Continuing its massive exercise to examine and regularise the 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), the expert panel will meet on April 23 and scrutinise over 50 FDC applications filed by the companies.

The expert panel had been set up by the CDSCO following the huge number of applications, running over 5000, and it held one meeting already. This will be the second meeting of the panel which consists of experts like Dr Santanu Tripathi, Dr Surendra K Sharma, Dr Rajender Prasad, Dr A U Athavale and Dr Usha Acharya.

The panel will go through the applications for the FDC products by Restech Pharma, Naxpar Pharma, I DM Pharma, Sun Pharmaceuticals, BRD Medilabs, Tee &TEE Healthcare, Rivpra Formulations, Arion Healthcare, Akums Drugs and Pharmaceuticals, Noel Pharma, Unix Biotech, Cipla, Logos Pharma, Suncare Formulations, Ravian Lifescience, Wallace Pharmaceuticals, Swiss Garnier, Aeon Formulations, Phoenix Biologials, Psychotropics India, RPG Lifescience, Pro Laboratories, Acme Lifesciences, CIAN Healthcare, Micro Labs, AGIO Pharmaceuticals, Alembic Pharmaceuticals, Kaizen Pharmaceuticals, Sain Medicaments, Gen Pharma, Shiva Biogenetic Pharmaceutica, Symbiotic Drugs and Diabetic, Healer’s Lab, GKM New Pharma, Sozin Flora Pharma, Safetab Life Sciences, MDC Pharmaceuticals, and Agron Remedies.

The panel will assess the efficacy and safety profile and presentations by the companies to decide on as many as 53 FDCs at the meeting. These include eight product applications submitted by Akum Drugs and Pharmaceuticals alone.

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 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 expert panel, at its first meeting, gave clearance to some, cancelled a few others and gave three months time to some companies to come up with additional scientific data and other proofs to prove the safety and efficacy of the FDCs.