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Dimapur, September 12 (MExN): The Ministry of Health and Family Welfare on Wednesday announced prohibiting the manufacture for sale or distribution for human use of 328 Fixed Dose Combinations (FDCs) drugs with immediate effect.
It has also restricted the manufacture, sale or distribution of six FDCs subject to certain conditions, the Ministry said in a statement, released by PIB. FDCs are two or more drugs combined in a fixed ratio into a single dosage form.
The Centre, in March 2016, had prohibited the manufacture for sale and distribution of 349 FDCs but this was contested by the affected manufacturers in High Courts and the Supreme Court, it added.
Complying with the December 2017 Supreme Court judgment, the Drugs Technical Advisory Board (DTAB) examined the matter and, in its report to the Centre, recommended prohibition of the FDCs saying, among other things, there was no therapeutic justification for the ingredients contained in them and that these FDCs may involve risk to human beings, it added.
According to a report in the Economic Times (ET), the notification could affect brands like Piramal’s Saridon, Macleods Pharma’s Panderm Plus cream and Alkem Laboratories’ Taxim AZ.
The ban is expected to shave off over Rs1, 500 crore from India’s Rs1.18-lakh crore pharmaceutical industry and would impact medicine brands across several therapy areas, the report said quoting pharmaceutical market research firm AIOCD Awacs PharmaTrac.
However, the ban notifications do not include 15 FDCs totaling over Rs740 crore that were manufactured since before 1988 including popular cough syrups and cold medicines like Phensedyl, Grilinctus and D’Cold Total, it added, citing senior ministry officials.