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The Department of Commerce (DoC), Government of India (GoI), has sought detailed inputs from Indian pharmaceutical exporters on regulatory and market access issues faced in the European Union (EU). The exercise is being coordinated through the Pharmaceuticals Export Promotion Council of India (Pharmexcil) to strengthen India's position during the proposed discussions between the Union Minister of Commerce & Industry and the EU Trade Commissioner on issues affecting India's pharmaceutical exports.
The DoC has asked Pharmexcil to compile industry-specific information on the regulatory hurdles encountered by Indian pharmaceutical companies exporting to the EU. The compiled data will support the government's engagement with the EU on trade and regulatory matters impacting the pharmaceutical sector.
Pharmexcil has urged all member companies exporting pharmaceutical products to the EU to submit comprehensive details of the challenges they face. Exporters have been asked to provide quantitative information, including the number of pending regulatory applications, the current status of approvals, approval timelines, financial implications, export value affected, and any other relevant details that can substantiate their concerns.
To ensure uniform collection of information, pharma exporters have been directed to submit their responses through an online form. They have also been requested to upload supporting documents wherever available. These may include correspondence with EU regulatory authorities, inspection requests, approval timelines, and other documentary evidence that can strengthen India's case during the forthcoming discussions.
Highlighting the importance of the exercise, Raja Bhanu, Director General, Pharmexcil, said, "The DoC, GoI, has requested Pharmexcil to compile industry-specific data on regulatory and market access challenges faced by Indian pharmaceutical exporters in the European Union. The information will be utilized to support discussions proposed to be held between Commerce Ministry and the EU Trade Commissioner on issues impacting India's pharmaceutical exports."
He further urged exporters to participate actively by providing detailed and evidence-based submissions, stating that the information would help present industry concerns more effectively during the high-level engagement with the EU.
According to an official, “The Commerce Ministry has taken this initiative to address regulatory barriers, improve market access for Indian pharmaceutical products in the EU, and support the continued growth of India's pharmaceutical exports through constructive bilateral dialogue.”
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