Approvals for Remdesivir — an investigational drug being used to treat Covid-19 patients — have been delayed by Indian drug watchdog Central Drugs Standard Control Organisation (CDSCO), as it awaits safety data from Hetero, Cipla, BDR, Jubilant, Mylan and Dr. Reddy’s Labs.
These six local firms have applied to CDSCO for permission to manufacture and market the drug in India. Five of them have also entered into an agreement with pharma major Gilead.
“Being an injectable formulation, testing for assay, identity, impurities, bacterial endotoxin and sterility become critical for patient safety, and this data needs to be provided by the companies. CDSCO is awaiting the data and is providing complete support to these companies. It has already waived the requirement of local clinical trials for these companies by invoking emergency provisions,” a press statement issued by the Ministry of Health and Family Welfare stated.
“These applications are being processed by the CDSCO on priority and in accordance with the laid-down procedures. The companies are at various intermediate stages of inspection of manufacturing facilities, verification of data, stability testing, emergency laboratory testing as per protocol etc,” the statement further said.
Gilead had, on May 29, applied to CDSCO for importing and marketing Remdesivir. After due deliberations, permission under emergency use authorisation was granted on June 1, in the interest of patient safety and obtaining further data.
For restricted use only
An updated clinical management protocol for Covid-19 was released by the Health Ministry on June 13, in which the drug Remdesivir has been included as an “investigational therapy” only for restricted emergency use, along with off label use of Tocilizumab and Convalescent Plasma.
The said protocol mentions that the use of these therapies is based on limited evidence and availability. “Use of Remdesivir under emergency use may be considered in patients with moderate disease (those on oxygen) but with no specified contraindications. This drug has still not been approved (market authorisation) by the US Food and Drug Administration; in India, it continues only under an Emergency Use Authorisation,” the Ministry has stated.
Restricted emergency use of drugs for treating suspected or laboratory-confirmed Covid-19 in adults and in children hospitalised with severe disease, will be subject to a written informed consent from each patient; results of additional clinical trials, active surveillance data of all treated patients, risk management plan, along with active post marketing surveillance, and reporting of serious adverse events have to be submitted. Also, first three batches of imported consignments are to be tested and reports submitted to (CDSCO, the Ministry has clarified.