The Ministry of Health on Wednesday banned the manufacture for sale or distribution of 328 fixed-dose combination (FDC) drugs, including painkiller Saridon with immediate effect, stating that there is no therapeutic justification for the ingredients. FDCs are two or more drugs combined in a fixed ratio into a single dosage form.
The government 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 26A of the Drugs and Cosmetics Act, 1940, in the larger public interest.”
Besides, it has also restricted the manufacture, sale or distribution of six other FDCs which include popular cough syrups, painkillers and cold medication subject to certain conditions, the official statement said. The sale of the six FDCs amount to over Rs 740 crore annually, reported News18.
The ban brings an end to a two-year-long legal battle between manufacturers of these combination drugs and the ministry, which has been working to get these “irrational” and “unsafe” drugs banned since 2016, reported The Times of India. Around 6,000 brands are likely to be affected.
The medicines that have been banned include painkiller Saridon, skin cream Panderm, combination diabetes drug Gluconorm PG, antibiotic Lupidiclox and antibacterial Taxim AZ. They are expected to have a combined market size of between Rs 2,000 crore and Rs 2,500 crore, according to News18.
The Health Ministry, through its notification published on 10 March, 2016, had prohibited the manufacture for sale and distribution for human use of 349 FDCs under Section 26 A of the Drugs and Cosmetics Act, 1940. But the matter was contested by the affected manufacturers in various high courts and the Supreme Court.
“Fifteen FDCs out of the 344 prohibited on the 10 March, 2016, which were claimed to be manufactured prior to 21 September, 1988, have been kept out of the purview of current notifications,” the statement added.
The board recommended that it is necessary to prohibit the manufacture, sale or distribution of these FDCs under the Drugs and Cosmetics Act, 1940 in the larger public interest.
Full list of banned medicines:
With inputs from PTI
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Updated Date: Sep 14, 2018 14:44:49 IST