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India Calling' could well be the most apt line to catch
the mood at global headquarters of multinational pharma
giants. These offices are buzzing with activity to get
the best out of the domestic market after '05, when
the product patent regime is implemented.
Confidence of these MNCs in India is at its peak. Investment
plans are reportedly being ramped up 5-7 times for clinical
trials in India. Further, some blockbuster products
may soon hit domestic pharmacy shelves and domestic
arms of MNC pharma companies are beefing up their legal
teams for possible IPR battles with desi companies.
"The change to product patent regime is symbolic
of India's serious intention of honouring IPR. We will
now be more tempted to invest in clinical research and
drug discovery from India. The country will then provide
a much better research environment than China,"
Eli Lilly India's CEO, Rajiv Gulati, told ET.
In fact, companies are now seriously considering India
a global hub for clinical trials. The likes of Pfizer,
Aventis, Novo Nordisk, Novartis, GlaxoSmithKline, Eli
Lilly and Organon are planning to leverage much of their
drug development activity through their Indian arms.
"The guarantee for data exclusivity in India from
'05 has done the trick," said BN Chakraborty, MD
of Organon India. Aventis, which had earlier focused
more on Phase II and IV studies in India, is now going
for Phase III work in therapeutic areas of diabetes,
cardiovascular and oncology.
Even the outsourced clinical research market in India
is estimated to rise to $500m by '10. MNC giants are
also planning to introduce many of their innovative
researched products in India.
"The IPR regime will provide us the reassurance
that we can bring the fruits of difficult R&D efforts
to India without having the products unfairly copied.
We at Pfizer India has formed a special team dedicated
for analysing the products we can launch in the post-05
era," said S Ramkrishna, senior director, Pfizer.
However, there is a serious concern on rising litigation
with desi companies. "There is already a lot of
confusion on the business environment, which might increase
clashes with Indian companies. Legal costs will rise
at least till '08 before things settle a bit,"
Mr Gulati said.
"There are chances of misusing the rules by competition
to gain backdoor access to patented products. Another
issue, which is yet to be resolved, is the ability to
price our new products appropriately, within a new price
control regime," Mr Ramkrishna said.
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