The ministry said the use of these FDCs is likely to pose risks to humans, although there are safer alternatives to the drug.
The government on Thursday banned 156 fixed-dose combination (FDC) drugs, including antibiotics, painkillers and multivitamins, after a review found they posed health risks.
The Union Ministry of Health and Family Welfare has issued a gazette notification, banning the manufacture, sale and distribution of these drugs.
Banned FDCs include antibiotics, anti-allergy drugs, painkillers, multivitamins, and combination doses for fever and hypertension, among others.
According to the notification, this decision was taken following recommendations from the Drugs Technical Advisory Board (DTAB) and an expert committee formed by the central government.
“The matter was examined by an expert committee appointed by the central government and the DTAB, and both the bodies recommended that there is no therapeutic justification for the ingredients contained in the said FDCs,” the notification said.
The top FDC drugs on the list include a combination of mefenamic acid and paracetamol injection, which is used to reduce pain and swelling in various conditions, and a combined dose of omeprazole magnesium and dicyclomine hydrochloride, which is used to treat abdominal pain.
Other FDCs include the combination of ursodeoxycholic acid and metformin hydrochloride used to treat fatty liver in people with diabetes, and a combination dose of povidone iodine, metronidazole, and aloe used to prevent and treat skin infections.
The ministry said the use of these FDCs is likely to pose risks to humans, although there are safer alternatives to the drug.
“The DTAB did not find the claims about these combination drugs to be correct and made the decision that the harm to the patient outweighs the benefit,” the bulletin notice said.
“Therefore, in the interest of the general public, it is necessary to prohibit the manufacture, sale or distribution of this FDC under Section 26A of the Drugs and Cosmetics Act, 1940,” the ministry added.
First published: August 22, 2024 | 15:32 IS
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