Govt prohibits manufacture, supply, sale of 328 FDC drugs

The government on Wednesday prohibited the manufacture, sale or distribution of 328 fixed-dose combinations (FDC) drugs for human use with immediate effect, thereby settling the dust on the fate of “irrational” FDCs.

It also restricted the manufacture, sale or distribution of six other FDCs in respect to specific indications subject to certain conditions.

The expert panel probing the efficacy of 349 banned FDCs, after considering these drugs “irrational”, cited safety issues and lack of therapeutic justification and recommended continuing the ban. It also found that many FDCs were formulated without due diligence, with dosing mismatches that could result in toxicity.

An FDC is a cocktail of two or more active drug ingredients in a fixed ratio of doses. According to US healthcare provider IMS Health, almost half the drugs sold in India in 2014 were FDC, making it a world leader in combination drugs.

FDCs’ popularity in India is due to advantages such as increased efficacy, better compliance, reduced cost and simpler logistics of distribution. FDCs have shown to be particularly useful in the treatment of infectious diseases like HIV, malaria, and tuberculosis was giving multiple antimicrobial agents is the norm. FDCs are also useful for chronic conditions especially when multiple disorders co-exist.

Given that there is not much data available on drug-drug interaction and side-effects in FDC, India’s system for collecting data for problematic drug reactions is weak. When multiple drugs from the same therapeutic group, like antibiotics, are clubbed together, it may lead to resistance. A lot of FDCs sold in India are unapproved, given the lack of coordination between state and central regulators. A study published in the journal of Public Library of Science (PLOS) in May found that over 70% of non-steroidal anti-inflammatory drug (NSAID) combinations, which are used as painkillers, were being marketed in India without central government approval.

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