Significant Reforms in NDPS Rules 2025: Key Changes in Import and Export Procedures

On 10-12-2025, the Ministry of Finance notified the Narcotic Drugs and Psychotropic Substances (‘NDPS’) (Amendment) Rules, 2025 to introduces significant procedural reforms to the import and export of narcotic drugs.

These provisions came into effect on 10-12-2025.

Key Points of NDPS Amendment Rules 2025:

1. The Amendment Rules have been issued under Sections 4, 9, and 76 of the Narcotic Drugs and Psychotropic Substances Act, 1985, to revise Narcotic Drugs and Psychotropic Substances Rules, 1985 (NDPS Rules).

2. The changes primarily focus on revising Form 4A and Form 5 of the NDPS Rules to:

   • Strengthen compliance and accountability.

   • Enhance traceability of narcotic substances.

   • Align domestic procedures with international narcotics control standards.

3. New Form No. 4A for Import Approval

   1. The previous Form 4A has been replaced with a detailed format for issuing import certificates under Rule 54.

   2. The form now includes:

      ❖ Item description, HSN Code, CAS number, GSTIN of importer.

      ❖ Conditions for import, including:

      ⮚ Import within 180 days from certificate issue date.

      ⮚ Port of entry specification.

      ⮚ Compliance with security, accounting, and reporting procedures under Rules 42—47.

   3. For manufacturing formulations for export:

      • No diversion for domestic sale.

      • Mandatory submission of export details (shipping bills, invoices) to the Narcotics Commissioner and Drugs Controller General of India.

      • State-level transport permits required.

      • Monthly returns and separate accounts for imported drugs and manufactured formulations.

   4. For analytical purposes:

      ❖ Strictly limited to analysis.

      ❖ Complete utilization reporting to the Narcotics Commissioner.

4. Any unutilized morphine, codeine, thebaine, or their salts/formulations will be surrendered to the Government Opium and Alkaloids Works, with proper accounting.

5. Revised Form No. 5 for Export: The export documentation table has been updated to include:

   • Number of packages.

   • Drug name and preparation details.

   • Basic substance content.

   • HSN Code, CAS number, and GSTIN.