New Rules Enhance Regulatory Control Over Import and Export of Narcotic Drugs and Psychotropic Substances

The Ministry of Finance, Department of Revenue, issued a notification, G.S.R. 889(E), on December 10, 2025, introducing the Narcotic Drugs and Psychotropic Substances (Amendment) Rules, 2025. These rules were enacted in exercise of powers conferred by sections 4, 9, and 76 of the Narcotic Drugs and Psychotropic Substances Act, 1985 (Act 61 of 1985), and serve to further amend the existing Narcotic Drugs and Psychotropic Substances Rules, 1985. The primary objective of this amendment is to strengthen the regulatory framework governing the import and export of narcotic drugs and psychotropic substances, particularly for legitimate purposes such as manufacturing formulations (pharmaceutical preparations) for export and analytical use. The changes primarily affect importers, manufacturers, and exporters of these controlled substances, as well as the regulatory authorities responsible for their oversight. The rules came into force on the date of their publication in the Official Gazette.

A significant change introduced by the amendment is the substitution of Form No. 4A, which is now titled "CERTIFICATE OF OFFICIAL APPROVAL OF IMPORT UNDER THE PROVISO TO RULE 54 of the Narcotic Drugs and Psychotropic Substances Rules, 1985." This revised form mandates detailed information for import consignments, including the Item Number, Name and description of the drug, HSN Code (Harmonized System of Nomenclature code for goods), CAS No. (Chemical Abstracts Service Registry Number, a unique identifier for chemical substances), and the GSTIN (Goods and Services Tax Identification Number) of the importer. Crucially, the new Form 4A outlines stringent conditions for import. If the import is for manufacturing formulations for export, the manufacturer must ensure that no part of the imported drug is sold or used for domestic sale, and that the manufactured formulations are not diverted to the domestic market. They are also required to furnish export details, including shipping bills, bills of lading, and invoices, to the Narcotics Commissioner and the Drugs Controller General of India. Furthermore, manufacturers must obtain transport permits from State Excise authorities or State Food and Drugs Administration, maintain separate accounts for imported drugs and produced formulations, and submit monthly returns to the Narcotics Commissioner. Compliance with procedures prescribed in Rules 42, 45, 46, and 47 concerning security arrangements, accounts, returns, possession, sale, and distribution is also mandatory. For imports intended for analytical purposes, the importer must ensure the drug is used solely for analysis, inform the Narcotics Commissioner upon complete utilization, and adhere to procedures in Rules 42, 45, 46, and 47. The amendment also stipulates that any unutilised quantities of morphine, codeine, thebaine, and their salts or finished formulations for export must be surrendered to the Government Opium and Alkaloids Works, with accounting submitted to the Narcotics Commissioner. Additionally, Form No. 5, pertaining to the export of narcotic drugs or psychotropic substances, has been amended to require similar detailed information, including the HSN Code, CAS No., and GSTIN of the exporter.

The legislative intent behind these amendments is to enhance the accountability and traceability of narcotic drugs and psychotropic substances throughout their lifecycle, from import to export or analytical use. The earlier legal position under the Narcotic Drugs and Psychotropic Substances Rules, 1985, while comprehensive, necessitated updates to address evolving challenges in preventing diversion and ensuring legitimate trade. The changes specifically target potential statutory gaps related to the end-use monitoring of imported substances, particularly those intended for re-export or research. By introducing more detailed reporting requirements and explicit conditions, the rules aim to prevent the illicit diversion of these controlled substances into the domestic market. The legislation provided: “If the import is for manufacture of formulations for export, the manufacturer shall,- (a) ensure that no part of the drug imported under this certificate shall be sold or used to manufacture formulations for domestic sale; (b) ensure that the formulations manufactured out of the drug imported against this certificate shall not be diverted for domestic sale;” This core principle underscores the stringent controls now in place. The amendments introduce new obligations for importers and manufacturers, requiring meticulous record-keeping, regular reporting, and adherence to specified security protocols. The inclusion of HSN Code, CAS No., and GSTIN in both import and export forms reflects a policy rationale to integrate these regulations with broader trade and tax compliance mechanisms, thereby improving data accuracy and facilitating inter-agency coordination. The enforcement mechanisms are strengthened through mandatory reporting to the Narcotics Commissioner and the Drugs Controller General of India, coupled with the requirement to surrender unutilised drugs, ensuring a closed-loop system for highly sensitive substances. These measures collectively aim to reinforce India's commitment to combating drug trafficking while facilitating legitimate pharmaceutical and scientific activities.

Keywords: Narcotic Drugs, Psychotropic Substances, Amendment Rules, Import Export, NDPS Act, Form 4A, Form 5, Narcotics Commissioner, Drugs Controller General, Ministry of Finance, Revenue Department, India, Drug Control, Regulatory Compliance, Pharmaceutical Export, Analytical Use Geo Tags: India, New Delhi District: Not Applicable