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.