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Ban of 150 fixed-dose combination drugs

Content Editor: Dr. Shubham

August 29, 2024 at 2:30:00 PM

Fixed Drug Combination (FDC), Drugs and Cosmetics Act, Public health laws

Content Editor: Dr. Shubham
  • The Indian government has banned 156 combination drugs, including painkillers, multivitamins, antibiotics, and drugs used for fatty liver with diabetes and irritable bowel syndrome. 

  • These Fixed Dose Combination (FDC) drugs are considered a potential risk to humans.

  • The government-appointed Drugs Technical Advisory Board (DTAB) and an expert panel declared these FDCs to be "irrational," the DTAB also discovered no medicinal basis for any of the components.

  • Safer alternatives exist, and the FDC drugs pose risks to human health, and the Board recommended prohibiting them. 

  • The ban was issued under Section 26A of the Drugs and Cosmetics Act.

  • The FDCs were considered risky for human use, so they were prohibited from being manufactured, sold, and distributed.

  • Companies with supporting data can continue, while others must withdraw their products.

  • The list includes hair treatments, anti-parasitic drugs, skincare products, and anti-allergic medications.

  • This prohibition follows earlier measures, such as the outlawing of 344 combination medications in March 2016 and an additional 14 in June 2023, as part of a larger attempt to regulate the pharmaceutical industry.

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