New biotech policy to ease regulation

The government's biotechnology policy, expected to be released next month, will simplify the regulatory process for the sector. The government is looking at reducing clearance time for products.

While low-risk products will have a two-step clearance process, those in the high-risk segment will invite more stringent criteria.

"There is a proposal for a single-window regulatory authority in the long run but as of the now, the government will go in for simplification of the existing mechanism," M K Bhan, secretary, Department of Biotechnology, said on the sidelines of the 2nd International Conference on Biotechnology today.

The policy will also take into account the recommendations of the Mashelkar and Swaminathan Committee.

Under the new policy, the government will also be looking at increasing public-private partnership to support innovations by medium enterprises. "The policy will look at easy funding for such ventures, besides setting up more biotechnology parks," he added.

India has three biotechnology parks at present and the government is looking at setting up a total of 30 in a few years. The government has also planned two molecular medicine research institutes based on such partnerships.

The policy will also look at promoting medical school research. "We have moved into the research institute system at the expense of the university system. This needs to be rectified," Bhan said.

The government will step in at an early stage of innovative research where most venture capitals do not move in because of the high risk involved.

The government is also looking at giving an impetus to stem cell research, Bhan said. "This research requires a lot of networking between the scientist and the physiciann and the government will try to support this area by providing a platform for networking," the secretary said.

The Indian biotechology industry was worth Rs 32.6 billion in 2003-04 and accounted for 1.5 per cent of the $46 billion global biotechnology sector during the period. Of this, bioservices, including contract research, was worth Rs 2.75 billion in 2003-04.

Cell policy

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• Low-risk products will have a two-step clearance process. The high risk segment, however will invite more stringent criteria
• More public-private partnership to support innovations
• India plans to set up 30 biotechnology parks in a few years. There are only three parks currently
• The policy will seek to give an impetus to stem cell research
• The government will seek to promote medical school research