Why India hasn't prescribed Remdesivir yet | Economic Times

New Delhi: India will allow Remdesivir to be sold in India only if it shows “meaningful benefit” in the treatment of Covid-19, the country’s drug regulator said.The US has given emergency approval to use the antiviral drug for the treatment of critical Covid-19 patients. On Thursday, Japan too granted similar approval for the drug, originally developed to treat Ebola.Drug controller general of India VG Somani told ET that the local regulator had taken note of the caveats that drug developer Gilead Science had disclosed while launching it in Japan. The US company has said it was not yet known if Remdesivir was “safe or effective” for the treatment of Covid-19. It also said there was a possibility of “unfavourable” results emerging from additional clinical trials.Cos Yet to Approach Regulator“It’s important to see the safety and efficacy of the drug even if the other countries decide to go ahead with it. We will see how beneficial the drug is in the present circumstances and then only allow it to be used,” Somani added.As reported by ET, Gilead has been in talks with several companies in India for granting voluntary licences for manufacturing the drug. While Somani said the Indian companies were yet to approach the drug’s regulatory authority, the health ministry held a video conference last week with senior executives of Indian companies such as Hetero, Jubilant Lifesciences and Cipla to understand their preparedness to make the drug.India is cautious because of Gilead’s declaimer on the possibility of unfavourable results from additional clinical trials and that the company and other parties might be unable to complete one or more of such trials in the currently anticipated timelines, or complete them at all.Gilead also said it could decide to discontinue development of Remdesivir or that the US Food and Drug Administration (FDA) and other regulatory agencies might not approve it. Also, any marketing approvals, if granted, may have significant limitations on its use. “As a result, Remdesivir may never be successfully commercialised,” it said.The Emergency Use Authorization the drug has got in the US allows it to be administered by doctors in hospitals treating patients with severe Covid-19.“The approval by the US FDA under the current circumstances adds weightage but necessary checks will have to be ensured before we try the drug on Indian population,” Somani said.