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Biotech revolution: US backs India

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Having showcased itself as the most attractive destination for development of low cost drugs for the world market, India has sought active partnership with the United States through enabling protocols and transfer of biological materials.

A meeting of the US-India High Technology Cooperation Group, held on Wednesday, went into the nitty-gritty of clinical trials, regulatory regimes, technology transfer, patent protection and potential for alliances.

Science and Technology Minister Kapil Sibal, who led the delegation and also held separate talks with Acting Deputy Commerce Secretary David Sampson, told reporters later that the US reaction to the Indian proposals was very positive.

A major barrier to collaboration has been the absence of a protocol between the US and Indian governments – an issue that is now expected to be sorted out with the Drug Controller General of India visiting here next month for talks with the Food and Drug Administration (FDA).

Sibal made out a case for the US transferring at least those categories of biological material that do not fall in its prohibitive dual-use technology classification.

Earlier, in a crisp presentation at the US-India Business Council (USIBC), Sibal aggressively marketed India as the destination of choice in the biotech sector, an area in which it is looking for a quantum leap through a set of recently announced initiatives.

The overall cost of developing and manufacturing drugs could be brought down dramatically if only the pharmaceutical majors turn to India for inexpensive clinical trials, cheap raw materials and low-cost skilled manpower, he said.

Sibal cited the Indian successes in development of low-cost drugs. Its anti-retrovirals have brought down the cost of medicines for AIDS victims from $10,000 per annum to as low as $250. And, Hepatitis-B vaccine that used to be imported at Rs 900 per dose is now being made in India for a mere Rs 18.

The minister assured the US companies that India was in the process of setting up the regulatory bodies to remove any roadblocks for collaboration. A single window clearance mechanism has already been announced for establishing biotech parks. Also 100 per cent foreign direct investment will be allowed in specified biotech areas.

USIBC president Ron Somers spoke of a collective desire on the part of private sector from both countries to spawn collaborations, build meaningful alliances and to join with Indian life science companies as they move up the value chain.

Representatives of 35 Indian biotech companies, brought together by the Federation of Indian Chambers of Commerce and Industry (FICCI) and the Confederation of Indian Industry (CII), took part in the deliberations.

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