The 42nd meeting of the Genetic Engineering Approval Committee (GEAC) under the Ministry of Environment and Forests has considered 15 applications from the pharmaceutical sector. While marketing approvals were accorded to eight of them, decision is pending in the case of others.
The companies who received marketing approvals are Shantha Biotechnics, Intas Pharmaceuticals, Emcure Biotech Limited, Panacea Biotech Limited, Shreya Life Sciences Pvt Limited, Hindustan Biosciences Limited and Kee Pharma Limited.
While Shantha received marketing/manufacturing permission for r-Streptokinase, Intas was given permission for conducting phase-III clinical trials on human Erythropoietin. In the case of Emcure, it was permission to import and market r-human Granulocyte colony stimulating factor rhG-CSF from Shanghai Sunway Biotech, China.
The GEAC also cleared the application of Panacea Biotech to manufacture and market r-human pentavalent vaccine and that of Shreya Life Sciences to import and market r-human Insulin from Bioton Co. Ltd, Warszawa, Poland. In the case of Hindustan Bio-sciences, it was permission for import and marketing of Recombinant Human Erythropoitein (EPOSINO) manufactured by Sandong Kexing Pharmaceuticals Co. Ltd; China to conduct phase III clinical trials. A similar approval for limited import of Interlukin-2 (rIL-II) from Beijing Four Rings Bio-Engineering Product Factory China for conducting trials were given to Kee Pharma also.
However, permission for import and marketing of r-human Erythropoietin (rhEPO) manufactured by Shenzhen SPEC- Bio- Pharmaceuticals Industry Co. Ltd. China by V.H. Bhagat Co, Mumbai was deferred as GEAC felt that the drug has not been extensively tested in the international market. Import permission for r-Human Interlukin-2 (rhuIL-2) from Laboratories Pablo Cassara Argentina by Glenmark Laboratories Pvt. Ltd was also deferred on similar grounds.
The application for a No Objection Certificate for use of enzyme from GMM (Genetically modified microorganisms) by Zytex Corp. Mumbai was deferred as GEAC felt that the company needs to carry out safety trials as per the protocol approved by the Ministry of Health.
Biocon India's application for permission to manufacture r-insulin got stuck with the GEAC finding that the company had conducted clinical trials without prior approval from the committee.
Two approvals, for the manufacture and marketing of r-Hu-G-CSF by Intas Pharmaceuticals, Ahmedabad and manufacture and marketing of r-Erythropoietin & conducting phase-III clinical trials by Shantha Biotechnics, Hyderabad, have been deferred after the committee called for RCGM recommendations in this regard.
The GEAC also deferred from a discussion on the application filed by Biological E Ltd for a permission to manufacture and market r- Hepatitis B Vaccine. The matter is to be considered in the next meeting.