The country’s top drug regulatory body, the Central Drugs Standard Control Organisation’s (CDSCO), on Saturday granted emergency use approval to two Indian drugmakers for generics of Gilead Science’s remdesivir, The Indian Express has learnt. These approvals will allow Cipla and Hetero Drugs to manufacture and supply the injectible medicine for the treatment of suspected or laboratory-confirmed cases of COVID-19 “with severe disease”, ending weeks of uncertainty over where they can access the drug from.
Drug Controller General of India Dr VG Somani approved these applications late on Saturday, said a senior Health Ministry official on condition of anonymity. The companies will have to follow the same conditions set out by the DCGI for Gilead when its remdesivir was approved at the beginning of the month.
“Hetero and Cipla have just got approval. The documents and samples they had submitted were extensively assessed before the approval was granted,” the official told The Indian Express.
Remdesivir is to be administered for a maximum of five days, as per the country’s clinical management guidelines. “This is a boon for the country. We are hoping these companies will be able to supply (remdesivir) to as many patients that require it in India, maybe more,” the official added. Four other companies — BDR Pharmaceuticals, Jubilant Life Sciences, Mylan Laboratories and Dr Reddys Laboratories — are still yet to get the final approvals, according to the official.
“The samples of the other companies are still to come and their test reports are yet to be made, but that too will be done,” they said.
Cipla and Hetero have not officially confirmed the development and queries to the companies on Saturday night remained unanswered by press time. The development is crucial as there has been a surge in demand for the drug here, but little clarity on where patients could get approved supply. Gilead, when receiving the approval, had stated on June 3 that there was “limited global supply” of the medicine and that it was anticipating new supply in July.
In the absence of such supply, patients had been procuring it from generic drug makers given the Central Drugs Standard Control Organisation’s (CDSCO) approval to supply their product on compassionate grounds. In other cases, some patients had even been attempting to import the drug from countries like Bangladesh, which another official had earlier said was not approved by CDSCO.
📣 The Indian Express is now on Telegram. Click here to join our channel (@indianexpress) and stay updated with the latest headlines