Govt Panel Makes This Approval Mandatory For New Drug Licenses

One of the key agenda items taken up was the issuance of product licenses for new drugs by SLAs without the mandatory approval from the CLA, in violation of regulatory requirements.

Members were apprised that, “As per the rules, the State Licensing Authorities must check the approval, in writing, in favour of the applicant to manufacture drug formulations falling under the purview of new drug as defined in rule 2(w)(iv) of NDCT Rules, 2019, from the Central Licensing Authority (CLA).”

Despite this clear mandate, the DCC noted ongoing violations;

“Time and again it has been brought to the knowledge of CDSCO that manufacturing permission for such new drugs are issued by State Licensing Authorities without necessary permission from the CLA.”

It was further highlighted that, “Various directions as well as letters have also been issued in this regard.”

After a detailed discussion, the committee reached a unanimous decision;

“After detailed deliberation, all the members unanimously agreed for compliance of necessary permission from CLA before granting any licence to the manufacturers.”

The recommendation highlights the importance of centralized regulatory oversight, especially for drugs falling under the “new drug” category, which require rigorous safety and efficacy review by the CLA under the New Drugs and Clinical Trials (NDCT) Rules, 2019.