India Bans 328 Combination Drugs With Immediate Effect

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 ban adversely impacted the drug manufacturer paving a way to question the government’s decision in India’s top court, supreme court. Following legal challenges raised by the drug producers, the supreme court called for a review on the ban by an advisory body.

The 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. The board recommended that it is necessary to prohibit the manufacture, sale or distribution of these FDCs 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.

Fifteen 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.

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. The government has also restricted the manufacture, sale or distribution of six FDCs subject to certain conditions.