Irrational FDCs will soon be ruled out from market

As a part of government’s intent to efficiently supply medicines for patient safety at large, irrational fixed dose combinations (FDCs) will soon be ruled out from the healthcare system. The latest findings which are currently under review however have revealed that some of the FDCs may be weeded out as irrational medicines. Some of the combinations are in the final stages of consideration and review taking the patient safety into account. The clarity on the same will be out in a few months time complemented with a rigid drug regulatory regime. The manufacturers are supposed to give their responses on the same in a stipulated time period of 90 days based on a recent request to the DCGI office. The State Licensing Authorities (SLAs) had given permission to manufacture and market FDCs, whose ingredients were already usually in use and being prescribed regularly by the medical practitioners  – may be even for 20 to 30 years, or more. The DCGI, as directed by the health ministry under 33-P had called for submitting efficacy and safety data for all combination SLA-approved products prior to October 1, 2012. Further the Central Drugs Standard Control Organization (CDSCO) stipulated that such applications must be made in Form 44, as there was no format specifically available for applications of SLA-approved and already marketed FDCs. The DCGI had earlier agreed to allow all pre-1988 FDCs to be licensed by SLAs provided proof of pre-1988 license is submitted. FDCs of vitamins, minerals, other nutrients; probiotics/ prebiotics/ synbiotics,antacids/enzyme formulations, cough and cold permutation combination products, topicals, and such simple FDCs should be cleared as rational in view of these being unlikely to have any concern with respect to safety concerns and being used on day-to-day basis as household products.Today, FDCs contribute 40 per cent of the Indian pharmaceutical market and in case these FDCs are discontinued abruptly, the Indian patients will be deprived of these affordable medicines and the manufacturers, retailers etc. i.e. the distribution chain, will be left with depleted stocks resulting in substantial loss, especially to the small scale sector. India is the world leader in FDCs and today, even regulated markets are seeing introduction of more combination products progressively.


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