Indian drug regulator has been reviewing the marketing authorisation applications of Remdesivir of 4 Indian companies: Cipla, Hetero, Jubilant Life Sciences and BDR Pharmaceuticals.
The await Gilead’s drug Remdesivir continues whilst governments and medical practitioners are scrambling for a drug to treat patients with severe novel coronavirus, or COVID-19.
The Indian drug regulator has been reviewing the marketing authorisation applications of Remdesivir of 4 Indian companies: Cipla, Hetero, Jubilant Life Sciences and BDR Pharmaceuticals. Except BDR, all other companies have licences from Gilead to supply and distribute the drug in 127 low and middle-income countries (LMICS). It is still unclear whether or not Mylan has approached India ‘s Drug Controller General (DCGI) for marketing clearance.
Spokespersons for Cipla and Hetero declined to discuss their marketing authorisation applications.
Cautious drug regulator
Sources told Moneycontrol that the drug might not be available within the market until July as DCGI has sought more data on safety and stability of the drug. the businesses are responding to the requests made by the regulator.
A person with knowledge of the case said that businesses anticipated the permitting process to be a forgone conclusion, as DCGI had authorized Gilead’s Remdesivir and their implementations were supported its data with the exception of BDR. They have been perplexed as the controller began to collect more information.
“We can’t blame with regulator as they need to try to to their job. this is often a replacement drug with a sophisticated manufacturing process. in order that they want to be doubly sure that the generic versions are nearly as good because the Gilead’s Remdesivir,” the person above said.
Gilead, the medication innovator, obtained DCGI’s permit application on June 2 under the expedited review process. it had been granted a waiver to conduct clinical trials in India.
The company said there’s limited supply of the drug at the present and new supply could possibly start to become available from July.
The management said it’ll work closely with the health authorities in India to supply guidance on anticipated drug supply, supported local incidence and severity of the disease.
As per the agreement with Gilead, Indian companies are liberal to price the drug. Gilead is yet to repair the worth for US or the other market.
The Institute for Clinical and Economic Review (ICER), the Boston-based independent non-profit organisation, which has undertaken cost benefit modelling, has estimated the worth of the drug at $4,460 (Rs 3,36,779) for a full course of treatment within the US, which is sort of expensive for many Indians.
Pressure from Maharashtra
Meanwhile, pressure is build up on DCGI to quickly approve the drug. Maharashtra State Housing Minister Jitendra Awhad, who’d been positively checked for coronavirus and was on a ventilator fighting the infection before eventually recovering, has sought the drug’s swift approval.
Maharashtra has reported 97,648 cases and three ,590 deaths thanks to COVID-19, the very best in country. The government is trying to import 10,000 doses of Remdesivir from Bangladesh companies.
Two Bangladesh drug makers, Eskayef Pharmaceuticals and Bexmico Pharma, have offered to provide Remdesivir to the Maharashtra government. But Moneycontrol wrote here that none of those companies have licence to sell Remdesivir in India and even importing limited doses of drug on compassionate basis requires DCGI approval.