Health Ministry Bans Saridon And 327 Other Drugs With Immediate Effect

| September 20 , 2018 , 12:41 IST

The Health Ministry has banned the manufacture, sale and distribution of 328 fixed dose combinations (FDCs) of drugs with immediate effect, including popular painkillers, antibiotics and cough medications such as Saridon and Corex, media reported on Thursday.

A total of around 6,000 brands are likely to be affected by the ban, such as skin cream Panderm, combination diabetes drug Gluconorm PG and antibiotic Lupidiclox apart from popular painkiller Saridon. For another 6 FDCs, the manufacture, sale and distribution is subject to certain conditions.

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According to reports, the ministry had been trying to get these “irrational” and “unsafe” drugs banned for the past two years. The official notification banning the combination drugs was announced based on the recommendations of an expert committee that the concerned combinations drugs were deemed to have no therapeutic basis.

In 2016, the government had banned 344 FDC but the ban was contested by their manufacturers im various high courts and the Supreme Court after which in 2017 the apex court directed the Drugs Technical Advisory Board (DTAB) to look into the matter.

After receiving the DTAB report, the health ministry said, “The Drugs Technical Advisory Board 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 26 A of the Drugs and Cosmetics Act, 1940 in the larger public interest.”

One of the petitioners in the Supreme Court case, the All India Drug Action Network, welcomed the ban and said in a statement, “The banned FDCs account for about Rs 2,500 crore and represent only the tip of the iceberg. In our estimate, the market for unsafe, problematic FDCs in India is at least one-fourth of the total pharma market which is valued at Rs 1.3 trillion.”

Meanwhile, several drug companies claimed that they would have in any case phased out such drugs or changed the combinations.