India removes export curbs on formulations from Paracetamol

Restrictions on export of the APIs remain

Updated - April 17, 2020 02:10 pm IST

Published - April 17, 2020 01:51 pm IST - HYDERABAD

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The Centre has permitted the export of formulations made from Paracetamol. The government has, however, decided to continue with the restriction on export of Paracetamol APIs that were placed, along with that on export of the formulations, on March 3.

On Friday, a Directorate General of Foreign Trade (DGFT) notification said the March 3 order is “further amended to the extent that the formulations made from Paracetamol, including FDC (fixed dose combinations), under any ITCHS code…, are made ‘Free’ for export with immediate effect. However, Paracetamol APIs will remain restricted for export.

A common fever medication globally, Paracetamol is the most sought after and widely used drug ever since the COVID-19 outbreak .

According to sources, 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.

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