Review Committee on Genetic Manipulation (RCGM), which took up a total of 650 applications during the nine meetings so far, has cleared as many as 15 r-DNA products in the pharmaceutical sector for conducting pre-clinical toxicity studies.
The recombinant products approved were from 11 institutions and companies both from the public and private sector, according to official sources. Based on the pre-clinical study reports, the RCGM has also recommended eight products from six private companies and institutions to DCGI during the last one year.
Mumbai-based Reliance Life Sciences got approval for five products. Recombinant human growth hormone (rhGH), recombinant human chorionic gonadotrophin hormone (rhCG), rituximab-monoclonal antibody, recombinant chimeric monoclonal antibody Abciximab and recombinant palivizumab were the products cleared for pre-clinical studies by Reliance.
Indian Immunological Ltd of Hyderabad got approval for its recombinant tick vaccine antigen and recombinant epsilon toxoid. Biocon India of Bangalore won approval for four products -- recombinant pegylated G-CSF, Bmab 200 (trastuzumab) monoclonal antibody, putatively targeting epidermal growth factor receptor (EGFR) and Bmab 100 monoclonal antibody putatively targeting vascular endothelial growth factor (VEGF), sources said.
Bharat Serums and Vaccines Ltd of Mumbai (recombinant human chorionic gonadotropin), USV Ltd, Mumbai (filgrastim injection ), ICGEB, New Delhi (malaria vaccine formulations), SciGen Bio Pharma Ltd of Pune (recombinant human insulin API), Bharat Biotech International of Hyderabad (recombinant parathyroid hormone), Lupin Ltd of Mumbai (recombinant human granulocyte colony stimulating factor), Panacea Biotec Ltd, Delhi (recombinant anthrax vaccine), and Shasun Chemicals and Drugs Ltd, Chennai (recombinant granulocyte colony stimulating factor) were among other companies who got clearance.
Recombinant human follicle stimulating hormone (rFSH) and recombinant human interferon gamm-1b of Reliance Life Sciences, recombinant human parathyroid hormone of Intas Biopharmaceuticals of Ahmedabad, combination malaria vaccine from ICGEB, recombinant Darbepoetin-alpha by Avesthagen of Bangalore and recombinant Etanercept of Zenotech Laboratories from Hyderabad were among those recommended by the RCGM to the DCGI for further clearance of clinical trials, sources added.