Pharmexcil urges govt to lift restriction on export of Remdesivir & Amphotericin-B injections

At present India is well stoked to meet any emergency demand for the said medicaments.

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Pharmexcil export of drugs

Last Updated on November 27, 2021 by The Health Master

The Pharmaceuticals Export Promotion Council of India (Pharmexcil) has urged the Union ministry of commerce and industry to lift the restriction on export of remdesivir and amphotericin-B injections considering the current circumstances of a reduction in the local caseload of Covid-19 and associated mucormycosis cases.

“This will allow the manufacturers to export surplus production to other countries so that countries and patients in need of these injections can benefit from the same supplies in a timely manner.” In a representation to BVR Subrahmanyam, “Where there is a peak in patient load/cases in India, the said restriction on the export of these products can be reintroduced.”

The removal of restrictions on remdesivir and amphotericin-B exports not only benefits patients across the globe, it would also facilitate the industry’s reaching the overall export target of US$ 400 billion set by the Prime Minister and a target of US$ 29 billion set for the pharma sector, it said.

The council has also sent representation to Amit Yadav, director general, Directorate General of Foreign Trade (DGFT), S Aparna, secretary, Department of Pharmaceuticals (DoP), Rajesh Bhushan, secretary, Ministry of Health & Family Welfare in this regard.

To ensure the availability of these medicines to needy patients during the second wave of C-19 in the country, DGFT put in place export restrictions for remdesivir and amphotericin B injections via notifications dated June 14, 2021 and June 1, 2021, respectively.

During the second wave of C-19 in the country, there was a huge demand for remdesivir injections as well as for antifungal medicine (‘amphotericin B” injections required for the treatment of mucormycosis (black fungal infection cases).

To meet domestic demand, a number of manufacturers and importers with permission from DCG(I) scaled up their production and bolstered India’s production capacity of remdesivir and amphotericin-B injections. At present India is well stoked to meet any emergency demand for the said medicaments.

“As a result of India’s multi-pronged strategy, daily reported C-19 cases have decreased from a peak of over 4 lakh cases per day in May 2021 to less than 10,000 cases per day now, which is less than 3 percent of the caseload in May 2021.

As 80 percent of the eligible population got vaccinated with at least one dose of the C-19 vaccine, the number of active C-19 cases had begun to decline, and the instances of mucormycosis have also seen an improvement, with a lesser number of cases being reported in recent months.

Hence, the domestic demand for remdesivir and amphotericin-B injections has reduced relatively, and the pharma industry has also ramped up the production of these medicines substantially to meet the demand of both domestic and export markets, ” said Sahil Munjal, chairman, Pharmexcil.

Amphotericin-B injections are not only used to treat mucormycosis but also to treat a variety of serious, possibly fatal fungal infections. There is a growing surge in export requests from countries in need of our help for these essential medicines for C19 and black fungal infection as several countries across the globe are still trying to keep C-19 and its related diseases under control.

Pharmexcil members are regularly receiving queries and orders from countries in need of these medicines. Many consonments are already prepared and awaiting dispatch, said Munjal.

“While the industry is fully cognizant of the pandemic and is putting in its best effort to ensure drug security, access, and availability in close coordination with the DoP, currently with existing restrictions on the export of remedesivir and amphotericin-B injections, special approvals need to be obtained for exports of restricted categories of products for every consignment.

Though DGFT is issuing each export permission on a case-by-case basis based on recommendation received from the DoP, the entire process of export approval takes a significant number of days for each export application.

With delayed clearances for export permissions, the overseas buyer cancels orders and imposes legal liabilities for non-fulfillment of export commitments. This impacts the perception, reliability, business continuity and export ability of the Indian pharma industry,” he said.

Earlier, on August 23, 2021, Pharmexcil had submitted a detailed representation with a request for relaxation for exports of remdesivir injections.

The council had on November 22 once again requested a relaxation of the restrictions on both remdesivir and amphotericin-B exports in the wake of a decline in C-19 cases as well as associated mucormycosis cases.

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