Expert panel on FDC to assess safety and efficacy of several FDCs on August 22 Ramesh Shankar, Mumbai Thursday, August 14, 2014, 08:00 Hrs [IST]

The Union health ministry's expert panel, constituted for the massive exercise of examining and regularising thousands of fixed dose combinations (FDCs) permitted for manufacture and sale in the country without due approval from the Drugs Controller General of India (DCGI), will hold its fifth meeting on August 22 to 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 held four meetings and examined several FDC drugs. T he experts who will be examining the FDC drugs on August 22 included Dr. YK Gupta of AIIMS New Delhi, Dr Shashank Parulekar of KEM Hospital Mumbai, Dr Lakhbir Dhaliwal of PGIMER Chandigarh, Dr SN Bhattacharya of UCMS New Delhi and Dr Asit Mittal of RNT Medical College Udaipur. 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 Laurochem Labs, Rexcin Pharmaceuticals, Universal Twin Labs, Psychotropics India Ltd, Yash Medicare, Psychotropics India, East West Pharma, Gelnova Laboratories, Sun Pharmaceutical Industries, Akums Drugs and Pharmaceuticals. Zuventus Healthcare, Glenmark Pharmaceuticals, Synokem Pharmaceuticals, Mepromax, Creatve Healthcare, Helios Pharmaceuticals, Curetech Skincare, Syncom Healthcare, etc. http://www.pharmabiz.com/NewsDetails.aspx?aid=83543&sid=1