The decision to ban 156 fixed-dose combination (FDC) drugs was taken after a sub-committee of the Drugs Technical Advisory Board (DTAB) found that they were irrational and did not provide any additional scientific advancement over available therapies, a senior official of the Central Drugs Standard Control Organisation (CDSCO) said on Friday. Following the recommendations of the Kokate Committee, the regulator has so far banned 499 FDCs in tranches; 34 more are under review.
FDCs are medicines that contain a combination of two or more active pharmaceutical ingredients (APIs) in a single form, usually manufactured and distributed in a fixed ratio.
While there is no data available on the market impact as of yet, brands likely to be affected by the ban include those marketed by several pharmaceutical giants such as Sun Pharmaceuticals, Cipla, Dr Reddy’s Labs (DRL), Emcure, Alkem and Torrent, among others.
The list of banned FDCs includes antibiotics, anti-allergy drugs, painkillers, multivitamins and combination doses for fever and hypertension, among others.
Notable ones 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.
Notable brands using the combination of Omeprazole Magnesium and Dicyclomine HCl include Ranispas from Mankind Pharma and Xenspas from Zoic Lifesciences.
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.
Prominent brands of ursodeoxycholic acid and metformin hydrochloride FDC include Hepexa M tablets manufactured by Eris Lifesciences, while Makdin AM ointment by Maksun Biotech and Poviol M ointment by Medcure Pharma are commonly available examples of a combined dose of povidone iodine, metronidazole, and aloe.
In a notice published in the official gazette on Thursday, the government said it considers that these FDCs are likely to pose risks to humans, while there are safer alternatives to the drug.
According to experts, FDCs became a contentious issue from a safety and regulatory perspective after a parliamentary standing committee report in 2012 observed that some state licensing authorities had issued manufacturing licenses for several FDCs without prior clearance from the CDSCO.
“This led to the market being flooded with FDCs that could put patients at risk, as their safety and efficacy had not been proven,” said one expert.
A senior CDSCO figure added that many of these FDCs may even have been available in the market for the last 15 to 20 years.
The standing committee report led to the formation of a committee chaired by CK Kokate, a senior pharmacologist, to examine the FDCs on the basis of their scientific rationale. A senior CDSCO official said the Kokate Committee evaluated 3,450 FDCs.
“Following their recommendations, the government has so far banned 499 FDCs in three stages. There are around 34 more FDCs that are under review,” the official added.
After these 34, the government expects that only those FDCs that are approved by the CDSCO will remain available in the market.
First published: August 23, 2024 | 19:50 IS
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