The Drugs Controller General of India (DCGI) has instructed State and Union Territory (UT) drug controllers to move against 35 fixed dose combinations (FDCs) that were recognized as unapproved new drugs. The FDCs were earlier approved by state regulators without central scrutiny of safety and efficacy, in contravention of the New Drugs and Clinical Trials (NDCT) Rules, 2019.

Key Highlights

35 FDCs Were Labeled as Unapproved New Drugs

• Such combinations were issued manufacturing licenses by SLAs without CDSCO approval beforehand.

• Such combinations involve such drugs as metformin + glimepiride + dapagliflozin, dextromethorphan + phenylephrine + diphenhydramine, and rosuvastatin + clopidogrel + aspirin, etc.

NDCT Rule Violations Raised Since 2013

• DCGI has been consistently warning State Licensing Authorities (SLAs) since 2013 regarding licensing new FDCs in the absence of CDSCO approval.

• Numerous licenses have been revoked or even surrendered voluntarily following show cause notices.

Urgent Appeal for Regulatory Scrutiny and Adherence

• DCGI Dr. Rajeev Singh Raghuvanshi has requested stringent scrutiny of SLA processes.

• Appeals to all States/UTs to facilitate uniform adherence and ensure public safety becomes the foremost consideration.

Risk to Public Health Emphasized

• Unapproved FDCs can lead to adverse drug reactions, interactions, or health risks due to absence of scientific verification.

• Regulatory loopholes have resulted in uneven enforcement all over India, compromising patient safety.

List Published and Countrywide Compliance Required
All drug regulators are requested to:

• Prohibit manufacture, sale, and supply of the 35 unapproved FDCs

• Enquire and act in accordance with NDCT Rules, 2019

• Inform action taken to CDSCO promptly

The recent directive by the CDSCO emphasizes its resolve towards ensuring consistent drug safety standards throughout India. While litigation and regulatory issues persist, this move enforces the imperative of scientific authentication prior to market approval. States and UTs are now required to move at a fast pace to enhance monitoring and safeguard patient safety by suspending all unapproved FDCs and ensuring strict adherence to central rules.