Centre bans 16 Fixed Dose Combination (FDC) drugs over safety and efficacy concerns

NEW DELHI: In a major move aimed at strengthening patient safety and ensuring the rational use of medicines, the Ministry of Health and Family Welfare on Saturday said that it has prohibited the manufacture, sale and distribution of 16 Fixed Dose Combination (FDC) drugs for human use across the country. 

The ban has been imposed under Section 26A of the Drugs and Cosmetics Act, 1940, and has come into effect immediately.

The decision follows directions issued by the Supreme Court, which had called for a comprehensive review of Fixed Dose Combinations available in the Indian market.

Acting on these directions, the Drugs Technical Advisory Board (DTAB) constituted an Expert Committee to examine various FDCs and assess their safety, efficacy and therapeutic value.

After conducting a detailed scientific evaluation, the Expert Committee concluded that 16 FDCs lacked adequate therapeutic justification and that their continued use could pose potential health risks. Based on these findings, the government decided to prohibit these combinations, stating that the risks associated with their use outweighed any potential benefits.  (IANS)

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