Health Ministry bans 328 fixed-dose combination drugs, including Saridon

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The Union Health Ministry on September 13 banned the manufacture, sale or distribution of 328 fixed-dose combination or FDC drugs, including Saridon on the grounds that the ingredients in these medicines do not add to benefits that people can get from taking them and they may pose health risks.

The ban on the said medicines came in wake of a report issued by top drug advisory body, the Drug Technical Advisory Board, claiming intake of 328 FDCs would be a health risk.

“The Drugs Technical Advisory Body recommended, amongst other things, that there is no therapeutic justification for the ingredients contained in 328 FDCs and that these FDCs may involve risk to human beings. The board recommended that it is necessary to prohibit the manufacture, sale or distribution of these FDCs under section 26A of the Drugs and Cosmetics Act, 1940 in the larger public interest,” government said.

While lauding government’s move Dr KK Agarwal, former president of Indian Medical Association said, “The Delhi High Court stayed this (FDCs ban) on technical grounds, but it is a good move for public health. Individual drugs are approved by the centre, but some manufacturers make combinations of two drugs and get state licences.”

Reportedly around 6,000 brands are likely to be affected. This includes painkiller Saridon, skin cream Panderm, combination diabetes drug Gluconorm PG, antibiotic Lupidiclox and antibacterial Taxim AZ.

According to reports these drugs are expected to have a combined market size of between Rs 2,000 crore and Rs 2,500 crore.