Centre Bans 16 Fixed-Dose Drug Combinations
Health Ministry prohibits manufacture and sale of irrational medicines with immediate effect
- Centre bans 16 Fixed Dose Combinations.
- Decision taken to protect public health.
- Drugs found lacking therapeutic justification.
- States directed to ensure strict enforcement.
GG News Bureau
New Delhi, 20th June: The Union Ministry of Health and Family Welfare has prohibited the manufacture, sale and distribution of 16 Fixed Dose Combinations (FDCs) for human use with immediate effect, citing concerns over their lack of therapeutic justification and potential risks to public health.
The action has been taken under Section 26A of the Drugs and Cosmetics Act, 1940, following recommendations of an Expert Committee constituted by the Drugs Technical Advisory Board (DTAB) as directed by the Supreme Court.
According to the Ministry, the banned FDCs include certain dermatological preparations, pain-relief and antispasmodic medicines, as well as antibiotic-based formulations that were found to be irrational and whose risks outweighed their benefits.
The government said the decision is part of its continued efforts to ensure that only safe, effective and scientifically validated medicines remain available to the public.
All State Drug Controllers and regulatory authorities have been directed to ensure strict implementation of the order, while manufacturers, importers and distributors have been asked to take necessary corrective steps to comply with the prohibition.
The Ministry stated that similar action has been taken in the past against irrational drug combinations as part of efforts to strengthen patient safety and evidence-based healthcare in the country.
