Daijiworld Media Network - New Delhi
New Delhi, Jun 20: In a significant step to strengthen patient safety and promote the responsible use of medicines, the Union Ministry of Health and Family Welfare on Saturday announced a nationwide ban on the manufacture, sale and distribution of 16 Fixed Dose Combination (FDC) drugs meant for human use.
The prohibition has been enforced under Section 26A of the Drugs and Cosmetics Act, 1940, and has taken immediate effect across the country.
The decision follows directions issued by the Supreme Court, which had ordered a comprehensive review of Fixed Dose Combination medicines available in the Indian market.
In response, the Drugs Technical Advisory Board (DTAB) constituted an expert panel to evaluate the safety, effectiveness and therapeutic value of various FDC formulations.
After an extensive scientific assessment, the committee concluded that 16 drug combinations lacked adequate therapeutic justification and could potentially pose health risks to patients. Based on these findings, the government determined that the risks associated with their use outweighed any possible benefits.
The prohibited medicines fall under multiple treatment categories, including certain dermatological products, pain-relief and antispasmodic medicines, as well as some antibiotic-based formulations.
According to the Health Ministry, these combinations were deemed irrational and unsupported by sufficient scientific evidence.
The ministry said the action forms part of the government's broader efforts to ensure that only safe, effective and scientifically validated medicines remain available to the public. It also noted that similar measures have been implemented in the past after detailed scientific reviews of irrational drug combinations.
With the latest notification now in force, the manufacture, sale, distribution and supply of the identified 16 Fixed Dose Combination drugs for human use stand prohibited nationwide with immediate effect.
The ministry has directed all state drug controllers, regulatory authorities and enforcement agencies to ensure strict implementation of the order.
Manufacturers, importers, distributors and other stakeholders have also been instructed to comply with the new regulations and immediately discontinue the affected products.
The government said the move reaffirms its commitment to evidence-based healthcare, patient safety and the rational use of medicines throughout the country.