Coronavirus | Pharma units in limbo amid confusion over hydroxychloroquine exports

Coronavirus | Pharma units in limbo amid confusion over hydroxychloroquine exports

Despite the External Affairs Ministry’s nod, the Directorate General of Foreign Trade maintains that the drug is still prohibited for export.

A week after the Ministry of External Affairs (MEA) announced that it would “license” the malaria drug hydroxychloroquine (HCQ) and supply it to various countries on a “government to government basis”, the Directorate General of Foreign Trade (DGFT) maintains that the drug is still prohibited for export, causing some confusion in industry circles.

“There is huge capacity in our industry for both HCQ and paracetamol production. But our manufacturers, especially the MSMEs and SMEs are confused about the process, given the DGFT’s notification banning exports.” Dinesh Dua, Chairman of the Pharmaceutical Export Promotion Council of India told The Hindu.

Stuck in warehouses

“Some small exporters have tonnes of finished goods lying in their FG warehouses and some at ports which is not being exported because of lack of clarity on the procedure,” he added.

“We are receiving many queries from various manufacturers due to this discrepancy; there is no transparency in the process at present as nothing is on paper officially,” said an official from another industry group, who asked not to be identified.

On Sunday, the government said it had cleared the release of HCQ for 13 countries.

“After making an assessment of the domestic requirement and keeping a buffer, which is assessed on a weekly basis by the Empowered Committee, a Group of Ministers had approved the release,” the Press Information Bureau spokesperson said at the daily press briefing on COVID-19 in Delhi.

The first shipment of HCQ landed in the U.S.’s Newark airport on Sunday, a week after Mr. Trump had called PM Modi to ask for the release of the drug orders placed by the US.

However, a number of industry sources pointed out that the decision to allow the exports has not yet been notified by DGFT, even though it had uploaded its previous two notifications of March 25 (54/2015-2020) and April 4(01/2015-2020) which banned the export of HCQ “without any exceptions”, and kept paracetamol on a restricted list.

As a result many manufacturers, especially smaller companies, say customs officials are not clearing their consignments of HCQ and paracetamol.

India is the lead producer for HCQ, an anti-malarial drug, while Indian-made paracetamol is used as a fever medication worldwide.

The sources pointed to a number of hurdles in exports, at a time when global demand is at its highest. A Hyderabad-based company, for example, reportedly has 1,000 tonnes of paracetamol that has been indented for, but is unable to send the shipment out.

Others said that none of the major markets in Africa, Latin America, and CIS countries had yet been cleared for the export of HCQ, at a time when demand from them is at its peak.

More confusion arose after Israeli Prime Minister Benjamin Netanyahu thanked Mr. Modi for HCQ supplies, although Israel is not on the list of companies cleared, and will probably receive them from the quotas cleared for the U.S. through a Tel Aviv based American company

Global market

“The Indian pharmaceutical industry has been painstakingly built over 25 years with a market of $22 billion to 206 countries. It would be a tragedy if we are not allowed to use our strength at this time when the world needs these products, by placing orders and even paying in advance and still unable to get these spareable medicines with huge capacity in India,” Mr. Dua said.

He added that several industry groups plan to petition the Commerce Ministry and the Ministry of External Affairs to clarify the rules for export.

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