The Review Committee on Genetic Manipulation (RCGM) has approved applications filed for 21 r-DNA pharmaceutical products by 13 Indian bio-pharma and pharma companies for conduct of pre-clinical toxicity studies and recommendations to conduct human clinical trials, during the last fiscal.
Shantha Biotechnics (Hyderabad) got the approval to conduct studies on DTPwHIB pentavalent combination vaccine. Emcure Biotech (Pune), Serum Institute of India (Pune) and Cadila Healthcare (Ahmedabad) were approved to conduct studies on rh-Erythropoietin.
Serum Institute has been approved to conduct studies on rh-PEG Eryhtropoietin, while Bharat Serum & Vaccines (Mumbai) is approved to conduct studies on rh-FSH. Cadila Healthcare, Biocon India (Bangalore) and Serum Institute have got the approval for rh-G-CSF.
Serum and INTAS Pharma (Ahmedabad) can conduct studies on rh-G-CSF (pegylated). Wockhardt (Aurangabad) has the approval for studies on rh-G-CSF (pegylated menthionyl). Emcure Biotech has been approved to conduct studies on rh-GM-CSF.
Application for conducting studies on rh-Growth Hormone by Zenotech Labs (Hyderabad) has been approved. Serum Institute has got the approval for rh-interferon alpha 2a and rh-interferon alpha 2a (pegylated). Studies on rh-interferon alpha 2b has been approved to Emcure, Relaince Life Sciences (Mumbai) and Serum.
Serum Institute, INTAS Pharma, Wockhardt and Virchow Biotech (Hyderabad) have been approved to conduct studies on rh-Interferon alpha 2b (pegylated). Cadila has been approved to carry out studies on rh-Interferon gamma 1b and rh-Interlukin 2 (IL-2).
Wockhardt has been approved to conduct studies on rh-Insulin Glargine and rh-Insulin Lispro and Insulin Lispro Mix. Biocon has got the approval to carry studies on rh-oral Insulin (IN-105). Zenotech and Dr Reddy's Laboratories (Hyderabad) have got the approval for conduct of studies on Rituximab (monoclonal antibody). Shasun Chemicals & Drugs (Chennai), Biocon and Virchow Biotech have been approved to conduct studies on r-Streptokinase, while Emcure Biotech has obtained the approval to carry studies on r-TNK-TPA.
It may be noted, the recommendations and procedures outlined by the Task Force on r-Pharma under the chairmanship of Dr RA Mashelkar, DG-CSIR was enforced with effect from April 1, 2006. Timelines for decisions by the regulatory committees / competent authorities has also been framed. RCGM approval for pre-clinical animal studies will take 45 days, DCGI approval for Human Clinical Trials protocol will take 45 days, DCGI examination of clinical trial data and response will take 90 days and DCGI and GEAC decisions (simultaneous) will take place within 45 days.