The Central Government 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 Supreme Court.
The matter was examined by the Drugs Technical Advisory Board 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 Expert Committee appointed by the Central Government had also examined these FDCs and made recommendations in line with those of the Board as indicated above.
The Central Government considered the recommendations of the Expert Committee 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.