Streamlining the Process for Issuing Written Confirmation Certificates for Active Substances Exported to the EU

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Dated: 30.03.2026

Streamlining the Process for Issuing Written Confirmation Certificates for Active Substances Exported to the EU

The Directorate General of Health Services (DGHS), under the Ministry of Health and Family Welfare, Government of India, has issued a circular to streamline the procedure for processing applications for “Written Confirmation” (WC) certificates for active substances exported to the European Union (EU) for medicinal products intended for human use. This initiative aligns with Article 46(2)(b) of Directive 2001/83/EC and aims to ensure a time-bound and efficient disposal of applications submitted through the CDSCO SUGAM portal.

Background

The European Union mandates that every consignment of Active Pharmaceutical Ingredients (APIs) from non-EU or non-listed countries must be accompanied by a Written Confirmation Certificate (WCC). This certificate, issued by the competent authority of the exporting country, certifies that the consignment complies with Good Manufacturing Practices (GMP) standards as outlined in EU guidelines or equivalent standards.

In India, the Central Drugs Standard Control Organization (CDSCO) is responsible for issuing WCCs based on recommendations from its zonal and sub-zonal offices. The new circular introduces a streamlined process to simplify and expedite the issuance of these certificates.

Purpose

The primary objective of the circular is to establish a clear and efficient procedure for reviewing and processing online applications for WCCs submitted through the SUGAM portal. This process ensures compliance with EU regulations and facilitates the export of active substances for medicinal products intended for human use.

Scope

The streamlined procedure applies to all online applications submitted via the SUGAM portal for the issuance, renewal, or endorsement of WCCs for active substances exported to the EU. The process is designed to ensure compliance with Article 46(2)(b) of Directive 2001/83/EC.

Key Procedures for Streamlined Processing 

1. Application Submission

Manufacturers must submit applications for WCC issuance, renewal, or endorsement through the SUGAM portal. The application must include all required documents, such as inspection reports, compliance verification reports, and recommendation letters.

2. Zonal/Sub-Zonal Office Review 

Upon receipt of the application, the Zonal/Sub-Zonal offices of CDSCO will:

Verify the appropriateness of the submitted documents.
Upload the inspection report, compliance verification report, and recommendation letter.
Forward the application to the CDSCO Headquarters (HQ) within three weeks of receipt.

3. Headquarters Review

The International Cell at CDSCO HQ will:

Review the adequacy of the documents within three weeks of receiving the application.
Issue queries to the applicant if necessary, based on input from the Zonal/Sub-Zonal offices.

4. Inspection and Compliance Verification 

For applications requiring site inspections:

If the firm has been inspected within the last two years and found compliant with GMP standards, no further inspection is required.
If the firm has not been inspected within two years, the Zonal/Sub-Zonal Head will assign officers to conduct an on-site inspection.
Any deficiencies identified during the inspection will be communicated to the applicant for compliance submission.
The Zonal/Sub-Zonal office will verify the compliance and prepare a compliance verification report.

5. Application Review and Approval 

The application will undergo multiple levels of review:

Reviewing Officer (RO): Verifies the completeness and adequacy of the application and raises queries if necessary.
Senior Reviewing Officer (SRO): Reviews the queries raised and forwards the application to the Decision Authority (DA).
Decision Authority (DA): Reviews the application and queries, and either approves or rejects the application based on recommendations.
Licensing Authority (LA): Makes the final decision to approve or reject the application.

6. Issuance of Written Confirmation Certificate 

Once the application is approved:

The Reviewing Officer prepares an electronic file for the issuance of the WCC.
The Licensing Authority signs the certificate.
The signed certificate is uploaded to the SUGAM portal and the CDSCO website.

Accountability and Responsibility 

Zonal/Sub-Zonal Offices: Responsible for verifying the completeness of applications and conducting inspections if required.
International Cell, CDSCO HQ: Responsible for reviewing applications and ensuring compliance with the SOP.
Licensing Authority: Responsible for issuing the final Written Confirmation Certificate.

Timeline for Application Processing 

The streamlined process ensures that applications are processed within three weeks of receiving a complete and adequate application. This time-bound approach aims to enhance efficiency and reduce delays in the issuance of WCCs.

References

The streamlined procedure is based on the following guidelines:

Directive 2001/83/EC (latest amended by Directive 2011/62/EU): GMP requirements for active substances exported to the EU.
WHO Good Manufacturing Practices (GMP): Annex 2-WHO Technical Report Series (TRS), No. 957, 2010.
ICH Q7 Guidelines: Good Manufacturing Practice guide for Active Pharmaceutical Ingredients.

Conclusion

The new SOPs introduced by the CDSCO aim to simplify and expedite the process of issuing Written Confirmation Certificates for active substances exported to the EU. By eliminating redundant steps and ensuring compliance with international standards, the initiative supports the pharmaceutical industry in meeting global regulatory requirements while maintaining high standards of quality and safety.

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Source: CDSCO

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