The Centre’s ban on 14 fixed-dose-combination (FDC) drugs is being accepted across pharmaceutical and civil society lines, as it comes after a long drawn battle to clear the market off “irrational and unscientific” medicines.

An FDC involves a combination of two or more medicines in a single product with fixed dosages. But the Centre’s latest move is unlikely to impact consumers, as this deliberation has been underway for about 15 years now, through multiple litigation and expert committees, industry voices told businessline. Companies have since moved to alternate formulations, they add, since the government’s overall direction was clear through the years.

Late last week, the Centre banned 14 FDCs from manufacture and distribution, harking back to an expert committee finding that they had “no therapeutic justification” and may in fact “involve risk to human beings”. The FDCs included those used to treat fever and infections. They included nimesulide+paracetamol dispersible tablets; Amoxicillin+bromhexine; Chlopheniramine maleate + Codine syrup, to name just a few combinations. And representatives with domestic and multinational companies said off record that the government’s latest directive was along expected lines and they had shifted to alternative products.


Explaining the backdrop to the latest directive, an All India Drug Action Network (AIDAN) statement said: “The Supreme Court, as part of its December 2017 order, had also agreed on the request of some companies, that the March 2016 ban on 344 + 5 FDCs will not apply to 15 FDCs approved before Sept 1988.”

The third expert committee also affirmed “that 12 of the 15 pre-1988 FDCs were fit for ban”, the note said, and this was the basis of the total on 14 FDCs.  

S Srinivasan, Aidan co-convenor and with Locost (a maker of essential drugs), was among the early interveners supporting the government ban.  “These FDCs are irrational and unscientific, the expert committees have said clearly. Most of the affected manufacturers were not able to prove the therapeutic rationale, safety and efficacy of their FDCs,” he said.

The Aidan statement said: “It also shows that our regulators can undo wrong decisions of the past, if they put their heart to it. In this case the push came from the plain talking 59th Report of the Parliamentary Standing Committee on the functioning of the Central Drugs Standard Control Organization (CDSCO).”