In a major move aimed at public health safety, the Central Drugs Standard Control Organization (CDSCO) has ordered an immediate halt on the manufacturing, sale, and distribution of 35 unapproved Fixed-Dose Combination (FDC) drugs across all states and union territories. The banned drugs include commonly used painkillers, nutrition supplements, and medications used to manage diabetes.
The CDSCO issued a directive to all state and UT drug controllers, instructing them to strictly enforce the relevant provisions of the Drugs and Cosmetics Act, 1940 and its associated rules. The organization emphasized the need to review the approval processes of such FDC drugs to ensure regulatory compliance.
What Are FDC Drugs?
Fixed-Dose Combination (FDC) drugs are formulations that contain two or more active pharmaceutical ingredients (APIs) combined in a fixed ratio. While such combinations can offer therapeutic advantages, they also require rigorous evaluation to ensure safety and efficacy.
Serious Risk to Public Health
According to the notification, the directive comes in light of findings that certain FDC drugs were licensed for manufacture, sale, and distribution without proper assessment of their safety and efficacy. The CDSCO warned that this poses a serious threat to public health and safety.
In a letter dated April 11, Drug Controller General of India (DCGI) Dr. Rajeev Raghuvanshi referred to a January 2013 communication from his office raising concerns about the issuance of manufacturing licenses for FDC drugs classified as “new drugs” without proper approval. The letter also noted that similar concerns had been repeatedly raised over the years, and multiple letters had been sent to concerned state licensing authorities.
This latest order signals a stricter regulatory stance by Indian drug authorities to prevent the circulation of potentially unsafe combination drugs in the market.
Dr. Deepak Baid, Head, NuLife Hospital, Mumbai said, “The fact that these medicines have entered the market highlights serious flaws in our regulatory system. The government needs to involve qualified healthcare professionals to help prevent such incidents from happening again.“
He Further said that If certain fixed-dose combination (FDC) medicines are banned, it indicates that the expert committee found valid reasons deeming them unsafe or inappropriate for consumption. Doctors still have alternative FDCs they can prescribe, but any ban suggests a need for caution and stricter oversight.
