Citing risks, govt bans 156 fixed-dose combo drugs

New Delhi, August 23

The Union Government has banned 156 fixed-dose combination (FDC) medicines, including those commonly used for allergies, hair growth, acne treatment, multivitamins and anti-parasitic.

The Union Ministry of Health and Family Welfare issued a gazette notification, prohibiting the manufacture, sale and distribution of these medicines, citing health risk.

The FDC drugs contain more than one ingredient. “Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under Section 26 A of the Drugs and Cosmetics Act 1940,” the notification said.

The list bans aceclofenac 50mg + paracetamol 125mg tablets used as pain relieving medicine. The list also prohibits the combination of paracetamol, tramadol, taurine and caffeine, which is used as an opioid-based painkiller.

Official sources said the banned combinations were not approved by the Central Drugs Standard Control Organisation (CDSCO) and they involved risk to human health whereas safer alternatives were available.

“These 156 FDCs are irrational. There is no scientific rationale behind these combinations. The use of these drugs is likely to pose risk to humans,” the official said.

The list of banned FDCs include ursodeoxycholic acid and metformin HCl combination used to treat fatty liver in people with diabetes and a combination of aloe and vitamin E to make soaps to prevent skin infections. In 2013, the Parliamentary Standing Committee had requested all states to ask the manufacturers concerned to prove the safety and efficacy of FDCs within a period of 18 months, failing which such FDCs would be considered for being prohibited for manufacture and marketing.