DCGI allows restricted emergency use of Remdesivir for treatment of COVID-19 patients

Amid the Coronavirus pandemic, the Central Drugs Standard Control Organisation considered an emergency and unmet medical need for COVID-19 and has approved restricted and emergency use of Remdesivir injectable formulation for treatment of patients with severe COVID-19 infection subject to conditions and restrictions.

Remdesivir is the first drug that showed positive results in COVID-19 patients in formal clinical trials. It was granted emergency use authorization by the US Food and Drug Administration last month and has received approval by Japanese health regulators. 

Drugs Controller General in a letter to Drugs Controller of all States/UTs has requested them to instruct their enforcement officials to keep a strict vigil on the matter to prevent the black-marketing and sale of the drug Remdesivir Injection above MRP. 

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READ: EU approves use of remdesivir to treat severe cases of coronavirus

First drug authorised at EU level 

European Medicines Agency (EMA) recommended the drug be approved for treating patients who require supplemental oxygen. Anti-viral medicine is reportedly the only anti-coronavirus medication to be given the green light in the European Union. The EU Commission earlier this week also said that they had begun negotiations with remdesivir manufacturer Gilead Sciences in a bid to secure doses for the EU member states. 

According to the press note released by the EU, “Remdesivir is now authorised for conditional marketing authorisation, one of the EU regulatory mechanisms created to facilitate early access to medicines that fulfill an unmet medical need, including those for emergency situations in response to public health threats such as the current pandemic”. 

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