India To Demand Quick Inspection of Pharma Companies By USFDA

India Pharma Outlook Team | Thursday, 11 January 2024

 India Pharma Outlook Team

At the Trade Policy Forum (TPF) meeting, India will strongly demand that the American health regulator expedite its USFDA inspections or audits of domestic pharmaceutical firms, lift the export ban on wild caught shrimp, and raise the issue of export control regulations for high-tech products and technologies, according to an official. The 14th TPF meeting will be co-chaired by US Trade Representative Katherine Tai and Commerce and Industry Minister Piyush Goyal here.

The Indian side will also raise the issue of reinstating the Generalized System of Preferences (GSP) status to India, the official said, as per economic times.

To sell pharmaceuticals in the United States, you must first obtain FDA permission. Before issuing permission, USFDA officials inspect the premises of production units to ensure quality standards.The official stated that at the discussion, the Indian side will address the subject of expediting USFDA inspections/audits of Indian pharmaceutical manufacturing units via digital or physical means in order to return to pre-pandemic levels.

America is India's main export market for pharmaceutical products, with current shipments of USD 6.79 billion (April-February 2023), accounting for about 30% of India's global exports. Exports to the United States have grown at a rate of 6.7% during the last five years.

Following the pandemic, the USFDA suspended inspections and audits in India for an extended length of time before resuming them, resulting in a massive backlog that impacted product and unit approvals/renewals.

India will also highlight the subject of export control restrictions for high-tech items and technologies, as the country has indicated interest in being recognized as a Trade Agreements Act (TAA) designated country by the United States.

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