India 's current regulatory system for clinical research is impeding early drug development; Biocon chairperson and managing director Kiran Mazumdar Shaw said here on 15 th December 2005.

"Though the Mashelkar Committee has reached a consensus on the regulatory pathway, there is no speed in its implementation. We hope to see it being implemented over the next few months," she said at TiE con India 2005, the annual entrepreneurs meet.

Besides the lacunae in the regulatory regime, India's richest woman entrepreneur said there is lack of adequate knowledge of pre-clinical research in India.

Addressing the meet, Shaw said, "The advent of the WTO-TRIPS (World Trade Organisation-Trade Related Intellectual Property Rights) product patent regime from January 1, 2005 this year is helping India pharma biotech companies bridge the gap and thinking on discovery led strategy."

Admitting that while there is no difficulty in companies getting the first stage or start-up funding for undertaking research, Shaw said it is in the second and third stage of research and development of drugs that companies are facing problems.

With 250 biotech companies in operation, a majority of them in pharma biotech, Shaw said India's biotech sector is expected to cross the $1 billion mark this year from current levels of $790 million. Of this, clinical research operations are alone expected to generate business of $100 million.

While venture capitalists are showing interest in India due to lower risk perception compared to rich nations, Shaw urged companies to "bring science to India and not merely become a base for low-cost advantage. Low cost high quality research and development in India would translate into new opportunities".

(http://news.webindia123.com)