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Biologicals Transfer Proposal between US and Indian Biotechnology

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 su
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