pharma update March 2020 issue

Vol.1 Issue 04 March 2020 Price - Rs.100/-

PHARMAUpdate

Assisting SMEs to access International Markets

Arun Sehgal - MD

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PHARMAUpdate Arun Sehgal
MD
Vol.1 Issue 4 March 2020
Chempro Pharma Private Limited
Editor
J. P. Sethi Pharma Exports To Diagnostics for Making India A $100 Bn
[email protected] Boost Growth Asymptomatic Malaria Biomanufacturing Hub By 2024

Corporate Advisor Page No. 5 Page No. 10 Page No. 12
Vishnu Ajitsaria Fca
Assisting SMEs to access International Markets ............................................................. 2
Hyderabad Correspondent Pharma Exports To Boost Growth ........................................................................................... 5
Hanuman Prasad Coronavirus spurs India to restrict exports of 2 dozen drugs ....................................... 7
Individual response to COVID-19 'as important' as government action .................... 9
[email protected] Sanofi and US Government partnered to create novel coronavirus vaccine ............. 10
Central govt to launch iVEDA portal for tracking drugs meant for export soon ..... 11
Layout Designer Making India A $100 Bn Biomanufacturing Hub By 2024 .............................................. 12
Jyoti Singh

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“Did you know that “I always rub
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PHARMAUpdate

Interview

Assisting SMEs to access International Markets

Chempro Pharma Private Ltd

Left to Right

Ankit Sehgal, Vishal Agarwal, Shubhit Sehgal, Arun Sehgal, Vandan Agarwal

Management Agarwal also comes with an extensive is not only the products that do business,
background in business operations. but also the people involved, and our
Chempro Group's Directors are all success is a by-product of this
professionally qualified first-generation Business Philosophy philosophy,” adds Sehgal.
entrepreneurs who began their careers in
reputably known Indian companies “Chempro was founded on three pillars. “Understanding how our competitors
before starting Chempro. They possess Customers are the first pillar and our give themselves an edge over others is
rich corporate experience with a deep business philosophy focuses on creating integral to our growth and evolution as a
understanding of systems and sound an outstanding Customer Experience. firm. We are always hungry to learn
business policies that helped Chempro Competition is the second pillar as we more about new systems, operations,
grow quickly over the last three decades. regularly study it in a healthy manner in and tools that can be used to improve
order to enhance the value-added p r o d u c t i v i t y, e f f i c i e n c y, a n d
The Chairman and MD – Mr. Arun Sehgal is services that we offer to our clientele. profitability,” says Mr. Vijay Agarwal.
an engineer from BITS, Pilani, and an MBA Our employees are the final pillar - most
from the Jamnalal Bajaj Institute of of whom have been with us for more than “All our employees know that we must
Management Studies (JBIMS), Mumbai. two decades and have become an work as a team in a dignified and ethical
He is a visiting faculty to the leading integral part of the Chempro family. We manner. Our primary goal is to ensure
business institutions and the professional believe in ensuring that all our that all customers have an outstanding
organizations like the JBIMS, SP Jain customers grow profitably with time due experience working with us at each step
Institute of Global Business Management, to their collaborative association with of the way”, says Mr. Deepkiran
and the various branches of the World our group companies, says Mr Arun Khanwalkar.
Trade Centre across India. The Vice- Sehgal
President – Mr. Deepkiran Khanwalkar is Aligning Country's needs with
also an engineer from BITS, Pilani, with a “We believe in the power of cultivating Company's strategy
degree in Business Management from meaningful relationships with our clients
Bangalore. Finally, the COO – Mr. Vijay and suppliers more than anything else. It “India has always been a country with an

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active Small-Scale Sector full of highly Initial Years API intermediates developed as a
talented individuals that has been natural strength.
hungry for growth but required Chempro started as a trading company
international marketing support. in 1989 that dealt in raw materials for “The underlying philosophy of
Chempro's objectives are aligned with Colors and Pigments. It later diversified “Customers First!” continues along with
the needs of our country's small and into the finished colors business and the strategy of Contract Manufacturing
medium scale sector and we have tied up simultaneously invested with its trading with Skilled and Groomed partners over
with reliable partners capable of making partners in their factories to the years, even in the Pharmaceuticals
products at par with international manufacture a few specialty domain” says Mr. Abhishek Khanwalkar,
quality standards with little support. intermediates and colors. “The strategy who is also the second generation
Since its inception, the company has has been to start trading first and later entrepreneur being groomed for
always forged partnerships with small integrate backwards into manufacturing family's business and is currently
and medium scale manufacturing with its trading partners who continue working and studying simultaneously
partners and has been instrumental in to look after manufacturing”, says Mr. and is in the process of completing his
exporting their products Vandan Agarwal, who is also a next management degree.
internationally”, says Mr. Sehgal. generation entrepreneur with a business
degree from USA and is currently Diversification into Intermediates
In its phase of expansion, Chempro Heading the Contract Manufacturing for Various applications including
invested capital in its existing partners' Division. Due to our strong technology Cosmetics
facilities for capacity expansion and/or base, diversification into
new manufacturing facilities and it pharmaceuticals and cosmetics' raw Due to its deep knowledge in customs
presently holds a stake in several materials came with ease. synthesis and collaborations with India's
manufacturing sites across India. leading research professionals spread
Chempro has manufacturing partners Diversification into Pharmaceuticals across different cities and its own in-
where it supports them with technology house R&D team, the company has built
development to meet quality After achieving a recognized export formidable capabilities in the area of
parameters of international buyers and house status in 1993 and creating an customs synthesis for manufacturing
manufactures products needed for the exports base in more than 40 countries - Specialty Intermediates for Cosmetics,
export markets under a Contract In 1999, Chempro began its Polymers, Electronic Chemicals,
Manufacturing Model. pharmaceuticals' operations with Electroplating Chemicals, Cosmetic,
finished formulations production under Food Colors and Printing Inks.
“It is a win-win situation for the company the Indian FDA's policy of Loan
and its partners as well as our country”, Licensing. We understood that in order Major Business Verticals
says Mr. Shubhit Sehgal, who is the next to succeed in this segment, we must also
generation entrepreneur in this family learn about the active pharmaceutical Today, Chempro is working tirelessly to
business and has returned after a ingredients (API) business and develop make this world colorful (Dyes and
Business Management Degree from the the quality of raw materials such that Pigments and their Intermediates),
USA., currently heading the quality of our finished dosages become healthy (Pharmaceuticals,
International Marketing Division for bio-equivalent to international brands. Nutraceuticals and their key starting
Europe and Latin America. Chempro has “It was this need that pushed Chempro raw materials) and beautiful (Key Raw
more than 500 manufacturing partners into API exports and development of APIs Materials for Cosmetics applications).
today that manufacture raw materials with low impurities and developing in-
and finished products across Colors, house purification technologies for the Outstanding Single Achievement
Pigments, Inks, Pharmaceuticals, same”, says Mr. Arun Sehgal.
Cosmetics, Electro-Chemicals, “Chempro has an ever-growing list of
Polymers, Agrochemicals' sector. “Most The company soon gained good customers across all continents in more
of these products are exclusively reputation amongst Japanese and South than 50 countries today, with nine
marketed by the Chempro Group and Korean partners who were looking for overseas stocking locations, and most of
many are stocked at overseas stocking purer APIs from India and were difficult these customers are considered as part
operations for regular international to find. However, manufacturing purer of the Chempro Family”, says Mr. Vishal
customers as Just-In-Time inventory APIs meant in process removal of Agarwal, who has rejoined the family
where most of these customers make isomers and that required the company business after a brief sabbatical and
payments after using the inventory.”, to build its own in-house R&D teams to holds a management degree from the
says Mr. Shubhit. accomplish what was desired by UK. The company ensures that all of its
international buyers. Manufacturing of customers always make profit first on

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account of its association with them. consumed by our customers worldwide” This is the future need of most
“Customers' needs and creation of an according to Mr. Sehgal. international markets as the world has
outstanding experience for them is the decided to shift from free movement of
key for company's business growth over Innovation is the key to continuous value goods to setting up of manufacturing
t h e y e a r s ” , s a y s M r. D e e p k i r a n creation for the customer. If you do not facilities to create employment.
Khanwalkar. innovate continuously then you stagnate
very fast. Our customers must always India with its vast infrastructure for
Chempro's Typical International make profit with us and our operations pollution control will continue to be a
Customer Profile must have enough checks in the critical base of manufacturing key
processes to ensure that. When a starting raw materials. Chempro is
It has established itself as an outstanding customer makes a complaint, it is our therefore rightly focusing on the
partner for any International Chemicals, responsibility to investigate and resolve development of new raw materials for
Colors, Cosmetics or Pharmaceutical it quickly. These are the key beliefs with its customers worldwide. A lot of
Manufacturer around the globe that does which company operates. intermediates that became scarce from
not have an office in India and is looking China have already been developed by
to develop an efficient supply chain in Quality assurance starts with agreement Chempro in its dedicated manufacturing
the verticals that the company operates on testing methods and matching results sites for its partners around the world
in. As a result, the company enjoys the with buyer's test results and thereafter and this business is likely to be under
confidence of numerous buyers who controlling the processes that need greater focus in the coming years.
outsource their supply chain excellent team performance for which
development with a goal of cost teams need to be trained and motivated There is also a need for natural
reduction, quality enhancement and - only then our promise is delivered. supplements in the field of
ensuring timely deliveries. Employees are the first customers of my nutraceuticals and Chempro has already
organization. Only happy employees started work in this domain and is
Chempro's Promise to the create happy customers. This is the work adding key nutraceuticals that have
International Customers culture at Chempro. proven efficacy for human and animal
health. Chempro is soon planning to
Delivery of Consistent quality at “Our Contract Manufacturing partners launch its own range of plant-based
affordable prices and timely deliveries as well as our customers must make nutraceuticals based on the Ayurveda.
by keeping Just-in-Time supplies to most profit before us and this is possible only These products are likely to be in the
of the customers on credit. There are if we continue our focus on innovation. area of anti-aging, anti-diabetic, skin
times when customers feel less India is a very dynamic country with and hair care to start with.
comfortable in buying Indian products newer innovators on horizon every year
from new sources that appear in all domains of chemistry, developing Chempro is a family business and luckily
attractive. Chempro offers them to buy an efficient supply chain therefore is a the next generation has taken interest
and consume first before making the continuous process that needs alertness in growing the family's business. There
payment. As a result, Chempro keeps and agility else you could be thrown out are four members from the next
stocks for a number of its customers of competition in no time,”says Mr. generation who have been with the
overseas and gets paid overtime while Sehgal. company between 6 to 14 years now
making upfront payments to its contract who are fully groomed and trained in
manufacturing partners. Chempro has The Future company's philosophies and strategies
investments in many of its to take this business to the next level.
manufacturing sites today where it With every country now shifting its focus The future will see greater investments
manages and controls raw materials' on creating jobs for its citizens, the in manufacturing with a core focus on
supplies, quality of finished products as world is surely moving towards the development of priceworthy
well as on-time deliveries. establishment of capacities within each supplies by leveraging inexpensive
country. Chempro is now focusing on manufacturing strengths of the small
“If anyone wishes to buy a cheaper setting up of pharmaceuticals' finished and medium sectors in India. The
product from India, with a focus on formulations production facilities in company with its second generation of
continuous profitable growth in any of developing markets by transferring entrepreneurs in command will
the Chemicals' Manufacturing Sectors technology. These projects are being continue to create outstanding
and does not have a full-time office in set-up on turn-key basis with supply of customer experience for doing business
India, then you need a strategic partner machinery, complete documentation with India.
like Chempro. We consider our products and manpower training to ensure the
are sold only after they are satisfactorily success of new manufacturing sites.

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Pharma Exports To Boost Growth

The report details about the trade scenario of the Indian pharma industry during the period April-December 2019 of FY20. In
addition to this, we also discuss about the possible impact of coronavirus outbreak on the pharma industry in India.

Drugs & pharma exports from India

Drugs and pharma exports from India increased at a faster pace of 12% to USD 15.6 billion in the first 9 months of FY20 compared
to the growth of 9.5% during the same period last year. The higher growth in exports was mainly driven by healthy 23% rise in
exports to the prime destination, USA (shipments to the country accounted for 32.7% of the total exports). Outbound shipments
to USA had increased by 8.9% during the first 9 months of FY19. Exports to other parts of the world except for USA increased at a
slower pace of 7.3% to USD 10.5 billion during April-December 2019.

Chart 1: Trend in drugs & pharma exports from India

An upward momentum in exports is
expected to continue for both the
markets in the last quarter of FY20
backed by demand for generics and
branded generics.

Subsequently, pharma exports from
India are estimated to rise by about 11%-
12% on a y-o-y basis to reach the level of
about USD 21.3 billion-USD 21.5 billion
during FY20. A major impact of
coronavirus is not expected in Q4FY20
which is discussed in the report going
forward.

Drugs & pharma imports by India

Source: CMIE The pharma imports by India declined by
2.6% to USD 2.7 billion during the first 9
Chart 2: Trend in drugs & pharma imports by India months of FY20. The scenario however
was different in the past 2 years where
the imports had increased by 9.3% to
USD 3 billion in FY18 and had grown by
18.8% to USD 3.6 billion in Fy19.

The overall imports of drugs and pharma
industry are primarily influenced by the
shipments of bulk drugs and drug
intermediates as it is the largest
segment in pharma imports. It
accounted for about 53% of the total
imports during April-December 2019 and
imports in this segment are mainly
guided by shipments from China with the
country having a lion's share in bulk
drugs and drug intermediates imports.
China accounted for 67.4% of the total
imports of the segment – bulk drugs and
drug intermediates as can be seen in the

Source: CMIE

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table below. The other segments that form part of pharma imports include drug formulations and biologicals, surgicals and
ayush & herbal products and they accounted for 35.2%, 10.8% and 1.2%, respectively, of the total pharma imports during April-
December 2019.

Table 1: Drugs & pharma imports by India during April-December 2019

Source: CMIE

The bulk drug and drug intermediates segment consist of inputs or raw materials that are used in making of formulations which
result in desired therapeutic effect in the human body. In terms of API/bulk drugs, the dependency of India on imports is
considerable. About more than 60% of APIs are sourced from other countries, and in case of certain specific APIs, the import
dependence is 80%-90%. Thus, any supply disruption in markets of a significant supplier (like China) is a major cause of concern
for the Indian pharma industry as the disturbance in supply-chain has a direct impact on making of drugs or formulations for
domestic and exports market of India.

Impact of coronavirus on Indian pharma industry

The above discussed case holds true in the current scenario of coronavirus outbreak in China. The virus was officially recognised
in early January 2020 with China sharing the genetic sequence of the novel coronavirus on 12 January 2020. Following this, the
Chinese New Year holidays (the Chinese New Year was observed on 25 January 2020) were extended by the government to
prevent the virus from spreading. The facilities that were originally to start by 1 February after the holidays were slated to
resume by second week of February and later to third week of February. The lockdown or closure of these facilities is likely to
delay the manufacturing and thus the supply chain of pharma inputs to India. This, in turn, will create a gap of APIs/bulk drugs
and intermediates for the Indian pharma industry that is largely dependent on drug intermediates from China as discussed
earlier.

The Indian pharma industry however is believed to have stocks of about 1.5 to 2 months to fulfil the input requirements that are
met from China. This is likely to keep their problems at bay latest till early April 2020 and Indian pharma supplies to the domestic
and exports market are thus expected to remain unaffected in the last quarter of FY20. The situation however will be different
for those pharma companies that have failed to maintain the stock levels.

The impact of coronavirus on the Indian pharma industry however is likely to be seen in the first quarter of FY21 as the pharma
companies are expected to face a shortage and witness price rise of intermediates or bulk drugs given the extension of holidays
and closure of facilities in China due to the virus. This shortage and increase in price may extend to the second quarter of FY21
depending on how coronavirus is contained in China.

Concluding remarks

Ÿ Pharma exports from India are estimated to rise by about 11%-12% on a y-o-y basis to reach the level of about USD 21.3 billion-

USD 21.5 billion during FY20.

Ÿ The impact of coronavirus on the Indian pharma industry is likely to be seen in the

first quarter of FY21 as the pharma companies are expected to face a shortage Source : Care Ratings

and witness price rise of intermediates or bulk drugs given the extension of Author : Bhagyashree C. Bhati

holidays and closure of facilities in China due to the virus. Deputy Manager - Industry Research

Ÿ The shortage and increase in price of APIs/bulk drugs and drug intermediates may [email protected]

extend to the second quarter of FY21 depending on how the virus is contained in 91-11-45333306

China.

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ICRA downgrades Indian pharma sector to 'negative' from 'stable'

As per a report published in Economic Times ICRA has downgraded the Indian domestic pharma sector to 'negative' from 'stable',
as the credit rating agency believes the lockout in parts of China following the outbreak of corona virus will affect Indian
pharma companies.

Though the majority of the pharmaceutical manufacturing facilities in China are located far away from the corona virus-
affected sites, there has been a disruption in the supply chain due to the lockouts.

Coronavirus spurs India to restrict exports of 2 dozen drugs

As the corona virus pressures the global drug supply chain, India has halted exports of 26 active ingredients and drugs, though a
government official insisted the restrictions are temporary. These include paracetamol––the ingredient in Tylenol––plus anti
virals like acyclovir for treating shingles and the antibiotic neomycin. Indian generic drug makers earlier warned of potential
shortages if the outbreak drags on in China, because India also relies heavily on APIs from its neighbor. ( source : fierce pharma)

Biogen cracks down on travel after 3 execs test positive for coronavirus

The novel coronavirus has hit home at Biogen, where three executives who traveled to a headquarters management meeting
have tested positive for the illness.

At last week's meeting, a “number of attendees reported varying degrees of flu-like symptoms,” the company said in a
statement reported in numerous publications. Some have confirmed influenza, while, so far, three joined the COVID-19 case
count.

It's exactly the sort of development drugmakers are trying to avoid by restricting travel, pulling out of conferences and pushing
employees who might be exposed to work from home.

"At the present time, these individuals are doing well, improving and under the care of their healthcare providers,” the Biogen
statement says. One traveled to the meeting from a U.S. location outside Massachusetts, and two are from Europe.

Biogen instructed all of the meeting attendees to work from home for two weeks and restricted company travel through the end
of March, the statement says. Aside from those who attended the meeting, employees should stay home if they feel sick and
contact healthcare providers as necessary. ( source : fierce pharma)

FDA takes action with Indian Government to protect consumers
from illicit medical products

The U.S. Food and Drug Administration today announced that its first bilateral enforcement operation with the Government of
India, stopped approximately 500 shipments of illicit, and potentially dangerous. ( source: worldpharmanews)

AstraZeneca divests rights to established hypertension medicines

AstraZeneca has agreed to sell the global commercial rights to Inderal (propranolol), Tenormin (atenolol), Tenoretic (atenolol,
chlorthalidone fixed-dose combination), Zestril (lisinopril) and Zestoretic (lisinopril, hydrochlorothiazide fixed-dose
combination) to Atnahs Pharma (Atnahs).

The agreement excludes the rights in the US and India, which were previously divested, and in Japan, which will be retained by
AstraZeneca. The medicines, used primarily to treat hypertension, have lost their patent protection globally.

(source: worldpharmanews)

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Preventing spread of SARS coronavirus-2 in humans

Several coronaviruses circulate worldwide and constantly infect humans, which normally caused only mild respiratory disease.
Currently, however, we are witnessing a worldwide spread of a new coronavirus with more than 90,000 confirmed cases and
over 3,000 deaths. The new virus has been named SARS coronavirus-2 and has been transmitted from animals to humans. It
causes a respiratory disease called COVID-19 that may take a severe course. The SARS coronavirus-2 has been spreading since
December 2019 and is closely related to the SARS coronavirus that caused the SARS pandemic in 2002/2003. No vaccines or
drugs are currently available to combat these viruses.

Zydus announces world's first drug for the treatment
of Non-Cirrhotic NASH

Zydus Cadila, an innovation-driven global pharmaceutical company announced that the Drug Controller General of India (DCGI)
has approved its New Drug Application (NDA) for Saroglitazar for the treatment of Non-Cirrhotic Non-Alcoholic SteatoHepatitis
(NASH) in India.

NASH is a progressive disease of the liver, which starts with fat accumulation in the liver known as Non-Alcoholic Fatty Liver
Disease (NAFLD). This condition could progress to cirrhosis and liver failure. It is a large unmet medical need as there is
currently no approved drug for the treatment of NASH anywhere in the world, a disease that is highly prevalent with 10% to 30%
of the global population being affected by it. The prevalence of NASH in India is estimated to be nearly 25% of the population.
NASH ranks as one of the major causes of cirrhosis, behind hepatitis C and alcoholic liver disease. Liver transplantation is the
only option for managing advanced cirrhosis with liver failure. (Source: https://www.pharmatutor.org/)

Stopping virus spread

A team of scientists led by infection biologists from the German Primate Centre and including researchers from Charité, the
University of Veterinary Medicine Hannover Foundation, the BG-Unfallklinik Murnau, the LMU Munich, the Robert Koch Institute
and the German Center for Infection Research, wanted to find out how the new coronavirus SARS-CoV-2 enters host cells and
how this process can be blocked. The researchers identified a cellular protein that is important for the entry of SARS-CoV-2 into
lung cells. "Our results show that SARS-CoV-2 requires the protease TMPRSS2, which is present in the human body, to enter
cells," says Stefan Pöhlmann, head of the Infection Biology Unit at the German Primate Center. "This protease is a potential
target for therapeutic intervention."

Promising drug

Since it is known that the drug camostat mesilate inhibits the protease TMPRSS2, the researchers have investigated whether it
can also prevent infection with SARS-CoV-2. "We have tested SARS-CoV-2 isolated from a patient and found that camostat
mesilate blocks entry of the virus into lung cells," says Markus Hoffmann, the lead author of the study. Camostat mesilate is a
drug approved in Japan for use in pancreatic inflammation. "Our results suggest that camostat mesilate might also protect
against COVID-19," says Markus Hoffmann. "This should be investigated in clinical trials." ( source: worldpharmanews)

Indian Government restricted export of Paracetamol and
other medication due to COVID-19 outbreak

The Government has made amendments in the export policy and restricted export of specified APIs (Active Pharmaceutical
Ingredients) and formulations made from 13 APIs for safety purpose due to COVID-19 outbreak in India. A notification issued by
Directorate General of Foreign Trade, Commerce and Industry says that the restrictions will come into immediate effect and
until further orders. (Source: pharmatutor.org/)

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Individual response to COVID-19 'as important' as government action

How individuals respond to government advice on preventing the spread of COVID-19 will be at least as important, if not more
important, than government action, according to a new commentary from researchers at the University of Oxford and Imperial
College London in the UK, and Utrecht University and the National Institute for Public Health and the Environment in the
Netherlands.

As the UK moves into the "delay" phase of dealing with a possible COVID-19 epidemic, a new commentary, published in The
Lancet, looks at what we know so far about the new virus. The researchers, led by Professor Sir Roy Anderson at Imperial College
and Professor Deirdre Hollingsworth at the University of Oxford's Big Data Institute, also suggest what can be done to minimise
its spread and its impact.

Professor Hollingsworth said: "Completely preventing infection and mortality is not possible, so this is about mitigation. Our
knowledge and understanding of COVID-19 will change over time, as will the response. High quality data collection and analysis
will form an essential part of the control effort. Government communication strategies to keep the public informed will be
absolutely vital.”

Vaccine development is already underway, but it is likely to be at least a year before a vaccine can be mass-produced, even
assuming all trials are successful. Social distancing is therefore the most important measure, with an individual's behaviour key.
This includes early self-isolation and quarantine, seeking remote medical advice and not attending large gatherings or going to
crowded places. The virus seems to largely affect older people and those with existing medical conditions, so targeted social
distancing may be most effective.

Government actions will be important, including banning large events such as football matches, closing workplaces, schools
and institutions where COVID-19 has been identified, and making sure that good diagnostic facilities and remotely accessed
advice, like telephone helplines, are widely available. Ensuring the provision of specialist healthcare is also vital. The
researchers warn, however, that large-scale measures may only be of limited effect without individual responsibility. All
measures, of course, will have an economic impact, and some stricter measures, such as shutting down entire cities, as seen in
Wuhan in China, may be less effective in Western democracies.

The aim of these social distancing measures is to "flatten the curve" of the infection, slowing the spread and avoiding a huge
peak in the number of new infections.

Flattening the curve can avoid overwhelming health services, keep the impact on the economy to within manageable levels and
effectively buy more time to develop and manufacture effective vaccines, treatments and anti-viral drug therapies.

Sir Roy said: "Government needs to decide on the main objectives of mitigation - is it minimising morbidity and associated
mortality, avoiding an epidemic peak that overwhelms health-care services, keeping the effects on the economy within
manageable levels, and flattening the epidemic curve to wait for vaccine development and manufacture on scale and antiviral
drug therapies. We point out they cannot achieve all of these - so choices must be made.”

The researchers highlight that wider support for the health service and health care workers during an epidemic is vital in any
case - during the Ebola epidemic in 2014-15, the death rate from other causes like malaria and childbirth rose sharply due to
overwhelmed health services. The number of deaths indirectly caused by Ebola was higher than the number of deaths from
Ebola itself.

While much has been made in the media of a number of "superspreading" events, where one infected individual has
inadvertently spread the disease to many others, the authors warn that there are superspreading events in every epidemic, and
care should be taken not to make too much of these.

Containing the spread of an infectious disease relies on keeping the "reproduction number", R0, the number of people infected
by each infected person, below 1, when the pathogen will eventually die out. If R0 rises above 1, i.e. each infected person
infects more than one other person, the pathogen will spread. Early data from China suggests that the R0 for COVID-19 could be
as high as 2.5, implying that in an uncontained outbreak, 60% of the population could be infected. There are many unknowns in

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any new virus, however, and with COVID-19, it is not currently clear how long it takes for an infected person to become
infectious to others, the duration of infectiousness, the fatality rate, and whether and for how long people are infectious before
symptoms appear. It is also not currently clear if there are cases of COVID-19 which are non-symptomatic.

In comparisons with influenza-A (usual seasonal flu) and SARS, it currently seems likely that the epidemic will spread more
slowly, but last longer, which has economic implications. Seasonal flu is generally limited by warmer weather, but as it is not
known if this will affect COVID-19, the researchers say it will be important to monitor its spread in the Southern Hemisphere.
Researchers will continue to collect and analyse data to monitor spread, while ongoing clinical research into treating seriously
ill patients is also necessary.

One of the main priorities for researchers and policymakers will be contact tracing, with models suggesting that 70% of people
an individual has come into contact with will need to be traced to control the early spread of the disease. The authors say other
priorities include shortening the time from symptom onset to isolation, supporting home treatment and diagnosis, and
developing strategies to deal with the economic consequences of extended absence from work.

Author Professor Hans Heesterbeek from the Department of Population Health Sciences at the University of Utrecht said: "Social
distancing measures are societally and economically disruptive and a balance has to be sought in how long they can be held in
place. The models show that stopping measures after a few months could lead to a new peak later in the year. It would be good
to investigate this further." (source: worldpharmanews)

Sanofi and US Government partnered to create novel coronavirus vaccine

Sanofi Pasteur, the vaccines global business unit of Sanofi, will leverage previous development work for a SARS vaccine which
may unlock a fast path forward for developing a COVID-19 vaccine. Sanofi will collaborate with the Biomedical Advanced
Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response,
expanding the company’s long-standing partnership with BARDA.

COVID-19 belongs to a family of coronaviruses that can cause respiratory disease. In late 2002, the SARS (severe acute
respiratory syndrome) coronavirus emerged and then largely disappeared by 2004. Sanofi plans to further investigate an
advanced pre-clinical SARS vaccine candidate that could protect against COVID-19. (Source: pharmatutor.org/)

Diagnostics for Asymptomatic Malaria

The fight against Malaria could get easier with a joint team of scientists
from Department of Biotechnology’s Bhubaneswar-based Institute of Life
Sciences (ILS) and Bengaluru-based Jigsaw Bio Solutions, coming up with a
method that promises to overcome the problem of inadequate
identification of asymptomatic carriers of the disease.

(Source: pharmatutor.org/)

FDA Approves First Generic of Daraprim

The U.S. Food and Drug Administration has approved an application for the first generic of Daraprim (pyrimethamine) tablets
for the treatment of toxoplasmosis (an infection caused by the parasite Toxoplasma gondii) when used with a sulfonamide (a
group of medicines used to treat bacterial infections).

Toxoplasmosis is an infection caused by a single-celled parasite called Toxoplasma gondii that, when severe, can cause
damage to the brain, eyes or other organs. A Toxoplasma infection can occur, among other ways, by eating undercooked,
contaminated meat or shellfish; drinking water contaminated with Toxoplasma; or by accidental swallowing of the parasite
through contact with cat feces that contain Toxoplasma. It is considered to be the leading cause of death attributed to
foodborne illness in the United States.

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PHARMAUpdate

News

Central govt to launch iVEDA portal for tracking drugs
meant for export soon

The central government will soon launch Integrated Validation of Exports of Drugs from India and its Authentication (iVEDA)
portal for drug authentication and tracking and tracing of the drug supply.

iVEDA portal developed by the Centre for Development of Advanced Computing (C-DAC) will replace Drugs Authentication and
Verification Application (DAVA) portal which has hit technical glitches hampering manufacturers and exporters from uploading
data on barcode on secondary and tertiary packs of drugs meant for export and maintenance of parent-child relationship
between them.

Taking serious note of this, Director General of Foreign Trade (DGFT) had postponed the date for implementation of track and
trace system for export of drug formulations with respect to maintaining the parent-child relationship in secondary and tertiary
packaging levels and its uploading on the central portal till March 31, 2020. However, the requirement of bar-coding on
secondary and tertiary packaging continues as per earlier notifications.

Having taken cognizance of the issues and concerns raised by the pharma industry with regards to trace and track and with
specific reference to data upload issues on DAVA portal, the department of commerce constituted an expert committee. The
recommendations arrived after series of consultations with the all the stakeholders led to the decision of developing a new web
portal for validation and authentication of drugs export from India.

With the iVEDA portal being rolled out by third week of March, 2020, the manufacturers and exporters are required to upload data
on barcode on secondary and tertiary packaging of drugs meant for export on the portal. Maintaining parent-child relationship
between secondary and tertiary packaging is an optional.

The manufacturer uploading data on the central portal must have manufacturer code and product code allotted by GS1 India.
The manufacturer can get CDAC codes in case he has not yet subscribed to get codes from GS1 or any other agencies. The
manufacturer must have Digital Signature Certificate of Class-II or Class-III issued by any Certifying Authority (CA) in India.

The responsibility of the correctness, completeness and ensuring timely upload of data on the central portal shall be with the
manufacturer. However, the manufacturer may extend the responsibility to anyone next to it in its supply chain i.e. wholesalers/
distributors/ retailers etc. in its supply chain.

The online system is envisaged to help manufacturers and merchant exporters to generate and utilise tertiary and secondary
level coded data in a user-friendly manner. It has the provision to upload product and production data.

The test run workshop on iVEDA portal was held by Pharmexcil in Mumbai, Ahmedabad, Hyderabad, Chandigarh on February 10,
February 11, March 3, March 5 respectively. The workshop was attended by manufacturer-exporters, merchant exporters,
contract manufacturer exporters etc. The objective of the workshop was to provide industry hands-on experience and get their
feedback to make the portal more robust, and industry friendly.

The industry has appreciated the portal.

Said Nipun Jain, Chairman, SME Panel, Pharmexcil, “The portal is industry friendly. With this portal, the challenges faced the
industry while uploading data on the central portal have been resolved. The trial run of iVEDA will help industry well-versed with
the portal before its launch.”

Said Uday Bhaskar, direector general of Pharmexcil, “We wanted to make the portal industry friendly and simplified and in this
process, we are designing the programme of the portal with CDAC. We have taken all concerns of the industry including merchant
exporters into the consideration.”

“The exporters who were earlier working with GS1 code are not required to change the entire system. They can continue with
data uploading on the portal with minor changes. Those who did not have GS1 code can also upload data,” he added.

(Source : pharmabiz)

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PHARMAUpdate

News

SMS Lifesciences bags new award

At India Pharma and Medical Device 2020 Conference
SMS Lifesciences has received the prestigious "INDIA PHARMA BULK DRUG COMPANY OF THE YEAR AWARD" on 5 March 2020 at
the 5th edition of India Pharma and Medical Device 2020 Conference held at Gandhinagar, Gujarat, organized by FICCI in
collaboration with Ministry of Chemicals and Fertilizers, Govt. of India. (Source : business-standard)

Making India A $100 Bn Biomanufacturing Hub By 2024

Industry experts outline how Prime Minister Narendra Modi's dream of 'Make in India' for the biomanufacturing sector can be
fulfilled in the stipulated time frame By Akanki Sharma.

As the year 2020 began, Prime Minister Narendra Modi came up with good news for the biotechnology sector. Speaking at the
inauguration of the 107th session of the Indian Science Congress at University of Agricultural Sciences in Bengaluru last month,
Modi said, “We aim to develop India as a world-class $100-billion biomanufacturing hub by 2024.”

“The growth story of India depends on its achievements in the science and technology sector. There is a need to revolutionise
the landscape of Indian science, technology and innovation. My motto for the young scientists burgeoning in this country has
been -innovate, patent, produce and prosper. These four steps will lead our country towards faster development. If we
innovate, we will patent and that, in turn, will make our production smoother and when we take these products to the people
of our country, they will prosper. Innovation for the people and by the people is the direction of our 'New India',” he added.

While the biotechnology sector is one of the key drivers for contributing to India's $5 -trillion economy target by 2024, the
Indian biotechnology sector is poised to grow exponentially over the next decade. Further, the country is among the top-12
destinations for biotechnology in the world, with approximately three per cent share in the global biotechnology industry.

The biotech sector can be broadly divided into five major segments — biopharma (which accounts for around 55 per cent of the
revenue of the total sector), bio-agri (22 per cent of market share), bioservices, bioindustrial and bioinformatics. According to
Invest India, the National Investment Promotion and Facilitation Agency, the Indian biotechnology industry was valued at $51-
billion in 2018 and is growing at almost 15 per cent year-on-year.

(Source: expresspharma)

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