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FPME seminar on DGFT’s new eBRC system focuses on quality assurance in pharma products
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Shardul Nautiyal, Mumbai
July 19 , 2024
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The Federation of Pharmaceutical and Allied Products Merchant Exporters (FPME) hosted a seminar on July 17 in Mumbai with the focus on developing a comprehensive certification framework for assuring quality in pharmaceutical products for merchant exporters. This initiative complemented with the enhanced electronic Bank Realisation Certificate (eBRC) system recently implemented by the Directorate General of Foreign Trade (DGFT).
R K Mishra, additional director general of foreign trade (DGFT), highlighted that the new eBRC module represents a substantial boost to the ease of doing business and e-governance. The system's digitisation and integration are expected to reduce processing times, minimize errors, and improve overall efficiency for exporters.
Mihir Shah from Universal Connections as the keynote speaker, focused on understanding the new eBRC module's purpose, methodology for creating eBRCs, and the services provided under the new system.
Sandeep Modi, joint secretary of FPME conducted the proceedings of the session.
Key highlights of the seminar included understanding the New eBRC Module. The seminar began with an overview of the new eBRC module on the DGFT website, highlighting its purpose and the necessity for a more streamlined and efficient process. Attendees were provided with a detailed explanation of the actual methodology for creating eBRCs in the new system, aiming to demystify the process for exporters.
The system allows exporters to search and view inward and outward remittances uploaded by banks against their PAN. Outward remittances are auto-linked to the corresponding inward remittances, simplifying tracking and management.
Exporters can now self-certify and generate eBRCs against one or multiple inward remittances based on self-certification criteria, significantly reducing administrative burden. The module provides the ability to search, view, and cancel unutilized self-certified eBRCs, ensuring greater control and flexibility. Exporters can request and download utilization reports for inward remittances linked to shipping bills/invoices and eBRCs, enhancing transparency and accountability.
Dharmesh Kharwar from NGB Laboratories Pvt. Ltd. and Dharmesh K Advisors proposed a unique scheme for additional assurance on top of basic certifications provided by manufacturers. Key aspects of the proposal include certification based on specific requirements. The scheme aims to certify products and plants based on the unique needs of each merchant exporter, ensuring compliance with various international regulations.
The proposal discussed that experts in quality control and assurance, good manufacturing practices (GMP), and other relevant fields will conduct on-site inspections to verify that facilities meet stringent standards. FPME will maintain a database of certified suppliers and manufacturers, promoting transparency and reliability within the industry.
“The initiative seeks to collaborate closely with industry regulators to ensure the success and credibility of the certification process. The initiative is designed to cater specifically to merchant exporters who may not have full-fledged manufacturing facilities but still aim to maintain high standards of quality and compliance. By implementing this certification scheme, FPME seeks to enhance export quality. It is poised to assure international customers of the quality and safety of exported pharmaceutical products. This will help exporters meet the regulatory requirements of over 100 countries, thereby facilitating smoother market access and promote industry standards. This will set a benchmark for quality and compliance within the pharmaceutical export industry,” explained Dharmesh Kharwar.
FPME members and other stakeholders were urged to actively participate in future workshops and events to stay informed about the latest developments in export certification and compliance.
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