FDCs are medicines that combine two or more drugs in a single dose. The Union Ministry of Health and Family Welfare on Thursday issued a gazette notification, banning the manufacture, sale and distribution of these drugs based on the recommendation of an expert panel that evaluated 324 FDCs.
“The review of these FDCs began in 2019 and then the COVID-19 pandemic hit. Companies were heard and thereafter, the committee issued its report in late 2021, recommending banning 156 FDCs,” a panel member said on condition of anonymity. “This is the largest FDC ban since 2016,” he added.
Some of the most popular FDCs include a combination of mefenamic acid and acetaminophen injection used to relieve pain, fever, and swelling, and omeprazole magnesium and dicyclomine HCl used for the treatment of abdominal pain.
The move could deal a blow to drug makers, including Sun Pharmaceuticals, CiplaDr Reddy’s Laboratories (DRL), Torrent and Alkem, among others.
According to the notice, the decision was made following the recommendations of the Technical Advisory Board on Medicines (DTAB), the country’s top advisory body on drugs, and a committee of experts formed by the government. “The matter was examined by a committee of experts appointed by the central government and the DTABand both bodies recommended that it not exist Therapeutic justification for the ingredients contained in said FDCs,” the notification states.
Recently banned FDCs include the combination of ursodeoxycholic acid and metformin hydrochloride used to treat fatty liver in people with diabetes; a combination dose of povidone iodine, metronidazole, and aloe used to prevent and treat skin infections; cetirizine and phenylephrine hydrochloride; levocetirizine and phenylephrine hydrochloride; acetaminophen and pentazocine; acetaminophen and mefenamic acid; and acetaminophen, diclofenac potassium, and caffeine anhydrous.
The government said the use of such FDCs likely poses risks to humans and that safer alternatives exist.
“The DTAB did not find the claims made about these combination drugs correct and took the decision considering that the harm to the patient is greater than the benefit,” the notice said. “Therefore, in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under Section 26A of the Drugs and Cosmetics Act, 1940,” it added.
The government ban in 2016 was imposed after a report submitted by a panel led by Chandrakant Kokatevice-chancellor of KLE University in Karnataka. The committee said these FDCs posed health risks and should therefore be banned, prompting some companies to challenge the government ban in the high court.
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