Home India Ministry of Commerce and Industry Implementation of the Track and Trace system for export of P...
Date: 2016-04-21 Category: Extra Ordinary State: Union Government Country: India

Implementation of the Track and Trace system for export of Pharmaceuticals and drug consignments

Issued by Ministry of Commerce and Industry · Department of Commerce

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Executive Summary & Key Takeaways

Executive Summary: This public notice amends Para 2(v) of Public Notice No. 52/2015-2020, dated 05.01.2016, regarding the implementation of the track and trace system for the export of pharmaceuticals and drug consignments. It provides exporters with an option to adhere to specific requirements mandated by the government of the importing country, and specifies a procedure for seeking exemptions from Indian barcoding requirements. The amendment is effective from April 21, 2016. Key Points / Main Content: * **Amendment to Barcoding Requirements:** * If the importing country's government mandates a specific requirement, the exporter can adhere to that requirement. * In such cases, compliance with sub-paragraphs (i) to (iv) of paragraph 2 of the original public notice is not required. * **Exemption Application Process:** * Exporters seeking exemption from barcoding prescribed by the Government of India can apply to the Pharmaceuticals Export Promotion Council of India (Pharmexcil). * The application should clearly specify the nature of the exemption requested. * Pharmexcil will handle applications on a case-by-case basis, subject to prior approval from the Government. * **Tertiary Packaging:** * Regardless of importing country requirements, tertiary level packaging will still require additional barcoding as per Para 2(i)(c) of the Public Notice. * **Other Terms and Conditions:** * All other terms and conditions outlined in Public Notice No. 52/2015-20, dated 05.01.2016, remain unchanged. Impact Analysis: * **Exporters of Pharmaceuticals and Drug Consignments** * *Impact:* Greater flexibility in meeting importing countries' requirements and a pathway to seek exemptions from Indian barcoding mandates. * *Action Required:* Understand the amended regulations, assess importing country requirements, and, if seeking exemption from Indian barcoding, prepare and submit an application to Pharmexcil with clear justification. * **Pharmaceuticals Export Promotion Council of India (Pharmexcil)** * *Impact:* New responsibility for processing exemption applications from exporters. * *Action Required:* Establish a procedure for receiving, evaluating, and processing exemption applications, and obtaining prior approval from the Government on a case-by-case basis. * **Government of India** * *Impact:* Oversight role in approving exemptions granted by Pharmexcil. * *Action Required:* Review and approve or reject Pharmexcil's recommendations on exemption applications.

Key Entities Referenced

Foreign Trade Policy, 2015-2020: A policy document governing import and export activities. Director General of Foreign Trade: The authority amending the public notice related to foreign trade. Public Notice No. 52/2015-2020: A notification being amended regarding export regulations. Pharmaceuticals Export Promotion Council of India (Pharmexcil): An organization to which exporters can apply for exemptions related to bar coding requirements. New Delhi, Delhi: Location where the public notice was issued. Ministry of Commerce and Industry: The government ministry overseeing the Directorate General of Foreign Trade. Track and Trace system: A system being implemented for the export of pharmaceuticals and drug consignments. Anup Wadhawan: Director General of Foreign Trade
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