The Union Health Ministry has banned 80 fixed-dose combination drugs, including antibiotics, painkillers and several medicines used to treat fungal and bacterial infections, hypertension and anxiety. Fixed-dose combination drugs, or FDCs, are medicines that combine two or more drugs and are marketed by pharmaceutical companies to circumvent the government’s price control orders.
These 80 drugs are part of a list of 294 drugs that were first banned in November 2007 as they were licensed without the approval of the Drugs Controller General of India. Drug manufacturers challenged the ban in the Madras High Court and managed to get a stay on proceedings. The Drug Technical Advisory Board then constituted a sub-committee to examine the rationality and safety of the drugs. The sub-commitee has found that there is no therapeutic justification for these 80 drugs, and based on its recommendation, the health ministry – in a notification dated January 11 – prohibited the manufacture, sale and distribution of these drugs.
In March 2016, the health ministry had banned 349 other FDCs. The pharmaceutical industry challenged the move in the Delhi High Court and got the ban overturned. The Centre appealed against the Delhi High Court decision in the Supreme Court, which asked the Drug Technical Advisory Board to reexamine the drugs. The board found that there was no therapeutic justification for 328 of the 349 FDCs.
In September 2018, the health ministry banned the manufacture, sale and distribution of these 328 FDCs and placed certain conditions on for the sale of six others. A few days later, the Supreme Court allowed the sale of three of the 328 banned drugs. Drug manufacturers continue to challenge in court the ban on many of these drugs.