The Central Drugs Standard Control Organisation (CDSCO) has introduced guidelines for the online issuance of No Objection Certificates (NOCs) for the manufacture of unapproved or approved new drugs specifically for export purposes. This initiative, aligning with guidelines from the Ministry of Health and Family Welfare and Rule 94 of the Drugs and Cosmetics Act, 1940, aims to streamline the regulatory process for manufacturers.
Manufacturers holding valid licenses in Form-25, Form-28, Form 28D, and their respective loan licenses can now obtain these NOCs from CDSCO’s Zonal offices. The new procedure is applicable to unapproved drugs and approved new drugs, with the exception of Narcotic Drugs and Psychotropic Substances (NDPS) and banned drugs.
The entire process is divided into two key steps:
Step I: One-Time Online Registration with Zonal Office
Applicants must first complete an online Integrated Registration Form (IRF), which serves as a one-time registration valid for one year. This IRF needs to be verified by the concerned zonal office. An Export NOC with one-year validity (or until the sanctioned amount is exhausted, whichever is earlier) for the applied products will be issued within 7 working days from the date of application.
The IRF requires the submission of several key documents:
- Export NOC Form / Integrated Registration Form (IRF): An automatically generated form.
- Legal Undertaking: In prescribed formats (Annexure-I for API manufacturers, Annexure-II for Formulation Manufacturers), digitally signed and executed on Rs. 100/- non-judicial stamp paper. These undertakings ensure the drugs are not diverted for domestic sale in India and meet international quality standards.
- Copy of Manufacturing License: A valid license from the State Licensing Authority (Form 25/28/28-D) and respective loan licenses. For subsequent NOCs, a quantity-specific export license from SLA for the specific product is required.
- Reconciliation Data: History of previously issued NOCs in a specified online format, detailing quantity sanctioned, manufactured, exported, left, country exported to, customer details, and PO/EI/SB details.
- NRA Approval Status of Importing Country: Documentation of approval from the National Regulatory Authority (NRA) of the importing country is required. If not available, alternative documents such as pharmacopeial status (IP/USP/BP/JP/EP) for APIs, or SRA (United States, EU, Canada, Japan, Australia, Switzerland) country approval for formulations/APIs, may be submitted. NRA approval is mandatory for NDPS and banned APIs.
- R&D Batches and NCE Batches: Specific documentation for R&D batches (API pharmacopeial status, SRA/importing country approval for formulation) and New Chemical Entity (NCE) batches for clinical trials/research (IUPAC name, COA, STP).
Step II: Procedure for Release of Consignment at Port Office
After obtaining a valid Export NOC from the zonal office, the applicant must submit specific details online to the concerned port office for consignment release. This step also involves verification by the port office.
Documents required for this step include:
- Valid Export NOC: Selected through the Auto Fetch system.
- Reconciliation Details for Quantity Exported: To be filled online for each export at the time of release.
- Test / Batch Release Certificate: Uploaded as a physical Certificate of Analysis (COA).
- Purchase Order (PO) / Export Invoice (EI) / Shipping Bill (SB) Details: Filled in the specified format and verified by the port office.
- Label: Original label for the applied product.
- Export License Copy from SLA: Copy of the export license issued by the State Licensing Authority.
Key Streamlining Features
- Quantity-specific/PO-specific NOCs are largely discontinued, except for NDPS and banned drugs.
- NOCs will now have a 1-year validity or until the sanctioned amount is exhausted.
- Timeline for NOC issuance is set at 7 working days (5 working days for Step I, 2 working days for Step II).
- Provisions for using un-exported quantities for subsequent export orders are detailed, with specific residual shelf-life allowances (60% for formulations, 3 months for API); otherwise, physical destruction in the presence of SLA is mandated.
This new online system is expected to significantly enhance the efficiency, transparency, and accountability of drug exports from India, ensuring compliance with both national and international standards.