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NEW RULES FOR CLINICAL TRIALS
Wednesday,
February 02, 2005 08:00 IST
P A
Francis
A pleasant outcome of the new patent regime in India
is the definite boost in investment in pharmaceutical R&D although
allowing product patent could lead to monopolies and push up drug prices
in the coming years. Patent protection has been one of the main conditions
of MNCs for increasing their investments in pharmaceutical sector ever
since Indian Patent Act was notified in 1970. And it was this patent
protection provided by the Indian government through this Act that kept
the pharmaceutical industry in this country grow over the last 35 years.
Everyone in this industry knew that the party time would get over from
2005 when India has to comply with the WTO requirement. Top Indian
companies like Ranbaxy, Dr.Reddy's, Lupin, Zydus Cadila and Wockhardt have
been thus investing heavily on new molecular research for the last five
years. In fact, R&D investments by Ranbaxy and Dr.Reddy's have been
quite high that their profitability is under tremendous pressure for last
two years. Probably in one year from now, investment plans of MNCs in
R&D will be quite clear. Pfizer and GSK, two world leaders in
pharmaceutical industry, are understood to be having major R&D plans
for India. Details are not known. Astra Zeneca has set up a huge research
project for developing drugs for TB in Bangalore. It is possible that more
MNCs will come to India with investments plans in pharmaceutical
research.
The main attraction for MNCs to invest in R&D in
India is the huge costs of developing new drugs in the US and Europe. On
the one hand, MNCs are finding it tough to get new molecules from their
research labs these days and on the other clinical development costs are
getting out of control. As the clinical trials account for almost 70 per
cent of the cost of a new drug, research based companies have to look for
cheaper options if they have to protect their bottomlines. India with
extremely low cost of volunteers and investigators and rich diversity of
patient pool thus stands out as the ideal location for pharmaceutical
R&D. Recent spurt in interest in setting up contract research
companies in India mainly to undertake clinical development work is an
attempt to encash this opportunity. In the absence of a set of clear rules
for clinical trials, there are possibilities that some of these MNCs and
CROs could undertake human trials without any right procedures and
safeguards. The government decision to notify a set of new rules for
clinical trials in this country by revising Schedule Y of the Drugs and
Cosmetics Act is to monitor this activity in the public interest. The
rules appear to be quite unambiguous in most respects and empower the
regulatory authorities for taking stringent action against violations.
What is now important is the effective and quick implementation of these
rules and for the government has to put in place an appropriate
infrastructure and a team of technically qualified staff without delay.
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