• Friday, August 12, 2022

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India Bans 328 Combination Drugs With Immediate Effect

An advisory board found that there is no therapeutic justification for the ingredients contained in 328 FDCs and that these FDCs may involve risk to human beings. (Photo Credit: Adeel Halim/Bloomberg via Getty Images).

By: Radhakrishna N S

In a blow to domestic and international pharmaceutical producers, the Indian government has prohibited the manufacture, sale or distribution for human use of 328 combination drugs referred to as Fixed Dose Combinations (FDCs) with immediate effect. It has also restricted the manufacture, sale or distribution of six FDCs subject to certain conditions. Earlier, the government had, through its notifications published on March 10, 2016, prohibited the manufacture for sale, sale and distribution for human use of 344 FDCs. Soon after the ban, the government had prohibited five more FDCs in addition to the 344 under the same provisions. However, the…

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