Health Ministry prohibits manufacture, sale and distribution of Fixed Dose Combinations

The Union Health Ministry on September 12, 2018, prohibited the manufacture, sale and distribution of 328 Fixed Dose Combinations (FDCs) for human use with immediate effect. The Ministry has also restricted the manufacture, sale and distribution of six FDCs subject to certain conditions. The action has been taken by the Ministry under the powers conferred by section 26A of the Drugs and Cosmetics Act, 1940.

Key Highlights:-

1. The prohibition on the FDCs was contested by the affected manufacturers in various High Courts and the Supreme Court.
2. In its recommendations, the drugs advisory board stated that there is no therapeutic justification for the ingredients contained in 328 FDCs and that these FDCs may involve risk to human beings.
3. The matter was examined by the Drugs Technical Advisory Board constituted under section 5 of the Drugs and Cosmetics Act, 1940, in compliance with the directions given by the apex court. The board then submitted its report on these drugs to the Union Government.
4. With regard to the six FDCs, the board recommended that their manufacture, sale and distribution be restricted subject to certain conditions based on their therapeutic justification.
5. The board recommended that it is necessary to prohibit the manufacture, sale or distribution of these FDCs in the larger public interest.
6. An expert committee appointed by the Union Government had also examined the FDCs earlier and had made recommendations in line with those of the board.
7. The 15 FDCs out of the 344 prohibited on March 10, 2016, which were claimed to be manufactured before September 21, 1988, have been kept out of the purview of current notifications.
8. An expert committee appointed by the Union Government had also examined the FDCs earlier and had made recommendations in line with those of the board.

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