The Indian pharma industry is already on a strong position in word for production.

India
is the 4th largest producer by volume and 13th by cost in world in pharmaceutical industry.
India is having highest USFDA approved plant (75 plants in 2008) for production after
USA. The cost of production is very less in India (20th times compare to USA). But still
there is a need of improvement.

The policies to make India a strong pharma hub can include

1. The quality for the export and domestic market are not kept same. Generally it is
known that the quality of domestic formulation is on a lower side than that of the
export formulation. It can be seen easily by packaging. Thus quality of the
product should be equal to that of export.

2. Improve the knowledge of IPR. It was well know that before 2005, India has to
fight to protect for the ancient use of many medicinal plant as some foreign
countries were claiming the patent of it. Government organizations such as
‘PETT” have done good remarks to file patent to individual by funding them for
their innovations. The government needs to provide clear guidelines on IPR and
resolve issues related to data exclusivity, incremental innovation, etc. This will
boost the confidence of MNCs to launch their products in India.

3. The investment for the R & D is kept very less. Government has taken good step
by giving exception in tax for the companies which invest in R & D.

India’s adoption of WTO’s TRIPS in 2005 has accelerated its role in global outsourcing.
Many companies like Astra Zeneca have already started outsourcing from India. As big
pharma companies like Pfizer, Astra Zeneca, GSK, Novartis, Sanofi-Aventis, J&J,
Merck, Roche, etc have started cost reduction aggressively which has created new market
potential.

Due to India’s potential of producing high quality pharmaceutical product at a low lost,
many companies have shifted their focus from pure generics to contract research and
manufacturing. Companies like Dishman pharma, Jubilant Organosys, Piramal
Healthcare, Dr. Reddy’s Lab, Divi’s Lab, Shasun Pharma, Suven Life Sciences, Cadial
health care, Hikal, etc are the key player for CRAMS (Contract Research And
Manufacturing Services). Many Indian companies like Dishman (acquisition of carbogen
amcisAG, Synprotec- UK), Jubilant (Hollister Stier-US, Clinsys Clinical-US, Cadista
pahrma- US), Piramal healthcare (morpeth- UK, Avecia- UK, Torcan-Canada) have
made acquisition which is playing important role in CRAMS.

Even process patent known as process re-engineering had played vital role in facilitating
Indian pharma to develop its own skills, due to which India is the cost effective drug
manufacturer.
India has a strong talent pool with expertise in chemistry and synthesis skills the most
important resource for drug discovery and research activity. Indian Contract research
organization also adheres to international regulatory and quality standards like ICH, ISO,
GLP, GCP, etc which provides confidence to India to emerge as a dominant provider of
drug discovery service.

India is now one of the best destination to carryout clinical trials because of its low cost
and accuracy. Many MNC’s set up their own research facility or make outsourcing to
local Clinical Research organizations (CROs). Many molecules such as vegamox,
meremen, lamictal etc’s clinical trial is done in India. India has good infrastructure and
medical set up for conducting these clinical trials at a low cost. India is having
advantages compare to other countries which includes least expense, highest patient
recruitment rate, moderate industrial trial experience, highest regulatory environment.

Revision of schedule Y of drug and cosmetics rule, 1945 in 2005 has provided India a
great depth to carry out clinical trials in phase II and III. India is having highest
transparency and accountability in Asia by creating Clinical Trial Registry- India (CTRI)
by Indian council of medical research. India takes average of about 3.5 months for
application review for conducting clinical trials which is less compare to China and
Brazil. Gov. of India has taken good initiative by exemption of service tax to clinical trial
of new drug.

Even collaborative work is carried out between MNCs and Indian pharma companies for
the generation of NCEs. Companies like Glenmack, Dr. Reddy’s Lab, Piramal
Healthcare, Alembic, Suven etc have made collaborative deals for NCE with Forest Lab,
Tejin Pharma, Eli Lilly, Merch & Co.Thus Indian pharma is expanding footprints in
notonly NCE but also in New Biological Entity Research. India is currently ranked
among the top 12 biotech destinations in the world and is the third biggest in the Asia
Pacific in terms of number of biotech companies.

Due to high expenditure healthcare market globally, generics are promoted. India has
already proven that it is top generic supplier. As patent expiry is increasing now days,
regulated generic market in India is also increasing. India has achieved a dominant
position in terms of ANDA approvals (24.2 % in 2007). Indian pharma industry has
shown good interest in domestic drug market.

India giants are challenging patents by filing para IV to get huge benefits by getting 180
days of generic market exclusivity. Companies like Lupin, Sun pharma, Ranbaxy and Dr.
Reddy’s lab have made such profits by filing para IV.

Even it was observed that MNC’s have acquired many Indian Pharma Industry. It
includes Daiichi Sankyo company Limited (Ranbaxy), Mylan Laboratories Ltd.( Matrix
laboratories), Actavis group (Grandix pharmaceutics).

New patent rule may impact on prices of formulation. The prices of formulation can
increase which will not come under DPCO.