FDCs are medicines that combine two or more drugs into a single dosage. The union health and family welfare ministry on Thursday issued a gazette notification, prohibiting manufacture, sale and distribution of these medicines based on the recommendation of an expert panel that evaluated 324 FDCs.
“The review of these FDCs started in 2019 and then Covid happened. The companies were heard and, thereafter, the committee gave its report at the end of 2021, recommending banning 156 FDCs,” a member of the panel said on condition of anonymity. “This is the largest FDC ban since 2016,” he added.
Some of the popular FDCs include a combination of mefenamic acid and paracetamol injection used for pain relief, fever and swelling, and omeprazole magnesium and dicyclomine HCl used for treatment of abdominal pain.
The move could deal a blow to drugmakers including Sun Pharmaceuticals, Cipla, Dr Reddy’s Laboratories (DRL), Torrent and Alkem, among others.
According to the notification, the decision was taken following the recommendations of the Drug Technical Advisory Board (DTAB), the country’s highest advisory body on drugs, and an expert committee formed by the government. “The matter was examined by an expert committee appointed by the central government and the DTAB, with both bodies recommending that there is no therapeutic justification for the ingredients contained in the said FDCs,” the notification said.
The newly banned FDCs include ursodeoxycholic acid and metformin HCl combination 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; paracetamol and pentazocine; paracetamol and mefenamic acid; and paracetamol, diclofenac potassium and caffeine anhydrous.
The government stated that the use of the said FDCs is likely to involve risk to human beings and that safer alternatives to them are available.
“The DTAB did not find the claims of these combination medicines correct and took the decision considering that the harm to the patient is more than the benefit,” the notification said. “Hence, in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under Section 26A of Drugs and Cosmetics Act 1940,” it added.
The government’s ban in 2016 was imposed after a report submitted by a panel led by Chandrakant Kokate, vice-chancellor of KLE University in Karnataka. The committee said these FDCs posed health risks and hence be banned, prompting some companies to challenge the government’s ban in the high court.
