What are ‘cocktail’ drugs and why has Health Ministry banned 156 of them?

The Union Health Ministry has banned 156 “irrational” fixed dose combinations (FDC) medicines––including widely-used antibiotics, painkillers, and multivitamins used for treating fever, cough, and infections––with immediate effect. As per a gazette notice issued under section 26 A of the Drugs and Cosmetics Act 1940, the Ministry said that the production, marketing, and distribution of these drugs are now prohibited due to their associated health risks.

“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 read.

One of the prominent pain-relief medicines on the list is the combination of Aceclofenac 50 mg and Paracetamol 125 mg tablet. “The Central government is satisfied that the use of the Fixed Dose Combination drug is likely to involve risk to human beings whereas safer alternatives to the said drug are available,” the notification read.

Mefenamic acid + Paracetamol injection, Cetirizine HCl + Paracetamol + Phenylephrine HCl, Levocetirizine + Phenylephrine HCl + Paracetamol, Paracetamol + Chlorphenamine Maleate + Phenyl Propanolamine and Camylofin Dihydrochloride 25 mg + Paracetamol 300 mg are some of the other fixed combination drugs on the list.

What are ‘cocktail’ drugs?

Fixed-dose combinations (FDCs), also called ‘cocktail’ drugs, are medicines that combine more than one drug in a single pill.

Consultant neurologist Dr Sudhir Kumar, Apollo Hospitals, Hyderabad hailed the ban and shared more about these ‘cocktail’ drugs.

Kumar said that there are no randomised controlled trials to assess the safety and efficacy of many of the FDCs, and hence, the prescription and usage of these are considered irrational. Combining two analgesics (pain killers) or a pain killer with an anti-histaminic are examples of irrational FDCs.

Here’s what to consider (Source: Getty Images/Thinkstock)

“There could be adverse effects (some of them serious) with the usage of these FDCs. Also, safer alternatives––tested in clinical trials––are available to treat these medical conditions,” Dr Kumar said.

According to Dr Kumar, a rational prescription for treating pain is to use one drug. If the first drug is found ineffective, a second drug may be added (in combination with the first one, or as a replacement for the first analgesic).

“There is no rationale for combining an analgesic or an antipyretic with an anti-allergic or anti-histaminic. We need to prescribe them individually based on the patient’s clinical symptoms. Overall, it is a good move by the Union Health Ministry to ban these irrational fixed drug combinations,” said Dr Kumar.

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