Health Ministry bans 328 fixed-dose combination drugs

FDCs

Citing major health concerns, the Health Ministry has banned 328 combination drugs, including Saridon, claiming that the medicines do not markedly add to the benefits that people can get from their consumptions.

A fixed-dose combination (FDC) drug contains two or more active ingredients in a fixed dosage ratio, i.e., a single drug is made up of a combination of the two that has been ascertained as unnecessary for consumption.

The top advisory body of India, the Drug Technical Advisory Board (DTAB) has said that there is no therapeutic justification for the ingredients contained in the banned FDC and they must be prohibited in public interest as these may involve health concerns.

The action has been taken under the section 26A of the Drugs and Cosmetics Act, 1940. Earlier in March 2010, the government had brought the notification to restrict about 344 categories of FDCs. However, it was challenged by various manufacturers in the court.

Delhi’s drug controller Dr. Atul Nasa appreciated the government’s move to ban combination drugs.

In 2016, pharmaceutical giants including Pfizer Ltd. and Glenmark Pharmaceuticals Ltd. had filed a petition to the Delhi High Court challenging centre’s move to ban a separate list of 344 FDCs including Vicks Action 500, Corex Cough Syrup, and D’Cold.

On December 15, 2017, the SC asked the DTAB to conduct an inspection for the matter, and the Drugs Technical Advisory Board in its report concluded that there was no therapeutic justification for the 328 combination drugs and also suggested that these could be a risk to people. Therefore, the board recommended a ban on them.

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