CDSCO's New Guidelines for Testing and NOC Issuance

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Dated: 26.02.2026

CDSCO’s New Guidelines for Testing and NOC Issuance

The Central Drugs Standard Control Organization (CDSCO), under the Directorate General of Health Services, Government of India, has issued a new circular aimed at enhancing the efficiency of the drug testing and approval process. This circular, dated February 23, 2026, outlines updated procedures for granting permissions for the import/manufacture of new drugs for sale or distribution, as well as the issuance of registration certificates for drug imports. The circular will come into effect on June 1, 2026, and is a significant step forward in ensuring timely and accurate drug testing and approval.

Key Highlights of the Circular

1. Revised Specifications and Re-Testing 

In cases where drug specifications are revised or updated after review or comments by CDSCO, a fresh No Objection Certificate (NOC) for testing will be issued. This ensures that the drug undergoes re-testing at designated laboratories based on the updated specifications, maintaining the highest standards of quality and compliance.

2. Designated Laboratories for Testing 

The testing of drugs is carried out by the following designated laboratories:

Indian Pharmacopoeia Commission (IPC), Ghaziabad
Central Drugs Testing Laboratory (CDTL), Mumbai
Central Drugs Laboratory (CDL) at CRI, Kasauli
National Institute of Biologicals (NIB), Noida

These laboratories conduct rigorous testing based on the specifications submitted by applicants. The test reports are then submitted to CDSCO for consideration of approval for the applied products.

3. Immediate Issuance of NOC 

To expedite the processing of applications, CDSCO has decided to issue NOCs for testing drug samples at the designated laboratories immediately upon receipt of applications. This proactive approach aims to reduce delays in the approval process, ensuring faster access to new drugs for patients.

4. Submission of Finalized Regulatory Specifications 

Applicants are required to submit finalized regulatory specifications as part of their filing documents. These specifications must be based on:

Prevailing Pharmacopoeia Standards: Compliance with relevant Pharmacopoeial Monographs and general chapters of the Indian Pharmacopoeia (IP) or other pharmacopoeias specified in the Second Schedule of the Drugs and Cosmetics Act, 1940.
Product-Specific Quality Management System (QMS): Ensuring adherence to quality standards tailored to the specific product.

5. Evaluation Criteria for NOC

CDSCO evaluates applications for NOC based on several factors, including:

Type of formulation, dosage form, and Critical Quality Attributes (CQAs).
Product development reports, forced degradation studies, and other relevant data.
Compliance with applicable guidelines and pharmacopoeial standards.

Implications for Stakeholders

This circular is a crucial development for all stakeholders involved in the drug approval process, including pharmaceutical companies, regulatory bodies, and testing laboratories. By streamlining the issuance of NOCs and ensuring rigorous testing based on updated specifications, CDSCO aims to enhance the efficiency and reliability of drug approvals in India.

Effective Date and Implementation 

The circular will be effective from June 1, 2026, and all stakeholders are advised to take necessary actions to comply with the updated procedures. Copies of the circular have been shared with relevant divisions of CDSCO, designated laboratories, and other stakeholders through the CDSCO website.

Conclusion

The updated guidelines reflect CDSCO’s commitment to maintaining high standards in drug testing and approval processes while ensuring timely access to new drugs. By prioritizing efficiency and compliance, this initiative is expected to benefit both the pharmaceutical industry and the public health sector in India.

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Source: CDSCO

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