The Genetic Engineering Approval Committee (GEAC) under ministry of environment and forests has given marketing approvals for 12 biotech products in the country. While 11 of them are for human use, one is a veterinary vaccine to be manufactured and marketed by Brilliant Industries, Hyderabad. The committee has also given permission to Wockhardt Ltd to use 150 L fermentation volume for lab scale r-human insulin process development and permission to Biocon India Ltd for large scale process optimization studies of r-human insulin (for R&D purpose).
Five of the products that are to enter the market following the GEAC approval are to be imported from China. This includes, rh-G-CSF from Shandong Geneleute Bio Pharmaceutical Co, Ltd, filgrastim from Xiamen Amoytop Biotech Co Ltd, Interferon alpha 2b from Anhui Anke Biotech Co Ltd., rhu EPO from Beijing Four Rings Bio Engineering Product Factory and hurG-GSF from Hangzhou Jiuyuan Engg. Co. Ltd. The Indian companies who are to import and market these products are Kee Pharma Ltd, Ranbaxy Laboratories Ltd (two products) Glenmark Laboratories Pvt Ltd and Cadila Pharmaceuticals Ltd.
The list of marketing approvals given by the committee, which met earlier this month, is as follows:
Import and marketing of r-human granulocyte stimulating factor (rh-G-CSF) by Kee Pharma Ltd. New Delhi. The company is to import the drug from Shandong Geneleute Bio Pharmaceutical Co, Ltd, China.
Manufacturing and marketing of Food and Mouth Disease vaccine by Brilliant Industries, Hyderabad.
Import and marketing of r-human insulin by Shreya Life Sciences Pvt Ltd, Mumbai from Bioton Company Ltd, Poland.
Import and marketing filgrastim 75 ug. 150 ug. And 300 ug by Ranbaxy Laboratories Limited, New Delhi from Xiamen Amoytop Biotech Co Ltd, China.
Import and market recombinant interferon alpha 2b by Ranbaxy Laboratories Ltd, New Delhi from Anhui Anke Biotech Co Ltd, China.
Import and marketing of human insulin anlogue injection formulations ( Bio. Synthetic, r-DNA origin) Novo Nordisk India Pvt Ltd Bangalore from Novo Nordisk, Denmark.
Import and marketing of recombinant erythroprotein by Intas Phamaceuticals Ltd, Ahmedabad from Laboratorio Pablo Cascra SRL Argentina.
Import and marketing of recombinant rhu EPO by Glenmark Laboratories Pvt Ltd from Beijing FOUR Rings Bio Engineering Product Factory, China
Import of bulk insulin and manufacturing its formulations from Novo Nordisk, Denmark by Torrent Pharmaceuticals Ltd, Ahmedabad.
Import and marketing of r-human Granulocyte colony stimulating factor (hurG-CSF) by Cadila Pharmaceuticals Ltd, Ahmedabad in 3 strengths 75 ug, 150ug, 300ug, from Hangzhou Jiuyuan Gene Engg Co Ltd China
Permission for manufacturing and marketing of insulin injection from Sherya Healthcare by Cipla Ltd, Mumbai
Permission for marketing Pegasys (peginterferon alpha 2a) (INF) from Switzerland by Roche Scientific Company (India) Pvt Ltd, Mumbai.
GEAC has also cleared the application of Cadila Health Care Limited to carry out 500 its formulation.