The Genetic Engineering Approval Committee (GEAC) in its 70th meeting held on August 17, 2006 has approved some key proposals for import and manufacture in the area of pharmaceuticals and biotechnology.

The approvals include permission for import of Indiage MAX L from Genencor International, The Netherlands by Lumis Biotech; import and marketing of purified Rabies Vaccine for human use - vero cell, manufactured by Liaoning Cheng da Biotechnology Co Ltd. (CDBIO), China by May (India) Laboratories, Chennai; and import and conduct of Phase II clinical trials of Chimerivax- JE in children of descending age from US by Quintiles.

The Mumbai-based Lumis Biotech is focused on manufacturing, formulation and marketing of industrial Enzymes for pharma industry. CDBIO has a production capability of 15,000,000 doses of rabies vaccines for human use and a production capability of 20,000,000 doses of inactivated purified Japanese encephalitis vaccines annually.

The proposal to conduct phase II clinical trials of Chimerivax-JE in children of descending age in India was approved by the GEAC subject to the conditions that patients would be recruited in a phased manner wherein after completion of the clinical trials in children of the higher age group (5 to 10 years). The company would submit the data for consideration of the GEAC before initiating the clinical trials in the lower age group.

GEAC has also accorded permission for manufacture of indigenous recombinant-Hepatitis C viral (HCV) antigen Core, NS-3, NS-4 and NS-5 by Sudershan Biotech, Hyderabad. The company has focus on industrial enzymes, diagnostic antigens and therapeutic proteins.

Worldwide, more than 200 million people are infected by the Hepatitis C virus (HCV). At least 50 million of these patients are potential targets of liver cirrhosis or cancer. Hepatitis C is mainly transmitted from person to person through blood contact. Therefore, almost every country has made it mandatory to screen blood donors for HCV. In order to produce a diagnostic kit, three to four of HCV antigens are used. Currently the kits available in India use these antigens imported from different countries.

Sudershan Biotech is to produces all four antigens (namely the proteins - Core, NS-3, NS-4 and NS-5). A team of scientists from US and India, headed by Dr Ramareddy V Guntaka of the University of Tennesee, Memphis, USA submitted the full sequence of the prototype HCV that is prevalent in India. This was the first ever virus to be sequenced in India, which was submitted to the GeneBank on August 16, 2001, as claimed by Sudershan.