DGFT has removed restriction on the export of formulations made from Paracetamol(including FDCs)

DGFT vide Notification No. 03/2015-20 dated 17.04.2020 has removed restriction on the export of formulations made from Paracetamol(including FDCs), with immediate effect.

India is among the leading manufacturers of Paracetamol globally. Some of the major producers are Farmson Pharmaceuticals, Granules, Sri Krishna Pharma and Bharat Chemicals. The production capacity is estimated to be 5,000 tonnes a month. From an export perspective, it is a low value, high volume product.

Paracetamol and its formulations were among the 13 APIs and their formulations that figured in the March 3 notification. Barring Paracetamol and formulations made from it, the DGFT had on April 6 allowed export of the 12 APIs and formulations made from them. With the latest notification, only Paracetamol continued to be ‘Restricted’ for export.

The decision allowing export of formulations made from Paracetamol come close on the heels of another permitting shipment of anti-malarial drug Hydroxychroloquine (HCQ) to the US and several other countries.

Though the efficacy of HCQ to treat coronavirus is not yet clinically proven, it shot to prominence in the wake of US President Donald Trump recently describing the product as a “game changer.” He had also called Prime Minister Narendra Modi asking for release of the HCQ orders placed by the US, something India subsequently agreed to. Since then, besides to the U.S., the country has reportedly permitted export to a few more countries as well.

Pharmaceutical Export Promotion Council of India wanted the Centre to resume export of Paracetamol APIs too.

Pharmexcil Director General Ravi Uday Bhaskar had earlier represented to the DGFT to permit export of Paracetamol API and formulations that were manufactured prior to March 3 and stocked for shipment at the ports. Welcoming Friday’s decision, he said Pharmexcil will renew its appeal on the APIs to the DGFT.

Notification can be downloaded by clicking here

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