Regulating biotech

The task force for a national biotechnology policy, headed by M S Swaminathan, has done well to suggest the creation of an apex body that will put an end to today's multiplicity of regulatory bodies.

The problem has its roots in the very nature of biotechnology. It straddles two disciplines, agriculture and pharmaceuticals. So you need not just an apex regulatory body but a hierarchy of regulators to take care of diverse aspects, and then a clear reporting line to a ministry.

Getting this right is important as biotechnology is one of the two areas, along with information technology, in which India is competitive because of high skill levels. But progress in one has far outstripped that in the other, partly because of the regulatory overload.

Biotechnology has to be carefully regulated as medicines and genetically modified agricultural products have to be screened before use. It takes inordinately long to get a GMO approved in India for commercial propagation (Bt cotton took four years to clear), compared to the speedy clearance available in (say) China.

As a result the Chinese economy has benefited from growing GM crops, whereas India has not. It is logical that a complex decision with serious long-term implications should take time but sterile bureaucratic processes should not be the reason.

The task force has pointed out that currently an additional secretary, in his ex officio capacity, heads the apex body, the genetic engineering approval committee, and six people have held the position in the last two years.

Hence the recommendation that an expert head the present body as an interim measure while a new apex body is created. This latter should confine itself to clearing things from the environmental and bio-safety angles. The Indian Council for Agricultural Research should clear specific transgenic crops. Correspondingly, bio-pharma products should be cleared by the drug controller general.

The one recommendation of the task force which is dubious is the one that has hit the headlines, namely that an additional Rs 1,200 crore should be spent by the government in the remaining three years of the current five-year plan period to create the institutional mechanism, going down to the district level, for developing, approving and monitoring biotechnology.

This sounds like a boondoggle. Considerable public investment has already been made in biotech research in the last 20 years, and the emphasis now should be on taking technology to the market.

Instead of jacking up government spending in the old fashioned way, it will be better to make more money available for and through venture capital funding, also recommended by the task force. This could even be done in public-private partnership, as in Israel.