest domestic player has
IVDs players and some IVDs companies such as a strong presence in small and medium-sized
Siemens, Arkray, Perkin Elmer, Sysmex Corporation, independent diagnostics centers across India.
Randox and so on, have set up their manufacturing
facilities in India.  Global IVDs companies are expanding their
operational footprint in India which presents a
India is till date dependent on imports for growing market for their products.
its IVDs needs with almost 80 per cent of IVDs
being imported. The cost of manufacturing in the Challenges
developed world is many times higher than the cost
of manufacturing in India hence there has to be a Tenders have restrictive and discriminatory clauses
strong push for MAKE IN INDIA IVDs’ to lower the that USFDA & CE marked products can only
healthcare costs in India. qualify in certain public procurement tenders. This
restricts Indian manufacturers from participating
Regulatory Landscape in these tenders. However due to the intervention of
Department for Promotion of Industry and Internal
The Central Government released the Medical Device
Rules, 2017 and ensured its operationalization, from
January 1, 2018. The new set of regulatory practices
aims to prepare India to meet its IVDs needs. These
new rules shall thus enhance ease of doing business
and ensure availability of quality IVDs across the
country. Also, for the very first time, periodic renewal
of licenses will not be required. Consequently,
manufacturing and import licenses will be valid
until it is suspended or cancelled. The new rules

26 COVER STORY OPINION BIOSPECTRUM | DECEMBER 2019 | www.biospectrumindia.com

Trade (DPIIT) these restrictive Diagnostic
clauses have been removed in some services in India:
public procurement tenders. More an untapped
stringent rules are required to potential
remove all restrictive clauses from
Public Procurement tenders to give «
MAKE IN INDIA IVDs’ a boost.
Rahul Rastogi,
Opportunities Co-Founder and CEO,
Agatsa, Noida
 Emerging Markets Exports:
In-vitro Diagnostic devices export With the second-largest population in the world, India
trade has grown by 58.7 per cent also has a massive disease burden which has barred
from $24 million in FY12 to $ it from enjoying its demographic dividend optimally.
39 million in FY16. In the current To identify and treat this, the diagnostic sector in the country
scenario i.e. in the year 2018-19 the must play a greater role. About a decade or two ago, it was
export is further increasing. quite difficult to easily access diagnostic services, especially
services related to radiology etc. There were fewer labs and in
 The Ayushman Bharat the pre-digital era, patients faced hassles in getting the required
scheme aims to set up 1,50,000 tests done. With the emergence of digital communication
health and wellness sectors across and evolution of the corporate sector towards the turn of the
the country. The large-scale influx millennium, the diagnostic industry also witnessed a shift. A
of patients to these centres will number of organized corporate diagnostic chains entered the
increase the demand for IVDs’. market. This has not only led to the standardization of this sector
and the pricing of tests, but also an improvement in the overall
 The Free Diagnostic Initiative quality of the services. The diagnostic sector is witnessing rapid
is intended by National Health growth, but there are still several challenges.
Mission to provide a set of essential
diagnostics at various levels of To begin with, there is a shortage of qualified service
care so that providers are able to professionals such as technicians to meet the market needs.
make rational decisions regarding India must urgently train more people that can be absorbed in
treatment and patients benefit by the industry. The patient to professional ratio leaves much to be
getting their tests conducted within desired. The higher cost of tests especially radiology services like
the facility free of cost is going to Ultrasound or MRI/CT-Scan is also a major roadblock. A leading
boost the demand for IVDs’ reason is that most of the diagnostic machines are imported from
other countries. This not only makes them much more expensive,
 Private equity investments in but also results in higher maintenance and operating costs. If the
pathology laboratories and stock machines develop any fault then getting them repaired becomes
listing of three lab chains (Dr. Lal’s, a costly and time-consuming process due to complexities of
Thyrocare & Metropolis) have led overseas warranties and unavailability of maintenance personnel
to growth of the IVDs industry. locally.

 National Essential There is also a challenge of accuracy. Quite often, the
Diagnostics List (NEDL) has been
developed by Indian Council of
Medical Research (ICMR) to build
on the Free Diagnostics Initiative
and other diagnostic initiatives
of Ministry of Health and Family
Welfare. The rollout of the NEDL
at public health facilities will lead
to an increase in demand for IVDs.

IVDs play a key role in
improving health and quality of
life. Recognising the fact that
diagnostics is a critical part of
healthcare both the private and
public sector is investing heavily
into diagnostics. This makes IVDs
the next big story after pharma.

BIOSPECTRUM | DECEMBER 2019 | www.biospectrumindia.com COVER STORY OPINION 27

diagnostic process takes longer than necessary and afford them. This governmental support has not only
there is always the risk of incorrect reports being brought more people under diagnostic coverage but
generated by lower quality machines. has also enabled expanding geographical coverage
of such services. Apart from the government-funded
Market size and growth enablers schemes, health insurance has emerged as a key
sector in the last few years. In a country where
With greater emphasis on improving healthcare majority of the public is used to paying out of their
coverage in India today, there has also been a pockets for medical treatments, the high cost of
commensurate growth of the Indian diagnostics diagnostic services has been a major drawback. In
market. Statistics peg the current market size at fact, this prevents almost 55 per cent of rural and
about Rs 40,000 crore, and this is further growing 60 per cent of urban Indians from availing them.
at a CAGR of 15 per cent to 20 per cent. A number However, with the emergence of health insurance
of developments in the last few years have led to the and public awareness around lifestyle diseases such
diagnostic industry playing a more significant role as blood pressure, diabetes, and heart problems, the
in the healthcare sector. For instance, the burden preventive approach has gained popularity.
of preventable lifestyle diseases has increased. This
has caused healthcare providers to make a strategic In conclusion
shift from the conventionally responsive healthcare,
to a more diagnostic-driven preventive system. The diagnostics sector in India has witnessed
Irrespective of whether a person is fit or unhealthy, tremendous growth in recent years due to various
it is advised that that they undergo periodic health conducive factors. However, to expedite the growth
check-ups to detect any health condition right at the of the sector, it is necessary to make these services
outset. more affordable. Greater emphasis is needed
towards domestic production of diagnostic devices
India’s battle against its disease burden has found and machinery as they would be less expensive
an important ally in the form of smartphones and compared to the imported ones and eventually
internet connectivity. The pan-India proliferation of bring down the test costs. The large-scale adoption
devices has enabled healthcare providers to reach of medical insurance and availability of public
out to the public in an effective manner. Using digital health insurance provided by the government will
communication via social media, they are now able to also play a major role in the growth of the Indian
disseminate information related to various diseases, diagnostics market.
their causes and treatments. Through such mass
communication, providers are also able to emphasize
the importance of diagnostic services in ensuring
better, faster results.

One of the biggest complaints against diagnostic
services in India has been the high cost of various
tests especially in radiology. However, with the
advent of digital technology in India, several
domestic medical device manufacturers have come
to the fore. The cutting-edge technology-based
products created by these manufacturers address
several concerns faced by the market. For instance,
now there are portable, pocket-sized devices available
that can not only provide accurate information about
vitals like blood sugar, blood-pressure or heart rate,
but also help monitor ECG. These domestic devices
are portable, cheaper than the imported variants,
and very easy to operate. The government should
further encourage the growth and innovation efforts
of such home-grown medical device innovators under
the ‘Make in India’ initiative. Such support will be a
much-needed boost to the quality of healthcare and
diagnostic coverage in India.

In recent years, the governments at the centre
and state levels have launched schemes offering
free-of-cost diagnostic services to those who cannot

28 COVER STORY OPINION BIOSPECTRUM | DECEMBER 2019 | www.biospectrumindia.com

AI will transform the way we
diagnose and treat diseases

« breast, brain, and prostate cancer. Additionally, AI
applications will be incorporated successfully in
Zoya Brar, the healthcare space in other forms starting from
Founder and CEO, managing patient records, operating routine tasks,
CORE Diagnostic, automated surgeries, to health tracking and aiding
New Delhi in the precise diagnosis of a critical disease like
cancer etc. With time, the medical fraternity’s trust
With the growing demand for quality on AI and ML will grow stronger in independently
healthcare services in our country, diagnosing disease and deriving clinical treatment
diagnostics firms are adopting aggressive decisions.
strategies to enhance the value of reports and
lower the turn-around time of overall diagnostic There’s an existence of numerous computer vision
procedures. In order to meet this rising demand models with labelled medical images (e.g. X-ray,
of quality diagnosis, minimal errors and positive ultrasound) with matched and clinically validated
medical outcomes, it is imperative for diagnostic patient diagnoses. Using such systems would help
centres to amp up their game by deploying some doctors process more patient cases and make fewer
degree of automation and Artificial Intelligence diagnostic mistakes. There are models out there
(AI) in their operations. AI is the mimic of human that have the ability to diagnose medical issues as
cognitive functions that further require input of raw simple as a fracture on an X-ray or a much serious
data to be able to perform a function. The technology condition like skin cancer better than humans. As an
will not only help them in making more accurate example, the Google InceptionV3 network trained
clinical decisions but even replace human judgement using 129,450 clinical images of 2,032 different
in some functional areas. skin diseases has learnt how to classify images
based on pixel inputs and disease labels only. This
Despite various developments in the execution system achieves superior performance compared
of AI and Machine Learning (ML), there will always to dermatologists. However, if there’s limited data
be few disparities between human and technological for the AI to learn from, it will not be able to deliver
performance. results equivalent to the level of expertise that a
human would.
Therefore, before AI systems are deployed in
healthcare applications, they need to be trained At present, AI is majorly receptive to structured
through the data generated during clinical data in specific formats. The deployment of AI in
procedures such as screening, diagnosing, testing, healthcare has been possible with the generation
etc. which is further available in limited forms and of large volume of data that can unlock clinically
formats (demographics, medical notes, images, relevant information hidden in the vast amount
etc.). Although, a technology driven bot or machine of data. Currently many AI applications analyze
can perform in a constrained environment, but it data generated from diagnostic procedures such as
is not equipped to tackle emotional quotients such imaging, genetic testing and electro-diagnosis and
as feelings, understanding, consciousness, and can also provide insights and suggestive actions in a
creativity. In spite of these limitations, AI is going to predictive manner with greater granularity.
change the way we diagnose and treat diseases.
We will get to witness a wider adoption of virtual
Many diagnostic centers are already using AI to nursing assistant applications—such as Sense.ly,
address pathological needs of patients exclusively, TAVIE, and Ada. Chatbots are increasingly becoming
in areas ranging from molecular profile analysis, the popular application of AI, with apps like Babylon
tailored treatment planning to image analysis for Health, which integrate AI and live physician
interaction through visuals and text.

It is an exciting phase of technological
transformation as we will see AI exhibiting intelligent
behaviors and abilities to understand human
characteristics such as compassion.

BIOSPECTRUM | DECEMBER 2019 | www.biospectrumindia.com COVER STORY 29

INDIGENOUS MEDICAL
DEVICE AND DIAGNOSTICS

MARKET GROWING AT 6% CROSSES

RS 36,000 CRORE
The market of indigenous medical device and
diagnostics is estimated at Rs 36,400 crore and launching new products. The companies are
growing at 6 per cent for 2018-19. The overall shifting their focus from acquiring market share to
market for medical device and diagnostics market creation.
in India is Rs 72,000 crore growing at
7 per cent over previous year’s market size of Rs India is a high-cost economy for capital
66,400 crore. Indian medical device and diagnostics equipment, and Indian manufacturers and investors
market comprises of over 800 companies involved constantly seek to reduce their capital costs. For this
in manufacturing of syringes, needles, catheters, reason, demand for refurbished and reconditioned
bandages, dressings, dental drills, dental chairs, equipment is high across a range of industry sectors.
dental x-ray machines, artificial joints, dental fixtures.
Indian companies have established their visibility in According to report from trade.gov, the
the consumables and disposables space. refurbished medical laboratory instruments are
finding a ready market in India. These instruments
In other segments like equipment, instruments, are used as back-up machines in top-of-the-line
patient aids and implants India still depends hospitals. Less sophisticated hospitals and district
on imports from global players such as Teleflex hospitals view refurbished medical laboratory
Medical, Terumo, Vygon, Zimmer, Stryker, Smiths instruments as optimal for their laboratories because
Medical, Smith & Nephew Healthcare, Santen, the investment cost is substantially lower than for
Olympus Medical Systems, O&M Halyard Health, new instruments. Some international companies
Mölnlycke Health Care, Merit Medical, Medtronic, operating in India also sell used medical laboratory
LivaNova, KCI Medical, Karl Storz, Johnson & Johnson instrument to their Indian customers.
Vision, Johnson & Johnson, Hoya Surgical Optics,
E.I. Dupont, Edwards Lifesciences, Cook Medical, However there are several restrictions on the
Coloplast, Cardinal Health, Boston Scientific, import of used equipment in India, prescribed by
Becton Dickinson, Baxter, B. Braun, Bausch & Lomb, India’s import-export policy. Second-hand capital
BARD, Asahi Intecc, Ambu, Alcon, 3M, Randox, goods with a minimum residual life of five years
GE Healthcare, Siemens Healthiness, Phillips can be imported by actual users of such equipment
Healthcare and many more. Imports are growing without a license.
rapidly as world-class hospital groups such as Max,
Hinduja Group, Fortis and Apollo build high-end India’s medical devices industry is poised for
infrastructure and open India to medical tourism, significant growth in the next five years with the
which now adds $2 billion to the Indian healthcare market size expected to reach $ 50 billion by 2025.
market.
The growing demand for quality healthcare
The domestic medical devices market is and the absence of matching delivery mechanisms
highly fragmented with less than 100 companies pose a challenge and certainly a great opportunity.
generating a revenue of over Rs 50 crore per year. In Infrastructure – building, equipping, managing,
Domestic companies like Transasia BioMedicals, and financing of super-specialty hospitals in India
Trivitron, J Mitra & Co, Agappe Diagnostics, Beacon through the foreign direct investment (FDI) route is
Group, Opto Circuits, Hindustan Syringes and an area for future growth.
Medical Devices Perfint, Skanray, Advy Chemicals,
Sushurt Adler Group are capitalising in opportunities The Indian government has allowed 100 per cent
FDI in the medical devices industry. Inflow of FDI is
expected to spur research and development (R&D)
activities and manufacturing innovations, which in
turn can help in driving the growth of the medical
devices market in India.

30 COVER STORY BIOSPECTRUM | DECEMBER 2019 | www.biospectrumindia.com

BioSpectrum Top Indigenous Medical Devices and Diagnostics Companies 2019*

S Name Revenue Revenue Per Location State Region
No for 2018- for 2017-18 centage
19 (in Rs growth Mumbai
1 Transasia Bio-Medicals Ltd. (in Rs over last Chennai Maharastra West
2 Trivitron Healthcare Pvt. Ltd. crore) crore) year (%) Ernakulam Tamil Nadu South
3 Agappe Diagnostics Ltd 1047 New Delhi South
4 J. Mitra & Co. Pvt. Ltd. 1032.5 -1 Navsari Kerala North
5 Beacon Group 700 70 Mumbai New Delhi West
6 Sysmex India Pvt. Ltd. 181 20 Mumbai West
7 Nureca Pvt. Ltd. 114 62.5 Faridabad Gujarat West
8 Medsource Ozone Bio Medicals Pvt. Ltd. 98 42 10 Kancheepuram Maharastra North
9 BioSystems Diagnostics Pvt. Ltd. 84 6 Maharastra South
10 Voxtur Bio Ltd. 75 38.43 Surat West
11 Genuine Biosystem Pvt. Ltd. 69 31 -12 Chennai Haryana South
12 Accurex Biomedical Pvt. Ltd. 44.6 -16 Mumbai Tamil Nadu West
13 Reckon Diagnostics Pvt. Ltd. 36 35 Vadodara West
14 Rapha Diagnostics Pvt. Ltd. 35 14 -43 Mumbai Gujarat West
15 Bhat Biotech India (P) Ltd. 33.89 29 Bangalore Tamil Nadu South
16 Recombigen Laboratories Pvt. Ltd. 26 3.17 New Delhi Maharastra North
17 XCyton Diagnostics Pvt. Ltd. 22 0.34 47 Bangalore South
18 Affigenix Biosolutions Pvt Ltd  20 59 Bangalore Gujarat South
19 Leucine Rich Bio Pvt Ltd.  18 Bangalore Maharastra South
20 Prantae Solutions Pvt. Ltd. 10 Bhubaneswar Karnataka East
4.67 New Delhi
0.54 Karnataka
0.02 Karnataka
Karnataka

Odisha

* We have not covered some of the indigenous and multinational medical devices and diagnostics companies as they are unable to participate in the BioSpectrum Survey 2019

Transasia Bio-Medicals Mumbai based Transasia Bio-
Ltd. gains Medicals Ltd. is a leading player in
the Indigenous Medical Devices
No 1 position and Diagnostics Industry with sales
revenue of Rs 1032.50 crore for the
in Indigenous Medical year 2018-19 followed by Chennai
Devices and Diagnostics based Trivitron Healthcare Pvt. Ltd.
with sales revenue of Rs 700 crore.
Industry Survey 2019*

BIOSPECTRUM INDIGENOUS MEDICAL DEVICES

AND DIAGNOSTICS SURVEY AND METHODOLOGY

BioSpectrum India, a We highlighted the companies This was done during November
leading B2B media (indigenous players) based on their 2019 (Sales revenues of all the
platform in Lifesciences achievements in the past financial companies are in Rs Crore and
space since 2003 has years. Rs 70= 1USD). Companies shared
re-launched its ranking information with us to the extent
special edition in June 2019 after A detailed questionnaire it was possible by them. We have
gap of 2 years. In this survey (survey form) was sent to over 800 collected information about listed
we looked at only the Medical companies in Medical Devices and companies from stock exchange
Devices and Diagnostics Industry. Diagnostics space to capture the and financial agencies as well.
needed information for the analysis.

#The revenues considered for the analysis are Medical Devices and Diagnostics sales figures. In several cases, where revenue figures were not available, estimates were arrived in discussion
with industry experts. #For all the ranking purposes, we have taken the Medical Devices and Diagnostics business only into consideration. Wherever ‘Revenue is mentioned, it means, sales
turnover from Medical Devices and Diagnostics division. Therefore, revenue wherever mentioned is not necessarily the total sales turnover of the company.

BIOSPECTRUM | DECEMBER 2019 | www.biospectrumindia.com COVER STORY 31

TRANSASIA 01
BIO-MEDICALS LIMITED
REVENUE
Mumbai headquartered diagnostic company Transasia
Bio-Medicals Ltd clocked a revenue of Rs 1032.5 crore ₹ 1032.5 crore
during the FY18-19 exhibiting slight decline in growth
in comparison to the revenue figure of Rs 1047.3 crore SURESH VAZIRANI
generated in the previous FY17-18. The company gathered
sales worth Rs 487.06 crore in the diagnostic kits space in the last financial Chairman &
year, in addition to Rs 238.92 crore generated in the medtech space. The Managing Director
company’s domestic business delivered the maximum share recorded at
Rs 702.3 crore while the exports brought in Rs 330.2 crores in the FY18-19.
Established in 1985, the company spent around Rs 32.6 crore on R&D
this year and announced the launch of new products in the urinalysis and
immunology areas. Laura, a continuous loading system for fast, simple and
efficient solution for laboratories with medium to high workload; and Laura
XL, that gives a completely new dimension to urinalysis, have user-friendly
features that simplify physical, chemical and sediment analysis, making it a
preferred choice for high workload labs were launched in the urinalysis area.
In the immunology space, Transasia has brought in Lisa XL, an
advanced, fully automated 6 plate ELISA processor to analyze all types
of ELISA panels. It is the first 6 plate ELISA processor in India. In addition,
Transasia has also introduced its hematology range of analyzers, from
the house of Erba Europe, customized for India’s diagnostic needs. A
range of three (H 360) and five part differential hematology analyzers
(H 560 and Elite 580), these instruments can aid in the screening of
hemoglobinopathies like thalassemia, sickle cell anemia and others.
Transasia plans to expand in the existing product range and venturing
deeper into other segments. Currently, the company is developing
low-cost tests for transfusion transmitted infections. With Calbiotech
on board after its acquisition in 2017 through its German subsidiary
Erba Mannheim, Transasia will soon be offering chemiluminescence
immunoassay products to penetrate the fast growing vitamin D market.
Through its UK-based subsidiary, the company will be soon introducing
in India, state-of-the-art patented molecular diagnostic products for
accurate and precise detection of diseases such as Tuberculosis, HIV,
respiratory diseases, dengue, malaria, etc.
Besides, it will also be foraying into some new technologies such as
point-of-care testing and cancer and hemoglobinopathy markers. In
addition, Transasia plans to further strengthen its service support and
innovate with the application of latest IT support solutions. On the global
front, the Transasia-Erba group intends to double its R&D spend to achieve
its objective of becoming a Total Solutions Company in In-vitro Diagnostics.
The company is targeting an overseas market of $100 million in the next
three years.

32 COVER STORY BIOSPECTRUM | DECEMBER 2019 | www.biospectrumindia.com

02 TRIVITRON
HEALTHCARE PVT LTD
REVENUE
Chennai based healthcare technology company Trivitron Healthcare
₹ 700 crore Pvt Ltd generated a revenue of Rs 700 crore during the FY18-19. The
year 2019 saw Trivitron Healthcare enter into a strategic partnership
DR G S K VELU by signing a Memorandum of Association (MoA) with the Centre
for Cellular and Molecular Platforms (C-CAMP) towards co-
Chairman & development of world-class healthcare technologies completely indigenously
Managing Director under Joint Intellectual Properties. Trivitron is currently working along with
C-Camp to co-develop relevant technologies and devices in the fields of point-
of-care testing, microfluidics, and multiplex detection, which are within the
domain of expertise and of strategic interest to Trivitron & C-CAMP.

Trivitron Healthcare has multiple brands associated with it namely Kiran
Medical Systems, Labsystems Diagnostics, Trivitron Healthcare Middle East,
Trivitron Healthcare Africa and Bome Trivitron. In July 2019, Trivitron took a
major leap in providing cost-effective diagnostic solutions with the launch of
super-efficient clinical chemistry analyzer Nanolab 200 and 5 part differential
hematology analyzer with retic - Cellenium 5D Retic. In addition, Kiran
Medical Systems, the radiology division of Trivitron Healthcare, introduced its
innovation driven surgical imaging system and Digital Mammography system
in January 2019. The FY18-19 also saw the launch of a complete portfolio of
Advanced Digital X-Ray systems, DSA C-Arm, Modular Smart OT Solutions
and Satin Touch Radiation Protection Products by Kiran Medical Systems. The
brand has also ventured into Color Doppler Ultrasound with the launch of
Kiran SonoRad V9 Color Doppler in India this year.

On the other hand, Trivitron’s Labsystems Diagnostics Oy, a leading brand
that develops and manufactures high quality diagnostic tests for clinical
laboratories and physicians, expanded its portfolio on advancing newborn
screening (NBS) by launching six new high quality NBS products- Neomass
AAAC Plus kit, CAH MASS Second Tier test kit, SCID-SMA Multiplex PCR kit,
NS496 Plus DBS Puncher, Neonatal T4 FEIA kit and Neonatal GALT Kit, during
the FY18-19.

For the coming year, Trivitron is focusing on creating new manufacturing
facilities in Chennai and Pune with an investment of Rs 10-15 crore, and rolling
out new products that will include point-of-care devices, self-testing devices
for thyroid and other disorders and deficiencies. Having a rich expertise in
research and development, Trivitron manufactures and distributes medical
technology products to 165 countries. Incepted in 1997, the company has a
network of around 1500 employees, 1200 channel partners and 9 world-class
manufacturing units spread throughout the world. Trivitron’s diagnostics
portfolio include a wide range of products such as Newborn Screening
Solutions, Clinical Chemistry, Hematology, Point of Care, Rapid cards,
Immunology, Clinical Electrophoresis, Histopathology, Liquid based Cytology,
Digital Pathology, Molecular Diagnostics and Analytical Instruments.

BIOSPECTRUM | DECEMBER 2019 | www.biospectrumindia.com COVER STORY 33

AGAPPE 03 J. MITRA & CO. 04
DIAGNOSTICS LIMITED PRIVATE LIMITED

Kerala based diagnostic reagents and equipment New Delhi headquartered biotechnology company
manufacturer Agappe Diagnostics Limited J. Mitra & Co. Private Limited generated a revenue
generated a revenue figure of Rs 181 crore during of Rs 114 crore during the FY18-19. Incorporated
the FY18-19. Founded in 1998, the company recently in 1969, the company manufactures a range of tests for
announced a tie-up with Japanese multinational Toyobo infectious diseases like HIV, HBV, HCV, Dengue, Malaria,
Co Ltd for technology licensing to manufacture early Typhoid, Leptospira in rapid and ELISA test formats. The
cancer detection devices. In addition, Agappe has other products include a range of anti-Sera products and
launched an indigenously-developed blood cell counter confirmatory tests like Western Blot for HIV. Apart from a
this year, in partnership with L&T Technology Services pan-India footprint, J Mitra is also the biggest exporter of
(LTTS). The equipment and reagents will soon be made diagnostics kits from India, and export to more than 45
on a commercial scale at its facility in Ernakulam. countries across the entire globe.

BEACON 05 SYSMEX INDIA 06
GROUP PRIVATE LIMITED

Gujarat based Beacon Group gathered a revenue of Mumbai based Sysmex India Private Limited
Rs 98 crore during the FY18-19 in the diagnostics generated a revenue of Rs 84 crore during the
space. The Beacon Group comprises of four FY18-19 exhibiting a growth of approximately
companies- Beacon Diagnostics Pvt. Ltd., Vector Biotek 20 per cent in comparison to Rs 70 crore generated in
Pvt. Ltd., Biogeny Diagnostics Pvt. Ltd. and VivaChek the FY17-18. Established in 1998, Sysmex is a subsidiary
Healthcare Pvt. Ltd, with the former three players growing of Sysmex Asia Pacific Private Limited having their
extensively in the diagnostics area. Beacon is engaged in reagent factory at Baddi. The company sells Coagulation,
manufacturing of Serology products and Biochemistry Urinalysis, Biochemistry, Flow Cytometry related products
reagents. Its Serology manufacturing includes Widal through direct operations; while Hematology division is
test, RPR, PPD and ASO, CRP, RF latex tests. It also managed through its distributors.
manufactures wide range of routine and specialized
biochemistry test reagents and System Packs.

NURECA 07 08MEDSOURCE OZONE
PRIVATE LIMITED
BIOMEDICALS PRIVATE LIMITED
Mumbai based Nureca Private Limited, a sister
concern of Nectar Biopharma Pvt Ltd, generated New Delhi headquartered diagnostics company
a revenue figure of Rs 75 crore with the medtech Medsource Ozone Biomedicals Private Limited
space clocking in sales worth Rs 73 crore, and the diagnostics gathered a revenue count of Rs 69 crore during
business brought in around Rs 2 crore during the FY18-19. the FY18-19 exhibiting a growth of 10 per cent in
Having developed a Pan-India network of 450 distributors, comparison to Rs 62.5 crore generated in the FY17-18.
Nureca has made its products with the latest technology Built in 2003, the company has expertise in Clinical
available at affordable prices across the country, including big Chemistry Serological Assays, Rapid Immunodiagnostic
metros as well as Tier 2 and 3 towns, through both on-ground Assays, Hematology Autoimmune Diagnostics, Point of
retail and online selling models. The company enjoys a Care/Near Patient Testing Electrolyte analysis, Molecular
considerable presence online through all major e-commerce Diagnostics, etc. Offering best quality products in IVD at
platforms like Amazon, Flipkart, Snapdeal, 1mg and Croma. most competitive prices, the company expects a further
com as well as its own ecommerce store, drtrust.in. growth of 15 per cent in the current FY.

34 COVER STORY BIOSPECTRUM | DECEMBER 2019 | www.biospectrumindia.com

BIOSYSTEMS DIAGNOSTICS 09 VOXTUR 10
PRIVATE LIMITED BIO LIMITED

Tamil Nadu based BioSystems Diagnostics Private Gujarat based diagnostic company Voxtur Bio
Limited clocked in a revenue of Rs 44.6 crore during Limited gathered a revenue of Rs 36 crore during
the FY18-19 showing a growth of around 6 per cent the FY18-19. Established in 2012, the company
in comparison to Rs 42.07 crore generated in the previous manufactures clinical laboratory diagnostic reagents and
year. It is a manufacturing JV of BioSystems SA (Spain) testing kits. The manufacturing facilities of Voxtur are well
and Trivitron Healthcare started in 2003. The company equipped and certified with FDA, GMP, ISO-9001:2015 and
has established a state-of-the-art In-Vitro Diagnostics ISO-13485:2016 accreditations. Its product range includes
(IVD) Reagents manufacturing facility at Trivitron Medical Rapid Testing Kits, Blood Grouping Sera, Latex Testing
Technology Park, Sriperumbudur, near Chennai. Kits, Febrile Antigen Reagents, ELISA Testing Kits, etc. For
the coming year, the company expects a growth of 25-30
per cent with a focus on launching an entire Microbiology
Testing range.

GENUINE BIOSYSTEM 11 ACCUREX BIOMEDICAL 12
PRIVATE LIMITED PRIVATE LIMITED

Chennai based Genuine Biosystem Private Mumbai based diagnostics company Accurex
Limited generated a revenue count of Rs 35 Biomedical Private Limited brought in a revenue
crore during the FY18-19. Established in 2008, the of Rs 33.89 crore during the FY18-19, showing a
company comprises of independent diagnostics units slight decline in growth in comparison to Rs 38.43 crore
involved in manufacturing and marketing of In-vitro generated in the previous fiscal. In operations since 1984,
Diagnostics, Reagents and Instruments both nationally the company has launched a complete range of point
& internationally. Genuine Biosystem has wide range of care testing products to ensure faster and convenient
of products in its kitty catering to clinical biochemistry, testing. With 200 employees, 400 distributors and 6,000
serology, immunoturbidimetry, blood grouping, to name customers pan India, the company is gearing up for a 20
a few. per cent growth this year.

RECKON DIAGNOSTICS 13 RAPHA DIAGNOSTICS 14
PRIVATE LIMITED PRIVATE LIMITED

Based in Gujarat, Reckon Diagnostics Private Limited Headquartered in Mumbai, Rapha Diagnostics
generated a revenue of Rs 26 crore during the Private Limited clocked in a revenue of Rs 22
FY18-19 exhibiting a decline in their growth when crore during the FY18-19. Founded in 2002, Rapha
compared to Rs 31 crore generated during the FY17-18. offers sustainable solutions to the Indian diagnostic
Reckon Diagnostics is part of a large conglomerate of fraternity in Urine Strips and Rapid Test segments. The
chemical industries with Latin Rasayani Pvt. Ltd. being company has commissioned its world-class, state-of-the-
the flagship Company into leather tanning chemicals, art manufacturing facility in 2016, located at Palakkad,
bulk drugs, dye-intermediates besides Diagnostics. The Kerala. Rapha is promoted by Dr Isac John, who has more
company develops, manufactures and markets a number than 22 years of experience to his credit in the Indian
of diagnostic instruments, quantitative analyzers, diagnostic industry.
immunochromatographs and immunodiagnostics.

BIOSPECTRUM | DECEMBER 2019 | www.biospectrumindia.com COVER STORY 35

BHAT BIOTECH INDIA 15 RECOMBIGEN LABORATORIES 16
PRIVATE LIMITED PRIVATE LIMITED

Bengaluru based diagnostics company Bhat Biotech Based in New Delhi, Recombigen Laboratories
India Private Limited clocked in a revenue of Rs Private Limited generated a revenue of Rs 18
20 crore during the FY18-19 exhibiting a decline crore during the FY18-19 exhibiting a growth of
in growth when compared to the revenue generation 25 per cent when compared to Rs 14 crore generated in
of Rs 34.9 crore in the FY17-18. Established in 1994, the previous year. In existence since 1999, Recombigen
the company has recently launched Life Science Kits, manufactures and distributes diagnostic products
Grouping Sera Raw materials, and Creatinine / Micro for clinical chemistry, rapid range microbiology,
albumin Strips. Bhat Biotech will soon be releasing chemicals, reagents and stains through direct sales and
new PCR machines as its latest invention. Besides the a distribution network encompassing more than 200
company is also developing new diagnostic kits, gluco dealers and distributors.
meter and gluco meter strips.

XCYTON 17 AFFIGENIX BIOSOLUTIONS 18
DIAGNOSTICS LIMITED PRIVATE LIMITED

Bengaluru based molecular biology company Bengaluru based diagnostic company Affigenix
XCyton Diagnostics Limited gathered a revenue Biosolutions Private Limited generated a
of Rs 10 crore during the FY18-19. Founded in 1993, revenue count of Rs 4.67 crore during the FY18-
XCyton has developed immunodiagnostic kits for the 19 showing a growth of approximately 50 per cent in
detection of a number of infections such as HIV, Hepatitis comparison to the revenue generation of Rs 3.17 crore
C, Neurocysticercosis and Japanese encephalitis. in the FY17-18. Formed in 2012, Affigenix has recently
In August 2019, the company has collaborated with established a state-of-the-art in vitro diagnostic (IVD) kit
MedGenome for boosting the integration its genetic tests manufacturing facility at Chennai to develop in house
for infectious diseases such as eye infections, brain and products and provide contract fee for services to start-up
blood infections, and also for MedGenome’s flagship test companies who have developed diagnostic products. The
for tuberculosis SPIT SEQ. company plans to build manufacturing facilities for rapid
immunodiagnostic kits such as lateral flow, and flow
through devices by 2020.

LEUCINE RICH 19 PRANTAE SOLUTIONS 20
BIO PRIVATE LIMITED PRIVATE LIMITED

Based in Bengaluru, microbiome company Leucine Odisha based biotech startup Prantae Solutions
Rich Bio Private Limited generated a revenue of Rs Private Limited generated a revenue of Rs 2.22
54.1 lakh during the FY18-19 exhibiting more than lakh during the FY18-19 as it gears up to address
50 per cent growth in comparison to the revenue figure the gap of early diagnosis especially for pregnancy
of Rs 33.5 lakh clocked in during the previous FY17-18. complication. Presently, its market presence is through
The company gathered Rs 36.8 lakh from the domestic the in-house developed plasmonic gold nanoparticle
front while Rs 17.3 lakh came through exports in the and magnetic nanoparticles as biosensors and services
FY18-19. Incepted in 2014, the company has developed a for innovative medical devices. It has two additional
gut microbiome profiling test BugSpeaks which is one inventive medical devices in the pipeline for 2020. It is
of its kind in India. The patent pending test has been an IP driven organization with 11 granted trademarks,
launched in select cities and will soon be made available 2 design registration 1 granted patent while equivalent
pan India. number with applied status.

36 SPONSORED CONTENT BIOSPECTRUM | DECEMBER 2019 | www.biospectrumindia.com

Sartocheck® 5 Plus Filter Integrity Tester

Keeps Your Risk Factors
Under Complete Control

Amit Khanna, A biotechnologist by training, Amit has
Technical been a part of Sartorius Stedim India’s
Manager – Separation Separation Technologies team for over
Technologies, a decade and a half, he leads a team
Sartorius Stedim India of technical specialists in India. Amit’s
expertise lies in filter process optimization
and scale-up; downstream purification;
integrity testing and trouble shooting.

Sartorius introduced the very first make the new Sartocheck® 5 Plus Filter Integrity
Sartocheck® Filter Integrity Tester in 1980 Tester the most advanced filter integrity tester yet
and over a period spanning more than 3 that surpasses the requirements of Quality Risk
decades, Sartocheck® Filter Integrity Tester Management (QRM). All these elements ensured
evolved into an extremely sophisticated that Sartocheck® 5 Plus Filter Integrity Tester wins
automated integrity test solution which is preferred the iF Design Award in 2018. This is how Sartocheck®
by customers across the globe. Sartocheck® 5 Plus 5 Plus Filter Integrity Tester meets key industry
Filter Integrity Tester, the latest upgrade to the requirements for filter integrity testing even in the
Sartocheck® product line, is the outcome of extensive most demanding environments.
research and customer-centric approach to optimize
the detection of operator errors, improper test setups Automatic detection of incorrect
and out-of tolerance environmental conditions. test setups and test conditions
Its patented software and sensor technologies
All diffusion and WIT programs can be defined

BIOSPECTRUM | DECEMBER 2019 | www.biospectrumindia.com SPONSORED CONTENT 37

with a minimum expected value. If the measured
value falls below that setting it is evident that
something is wrong, for example, the filter being
tested is blocked, the wrong filter type is being tested
or the downstream valve is closed. The bubble point
programs can be defined with a minimum flow
expected to be achieved at the end pressure of the
test.

Image 1- Automatic detection of incorrect set up with active limits for diffusion Image 3- A pressure increase, instead of decay, resulting in test abortion

If the actual bubble point exceeds a certain Faster Testing
level it is considered atypical. The BPmax (if set to With the Sartocheck® 5 Plus Filter Integrity Tester
lower than Pend) allows detection of these atypical
situations. Pend is set in order not to exceed the the duration of diffusion and water intrusion testing
pressure resistance of the filter setup and will can be significantly reduced by using the automatic
terminate the test, even if the bubble point has not test time. When activated, the test will be truncated if
been reached. the test value of 10 subsequent measurement points
is stable within a pre-defined range.

Image 2- BP pressure must not exceed the max limit set by the user Image 4- Test truncation before standard test time limit

When a filter is being tested, it always generates The accelerated bubble point of the
a certain pressure decay. If a pressure increase is Sartocheck® 5 Plus Filter Integrity Tester uses
detected instead of a pressure decay, it may indicate progressively larger pressure steps once the
a temperature change or that the downstream side of minimum bubble point has been exceeded by one
the filter is being pressurized. pressure step. This results in a faster bubble point
test with fewer pressure steps, yet with the same
stringent accuracy at the critical pass/ fail
threshold of the minimum bubble point.

38 SPONSORED CONTENT BIOSPECTRUM | DECEMBER 2019 | www.biospectrumindia.com

user and user roles, while still ensuring fulfilment of
password complexity and supervised password ageing

Automation
The Modbus TCP protocol is a commonly used

industrial automation protocol. Compatibility to other
automation network control protocols like DeviceNet,
Profinet, etc. can be achieved by using third-party
gateways (Image 6). Sartocheck® 5 Plus Filter Integrity
Tester supports two automation modes:

 Semi-automated: A full test recipe can be sent
to and stored on the device till an operator logs in and
starts the test.

 Fully automated: A full test recipe can be sent to
the device following which the test can be started and
monitored by an MES.

Image 5- Progressively larger pressure steps for faster test time without accuracy loss Image 6- Communication with industrial automation protocol

Data Integrity Health , Safety and Enviroment (HSE)
Sartocheck® 5 Plus Filter Integrity Tester uses a Integrity testing often involves the use of chemicals

custom Linux-based OS with Sartorius Stedim Biotech and hazardous materials. The Sartocheck® 5 Plus
custom architecture to provide inherent protection Filter Integrity Tester is certified for use in explosion
against virus and malware attacks for maximum hazardous areas (ATEX), this allows safe testing of IPA
security. The route file system is write protected wetted filters and is also compatible with all current
making it impossible for a virus to reside in the cleaning agents and VHP. This ensures maximum
system. All data generated is instantly backed up on safety for operators and manufacturing facilities. It is
the internal inaccessible 8 GB SD card. This prevents also rated a splash-proof (IP64) for performance under
any loss of data even in the unlikely event of system the most stringent conditions in wet environment.
crash. The encryption protects data to prevent its Continuous and clear visualization of pressure status
disclosure, theft or misuse. All GMP relevant actions avoids mishandling by operator while system is under
are time stamped in the audit trail to comply with 21 pressure. PFA tubes flow path of Sartocheck® 5 Plus
CFR part 11. When parameters are changed, before Filter Integrity Tester are FDA 21 CFR 177 and USP Class
and after values are displayed so that full traceability VI compliant. Automated cleaning of all pneumatics
of “who did what and when” is shown. Data integrity with up to 0.5 M NaOH at 50°C using an optional
also includes a reliable time stamping of the events. cleaning kit is possible.

When Sartocheck® 5 Plus Filter Integrity Tester The Sartocheck® 5 Plus Filter Integrity Tester
is connected to the network and NTP function is performs all standard integrity tests combined with
activated, automatic time zone synchronization occurs ultimate level of data Integrity, intuitive usability
thus generating reliable time stamps in the audit trail. and top level health and safety requirements. The
Barcode scanner allows seamless data entry during enhanced features of the Sartocheck® 5 Plus Filter
programming of the test. The barcode scanner can be Integrity Tester add automation capabilities and the
set to mandatory to ensure a much safer, faster test highest level of QRM through automatic detection of
procedure. abnormal test conditions.

Ease of Use
Twelve inch (12.1”) touchscreen with a viewing

angle of 88° contributes to ease of use regardless
of the operators’ height and position. The screen
is also compatible with gloves. Sartocheck® 5 Plus
Filter Integrity Tester supports Lightweight Directory
Access Protocol (LDAP) which allows all operators to
utilize their network credentials to access the device.
It supports local users with the option to transfer

BIOSPECTRUM | DECEMBER 2019 | www.biospectrumindia.com EVENT REPORT 39

2019 WORLD CONFERENCE ON ACCESS TO MEDICAL PRODUCTS

“Let us develop robust
system of knowledge sharing”

“The discussions and knowledge sharing from The Union Minister for Health & Family Welfare, Science
this world conference need to be utilized for & Technology and Earth Sciences, Dr. Harsh Vardhan
larger public welfare. We must optimally addressing at the inauguration of the 2019 World Conference
develop a robust system of sharing knowledge & other on Access to Medical Products: Achieving the SDGs 2030, in
resources to practically translate discussions from this New Delhi on November 19, 2019.
platform into action” said Dr. Harsh Vardhan, Union
Minister for Health & Family Welfare (MoHFW) as he Surveillance Approach’ and the ‘National Guidelines
inaugurated the ‘2019 World Conference on Access to for Gene Therapy Product Development and Clinical
Medical Products Achieving the SDGs in New Delhi on Trials’.
November 19.
Access to essential medicines is a priority in the
Dr Harsh Vardhan stated that under the dynamic Regional Flagships on Universal Health Coverage
leadership of Prime Minister Narendra Modi, health (UHC) for the South-East Asia Region. Following
has taken a centre stage among all policy decisions the UN High-Level Meeting (UN HLM) on UHC,
and programs, “Efficient healthcare delivery systems the 2019 World Conference seeks to take forward
providing equitable, affordable and easily accessible the international and national agenda on access to
healthcare is at the heart of all our efforts. This World medical products. The Conference is a follow on from
Conference thus takes prominence for all of us across the “2017 and 2018 World Conference on Access to
the world thinking about path breaking technologies Medical Products” organized in November 2017 and
of healthcare”. October 2018 by the MoHFW, Government of India.
The recommendations made at the two previous
Calling the Conference a valuable platform for World Conferences are being pursued at international
sharing experiences and advancing increased access to and national level by key ministries in India. This 2019
medical products globally as part of Universal Health Conference provides a platform for discussions focused
Coverage (UHC), he stated “This Conference will on creating an enabling legal and trade environment
spur innovative thinking around issues surrounding for public health which are critical to achieving the
provisioning of affordable, quality medical products Sustainable Development Goals 2030 Agenda. The
as part of public health care delivery systems.” He main objective of the 2019 World Conference is to
added that medical technologies underpinned by track the progress on recommendations from the 2018
latest ideas and pooled-in knowledge, form a critical World Conference for access to medical products for
pillar of healthcare. achieving UHC in the context of SDGs. This 3-day
Conference has been designed as a forum to take these
Dr. Tedros Adhanom Ghebreyesus, Director discussions further for access to medical products
General, WHO, joined the conference through a video on the themes of ‘UHC and innovation’, ‘Regulation
message. He reiterated the commitment of WHO of medical products and access’ and ‘Legal landscape
to affordability and availability of medical products and trade-related aspects in the context of access to
to people around the world. Dr Tedros added that medical products’.
with the increasing burden of Non Communicable
Diseases (NCDs), the need for long term treatment,
and the ensuing healthcare cost have increased. In
addition, ageing population creates demand for more
affordable assisted technologies. Advances in medical
technologies everyday gives hope to people for better
healthcare. This simultaneously increases the pressure
for providing affordable medical care. “Through our
efforts we shall continue to put people first”, he stated.

The inaugural session saw the release of ‘Position
Paper-2019 World Conference on Access to Medical
Products–Achieving the SDGs 2030’, ‘White Paper
on Safety of Rotavirus Vaccine in India: Smart Safety

40 EVENT REPORT BIOSPECTRUM | DECEMBER 2019 | www.biospectrumindia.com

BENGALURU TECH SUMMIT 2019

Hand-holding start-ups has been a cornerstone
of the state policy: Dr Ashwath Narayan

“The Biotechnology sector has significantly (L-R) Dr C N Ashwath Narayan, Deputy Chief Minister and
enhanced the growth of India’s global Minister for Higher Education and Medical Education,
profile. Karnataka and particularly Information Technology, Biotechnology and Science and
Bengaluru has been widely referred to as one of the Technology, Government of Karnataka along with B S
fastest growing technology hubs in the world and Yediyurappa, Chief Minister, Government of Karnataka
supporting and hand-holding start-ups has been a inaugurating the 22nd edition of Bengaluru Tech Summit 2019
cornerstone of the state policy, “ said Dr C N Ashwath by lighting the lamp on November 18 in Bangalore.
Narayan, Deputy Chief Minister and Minister for
Higher Education and Medical Education and IT, BT in Bengaluru. The number of startups are increasingly
and S&T, Government of Karnataka. growing in Bengaluru with a large number of first
generation of entrepreneurs budding here. There
Speaking at the inauguration of the 22nd edition are around 3000 startups in India currently out of
of Bengaluru Tech Summit 2019, the flagship event which 957 were created within the last 12 months. The
of the Department of IT, BT and S&T, Government health-tech sector in the future largely depends on
of Karnataka, which was opened by B S Yediyurappa, the area of IT-led Biodiagnostics which incorporates
Chief Minister, Government of Karnataka, on utilization of new age technologies such as artificial
November 18 in Bangalore he said “Through intelligence, big data etc. This convergence of IT & BT
the ‘Smart Bio #Enterprise Connect, being held is the inflection point for the healthcare sector where
exclusively for Biostartups we are providing a platform huge opportunities lie.”
for early-stage ventures to engage and showcase their
innovative ideas to large corporate entities, investors The Bangalore based companies Mallipathra
and industry leaders considering start-ups spend a lot Nutraceutical (Agriculture), Equine Biotech
of time and effort to reach out to the right people in (Animal Biotech), Aspartika Biotech (BioIndustrial),
the industry in order to sell their product/concepts/ Stempeutics Research (BioPharma & Healthcare),
ideas. This is the first organized Enterprise Connect IC Bio Clinical Research (BioServices) and Trident
for Bio start-ups attempted by any State wherein we Diagnostics (Medical Diagnostics) received the Smart
have over 20 biotech enterprises already confirming Bio Awards 2019 at the summit.
their participation. This whole initiative is to support
start-ups in the areas of BioTech, MedTech, AgriTech The summit has an excellent gathering of the
and Diagnostics”. world’s most influential leaders, Innovators, Industry
Captains, Research Heads, Policy makers and Start-
Delivering the inaugural address, B S Yediyurappa Ups from India and leading countries like Canada,
Chief Minister, Government of Karnataka said, The Netherlands, Finland, UK, USA, Australia,
“Karnataka is moving towards becoming an innovation Switzerland, Israel, Germany, France, Japan, Sweden,
hub, a gradual shift from the services sector to product Austria, Uzbekistan, Armenia, Belgium, Denmark,
development. The state is recognized as the innovation Lithuania and Estonia. The three days summit ended
capital of the region, which again is endorsed by the fact on November 20.
that Bengaluru has produced 9 of the 27 unicorns in
the country. Dynamic policies, framed in consultation
with key stakeholders of the ecosystem, have played
a key role in making Karnataka ‘The Silicon Valley of
India’ and the ‘Innovation Capital of India’. The State
Government is keen to ensure that Karnataka remains
the national leader in Innovation and enhances its
place in the global economy by focusing on skilling,
incubating startups, developing global alliances, and
providing a framework for supporting innovation. ”

In her address, Dr. Kiran Mazumdar pointed out,
“The Indian Bioeconomy has crossed $51 billion in
2019. This has been possible because of the technology
explosion that is taking place within India especially

BIOSPECTRUM | DECEMBER 2019 | www.biospectrumindia.com SCIENCE NEWS 41

CSIR announces IITM develops
completion of standing wheelchair
whole genome
sequencing project The Indian Institute of Technology Madras
(IITM) in collaboration with Tamil Nadu
Research laboratories working under the based Phoenix Medical Systems has launched
Council of Scientific and Industrial Research India’s first indigenously-designed Standing
(CSIR) have announced completion of Wheelchair. The standing wheel chair branded
whole genome sequencing of 1008 Indian as Arise enables a differently-abled person
individuals representing diverse ethnic requiring a wheelchair to shift from
groups in the country. The data will act as sitting to standing position, and
baseline information for developing various vice versa, independently and in a
applications in predictive and preventive controlled manner. The wheel chair
medicine. The genomic data will help was designed and developed by the
scientists understand genetic diversity of TTK Center for Rehabilitation Research and
the Indian population and make available Device Development at IITM, headed by Sujatha
genetic variant frequencies for clinical Srinivasan in the Department of Mechanical Engineering.
applications. The data and knowhow are The commercialisation of the wheel chair technology was
expected to produce evidence and help in made possible through support from Wellcome, UK, through
development of technologies for clinical an ‘Affordable Healthcare in India’ Award, which brought
and biomedical applications. The project together the research and manufacturing partners. Arise
called IndiGen was implemented by Delhi- has been designed such that the user can actuate it from
based Institute of Genomics and Integrative the sitting position to the standing position and vice versa
Biology (IGIB) and Hyderabad-based Centre independently and in a controlled manner. This can be done
for Cellular and Molecular Biology (CCMB). using the power of the user’s arms.

42 ACADEMIC NEWS BIOSPECTRUM | DECEMBER 2019 | www.biospectrumindia.com

IITK to IITD, JNU ink MoU for
establish academic cooperation
Centre for
Engineering Indian Institute of Technology, or more disciplines of science,
in Medicine Delhi (IITD) and Jawaharlal engineering, management and
Nehru University (JNU), social sciences, and their mutual
Indian Institute of New Delhi have signed a interest in engaging themselves
Technology (IIT) Memorandum of Understanding in academic cooperation. Under
Kanpur is all set to (MoU) for academic this MoU, the two institutions will
get a new Centre cooperation. The focus on: Enabling postgraduate,
for Engineering in MoU intends including PhD students, to
Medicine. The centre to further enroll for courses at the other
is being developed the academic
by the institute as objectives of each institution; Joint research
part of the MoU institution and to activities; Participation in
signed between IIT promote better seminars and academics
Kanpur and United understanding meetings; Exchange of
States-based Mehta between the academic materials and others
Family Foundation. faculty and students
Once established, the of IITD and JNU. IITD and information; Courses
centre will formally JNU recognise their strengths offered jointly
be named as ‘The in research and education in one with faculty
Mehta Family Centre from the two
for Engineering in institutions.
Medicine’. The Centre
for Engineering in Gujarat Ayurveda University
Medicine will have to promote ancient science
three key focus areas
on which it will be Gujarat Ayurveda University has signed a Memorandum of Understanding
conducting active (MoU) with a wellness brand Sri Sri Tattva. Established in 1965 by an
research. These Act of Gujarat State Government, Gujarat Ayurveda University aims to
include Regenerative promote the ancient science of Ayurveda by carrying joint studies, trial
Medicine, Molecular and R&D projects in the field of Ayurveda. The MoU signed between the
Medicine and Gujarat Ayurveda University and Sri Sri Tattva will be complimenting each
Digital Medicine. other’s area of expertise on the subject of Ayurveda. It covers a wide area
The new Centre of cooperation like creating joint post-graduate exchange programme;
for Engineering conducting joint clinical trials, research on Ayurvedic formulations for
in Medicine will various diseases, and utilization of resources for joint learning exercises.
look to identify and
develop innovative
ways to solve
challenging medical
problems. The centre
will amalgamate
medicine and
engineering domains
to come up with
new-age solutions
for contemporary
medical problems
faced by people.



44 SUPPLIER NEWS BIOSPECTRUM | DECEMBER 2019 | www.biospectrumindia.com

Promega enters Agilent expands
portfolio of smart
global collaboration connected GC instruments

with Merck Agilent Technologies Inc. has introduced a micro gas
chromatograph that is small, fast, smart, and easy to
Promega Corporation has announced that it use. The new Agilent 990 Micro GC system is designed
has entered into a global collaboration with to monitor the safe distribution, calorific valuation, and
Merck, known as MSD outside the United odorant level in natural gas. Compact and rugged, it
States and Canada, to develop Promega’s delivers laboratory-quality data whenever and wherever
microsatellite instability (MSI) technology it is needed. The 990 Micro GC combines Agilent’s
as an on-label, solid tumor companion proven microfabrication and smart-connected digital
diagnostic (CDx) for use with Merck’s anti- technologies in an all-new modular platform. The system’s
PD-1 therapy, KEYTRUDA (pembrolizumab). plug-and-play architecture and smart-connected user
The global collaboration will initially seek assist functions make the 990 Micro GC easier to install,
regulatory approval for the Promega MSI CDx use, and troubleshoot, reducing the cost of ownership and
in the United States and China. Plans to seek improving productivity.
approvals in additional territories may follow.
Promega MSI technology has been validated
in labs around the world to characterize solid
tumor MSI status. MSI testing functionally
measures the genomic accumulation of
insertion or deletion (INDEL) errors caused by
a deficient mismatch-repair system (dMMR)
that occurs in certain types of solid tumors,
and this screening may be used to better
characterize tumors and guide therapeutic
choices for MSI-High cancer types.

Thermo Fisher brings RT stable cell culture media

For biological researchers looking from Thermo Fisher Scientific BenchStable Media are packaged
to reduce their reliance on cold and provide a flexible alternative in fully recyclable boxes. The
storage without disrupting their for biological researchers that packaging virtually eliminates
existing workflow, Thermo Fisher also saves energy. The new light exposure, which can degrade
Scientific’s new cell culture culture media are shipped in basal media components and
media are the first to sustainable packaging. Gibco alter their performance. In
remain stable at room
temperature. addition, Gibco media
Gibco bottles are made
BenchStable from polyethylene
Media are terephthalate with
the latest a high-density
offering in polyethylene lid,
the Gibco two of the most
product line highly recycled
plastics.

BIOSPECTRUM | DECEMBER 2019 | www.biospectrumindia.com PRODUCT SPOT LIGHT 45

Corning® 5L Erlenmeyer flask

The Corning 5L Erlenmeyer flask is designed to help scale-up suspension culture with space efficiency in mind. The flasks are
sterile and ready-to-use, ideal for shaker culture applications, and storage.

Erlenmeyer flasks are commonly used for expansion of a variety of suspension
cell lines for bioprocessing applications. Corning provides disposable
Erlenmeyer flasks ranging from 125 mL to 3L in size. Corning has recently
developed a 5L Erlenmeyer flask with the same footprint as a traditional 3L
Erlenmeyer flask.

The 5L shape has been optimized for increased gas exchange compared to the
more traditional Erlenmeyer flask designs. Due to gas exchange limitations,
most traditionally shaped Erlenmeyer flasks can only accommodate
approximately one third of the stated volume of the vessel during culture.
Corning’s new 5L shape design allows for the culture volume to be increased to
one half of the stated volume of the flask, resulting in a greater number of cells
cultured in the same footprint as a 3L flask.

With the introduction of 5 L Erlenmeyer flask, the seed train can be better optimized with the equivalent cell density and helped the
customer to reduce the process steps. New work flow demonstrates the elimination of seed expansion in 10L bioreactor and helps to
reduce the number of low volume Erlenmeyer flask during the seed expansion.

Workflow with 5L flask: 125mL 500mL 1L (less) 5L 50L bioreactor

A statistically higher CHO cell yield was observed with Corning 5L Erlenmeyer flasks compared to other flask.
Spent media analyses demonstrated statistically higher levels of dissolved oxygen and lower levels of lactate in Corning 5L Erlenmeyer
flasks, suggesting that the Corning flasks provide a more optimal culture environment for CHO cells under these conditions.

India [email protected]

t 91 124 4604000
f 91 124 4604099

46 BUSINESS INSIGHT BIOSPECTRUM | DECEMBER 2019 | www.biospectrumindia.com

Innovating To Create
A Better World

« We are proud to offer a comprehensive range
of high-quality, innovative laboratory products
Sudhir Pillai, and solutions for a wide spectrum of life science
Commercial Director, applications. The acquisition of Becton Dickinson’s
Corning Life Sciences, Discovery Labware business in 2012 brought the
India Falcon®, BioCoat™, Matrigel®, and Gentest™ brands
into the Corning portfolio next to the Corning,
Corning is one of the world’s leading innovators Axygen®, and PYREX®, brands. These trusted brands,
in materials science. For more than 165 years, backed by technical expertise, provide researchers
Corning has applied its unparalleled expertise with better ways to advance their research.
in specialty glass, ceramics, and optical physics to
develop products that have created new industries Where is India in the overall growth
and transformed people’s lives. Corning operates segmentation for Corning Life Science
in five reportable segments: Display Technologies, business?
Optical Communications, Environmental With a population of 1.3 billion people, India has
Technologies, Specialty Materials and Life Sciences, tremendous opportunities for healthcare and is poised
and manufactures products at 98 plants across 17 for long term growth. For us, India has shown great
countries. BioSpectrum Podcast Host Ankit Kankar potential and continues to grow significantly and drive
spoke to Sudhir Pillai, Commercial Director, Corning growth for Corning Life Sciences outside of the US
Life Sciences, India to know more about Corning’s market. India is one of our fastest growing markets
vision for the Indian market. in the APAC region. The acquisition of the Discovery
Labware business in 2012 expanded the Corning Life
Sciences product portfolio and provided access to
an extensive dealer network that allowed us to better
serve customers in India and throughout the world.

Tell us about Corning Life Science’s business What is the current market share and the
globally and in India? growth expected by 2020 in India?
Corning Incorporated’s businesses and markets are Overall, Corning Life Sciences’ addressable market
constantly evolving. Overall, our global business is in India is forecasted for consistent growth. India is
growing faster than the market. Corning Life Sciences third largest pharmaceutical market in the world by
develops, manufactures and supplies trusted products incremental growth and seventh largest by volume,
to scientists seeking new approaches to increase providing Corning Life Sciences an immense growth
efficiencies, reduce costs and compress timelines opportunity. India continues to be a strong market
in cell culture and bioprocessing, drug discovery, for us. We sell both direct and through distribution,
microbiology & quality testing, and chemistry. shipping to over 100 different locations across India.
Globally, we are excited about growing segments such
The Life Sciences business is one of Corning’s as bioproduction, 3D cell culture, and cell and gene
longest running businesses as well as a growth therapy.
area. Since the invention of PYREX® glass labware
in 1915, Corning has remained a market leader Who are your customers for Life Sciences in
for 100 years, and one of the fastest growing life India?
sciences organizations in our market segment. We We work closely with established academia,
have four categories in our Life Sciences business pharma, biotech, CROs and CMOs. We also see a
- Moving Liquids, Growing Cells, Bioprocess, and lot of interest in our products from start-up biotech
Microbiology.

BIOSPECTRUM | DECEMBER 2019 | www.biospectrumindia.com BUSINESS INSIGHT 47

companies. Corning’s bioprocessing tools have new data, particularly from cancer research, showing Podcast
been facilitating Indian biopharma companies that culturing cells in 3D mimics cells in the body
in the development and production of a range of better than culturing them in 2D.
vaccines and biosimilars. Not only that, our cell
culture products are of great interest to Indian So, ease of use plus increasing recognition that the
pharmaceutical companies. science is providing us with better information have
made this a major trend. The global 3D cell culture
What sets Corning apart from its competitors in market is expected to grow at a CAGR of 25.50%
the Life Sciences space? during the period 2018-2023*.
Corning offers a broad range of innovative life science
products and solutions, which help to accelerate the What is Corning Life Sciences doing in 3D cell
industry’s discovery of new drugs, therapies, and culture? What’s next in cell culture?
breakthroughs that save and change lives. As this wave keeps building, Corning is sharing
the knowledge and experience that come from
An example of this is our recent innovation in cell three decades pioneering this field. What I’m most
counting that led to development of the Corning® enthusiastic about is that the products we are
Cell Counter. This product was awarded “Scientists’ bringing to the market are getting a very strong
Choice Award” by SelectScience for Best New Life customer reception. They see the promise and
Sciences Product, 2018.. The Cell Counter is the first potential for scientific discovery, and that’s why we
automated benchtop cell counter that combines the are in this business.
benefits of both manual cell counting and automated
image-based cell counting. Using state-of-the-art For more than 25 years, Corning has delivered
optics and image analysis software, it can accurately innovations that have advanced the science of 3D cell
and precisely measure cell concentrations and culture. We pioneered the development of novel tools
viability. providing easier access to in vivo-like 3D models,
such as Corning Matrigel® matrix, Transwell®
We have developed technologies that change the permeable supports, spheroid microplates and
way researchers work, including optimised synthetic our new Corning Elplasia® plates which enable
surfaces for cell culture and assays, biological surfaces, researchers to grow thousands of spheroids on one
single-use products and closed system solutions for plateAnd we continue to support our customers
more efficient scale-up and downstream bioprocess, with a diverse and evolving portfolio of innovative
such as our industry-leading Corning HYPERStack® 3D cell culture products, solutions, protocols, and
vessels. We also develop automated solutions for expertise. Corning is committed to working in critical
liquid handling and high-throughput assays, as well areas like cancer biology, tissue engineering, and
as Next-Generation Sequencing solutions to simplify regenerative medicine – to help bring safe, effective
genomic sample preparation and library construction. drugs and therapies to market in less time with
These technologies are bringing new efficiencies and greater certainty. We have the body of 3D cell culture
improved results to scientists around the world. knowledge and depth of resources and so many
scientists working in academic and biopharma labs
In addition, Corning seeks to maintain a look to Corning for solutions, guidance, and support
competitive advantage through emphasizing superior when it’s time to get started in 3D cell culture.
product quality, a global distribution network, supply
chain efficiencies, superior product attributes and by How do you reach your customers in India? And
offering a world-class customer experience. any challenges that you face in India?
Our products are marketed globally, primarily
Now coming to cell culture, we have often through distributors, to pharmaceutical and
heard about 3D cell culture. Can you share your biotechnology companies, academic institutions,
perspective on how 3D cell culture will help in hospitals, government entities, and other facilities.
future?
3D cell culture in simple terms, is a way to do Each market and customer segment has different
research in an environment that is more similar needs, and we are continuously working with our
to the environment in the human body. Instead of team in India to meet India-centric needs. For
doing research with cells that are grown on a flat, example, we have been working to supply products
2D surface, scientists can grow these cells in a 3D that meet Indian customers’ specific and unique
structure, similar to how they are growing in your dimensional requirements.
body. It provides a much closer simulation than
anything offered through other techniques. 3D cell Ankit Kankar
culture is growing as there has been an emergence of Podcast Host

[email protected]

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BIOSPECTRUM | DECEMBER 2019 | www.biospectrumindia.com PEOPLE NEWS 49

ADMI announces
new leadership team

TAKE Solutions ropes Association of Director of Accurex
in Swiss based pharma Diagnostics Biomedical and
veteran on Board Manufacturers of Vinayak Bhat is the
India (ADMI) has Managing Director of
TAKE Solutions, a globally recognized domain announced a new Asritha Diatech India.
intensive services provider in Life Sciences, has leadership team. The new leadership
announced the appointment of Srini Srinivasan Veena Kohli takes team has decades
as an Independent Director in TAKE Solutions over as President; of experience in the
Board of Directors. Srinivasan has over three Nital Patel as Vice In Vitro Diagnostics
decades of experience at Pfizer, Novartis, President; Abhinav manufacturing
GSK and Astra in global leadership roles in Thakur as Secretary sector. This team
General Management, Commercial, R&D and Vinayak Bhat as was instrumental in
and Manufacturing. He has led global cross- Treasurer of ADMI. several reforms in
functional teams and launched brands in both Dr D. K. Joshi will the sector through its
Specialty and Primary Care across numerous continue as member expert support to the
therapeutic areas - Respiratory, Cardiovascular, of the Governing
Metabolism, Neuroscience, Infectious Diseases, Council as Immediate industry in
Oncology and Immunology. He is an advisor to Past President. the past.
American Society of Clinical Oncology’s Cancer Veena Kohli is CEO &
LinQ. He lived and worked in Europe, USA, Founder of Vanguard Veena Kohli
Asia Pacific and India. He holds a degree from Diagnostics,
Madras Medical College, an MBA from London Nital Patel is the
Business School and received executive training Managing
at Harvard Business School. Director of
Reckon
Diagnostics,
Abhinav
Thakur
is the
Managing

Dr Anjana receives recognition from ICMR

Dr R M Anjana, Managing Balram Bhargava, Director
Director, Dr. Mohan’s General (DG), Indian Council
Diabetes Specialities Centre of Medical Research (ICMR).
and Consultant Diabetologist The Shakuntala Amir Chand
& Vice-President of Madras Prize recognizing significant
Diabetes Research Foundation contributions to Biomedical
has received the Shakunthala Sciences by young scientists
Amir Chand Prize for Young was instituted by (late) Major
Scientist by the Indian Council General Amir Chand in 1953.
of Medical Research (ICMR). This award is presented for
This is the highest award by the best published research
ICMR to young scientists work in the field of Biomedical
under the age of 40. She was Science including clinical
conferred the Award by Dr research. Dr Anjana was
Harsh Vardhan, Minister of awarded for her research work
Health and Family Welfare, in ‘Epidemiology of Diabetes
Government of India and Dr and its risk factors in India’.

50 BIO EVENT BIOSPECTRUM | DECEMBER 2019 | www.biospectrumindia.com

6TH NATIONAL NHM SUMMIT

“Let us take back new ideas,
innovations and knowledge, & ensure
that we implement these in our states”
“This National Health Mission (NHM) Summit
is a celebration of ideas, innovations and Dr Harsh Vardhan,
knowledge sharing and we all must take Union Minister
back these and ensure that we implement at-least a few for Health &
of them” said Dr Harsh Vardhan, Union Minister for Family Welfare,
Health & Family Welfare (MoHFW) as he inaugurated government of
the Sixth National Summit on Good, Replicable India presenting
Practices and Innovations along with Union Minister awards to states at
of State for Health & Family Welfare Ashwini Kumar the 6th National
Choubey, Vijay Rupani, Chief Minister, Gujarat, NHM Summit
Nitinbhai Ratilal Patel, Dy. CM & Minister of Health & at Gandhinagar
Family Welfare, Gujarat and Dr Vinod K Paul, Member (Gujarat), on
(Health), NITI AAYOG at Gandhinagar (Gujarat), on November 16.
November 16.
capable HR, health commodities, service delivery
Calling the Summit as the aggregating ground which is equity & quality driven, information systems,
of new ideas, thoughts and expression, the Union and community participation for social and behaviour
Health Minister stated “MoHFW endeavours to change.”
foster cross learning amongst the state governments,
NGOs, Healthcare organizations and other academic The Summit saw the launch of SAANS campaign
institutions so that these work in concordance to i.e. “Social Awareness and Action to Neutralise
achieve the overarching public health goals.” Pneumonia Successfully” to control Pneumonia. This
campaign will mobilize people’s for protecting and
Dr Harsh Vardhan suggested that similar to the preventing children from pneumonia; and health
National NHM Summit, the states also can have State/ personnel, governments & other stakeholders to
Regional conferences for sharing of knowledge within prioritize treatment towards the control of Pneumonia
the districts. “Let the national knowledge and ideas — one of the most fatal childhood illnesses. Under
be transmitted to the districts level health workers, the SAANS campaign, new interventions have been
functionaries through the state/regional conferences”. included like a child suffering from Pneumonia will be
He added that in addition to presenting best practices, treated with pre-referral dose of Amoxicillin by ASHA;
states must also emulate and roll out the best practices Pulse Oximeter will be used at the Health and Wellness
from other states. He stressed the importance of self- Centre for identification of low oxygen levels in the
auditing for performance assessment. blood and if required treated by use of Oxygen. The
initiative also aims to create mass awareness about
Ashwini Kumar Choubey, Minister of State for the most effective solutions for pneumonia prevention
Health & Family Welfare appreciated the efforts like breast feeding, age appropriate complementary
made by the Centre and States to reach out to the feeding, immunization, good quality air etc.
beneficiaries and provide access to quality healthcare
services. He said that “The Summit provides a valuable The web portal for home based care of children
platform for sharing of knowledge and experiences. including new born visited by ASHA, was also
This will immensely contribute to meeting our health launched at the Summit. This portal has all the
outcomes”. resource materials (training materials, IEC videos,
audios, banners, posters etc.) for the home visits of
Dr Vinod K Paul, Member (Health), NITI AAYOG ASHAs.
addressing the summit emphasized the importance of
system level change for greater strides in healthcare The dignitaries also unveiled the Coffee Table
and termed NHM as great program for healthcare Book documenting the Good and Replicable Practices
delivery to the populace. He said ”There are seven presented during the Summit. More than 300
building blocks for the future advances in the health participants attended the summit. At the summit
sector- focused stewardship, adequate finance, 37 good practices were presented and 73 emerging
good practices were showcased in the form of poster
presentations.