An agreement in principle to enable the smooth transfer of microorganisms and biological materials from the US to India is an encouraging sign for Indian bioscience. But slow implementation of the country's broader biotech goals, including India's grandiose scheme to become the global hub of contract research and clinical trials, may threaten its goal of becoming a major player.
Discussions in mid-June between acting US deputy secretary of commerce David A. Sampson and an Indian delegation led by science minister Kapil Sibal led to the biologics transfer proposal. Under the plan, India's Department of Biotechnology (DBT) would procure biological material from the American Type Tissue Collection (ATCC) and warrant against their misuse or subsequent acquisition by bioterrorists, with safeguards and export controls similar to those around nuclear technology. We are in the process of resolving this important issue. Although ATCC says its regulations for export and distribution of infectious agents did not change after 9/11 and that Indian Scientists have full access to the public database, researchers claim problems working with the US based repository. "ATCC is usually prompt, but if you ask for a type strain or a reference strain, they do not even respond,: says a senior scientists at the Institute for Microbial Technology in Chandigarh, which operates the Microbial Type Culture Collection, MTCC, India's only such culture collection.
Industry scientists admit that they cannot document the source of many for the basic tools for making vaccines and drugs, a potential basis for challenging bioenergetics patents. One solution, says FICCI is to create a global bank that will compulsorily collect patent protected biological materials an offer these to industries at a nominal cost, clearly establishing ownership. Government reluctance to grant exclusivity of clinical trial data may also scare away companies, analysts say. And even if implemented successfully, the $2.5 billion per year business model ironically built on high disease prevalence and a billion plus, genetically diverse and economically weak population has it critics.
Samit Brahmachari, director of the Institute of Genomics and Integrative biology in New Delhi, India could create a substantial fund for buying intellectual property rights from small and medium enterprises around the world and turn them into higher value products in collaboration with MNCs. Visalakshi's study of 229 Indian biotech companies concludes that 20 years after setting up DBT, India still has no clear definition of biotech. "Everything from fermentation to aquaculture and sericulture to bio fertilizer is clubbed under biotech, resulting in sub critical funding," India needs 'to set priorities in the R&D work program," it says, and should urgently address problem arising out of a large number of agencies dealing with biotech which has led to duplication of research funding and a lack of coordination.
Source: Nature Biotechnology.