The sixth meeting of the Union health ministry's expert panel on fixed dose combinations (FDCs) will be held on August 27 to assess safety and efficacy of several FDCs which were permitted for manufacture and sale in the country without due approval from the Drugs Controller General of India (DCGI).
The expert panels were constituted by the ministry for the massive exercise of examining and regularising the thousands of FDCs permitted for manufacture and sale in the country without due approval from the DCGI. The panel will scrutinise several FDC applications filed by different pharma companies.
The expert panels, set up by the CDSCO following the huge number of applications, running over 5000, have already examined several FDC drugs. The experts who will be examining the FDC drugs on August 27 include Dr. Krishna Biswas of Safdarjung Hospital, Delhi; Dr Nikhil Tandon of, New Delhi; Dr Anil Bansali of PGIMER, Chandigarh; Dr Neeraj Kumar Agrawal of IMS BHU, Varanasi; and Dr Shantanu Tripathi of School of Tropical Medicine, Kolkatta.
The panel will assess the efficacy and safety profile and presentations filed by these companies before taking any final decision. After the DCGI asked the industry to prove the efficacy of the FDCs permitted by the SLAs without concurrence of the DCGI, thousands of applications came to the DCGI office. The authorities then set up a committee to work out the modalities on how to examine the applications as there were not guidelines and norms in this regard.
The panel will go through the applications for several FDC products filed by pharma companies like Shield Healthcare, Safetab Life Science, Goodman Pharmaceuticals, East West Pharma, Darwin Formulations, Sun Pharma, Indus Drugs Pvt Ltd, Dr Reddy's Laboratories, Ravian Life Science, Windlas Biotech, Swiss Garnier, Glenmark Pharmaceuticals, Ordain Healthcare, Alchemist Ltd, Akums Drugs & Pharmaceuticals, USV Ltd, Acme Formulations, Inventia Healthcare, Aeon Formulations, Sunglow Pharma, Savi Pharma and GKM New Pharma.