|
Pharma exporters hail removal of export curb on Covid drugs--remdesivir, amphotericin-B, enoxaparin, IVIG
|
|
Laxmi Yadav, Mumbai
February 26 , 2022
|
|
|
The Director General of Foreign Trade (DGFT) has lifted restriction on export of remdesivir injection and API, amphotericin-B injections, enoxaparin (formulation and API), and intravenous immunoglobulin (IVIG) with immediate effect thus bringing cheers to drug exporters.
The export restriction was removed by DGFT on February 24, 2022 at a time the Covid-19 pandemic in the country is relatively under control with decreasing daily caseload.
Hailing the DGFT’s decision to remove restriction on export of remdesivir & amphotericin-B injections, enoxaparin and IVIG, Sandeep Modi, secretary, Federation of Pharmaceutical and Allied Products Merchant Exporters (FPME) said “The removal of restriction on export of these drugs 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.”
He expressed token of appreciation for Pharmaceuticals Export Promotion Council of India (Pharmexcil) chairman Sahil Munjal, vice chairman SV Veeramani, Nipun Jain, chairman of Small and Medium Pharma Manufacturers Association (SMPMA), Dr Viranchi Shah, national president of Indian Drug Manufacturers’ Association (IDMA) and Kamlesh Shah, president, FPME who had taken up the matter with concerned authorities time and again.
Earlier Pharmexcil had 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.
The council had also sent representation to Amit Yadav, director general, DGFT, S Aparna, secretary, Department of Pharmaceuticals (DoP), Rajesh Bhushan, secretary, ministry of health & family welfare in this regard.
The directorate had on January 10, 2022 imposed restrictions on export of anticoagulant enoxaparin (formulation and API) and IVIG to ensure their adequate supply in the domestic market amid the rising cases of Covid-19 and Omicron variant in the country.
Enoxaparin is being used for therapeutic mitigation of Covid associated coagulopathy (CAC). Patients with Covid-19 are at high risk of developing a venous thromboembolism (VTE). Studies have suggested that enoxaparin significantly reduces venous thromboembolism and is also associated with reduced all-cause mortality.
There is strong evidence indicating that a cytokine storm occurs during the evolution of SARS-CoV-2 infection. The development of cytokine storm leads ultimately to the necrosis of epithelial cells, increased permeability of vascular cells, and abnormal cellular and humoral immunity, eventually resulting in acute lung injury, acute respiratory distress syndrome (ARDS), and death.
Clinical data on the effect of enoxaparin on Interleukin-6 (IL-6) level have been already documented several years ago. IL-6 is involved in Covid-19-associated cytokine storm.
On the other hand, IVIG which are produced from thousands of pooled plasma donations contain antibodies the donors have generated against SARS-CoV-2. IVIG can therefore protect people with immune deficiencies against the coronavirus.
IVIG is one of the alternative treatments for Covid-19 patients. It is considered a therapeutic option for hyper inflammation in patients with severe Covid-19.
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).
Remdesivir is an injectable antiviral drug manufactured by US based Gilead Sciences Inc. It is the first drug to have received approval from the US Food and Drug Administration (FDA) in October 2020, making it the first medicine for treating Covid-19 infections. It is said to shorten the recovery of the patients by controlling the multiplication of the virus within.
Seven Indian companies - Mylan, Hetero, Jubilant Life Sciences, Cipla, Dr Reddy's, Zydus Cadila and Sun Pharma entered licensing pact with Gilead Sciences to manufacture remdesivir injections.
The total installed capacity of the seven manufacturers of remdesivir was 38.80 lakh vials per month until the government had stepped in last year and announced setting up of seven additional sites with a production capacity of 10 lakh vials per month to meet the rising demand of the drug during the second wave of the pandemic.
|
|
|
|
|
|
|
|
TOPICS
|
That foods might provide therapeutic benefits is clearly not a new concept. ...
|
|
|
|
|