DGFT imposes restriction on export of anticoagulant enoxaparin and intra-venous immunoglobulin

Mumbai, January 11, 2022:

Amid the rising cases of Covid-19 and Omicron variant in the country, the Directorate General of Foreign Trade (DGFT) has imposed restriction on export of anticoagulant enoxaparin and intravenous immunoglobulin (IVIG) active pharmaceutical ingredients and their formulations to ensure their adequate supply in the domestic market.

The export of enoxaparin (formulation and API) and intravenous immunoglobulin (formulation and API) has been put under restricted category with immediate effect, DGFT stated in a circular on January 10, 2022.

With this, export of these APIs and formulations requires licence from the DGFT. Earlier, there were no restrictions on outbound shipments of these products.

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, intravenous immunoglobulins 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.

It may be recalled that DGFT had on March 3, 2020 put restriction on export of 13 APIs and their formulations-- paracetamol, tinidazole, metronidazole, acyclovir, vitamin B1, vitamin B6, vitamin B12, progesterone, chloramphenicol, erythromycin salts, neomycin, clindamycin salts, ornidazole with immediate effect and till further orders to ensure their sufficient supply in the country.

The directorate had lifted export restrictions on these APIs and formulations in April 2020. Pharmabiz