8th June 2025,

During the 66th meeting of the Drugs Consultative Committee (DCC) held at CDSCO, New Delhi, a significant regulatory concern regarding the unauthorized issuance of manufacturing licenses for new drugs by certain State Licensing Authorities (SLAs) was deliberated.

⚠️ Key Concern Raised

The DCC flagged repeated incidents where SLAs granted manufacturing permissions for new drug formulations without prior approval from the Central Licensing Authority (CLA) i.e. CDSCO. Such actions directly violate Rule 2(W) of the New Drugs and Clinical Trials (NDCT) Rules, 2019—an essential provision that governs the approval and control of new drug entities in India.

📌 What Do the Rules Say?

As defined under Rule 2(W) of the NDCT Rules, 2019:

“A new drug” includes:

  • A New Chemical Entity (NCE) not yet approved in India,
  • A modified release dosage form of an existing drug,
  • A fixed-dose combination involving one or more new drugs,
  • Any approved drug with a change in indication, route, dosage, or form,
  • Or a drug developed using a novel drug delivery system.

If a formulation falls into any of these categories, written approval from the CLA is mandatory before any manufacturing license can be issued by the SLA.

✅ Unified Resolution by DCC

After detailed discussion, the DCC reached a unanimous consensus:

“No State Licensing Authority shall issue a manufacturing license for any product falling under the definition of a new drug unless prior written approval has been obtained from the Central Licensing Authority.”

This decision reinforces a centralized regulatory system for new drug approval, ensuring that all such drugs undergo proper evaluation for safety, efficacy, and quality.

🏭 How This Impacts Manufacturers — And What They Must Do

Manufacturers who bypass CLA approval and directly approach SLAs may find themselves facing license cancellations, regulatory penalties, and forced production halts. Even if a license is issued by the SLA, it will be considered invalid without CLA clearance.

It is the manufacturer’s responsibility to first evaluate whether the product qualifies as a “new drug” under Rule 2(W). If it does, the CLA’s written approval is legally required before engaging with any SLA for manufacturing permission. Skipping this step is not a process gap—it’s a serious regulatory violation.

🛡️ How Vaayath Consulting Can Help

At Vaayath Consulting, we partner with pharmaceutical manufacturers to ensure full regulatory alignment under NDCT Rules. Our comprehensive support includes:

  1. Regulatory Classification Support
  2. CLA Approval Process Handling
  3. Documentation Preparation & Review.
  4. Regulatory Representation & Filing Support

📎 For more information, review the official order. 

📞 Need assistance with compliance or product review?
Contact us at info@vaayath.com