CDSCO Circular (23–24 February 2026)

Key highlights from the **CDSCO circular on “Testing of drugs for grant of permissions for import/manufacture of New Drug for sale or for distribution and issuance of RC (Registration Certificate) for import of drugs etc.” released by the Central Drugs Standard Control Organization (CDSCO) on 24 February 2026 (the circular is dated 23 February 2026 on the CDSCO website) :

1. Objective of the Circular

• The circular provides updated procedural guidance related to testing and regulatory permissions for:
  • Importing new drugs or investigational new drugs
  • Manufacturing new drugs for sale or distribution
  • Issuance of Registration Certificate (RC) for the import of drugs
• It aims to standardize and streamline drug testing requirements, compliance checks, and processing of applications for permissions under the Drugs and Cosmetics Act, 1940 and associated Rules.

2. Scope Covered

The circular covers (but is not limited to):

• Testing of drug samples that are part of applications for new drug approvals.
• Reference to laboratory testing standards and procedures that applicants must follow.
• Requirements for submission of quality test reports as part of permission applications.
• Updated guidelines for CDSCO laboratories and State Drug Testing Laboratories (SDTLs) in handling sample testing requests linked to import/manufacture permissions and import RC issuance.  

3. New Drug Permissions

• Applications for permission to import or manufacture new drugs for sale or distribution must be accompanied by quality test data and compliance evidence as specified in the circular.
• The circular emphasizes proper submission of analytical test reports prior to grant of permissions.
• This is aligned with the regulatory requirement that no new drug can be marketed in India without CDSCO approval following clinical evaluation and safety/efficacy assessment.  

4. Issuance of Registration Certificates (RC)

• For importation of drugs (including new drugs), CDSCO issues Registration Certificates (RC) once statutory requirements are fulfilled, including satisfactory drug testing results.
• The circular re‑iterates that drug consignees and importers must ensure compliance with testing norms before RC issuance.
• This supports enforcement of quality standards under Chapter III of the Drugs & Cosmetics Act and related drugs rules.

5. Testing Laboratories & Procedures

• CDSCO’s network of Central and Port Laboratories — including national drug testing laboratories — are to conduct sample analysis as per the latest pharmacopoeial and regulatory standards.
• The circular reinforces coordination between CDSCO zonal/port labs and SDTLs to expedite quality assessment linked to regulatory permissions.
• Periodic reporting of sample testing outcomes (including results of drugs “Not of Standard Quality”, or NSQ) is essential to CDSCO’s surveillance system.  

6. Emphasis on Compliance and Enforcement

• Non‑compliance with testing mandates — e.g., incomplete test reports or failure to follow required sampling procedures — can lead to delay, suspension or refusal of permissions for import/manufacture or RC issuance.
• The circular indirectly reinforces CDSCO’s broader quality monitoring framework, which routinely flags NSQ samples and enforces corrective actions.

7. Practical Impact for Industry

For pharmaceutical manufacturers, importers, and regulatory professionals, this circular means:

• Ensure complete analytical and quality data accompanies all ND/INND import/manufacture applications.
• Coordinate with designated labs early to avoid processing delays.
• Stay updated on evolving CDSCO requirements and timelines on the SUGAM/NSWS portal.

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