The seventh meeting of the Union health ministry's expert panel on fixed dose combinations (FDCs) will be held on September 5 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 seventh meeting was earlier scheduled to be held on August 29, which has now been postponed to September 5.

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 September 5 include Dr. Dipankar Bhattacharya of IPGMER & SSKM, Kolkatta; Dr Sudhir Gupta of Government Medical College, Nagpur; Dr Goswami of Guwahati Medical College, Guwahati; Dr Sanjeev Sachdeva of GB Pant Hospital, New Delhi; and Dr K Narayan of Madras Medical College, Chennai.


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 Vivimed Labs, Restach Pharma, Acron Pharmaceutical, Skan Research Lab, Selvok Pharmaceuticals, FDC Ltd, Livin Formulation, Espi Industries, Pharma Synth Formulations, Aboris Healthcare, Indoco Remedies, RPG Lifesciences, Elder Pharmaceuticals, etc.