Civil

Why drugs are being taken off pharmacy shelves

21.03.2016

Headlines in recent days and weeks have reported hundreds, even thousands of drugs being banned from sale in India. Pharmacists are warning of shortages, a kinder way of saying rising prices, while also informing the Drug Controller General of India of the heightening probability of closure of shops, a.k.a., a strike. But why the sudden onset hostility towards certain medicines?

The banning of drugs may seem to have sprung out of the blue but there is method in the pharmacophobia. Circa June of 2013, the Directorate General of Health Services, under the auspices of the Ministry of Health and Family Welfare, released a report, ‘Policy Guidelines for Approval of Fixed Dose Combinations (FDCs) in India’. Prepared under the aegis of Professor C.K. Kokate, the Report considered the prevalence of ‘Fixed Dose Combination’, drugs comprising two or more active ingredients in a fixed ratio. The rationale behind FDCs is simple: two or more ‘actives’ that complement each other or provide the benefit of two products in one swallowing. But, to ensure FDCs’ benefits outweighing their risks, the Report called for called such preparations being based on “convincing therapeutic rationalization and be carefully justified and clinically relevant.” Categories of FDCs were penned and the onus was on manufacturers to show the rationale behind having two or more active ingredients in one preparation.

The Report birthed the ‘Kokate Committee’: tasked with the implementation of recommendations in the report, the Committee has spent over one year perusing thousands of drugs. As of January 2015, the Committee had found only 42.07 per cent of FDCs submitted for perusal as rational, and over 30 per cent as requiring further data or deliberation.

Tags : Ministry of health fixed dose combinations rationale

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