In a major move to protect public health, the Union Ministry of Health and Family Welfare has banned the manufacture, sale, and distribution of 16 Fixed Dose Combinations (FDCs) with immediate effect.
Issued under Section 26A of the Drugs and Cosmetics Act, 1940, this directive aims to eliminate irrational and scientifically unjustified drug combinations from the market.
The decision follows a Supreme Court-mandated comprehensive review. Acting on these directions, the Drugs Technical Advisory Board (DTAB) formed an Expert Committee to evaluate available FDCs. The committee’s scientific assessment revealed that these 16 formulations lack therapeutic justification and pose potential health risks that outweigh their benefits.
The banned combinations span multiple therapeutic categories, including dermatological preparations (such as various Aloe Vera, Vitamin E, and oil blends), analgesics, antispasmodics (including Dicyclomine and Paracetamol combinations), and antibiotic-based formulations containing Amoxicillin or Cefuroxime mixed with Serratiopeptidase.
State Drug Controllers and regulatory authorities have been ordered to enforce strict compliance nationwide. Stakeholders, including manufacturers and distributors, must implement immediate corrective measures. The complete list and official e-Gazette notifications are accessible at egazette.gov.in.
Written by: Pragna Biswas
Graphics by: Pramit Hazra
