34 more fixed-dose combination under scanner, says CDSCO official

The move to ban 156 fixed-dose combination (FDC) drugs came after they were found to be irrational, providing no additional scientific advance over available therapies by a subcommittee of the Drug Technical Advisory Board (DTAB), a senior official in the Central Drug Standard Control Organisation (CDSCO) said on Friday. Following recommendations of the Kokate Committee, the regulator has so far banned 499 FDCs in tranches; 34 more are under review.

FDCs are drugs 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 now, the brands likely to be affected by the ban include those marketed by several pharma giants such as Sun Pharmaceuticals, Cipla, Dr Reddy’s Labs (DRL), Emcure, Alkem, and Torrent, among others.

 

The list of FDCs banned includes antibiotics, anti-allergics, painkillers, multivitamins, and combination doses for fever and hypertension, among others.

Prominent ones include a combination of Mefenamic Acid and Paracetamol Injection, which is used to reduce pain and swelling in various conditions, and a combination dose of Omeprazole Magnesium and Dicyclomine HCl, which is used to treat abdominal pain.

Prominent brands with Omeprazole Magnesium and Dicyclomine HCl combination include Mankind Pharma’s Ranispas and Xenspas from Zoic Lifesciences.

Other FDCs include the Ursodeoxycholic Acid and Metformin HCl combination 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 for the Ursodeoxycholic Acid and Metformin HCl FDC include Hepexa M tablets manufactured by Eris Lifesciences, whereas Makdin AM ointment from Maksun Biotech and Medcure Pharma’s Poviol M ointment are commonly available examples of a combination dose of Povidone Iodine, Metronidazole, and Aloe.

In a gazette notification released on Thursday, the government said that it feels that these FDCs are likely to involve risks to human beings, whereas safer alternatives to the said drug are available.

According to experts, FDCs became a contentious issue from a safety and regulatory point of view after a parliamentary standing committee report in 2012 observed that some state licensing authorities had issued manufacturing licences for several FDCs without prior clearance from the CDSCO.

“This led to the market being flooded by FDCs that could potentially put patients at risk, as these were not tested for safety and efficacy,” an expert said.

A senior figure from the CDSCO 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 C K Kokate, a senior pharmacologist, to examine FDCs on the basis of their scientific rationale. A senior official at CDSCO said that the Kokate Committee evaluated 3,450 FDCs.

“Based on its recommendations, the government has banned 499 FDCs in three tranches till now. There are around 34 more FDCs which are being reviewed,” 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.