The Genetic Engineering Approval Committee (GEAC) under the ministry of environment and forests has accorded approval to Merck to import cetuximab (Erbitux), an anti cancer monoclonal antibody from Germany for conducting phase III clinical trials. The GEAC also accorded permission for import of r-human erythropoietin to conduct clinical trials by Clinlnvent Research Pvt. Ltd. Mumbai. Both approvals are subject to the clearance from the Drugs Controller General of India (DCGI).
The 57th meeting of GEAC which held here recently had approved six new cases to import / market / manufacture drugs for R&D (clinical trial) and marketing purposes. It also gave its stamp of 'No Objection' for revalidation of the GEAC approval in four other cases. Among the other cases that were cleared by GEAC are the applications made by Wockhardt Ltd to conduct phase III trials of r-insulin Lispro Cr-DNA origin and phase III clinical trials on r-h GCSF manufactured by Wockhardt. The company has also been permitted to import erythropoietin (EPREX- with HAS, EPREX-without HAS and Neorecormon) for test analysis and to scale up the production of r- insulin using Pichia pastoris utilising 300 L fermenter for R & D purposes.
The companies that received revalidation permission were LG Life Sciences India Pvt. Ltd and Bharat Biotech International. While LG Life Sciences got permission for import & marketing LG Euvax (r-hepatitis B vaccine), L. G. Espogen (r-human erythropoietin) and r-interferon injection (Intermax 3, 6,9, MIU), Bharat Biotech got revalidation permission for manufacture & marketing of r-hepatitis B vaccine produced from Pichia pastoris. The committee has conveyed their 'No Objection' for revalidation of the GEAC approval with an instruction to obtain information on the quantity of the drugs marketed by these companies in India as of date and during the last 3 years.