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Health Ministry bans use of 328 FDCs

ANI  |  New Delhi [India] 

The has banned the manufacture for sale, sale or distribution for human use of 328 Fixed Dose Combinations (FDCs).

In a gazette notifications issued on September 7, the ministry also restricted the manufacture, sale or distribution of six FDCs subject to certain conditions. The government had prohibited five more FDCs in addition to the 344 under section 26 A of the Drugs and Cosmetics Act, 1940.

The earlier in March 2016 banned the manufacture for sale, sale, and distribution for human use of 344 FDCs under the same provisions. However, the matter was contested by the affected manufacturers in various High Courts and the

The matter was examined by the which 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.

With regard to six FDCs, the board recommended that their manufacture, sale, and distribution be restricted subject to certain conditions based on their therapeutic justification. 15 FDCs out of the 344 prohibited on March 10, 2016, which were claimed to be manufactured prior to September 21, 1988, have been kept out of the purview of current notifications.

Earlier, an appointed by the had also examined these FDCs and made recommendations in line with those of the Board as indicated above.

The considered the recommendations of the and Drugs Technical Advisory Board, and based on such consideration, it was concluded that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale, and distribution for human use of these 328 FDCs in the country.

(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

First Published: Fri, September 14 2018. 23:55 IST
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