The Narcotic Drugs and Psychotropic Substances (Amendment) Rules, 2025

The Ministry of Finance, Department of Revenue, has issued a significant notification on December 10, 2025, introducing amendments to the Narcotic Drugs and Psychotropic Substances Rules, 1985. This notification, published in the Official Gazette, marks a pivotal step in regulating the import and export of narcotic drugs and psychotropic substances in India. Here’s a detailed overview of the changes and their implications.

Key Highlights of the Notification

1. Title and Enforcement

The amended rules are officially titled the Narcotic Drugs and Psychotropic Substances (Amendment) Rules, 2025. These rules came into effect on the date of their publication in the Official Gazette, i.e., December 10, 2025.

2. Amendments to Form No. 4A

The notification introduces a revised Form No. 4A, which serves as the Certificate of Official Approval of Import under Rule 54 of the Narcotic Drugs and Psychotropic Substances Rules, 1985. This form is issued by the designated authority to approve the importation of narcotic drugs into India.

The updated form includes the following details:

Item Number
Name and Description of Drug
HSN Code
CAS Number
GSTIN of Importer

The certificate specifies the conditions under which the import is permitted, such as:

The consignment must be imported within 180 days from the date of issue of the certificate.
If the import is for manufacturing formulations for export, the drugs must not be sold or used for domestic purposes.
Importers must maintain detailed accounts of the imported drugs, formulations produced, and exported consignments.
Monthly returns of receipt, consumption, and export must be submitted to the Narcotics Commissioner.
Compliance with security arrangements, possession, sale, and distribution procedures as per Rules 42, 45, 46, and 47.

For imports intended for analytical purposes, the importer must ensure the drugs are used solely for analytical purposes and report their complete utilization to the Narcotics Commissioner.

3. Amendments to Form No. 5

The notification also revises Form No. 5, which pertains to the export of narcotic drugs or psychotropic substances. The updated table in Form No. 5 now includes:

Item Number
Number of Packages
Name of Drug Substance/Preparations
Basic Drug Substance Content
HSN Code
CAS Number
GSTIN of Exporter

These changes aim to enhance transparency and accountability in the export process.

Conditions for Import and Export 

The notification outlines strict conditions for both import and export of narcotic drugs and psychotropic substances. These include:

Ensuring no diversion of imported drugs for domestic use.
Maintaining detailed records of all transactions.
Submitting monthly returns to the Narcotics Commissioner.
Complying with security arrangements and procedures for possession, sale, and distribution.

Additionally, any unutilized quantities of morphine, codeine, thebaine, and their salts or finished formulations for export must be surrendered to the Government Opium and Alkaloids Works. Importers are required to submit accounting details to the Narcotics Commissioner at the end of the import/export period.

Implications of the Amendments

The amendments to the Narcotic Drugs and Psychotropic Substances Rules, 1985, reflect the government’s commitment to strengthening the regulatory framework for narcotic drugs and psychotropic substances. By introducing stricter conditions and detailed documentation requirements, the government aims to:

Prevent the misuse and diversion of narcotic drugs for unauthorized purposes.
Ensure compliance with international standards for the import and export of controlled substances.
Enhance transparency and accountability in the trade of narcotic drugs and psychotropic substances.

These changes are particularly significant for businesses involved in the pharmaceutical industry, as they will need to adhere to the updated rules to ensure smooth operations and avoid penalties.

Conclusion

The Narcotic Drugs and Psychotropic Substances (Amendment) Rules, 2025, are a crucial step in regulating the import and export of narcotic drugs and psychotropic substances in India. By revising key forms and introducing stringent conditions, the government aims to curb misuse and ensure compliance with national and international regulations. Businesses and stakeholders in the pharmaceutical and analytical sectors must familiarize themselves with these changes to ensure adherence to the law and contribute to a safer and more regulated industry.

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Source: Ministry of Finance

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