Source: The mint
New Delhi: The Central Drugs Standard Control Organization (CDSCO) has allowed companies to manufacture and market five fixed dose combinations (FDCs) that were banned last year. The permission comes with certain conditions, as per a notice issued by Dr Rajeev Raghuvanshi, Drugs Controller General of India (DCGI).
An expert committee headed by Dr M.S. Bhatia recommended two fixed FDCs as reasonable under certain conditions. For the three others, it asked for more data, including on safety and efficacy.
The committee under the chairmanship of Dr Bhatia, professor and head, department of Psychiatry, University College of Medical Sciences, New Delhi, examined the 19 FDCs approved before 1988 for their rationality.
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The committee recommended for continued manufacturing and marketing of the Paracetamol 500mg plus, Phenylephrine Hydrochloride 10mg plus, caffeine anhydrous IP 32mg tablets, with the condition to generate safety and efficacy data by way of conducting Phase IV clinical trial within time frame of one year. The five formulations are, variously, for treating common cold symptoms, headaches, depression, cough, and allergy.
The Central government, in June, 2023, issued notifications prohibiting manufacturing, sales and distribution of 14 fixed dose combinations (FDCs) licensed prior to the year 1988, including cough syrups, anti allergy drugs and pain relief drugs with immediate effect, following advice from an expert committee in a report submitted on April 1, 2022, that these drugs may involve risk to human beings.
According to the professor Kokate Committee’s recommendations, the Central government banned 344 combinations on 10 March 2016, citing public interest and the possibility of human risk when using these FDCs in the absence of safer alternatives.
