THE Genetic Engineering Approval Committee (GEAC) has cleared the applications of four Hyderabad-based biotech companies, among others, for conducting phase III clinical trials of r-DNA drugs. The companies are Bharat Biotech International Limited, Indian Immunologicals Limited, Zenotech and Shantha Biotechnics.

With the GEAC clearance, Bharat Biotech can now conduct phase III clinical trials Of R-human Epidermal growth factor and r-human Insulin. Permission to Zenotech came for clinical trials of r-human G-CSF and r-human GM-CSF. Shantha has also been allowed to conduct phase III clinical trails using r-human G-CSF. The other application from Shantha that has been cleared is for a DTPw a trivalent vaccine to make a combination of DTPw with r-Hepatitis B. The request was to conduct Phase -III clinical trials of the combination vaccine (DTPw + r-Hepatitis B vaccine). The permission accorded to Indian Immunologicals Ltd is for conducting trails of r-human Hepatitis vaccine. All these drugs were indigenously developed by the companies.

The GEAC gave ex post facto approval for conducting phase III clinical trials and permission for manufacture and marketing of r-Hu-G-CSF to Intas Pharmaceuticals Ahmedabad. Ex post facto approval for phase III clinical trials for r-Erythropoetin was given to Shantha Biotech also. The other company that received GEAC ex post facto approval for conducting phase III clinical trials and permission for manufacture and marketing of r-Insulin was Biocon India Ltd. Bangalore.

The committee also revalidated its approval given for import and marketing of Somatropin Injection (r-DNA) by Eli Lilly (India) Pvt. Ltd. Gurgaon. New Delhi-based Kee Pharma was the other company whose applications were considered by the committee in its recent meeting. GEAC gave approval to Kee Pharma for "limited import" for r-human interferon from Tianjin Hualida Biotechnology Co. Ltd. China. However, it rejected Kee Pharma's request for waiver of Phase-III clinical trials of r-interlukin.