Centre allows export of 12 APIs\, formulations

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Centre allows export of 12 APIs, formulations

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Paracetamol, its formulations remain on the restricted list

A little over a month after it imposed restrictions on export of 13 specified Active Pharmaceutical Ingredients (APIs) and formulations made from them, the Centre has permitted the export of 12 of the APIs and their formulations with immediate effect.

API paracetamol and its formulations, however, continue to remain in the restricted for export list.

On Monday, the Directorate General of Foreign Trade (DGFT) issued a notification in this regard amending most of its March 3 order in which it had imposed curbs on export of the 13 APIs and formulations made from them.

Twelve APIs and their formulations are “made ‘Free’ for export, with immediate effect,” Director General of Foreign Trade Amit Yadav said in the latest notification. The list includes Vitamin B1, B6 and B12, Acyclovir, Erythromycin Salts, Neomycin and their formulations.

The Pharmaceuticals Export Promotion Council of India (Pharmexcil), which had expressed concern on the export restrictions and represented to the DGFT, is keen on paracetamol and its formulations being also taken off from the list.

“Paracetamol and its formulation should also be exempted,” Ravi Uday Bhaskar, Director General of Pharmexcil said.

In its representation, the Council Pharmexcil had said most of the manufacturers and exporters have manufactured the listed items before the COVID-19 outbreak. “They have planned and committed to ship the consignments to their customers in agreed timelines,” it said.

Also, the Council had sought to highlight how the formulations manufactured for exports, as per the specific country’s pharmacopoeia specifications/labels/printing material used) cannot be diverted or utilised in the domestic market. Even the APIs manufactured with USP/BP specification cannot be utilised for manufacture of domestic formulations.

Subsequently, DGFT had allowed certain relaxations with regard to export of the APIs and formulations.

While export of the 12 APIs and formulations made from them have been permitted, a lot on the ground would depend on logistics. Pharmexcil had recently cited transportation and manpower constraints as a result of the Covid-19 situation.

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