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

The Union Health Ministry recently imposed a ban on 156 “irrational” fixed-dose combinations (FDC) medicines, which include widely-used antibiotics, painkillers, and multivitamins often prescribed for treating common ailments such as fever, cough, and infections. This ban, effective immediately, comes under section 26A of the Drugs and Cosmetics Act of 1940, as stated in a gazette notice issued by the Ministry. The manufacturing, marketing, and distribution of these drugs are now prohibited due to the significant health risks they pose.

FDCs, often referred to as “cocktail” drugs, are medications that combine two or more active ingredients in a single dosage form. While the idea behind FDCs is to enhance treatment efficacy, some combinations lack scientific evidence or therapeutic justification, leading to unnecessary exposure to potential side effects.

The Ministry’s decision followed an in-depth review by an expert committee and the Drugs Technical Advisory Board (DTAB). Both bodies concluded that there was no valid therapeutic reason for the ingredients in these specific FDCs, raising concerns over their safety and efficacy.

“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 official notification stated.

This ban reflects the government’s effort to regulate the pharmaceutical market and protect public health by ensuring that only scientifically validated and safe medicines are available to consumers.