The Genetic Engineering Approval Committee (GEAC) set up by the Ministry of Environment and Forests has approved USV Ltd to develop and market r-human insulin formulations in the country. The company would be sourcing bulk r-human insulin from Biocon India Ltd. The GEAC had noted that the USV application was for preparation of formulation of r-insulin from the bulk procured from Biocon. Since the r-insulin developed by Biocon has been approved for manufacture and marketing of the product in India by the GEAC and has also been cleared by the DCGI approval could be granted, the committee concluded.
The meeting also conveyed its 'no objection' for import and Marketing of Recombinant Human Growth Hormone (SAIZEN)) and Recombinant Human Follicle Stimulating Hormone (follitropin aplha) Gonal-F by Serum Institute of India Ltd.
However, the committee did not give a final view on the plea of Bharat Biotech International Ltd for permission for manufacture and marketing of r-human Epidermal Growth. The GEAC in its previous meeting had given Shantha Biotechnics Ltd. Hyderabad the permission to manufacture and marketing of Diphtheria, Tetanus and Perturisis and hepatitis- B combination vaccine (DPTH) in the country. Approval was also accorded to Intas Pharmaceuticals Ltd. Ahmedabad for manufacture and marketing of the bulk and finished formulation of r-human Erythropoietin (r-h-EPO).