World’s pharmaceutical development and manufacturing base moving to
20 August 2013
The India Brand Equity Foundation (IBEF) predicts that the Indian pharmaceutical market
will progress from the major generics producer to a world centre for
development and production of patented products.
Over the last three years exports of pharmaceuticals (largely
generics) have grown at over 21.5% (CAGR) and now accounts for over
US$13bn in annual sales. Highlighting India’s dominance, nearly 40% of
Abbreviated New Drug Applications (ANDA) received by the FDA in 2012
were from India, with a further 87 confirmed and another 25 already
received between January and June 2013.
This huge growth in generics production has seen the country
become a hotbed of manufacturing innovation — India has over 3000
DMFs registered with the US FDA — which coupled with increased
investments in R&D, says IBEF, means India is now ready to challenge traditional
big pharma and start producing more patented products.
evolution of the success of the generics market has been the rise in supergenerics across India where much R&D spend is currently being
invested (eg Lincoln Pharma’s patent for NDDS).
With the world’s pharmaceutical development manufacturing base
moving to India — there are 546 US FDA approved company sites (second
only to the US), 23 companies holding 1100 authorisations with UK's
MHRA, and 166 companies with CEPs (Certificates of Suitability) from
EDQM — coupled with the rise in supergenerics, the country’s next
natural step is to use its world leading development expertise in
the creation of new chemical entities.
Recognising this opportunity, the Government of India is putting
in place supportive initiatives with the goal of cementing the
country’s position as the ‘pharmacy of the world’ and creating a
global innovation hub.
With generics predicted to rise to 35% of
global pharmaceutical market value by 2016 (some $400bn+), and with
an annual growth rate of 27% amongst Indian generics exports
(comparing very favourably with the global average of 10%) the
Government and Pharmexcil are forecasting much of this revenue will
be reinvested across the country in new research, leading to a
steady pipeline of future drug targets.
In support of this, the Indian Government has committed to three
schemes including a major multi-billion dollar initiative with 50%
public funding through a public-private partnership (PPP) model to
harness India’s innovation capability.
In addition, the Government
- made tax-breaks available to the pharmaceutical sector and a
weighted tax deduction of 150% for any R&D expenditure incurred;
- introduced 19 dedicated Special
Economic Zones to help stimulate pharma sector investment across the
- taken steps to streamline procedures covering
development of new drug molecules and clinical research, including
two schemes —the ‘New Millennium Indian Technology Leadership Initiative’
and the ‘Drugs and Pharmaceuticals Research Programme’, which has
been specially targeted at drugs and pharmaceutical research.
Already this year, India’s Dr Reddy’s, Lupin Labs, Sun Pharma,
Ranbaxy and Cipla have invested over $500million in R&D, which is
allowing increased innovation in manufacturing processes and will
ultimately help to lower the cost of medicines production.
“India, termed as the Pharmacy of the World, has a basket of wide
spectrum of generics that are second to none in terms of quality.
The industry is on the track to expand its reach to newer markets,
which makes it equally critical for the Indian pharmaceutical
industry to keep its focus on quality, affordability and
accessibility of medical solutions for the global pharma market.
The country’s success in generics manufacturing is helping to keep our
industry at the forefront of innovation and over the next few years
we are lending our support to the R&D effort across the country so
that we are leading in generics production and even developing new
drugs out of India” said Mr Rajeev Kher, Additional Secretary,
Department of Commerce, Ministry of Commerce and Industry,
Government of India.
“Being a world leader in generics, India already has a huge
presence in the highly regulated markets in terms of pharma exports.
Almost two thirds of Indian generic exports are to the highly
regulated markets (eg the US and Europe), which speaks volumes
about the quality of Indian medicines. The Government of India is
supporting Brand India Pharma campaign to reiterate that the Indian
pharma market offers credible, affordable and sustainable healthcare
solutions,” said Dr P V Appaji, Director General, Pharmexcil.