CDSCO: Guidance document on Export NOC for Pharma Industry

Last Updated on July 16, 2024 by The Health Master

Export NOC

This article dives into the recent changes implemented by the Central Drugs Standard Control Organisation (CDSCO) regarding the Export NOC (No Objection Certificate) process for exporting unapproved, banned, or new drugs.

Centralized Export NOC Application

Previously, manufacturers seeking to export these specific drug categories obtained Export NOCs from State and Union Territory (UT) Licensing Authorities.

However, the CDSCO has now centralized the application process.

As of May 15, 2024, all manufacturers must obtain export NOCs directly from the respective zonal offices of the CDSCO through the Sugam online portal.

Required Documents for Export NOC

To obtain an export NOC, companies must submit a comprehensive application package, including:

• Company Documents: Application on company letterhead with authorized signatory’s stamp and signature, valid manufacturing license.
• Product Details: List of drugs for export, names, dosage forms, composition, strengths, quantities, and countries of destination.
• Quality Control Testing: Specify whether testing will occur at the manufacturing site, destination country, or both.
• Export Agreements: A copy of a valid purchase order, export order, or proforma invoice from the foreign buyer (addressed to the manufacturer with specified quantities). If a trader is involved, a letter from the trader to the manufacturer with a valid purchase order number is also required.
• Previous Export History (if applicable): A self-certified order (not exceeding six months old) and a proforma invoice/purchase order from the importing country detailing the specific drug(s) to be manufactured.
• Reconciliation Data (if applicable): For manufacturers with previous export permissions, a formatted data sheet outlining details like manufacturing license number, previous export NOC details, quantities and destinations, and recipient firms.
• Legal Undertaking: Separate formats are available for bulk and formulation drug manufacturers, requiring a signed undertaking on a Rs. 100 non-judicial stamp paper.

Existing NOCs

This centralization aims to streamline the Export NOC process and ensure consistency.

Existing NOCs issued by State/UT Licensing Authorities between August 20, 2018, and May 14, 2024, will be transferred to the respective CDSCO Zonal Offices.

Future Considerations: One-Time NOC

The Drugs Consultative Committee (DCC) is exploring the possibility of a one-time export NOC and manufacturing license system for specific categories (approved/unapproved new drugs, excluding banned drugs) solely for exports.

Additionally, the DCC is considering relaxing NOC conditions related to the destruction of excess unapproved or approved new drugs for export, aiming to minimize economic losses.

This shift in the NOC process signifies the CDSCO’s commitment to simplifying pharmaceutical exports while maintaining regulatory control.

By centralizing the application process and offering potential future relaxations, the CDSCO aims to enhance India’s role in the global pharmaceutical export market.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.

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