The Union government has prohibited 14 fixed-dose combinations (FDC) medicines that lack therapeutic relevance. This ban was implemented through a Gazette notification issued on Saturday, 3 June.
The banned FDC medicines include those used for cough, fever and infections, which are commonly sold over the counter.
The Central Drugs Standard Control Organisation (CDSCO) defines FDC drugs as medications that contain a combination of two or more active pharmaceutical ingredients (APIs) in a single form.
Typically, these medicines are manufactured with a fixed ratio of the components with the molecules distributed accordingly.
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The banned FDCs
- Nimesulide + Paracetamol Dispersible
- Amoxicillin + Bromhexine
- Pholcodine + Promethazine
- Chlorpheniramine Maleate + Dextromethorphan + Guaiphenesin + Ammonium Chloride + Menthol
- Chlorpheniramine Maleate + Codeine Syrup
- Ammonium Chloride + Bromhexine + Dextromethorphan
- Bromhexine + Dextromethorphan + Ammonium Chloride + Menthol
- Dextromethorphan + Chlorpheniramine + Guaiphenesin + Ammonium Chloride
- Paracetamol + Bromhexine Guaiphenesin + Phenylephrine+ Chlorpheniramine + Guaiphenesin
- Salbutamol + Bromhexine
- Chlorpheniramine + Codeine Phosphate + Menthol Syrup
- Phenytoin + Phenobarbitone Sodium
- Ammonium Chloride + Sodium Citrate + Chlorpheniramine Maleate + Menthol
- Salbutamol + Hydroxyethyltheophylline (Etofylline) + Bromhexine
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No therapeutic justification
The ban on the above-mentioned FDC medicines is based on the recommendations of an expert committee and it is effective immediately. The committee was formed specifically to assess the effectiveness of these drug combinations.
The notification stated the expert committee recommended: “There is no therapeutic justification for these FDCs and the FDCs may involve risk to human beings.”
It added: “Hence, in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of these FDCs under section 26 A of the Drugs and Cosmetics Act, 1940. In view of the above, any kind of regulation or restriction to allow for any use in patients is not justifiable.”
It also said: “And whereas, on the basis of the recommendations of the Expert Committee and the Drugs Technical Advisory Board, the central government is satisfied that it is necessary and expedient in the public interest to regulate by way of prohibition the manufacture for sale, and distribution for human use of the said drug in the country.”
Hyderabad’s Aditya Hospital general physician Dr Rajeev Kaushik told South First: “Without proper testing and validation, the risks and benefits of such combinations may not be well understood. Also, If a drug or drug combination is found to lack therapeutic relevance, it means that it does not provide significant clinical benefits or may even pose risks to the patients.”
He added: “Some drugs may have a high potential for misuse or abuse, leading to addiction, dependence, or other adverse consequences.”
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Earlier bans
“The Central government is satisfied that it is necessary and expedient in the public interest to regulate by way of prohibition the manufacture for sale, sale, and distribution for human use of the said drug in the country,” the notification said.
In 2016, the Union Health Ministry prohibited the sale of 344 FDCs, which included the recently banned FDCs.
However, the manufacturers of 15 of these drugs challenged the decision in the Delhi High Court.
In India, all drugs must obtain marketing approval from the CDSCO before acquiring manufacturing licences from state drug administrations.
However, in the case of FDCs, some companies obtained manufacturing licences from states without obtaining marketing approval from the CDSCO.
The CDSCO requires a therapeutic justification for the drug before granting marketing approval.
While the majority of drugs from the original list of 344 banned ones are no longer available in the market, some pharmaceutical companies contested the decision in the Delhi High Court for 15 drugs.
They argued that these drugs were launched prior to 1988 when the rule mandating marketing approval by the CDSCO for every drug came into force.
The case led to the formation of another committee specifically assigned to investigate the matter. The recent notification banning the 14 FDCs is a result of the recommendations made by this second committee.
It should be mentioned that India, known as the largest exporter of generic medicines, suffered a blow to its reputation when the World Health Organisation (WHO) found toxins in cough syrups manufactured by three Indian companies.
The syrups manufactured by two Indian pharmaceutical companies were held responsible for the deaths of 70 children in The Gambia and 19 children in Uzbekistan last year.
The latest move by the Indian government is seen as a step to tighten the regulation of drug manufacturing and export from India.
