Mumbai, Feb 24 (UNI) The government must create a congenial and enabling regulatory environment to give an impetus to the rapidly-growing and successful Indian biotech industry, said Biocon chairman and managing director Dr Kiran Mazumdar-Shaw here today.
She was speaking at a function organised by the Indian Merchants' Chamber (IMC) where she was presented the IMC's Diamond Jubilee Endowment Trust's Eminent Businessperson of the Year' Award, 2006, by Maharashtra governor S M Krishna.
Dr Mazumdar-Shaw said India enjoyed numerous advantages over that in the developed world which facilitated unprecedented growth opportunities for the biotech industry.
Dr Mazumdar-Shaw, however, lamented the fact that many roadblocks were thwarting entrepreneurial initiatives in India.
''We do not have a strong regulatory framework necessary for growth of nascent biotech industries. Our regulatory systems impeded speedy development of drugs,'' she said.
''Also lack of pre-clinical test laboratories, especially concerning small and large animals is a major handicap. Besides, our industry has so far focused mainly on generics, and has been facing shortage of regulatory expertise to evaluate and approve new drugs,'' she pointed out.
Contrasting India's huge reservoir of talented human capital, capabilities to develop new drugs, a vast and growing market and demographics, as against the disadvantages faced by international biotech companies such as high investment costs and difficult funding environment for drugs development, she pointed out that ''in this scenario, overseas biotech companies with a rich pipeline of early stage molecules, have been eagerly exploring collaborations in India and other Asian countries.'' Highlighting the trend of discovery-led companies getting premium valuations with the advent of the WTO-TRIPS product patent regime from January 1, 2005, she said that venture capital companies were investing in discovery research in India as a low-risk option.
''Large MNCs are setting up R&D centers to leverage India's low-cost base,'' she said, adding that ''Indian companies are now reinventing themselves as innovators.'' She said India ranked first for USFDA plant approvals outside the US in respect of improving standards of bio-manufacturing and many MNCs like Glaxo, Merck and Novartis had leveraged this advantage of increasing capabilities in clinical development.
Indian biotech companies have also been benefiting from increased entrepreneurial opportunities like R&D, diagnostics and vaccines and entering foreign collaborations, in addition to undertaking contract research and manufacturing, she pointed out.
The Biocon founder-chairperson, however, lamented the fact that small biotech companies which were unable to develop their discovery programmes beyond pre-clinical stages, were forced to license their discovery programmes at low cost.
''Inaffordability has been stunting the value of innovation,'' she said.
Maharashtra governor S M Krishna said that Dr Mazumdar-Shaw had now not only joined the galaxy of eminent personages like JRD Tata who had won the IMC's award earlier, but ''she has raised the prestige of this coveted award several notches higher.'' Dr Mazumdar-Shaw was selected for the award by a panel of judges headed by Ms Bakul Patel, former sheriff of Mumbai.
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