Pharmexcil requests DGFT for guidelines on procedural formalities to export paracetamol, HCQ

India has already shipped 35.82 lakh tablets of hydroxychloroquine to the US, and 11.7 lakh paracetamol tablets to the UK

The Pharmaceuticals Export Promotion Council of India (Pharmexcil) has requested the Directorate General of Foreign Trade (DGFT) to issue guidelines about the procedural formalities that need to be followed by pharma companies to obtain permission to export formulations of paracetamol and hydroxychloroquine (HCQ).

Dr Dinesh Dua, Chairman, Pharmexcil informed, “We have made our representation on April 13, 2020, requesting the DGFT to issue guidelines for the industry about the procedural formalities to get permission to export paracetamol and hydroxychloroquine. However, for our members, we have prepared reference guidelines to obtain permission for the export of these drugs.”

Many countries across the globe had asked India to relax its ban on exports of paracetamol and HCQ, both used in COVID-19 treatment. On April 7, the Ministry of External Affairs had informed that the Indian government would license paracetamol and HCQ in appropriate quantities to all our neighbouring countries who are dependent on our capabilities. The government will also supply these essential drugs to nations who have been badly affected by the pandemic.

Within a week’s time, on the request of President Donald Trump to PM Modi, India has shipped 35.82 lakh tablets of hydroxychloroquine to the US, with nine metric tons of active pharmaceutical ingredients (API) which is required in the manufacturing of the drug.

11.7 lakh paracetamol tablets manufactured by Indoco Remedies was also sent to the UK, as part of the Government initiative to fight against novel coronavirus (COVID-19). The entire consignments were airlifted on April 12 from Goa airport, and the permission granted by the Government for a total air shipment of 4.48 crore tablets. The remaining quantity is ready for shipment and will be airlifted depending on availability of flights. The spokesperson of Indoco Remedies said, “We are thankful for the Government’s guidance as well as support in executing the paracetamol consignments to the UK. Besides this, we have not received any intimation from the Ministry of External Affairs, Government of India for paracetamol consignments to any other country.

It is understood that the requests received by the Ministry of External Affairs, Government of India from the Embassy/ Health Ministry/ other Government officials of the importing countries for the supply of these drugs would be examined by concerned departments of our country on a case-by-case basis and accordingly, the consignments may be released for export.

Therefore, importing partners of paracetamol and HCQ have requested the embassy officials of their countries to send a detailed representation to the Ministry of External Affairs (MEA), Government of India ([email protected]) specifying the need of the country for these medicines, the quantity required, details of Indian manufacturer/exporter as well as the details of importers. Details of shipment(s) may be furnished in the DGFT proforma for processing permissions to export. The request/s received by the MEA will be assessed /examined by the Department of Pharmaceuticals along with Drugs Control General of India (DCG(I)). Upon clearance from these departments, permission to export will be granted to the exporter.

Since there are no specific guidelines available presently, Pharmexcil has prepared reference guidelines for its member companies to extend export support (Check the box below)

However, Bhavin Mehta, Director, Kilitch Drugs has expressed concerns about the complexities of getting export permissions. He said,” “The procedure set by the government is very cumbersome for any MSME to get the export permissions. Moreover, MSMEs are in such hard times and overburdened by unfulfilled export orders. Goods are lying at the port, they are ready for dispatch and manufactured for exports, but now we have to follow-up with five departments for one simple permission, and that is a daunting task.

He recommended, “The Government should have taken into consideration and representation made by SPMPA, IDMA, Pharmexcil, FOPE and other associations to allow ‘Free Exports’ as there is enough stock of paracetamol, raw materials and tablets. To substantiate this stand, enough data has been submitted to the Ministry and a more humanitarian approach by the Government will help India regain its title of ‘Pharmacy of the World’.

VV Krishna Reddy, Director of Sri Krishna Pharma and President, Bulk Drug Manufacturers Association did not choose to comment on this development.

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