18September2018

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India bans sale of 328 FDCs

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Rohit Shishodia
India’s health ministry has banned the sale, manufacturing and distribution of 328 Fixed Dose Combination (FDC) drugs for human use with immediate effect. It has also restricted the manufacturing and sale of six FDCs subject to certain conditions.

The decision to ban the 328 FDCs was taken on the recommendation of expert committee and Drugs Technical Advisory Board (DTAB) that found that these FDCs may involve risk to human beings.

Earlier, on March 10, 2016, the ministry through its notification banned sale and manufacturing of 344 FDCs under section 26A of the Drugs and Cosmetics Act, 1940. It had also prohibited five more FDCs in addition to the 344 under the same provisions.

A health ministry press note reads that the matter was contested by the affected manufacturers in high courts and the Supreme Court. In compliance with the directions given by the SC in its judgment on December 15, 2017, the matter was examined by the DTAB formed under section 5 of the Drugs and Cosmetics Act, 1940, which furnished its report on these drugs to the government.

The DTAB 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 DTAB 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 the current notifications.

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