Be suspicious about extra regulation. That thumb rule would certainly seem to apply to the government?s bright idea of creating a National Biotechnology Regulatory Authority (NBRA). There?s already a regulator, the Genetic Engineering Approval Committee (GEAC). GEAC, which meets every month, and is a single-window clearance system for genetically modified products. Its track record has been good so far, especially after the Supreme Court intervened to reform its functioning. GEAC in fact is an unsung regulatory success?usually anti-GM activists hog all the headlines. The committee, post-court directives, has usually passed the test of both thoroughness and speed. GEAC has approved over 150 cotton hybrids and cotton hybrids are a success story. Other GM crops are in the trial pipeline. True, GEAC?s mandate applies to genetically modified crops and organisms and these constitute just one of a possible 30 areas in biotechnology. And India?s strength in biotech is most concentrated in health applications. So a regulator for all of biotech is a good idea?but two regulators is a very bad idea. Indeed, the NBRA idea seems a ministerial turf battle. GEAC answers to the ministry of environment and forests, while the proposed NBRA will have the science & technology ministry, which has the department of biotechnology, as its master. Call it by whatever name, but have one regulator answerable to one ministry.
This clarity is crucial because India is a potential global player in biotech. Kiran Mazumdar Shaw?s Biocon is one of over 160 firms in the sector. India?s biotech firms have the chance to produce innovative as well as generic drugs and vaccines at costs far less than those apply to giant Western firms. The government recognises this and gives rebates on R&D, allows 100% foreign direct investment and offers excise and customs duty waivers on certain products. The biotech industry is $3.5 billion in size now. In two years, by 2010, it is expected to grow to $5 billion. The official ambition is to have India account for around 10% of the global biotech firms by 2015. This is possible but not if regulation is two-headed. The biotech regulator must avoid the fate of the new food safety rules, which had been caught in crossfire between the ministries of health and consumer affairs.
