New Delhi: The Union Health Ministry Friday published a gazette notification banning 14 fixed dose combination (FDC) drugs citing lack of therapeutic justification and an expert committee’s recommendation for their prohibition. A copy of the notification is with ThePrint.
FDC drugs are those which contain a combination of two or more active pharmaceutical ingredients (APIs) in a single form which is usually manufactured in a fixed ratio (the molecules in a particular ratio) and distributed.
The drugs in the latest notification are used for treating cough, common infections, fever and body ache and combinations such as Nimesulide + Paracetamol dispersible tablets, Amoxicillin + Bromhexine and Pholcodine +Promethazine.
These FDCs were part of a group of 344 drug combinations that were banned in 2016 by the government after an expert panel, constituted at the behest of the Supreme Court, declared them as “irrational” and found that they were marketed to patients without scientific data proving their efficacy and safety.
Chinu Srinivasan, an activist-entrepreneur associated with the patient rights group, All India Drug Action Network, who had filed a case against the FDCs in the apex court, explained that all drugs in India are required to secure a marketing approval from the Central Drugs Standard Control Organisation (CDSCO) before obtaining manufacturing licences from state drug administrations.
“However, in the case of FDCs, the companies secured manufacturing licences from states without getting marketing license from the CDSCO which requires them to submit a therapeutic justification for the drug,” he said to ThePrint.
While most drugs – out of the list of 344 drugs originally banned for sale and marketing in India – are now out of the market, some pharma companies contested the decision in the Delhi High Court for 15 drugs, saying that those were launched prior to 1988 when the rule mandating marketing approval by the CDSCO for every drug came into force.
“The case reached the Delhi High Court following which another committee was formed and directed to look into the matter,” Srinivasan said. The latest notification is the result of recommendation of this second committee.
(Edited by Smriti Sinha)
Also read: India considers policy on non-sugar sweeteners after WHO guidelines caution against adverse effects