Pharmexcil urges govt to lift restriction on export of remdesivir and amphotericin-B injections

Mumbai, November 25, 2021:

The Pharmaceuticals Export Promotion Council of India (Pharmexcil) has urged the Union ministry of commerce and industry to lift restriction on export of remdesivir and amphotericin-B injections considering current circumstances of reduction in 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 scenario, where there is a peak in patient load/cases in India, the said restriction on export of these products can be reintroduced,” stated Pharmexcil in a representation to BVR Subrahmanyam, secretary, ministry of commerce on November 22, 2021.

The removal of restriction on remdesivir and amphotericin-B exports not only benefits the patients across the globe, it would also facilitate the industry to reach 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 the needy patients during the second wave of Covid in the country, DGFT had put in place export restrictions for remdesivir and amphotericin B injections vide notifications dated June 14, 2021 and June 1, 2021 respectively.

During the second wave of Covid in the country, there was a huge demand for remdesivir injections as well as for antifungal medicine 'amphotericin B' injection required for 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 Covid 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 per cent of the caseload in May 2021. As the 80 per cent of eligible population got vaccinated with at least one dose of Covid vaccine, the number of active Covid cases had begun to decline and the instances for mucormycosis have also seen an improvement with a lesser number of cases being reported in the recent months. Hence the domestic demand for remdesivir and amphotericin-B injections have 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 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 Covid and black fungal infection as several countries across the globe are still trying to keep Covid-19 and its related diseases under control. Pharmexcil members are regularly receiving queries and orders from countries in need of these medicines and many consignments lined up 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 export of remedesivir and amphotericin-B injections, special approvals need to be taken 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 for relaxation of the restrictions on both remdesivir and amphotericin-B exports in the wake of decline in Covid-19 cases as well as associated mucormycosis cases.

PharmaBiz