Cheston cold, Candibiotic, other painkillers among 324 cocktail drugs that could be banned

Commonly-sold cold and flu medicine such as Cheston Cold, ear drops Candibiotic and painkiller Etogesic among list, pharma industry wants those who prescribe FDC to judge efficacy.

Medicines | Representational image | ThePrint

New Delhi: Commonly-sold cold and flu medicine Cheston Cold, ear drops Candibiotic and the painkiller Etogesic are among 324 drugs under the scanner as the government looks to weed out ‘irrational’ cocktail drugs.

The government has given companies a chance to convince the expert panel about the rationale behind these fixed-dose combinations (FDC) as they face the possibility of a ban.

FDC, or cocktail medicines, combine more than one drug in a single pill, and have increasingly come under the government lens since such combinations of drugs, such as antibiotics, can result in the disease-causing organism to develop resistance to the drug.

The apex drug regulator of India, Central Drugs Standard Control Organisation (CDSCO) has formed a subcommittee under the Drug Technical Advisory Board (DTAB), to be chaired by Nilima Kshirsagar, former chair in clinical pharmacology, Indian Council of Medical Research (ICMR), to examine these FDCs.

A 2015 panel headed by the Kokate Committee had earlier considered the listed medicines as “irrational”.

In a series of meetings, scheduled for 19 days between 19 April and 7 May, the sub-committee will weigh in on the efficacy of some of the cocktail drugs being sold in India by brands including top pharma companies like Cipla, Glenmark and Zydus Cadila.

Companies marketing the listed drugs have been invited for a discussion on a virtual platform, to “present additional new information”, according to a notice issued by the CDSCO on 23 March, which has been sent to the pharmaceutical companies concerned.

“In the event that the applicant does not attend the hearing, the sub-committee reserves the right to make its decision on the basis of information available before it,” the notice stated.

The FDC issue  

Cocktail drugs have been under the scanner because a previously lax regulatory framework allowed several unscientific combinations to flood the market and there are fears that this may increase drug resistance in people.

The government, in 2016, had started a drive to filter out many of these FDCs from the Indian pharmaceutical industry by banning around 350 of them, impacting over 2,700 branded drugs.

The latest list of 324 formulations combines several categories of medicines, including those for cough and cold, anti-allergens, painkillers, oral management medicines and orthopaedic drugs in the form of tablets, syrups, capsules, injections and drops. Manufacturers include top pharma companies like Glenmark, Zydus Cadila, Cipla, Unichem Laboratories, Blue Cross Laboratories, and Alkem apart from others.

Fear of ban looms

The DTAB, in 2018, had evaluated the safety and efficacy of an initial lot of 349 listed FDCs. Barring six, all others had been banned. The pharmaceuticals industry is now apprehensive of the same fate befalling the majority of the FDCs on the latest list.

A spokesperson for Glenmark said they were “studying the list and exploring options” and couldn’t comment at this stage. Dr R.K. Sanghavi, chairman of the medical committee, Indian Drug Manufacturers’ Association, the lobby of Indian drug-makers, said, “Though these FDCs have been approved by the state-licensing authorities (SLAs), their efficacy will again be deliberated between stakeholders and a committee like the last time. However, if the line of assessment follows the same pattern as before, we fear, most of these 324 FDCs will also be banned.”

The industry representative is of the opinion that practicing doctors who prescribe such combination drugs should evaluate their efficacy. Sanghavi also cited the example of the Candibiotic Ear Drop, one of the listed FDCs, and notes that the composition is approved by 22 countries across the world.

According to another industry veteran, representing another drug-makers’ lobby, said the experts were self-contradicting themselves, and noted how the panel till last year wasn’t convinced of the suitability of adding zinc to cold and flu medicines, though they are now propagating its usage.

“Now the very same experts are advocating zinc for coronaviruses,” the industry expert said.

(Edited by Poulomi Banerjee)