Indian Pharmaceutical Industry - The State of Pharmaceutical Industry in India - An Overview, Health News, ET HealthWorld

2/17/2018 Indian pharmaceutical industry: The State of Pharmaceutical Industry in India – An Overview, Health News, ET HealthWorld
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The State of Pharmaceutical Industry in India –

An Overview
The pharmaceutical industry is expected to reach $55 billion by 2020, as per research studies, with the industry
shifting towards digitization and increasing investments on research and development.
ETHealthWorld | August 29, 2017, 13:23 IST
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The inside story of how
New Delhi:
Financial Indian
Results pharmaceutical industry, with current market size of $27.57 Ajay Piramal’s pharma
billion (last reported in 2016) is expected to reach a mark of $55 billion by 2020 empire received a boost
after the Abbott sale
at a CAGR of 15.92%, according to a report by the Indian Brand Equity
Foundation (IBEF). In the next three years, India is projected to be among the AstraZeneca Pharma
top three pharmaceutical markets in terms of growth rate and the sixth largest launches anti-diabetic
tablet Xigduo XR
market globally in absolute size.
Sanofi bets on India with

“Currently the industry is growing at a rate of 9-10% year-on-year, which is a portfolio of drugs for
healthy growth because this is largely a volume led business. This is a diabetes, rare diseases
fundamental advantage of an emerging market economy like India; given the
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countries like United States,” said Kedar Upadhye, Global Chief Financial
Officer, Cipla Ltd.
Pharmaceutical Export Trend
India accounts for 20% of global exports in generics. In FY16, India exported
pharmaceutical products worth $16.89 billion, with the number expected to reach
$40 billion by 2020. Pharma exports in India grew at 9.44% in FY16 and are
expected to register double digit growth in FY17.
Talking about Cipla, Upadhye said, “We have a very strong presence in South
Africa’s private as well as tender market. Cipla is the 4th largest company in the
private pharma market and 3rd overall, including tender business. United States
is also our priority market and our focus will be to grow our US franchise
disproportionately.”
More Interest in Bio-Technology
Many Indian companies are now in the race to create generic versions of
biologic drugs or biosimilars as stated by Kiran Mazumdar-Shaw, chairman and
managing director, Biocon. She added, “Biosimilars are far more complex to
make but offer a large global opportunity. Since 2008, the Indian biosimilar
industry has been growing at a CAGR of 30%. There are around 25 Indian
companies operating in the biosimilar space, marketing close to 50 products in
the Indian market. Today, Indian patients have access to some of the biosimilars
like Insulins, Insulin analogues, Filgrastim, Trastuzumab, Rituximab, Adalimumab
etc. This early experience with developing biosimilars is paving the way for
Indian players to capitalize on the unfolding global opportunity.”
The global biosimilars market in 2020 is projected to be between $25 billion and
$35 billion.
Biosimilars are very heavy resource intensive investment business. “Given the
level of investments and long gestation period, we have decided to reposition our
Biotech business and shift focus towards business development and licensing
based model, rather than organic manufacturing and development model. This
will also help us in reallocating capital towards Specialty in US and other
strategic priorities,” said Upadhye.
Shift from Infectious Diseases to NCDs
“As a dynamic sector, there are both interesting and challenging times for the
pharmaceutical industry. There has been a shift from infectious diseases to
non-communicable diseases (NCDs) as populations are aging and lifestyles and
habits are changing. Companies will need to align their product portfolio in this
direction,” according to a spokesperson of Abbott India.
Upadhye stated, “We are implementing a number of patient education and

market shaping initiatives. For example, we are trying to combat the stigma
attached with inhalation problems, for which we develop respiratory devices and
oral products. Cancer and diabetes are spoken about a lot but not respiratory
ailments.”
Challenges Ahead
Recently, the union government implemented the Goods and Services Tax
(GST), which had a major effect on the pharmaceutical industry in the first
quarter of the current financial year. “After the announcement of GST, the
stockists withheld the purchasing for May and June, which resulted in lower
sales in the first quarter of FY 2017-18. However, we expect the market to

stabilize in the near term,” said Upadhye.
Talking about another challenge, Upadhye said, “At times, US FDA takes longer
to visit our locations for inspection, which is challenging. A company which is
trying to increase its sales in the US will find delayed visits or inspections by the
FDA challenging. However, Cipla has always worked in compliance with the
Current Good Manufacturing Practices (CGMPs).”
The biotech industry in India faces a gamut of challenges that include a time-
consuming approval process, sub-optimal infrastructure, high regulatory
barriers, lack of funding avenues, little or no incentives and a shortage of highly
skilled talent, among others as shared by Kiran Mazumdar-Shaw of Biocon.
To which, Upadhye added, “There are many promises of diagnosing more

patients, spreading healthcare, expanding to rural areas in terms of socio-
economic classifications in Tier I, II, III towns. I think healthcare has not
reached where it should have by now. Products like carbonated drinks,
toothpastes and other FMCG products have penetrated these towns but not
pharmacies and healthcare. We are trying to make our products available in
these small towns.”
“India has made considerable progress in healthcare outcomes over the past
few decades. The average life expectancy of Indians has risen from 58 years in
1990 to 66 years in 2013. However, there is much work to be done in terms of
improving healthcare access to citizens. We believe this can be accomplished
through an effective healthcare delivery system – one that is about creating
value for people by keeping their interest at the core of everything we do,” said
Abbott India’s spokesperson.
Suggested Solutions
Indian pharmaceutical companies are now investing on research and

development. “Historically, we used to spend less than 4% on R&D but now we
spend about 8% of our sales into research and development efforts,” shared
Upadhye. While Sun Pharma spent 9.1% of its total sales on research and
development, Lupin’s R&D budget stood at 12-15% of its total sales value in FY
16.
“What is also important is the move from creating medicine to creating holistic
healthcare solutions that address the entire continuum of care. This is where
technology and digital interventions play an important role. In our country, where
the doctor to patient ratio poses a challenge, in order to serve our patients
better, pharma needs to collaborate with partners such as hospitals, devices and
diagnostics companies so that we can integrate, optimize data and generate
insights and interventions for better health outcomes for the patients,” said the
spokesperson of Abbott India.
India in 2016 announced draft guidelines for "similar biologics" that will enable
such drugs to be developed and brought to the market in an affordable and
expeditious manner, whilst ensuring quality, safety and efficacy.
“The government's ‘Start-Up India’ initiative is creating an enabling ecosystem

through a number of policies that include seed and venture funding to support
biotech entrepreneurs, incubators and accelerators. India has also recently
unveiled the National Biopharma Mission, which is an industry-academia
collaborative mission for accelerating discovery and early development of
biopharmaceuticals,” concluded Kiran Mazumdar-Shaw.
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Maheswaran • 6 months ago

Its a Indian style of showing USFDA that they are genuine to escape from big
warning letters and protect their existing high value products exported. They
manufacture only one batch of low cost product not commonly used for a
disease and as soon as it reaches distributor, they recall it and inform USFDA to
get good boy name.
This is a trend of many Indian companies.
They no need to recall for products marketed in India because they are not
audited by Indian FDA as they get money for giving licence.
All they give is fake document of formula, stability data etc and Gandhi Notes.Its a
setup and all drug inspectors never take any product of reputed companies from
medical shops as they are given list of companies given money to FDA.
△ ▽ • Reply • Share ›
Maheswaran • 6 months ago

90% of the products marketed by Indian pharma companies are not stable still
shelf life, that is, it expires after 1 year.Also all the products are given license
shelf life, that is, it expires after 1 year.Also all the products are given license
without auditing actual bioequivalence and stability data by getting money through
state FDA and central DCGI.
Its a shame to DCGI that USFDA fly to India to audit for saving americans from
Indian companies.But being inside India, no audits done since CDSCO or DCGI
was established.
△ ▽ • Reply • Share ›
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2/17/2018 Indian pharmaceutical industry: The State of Pharmaceutical Industry in India – An Overview, Health News, ET HealthWorld

 NEWS SITES  Sign in/Sign up   

Health News / Latest Health News / Pharma

The State of Pharmaceutical Industry in India –

Share 3 Share Share 94 Tw eet   A A  Newsletter

Your Email Join Now!

Most Read This Week

Singh brothers siphoned Rs 500 crore

from Fortis, claims report

Ayushman Bharat Yojana to bring 'paradig…

Govt to bring major changes in Drug Pricin…

Big Modi govt push for health? Key schem…

The inside story of how Ajay Piramal’s pha…

Most Read in Pharma

This Week This Month

Brand Solutions Govt to bring major

Sanofi bets on India with

Pharmaceutical Export Trend

More Interest in Bio-Technology

Shift from Infectious Diseases to NCDs

Upadhye stated, “We are implementing a number of patient education and

sales in the first quarter of FY 2017-18. However, we expect the market to

To which, Upadhye added, “There are many promises of diagnosing more

Indian pharmaceutical companies are now investing on research and

“The government's ‘Start-Up India’ initiative is creating an enabling ecosystem

Share 3 Share Share 94 Tw eet   A A  Newsletter

Join the discussion…

Maheswaran • 6 months ago

This is a trend of many Indian companies.

Maheswaran • 6 months ago

Pot Pharm: Booming Canada weed sector

Govt to come out with new pharma policy:

 Click Here to Read This Story

Cremica, Ajanta to invest Rs 800 cr in region

 Click Here to Read This Story

Follow ETHealthw orld /  /  / 

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