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      Entire Sector of Drugs & Pharmaceuticals freed from industrial licensing

      Posted AtPharmaBiz

      In a move meant to boost the growth of Indian biotechnology sector, union commerce ministry has notified the deletion of all items relating to drugs and pharmaceuticals from industrial license requirement. The changes would free the manufacturers of bulk drugs produced by the use of recombinant DNA technology, bulk drugs requiring in-vivo use of nucleic acids, and specific cell/tissue targeted formulations from the clutches of industrial licensing. The notification issued by the Department of Industrial Policy and Promotion states that the Item No 16 in Schedule II of the Principal notification - S.O 477 (E) which relates to drugs and pharmaceuticals and the entries related shall be omitted.

      The government had long back abolished the practice of industrial licensing for all bulk drugs cleared by Drug Controller General (India), all their intermediates and formulations. The only ones remaining in the list were bulk drugs produced by the use of recombinant DNA technology, bulk drugs requiring in-vivo use of nucleic acids as the active principles and specific cell/tissue targeted formulations.

      The abolition of industrial licensing requirement was one of the long- standing demands of Indian biotech industry. The "National Biotechnology Development Strategy" of the Central Government had also called for simplification and streamlining of regulatory procedures in biotech sector. The policy document also envisages an annual turnover of US$ 5 billion for Indian biotech sector by 2010. At present, exports account for 56% of revenue in biotech industry. The biopharma sector occupies the largest market share of 76% followed by bio-agri 8.42%, bio-services 7.70%, industrial products 5.50% and bioinformatics 2.45%. The bio-service sector registered the highest growth (100%) in 2003-2004 with bio-agri 63.64% and biopharma 38.55%.

      According to estimates of Association of Biotechnology Led Enterprises (ABLE), Indian biotechnology industry posted sales of around at Rs 47.45 billion (>US$ 1 billion) during FY2005 (this included bio supplies and hybrid seeds also). The sales of biotechnology products in FY2005 marked a growth of 36.5% over the previous year led largely by higher sales in biopharmaceuticals, they noted.

      October 19, 2005


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