New Delhi: The Central Medicine Normal Management Group (CDSCO) has allowed corporations to fabricate and market 5 mounted dose mixtures (FDCs) that have been banned final yr. The permission comes with sure circumstances, as per a discover issued by Dr Rajeev Raghuvanshi, Medicine Controller Basic of India (DCGI).
The CDSCO order, dated 11 January, learn that in 2023, the Central Licencing Authority had banned 14 FDCs out of an inventory of 19 drug cocktails that have been licenced earlier than 1988 for manufacture and sale within the nation with out requiring approval.
An knowledgeable committee headed by Dr M.S. Bhatia really useful two mounted FDCs as affordable beneath sure circumstances. For the three others, it requested for extra information, together with on security and efficacy.
The committee beneath the chairmanship of Dr Bhatia, professor and head, division of Psychiatry, College Faculty of Medical Sciences, New Delhi, examined the 19 FDCs authorised earlier than 1988 for his or her rationality.
The committee really useful for continued manufacturing and advertising of the Paracetamol 500mg plus, Phenylephrine Hydrochloride 10mg plus, caffeine anhydrous IP 32mg tablets, with the situation to generate security and efficacy information by the use of conducting Section IV medical trial inside timeframe of 1 yr. The 5 formulations are, variously, for treating widespread chilly signs, complications, despair, cough, and allergy.
The Central authorities, in June, 2023, issued notifications prohibiting manufacturing, gross sales and distribution of 14 mounted dose mixtures (FDCs) licensed previous to the yr 1988, together with cough syrups, anti allergy medication and ache aid medication with instant impact, following recommendation from an knowledgeable committee in a report submitted on April 1, 2022, that these medication could contain danger to human beings.
In response to the professor Kokate Committee’s suggestions, the Central authorities banned 344 mixtures on 10 March 2016, citing public curiosity and the potential of human danger when utilizing these FDCs within the absence of safer alternate options.
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Revealed: 17 Jan 2024, 11:01 PM IST
Supply: Live Mint