In a significant policy shift, the Directorate General of Foreign Trade (DGFT), under the ministry of commerce and industry, has announced the withdrawal of Para 2.76 of the Handbook of Procedures (HBP) 2023. The provision, which previously mandated a Track and Trace system for export consignments of drug formulations, has been officially rescinded with immediate effect.
The withdrawal of this provision also means that the implementation of authentication mechanisms for exported drugs will now be overseen by the Union ministry of health and family welfare under the provisions of the Drug Rules, 1945.
The immediate impact of this decision includes a drastic regulatory shift. The responsibility for enforcing drug export authentication now transitions entirely to the Union ministry of health and family welfare.
The revised approach is expected to enhance efficiency while ensuring compliance with global pharmaceutical export standards.
The Track and Trace system, initially introduced under Para 2.90A of the Handbook of Procedures 2015-2020 and later incorporated as Para 2.76 in HBP 2023, aimed at ensuring the authentication and traceability of exported drug formulations.
Pharmaceutical exporters may need to align with new guidelines expected to be issued by the ministry of health and family welfare. Exporters currently adhering to the Track and Trace system will need to modify compliance strategies as per new regulatory frameworks.
Santosh Kumar Sarangi, director general of Foreign Trade and Ex-officio Additional Secretary, stated that the move is in line with ongoing regulatory restructuring to streamline the export compliance process.
The withdrawal of the Track and Trace system for exported drug formulations signifies a strategic regulatory shift, placing greater emphasis on compliance under the Drug Rules, 1945. Exporters and stakeholders in the pharmaceutical sector are urged to stay informed about forthcoming guidelines from the ministry of health and family welfare to ensure seamless compliance in international trade operations.
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