Centre clarifies reasons for delay in approvals for remdesivir

A press statement from the Ministry of Health and Family Welfare has clarified on the reasons for the delay in approvals to manufacture and market remdesivir.

Hetero, Cipla, BDR, Jubilant, Mylan and Dr Reddy’s Laboratories are the companies which have applied for permission to manufacture and market the drug in India. Five of these companies have also entered into an agreement with Gilead Sciences.

Informing that CDSCO is awaiting data from these companies to grant the required approvals, the statement said, “These applications are being processed by the CDSCO on priority and in accordance with the laid down procedures.”

Specifying that the CDSCO is providing complete support to these companies, it updated, “The companies are at various intermediate stages of inspection of manufacturing facilities, verification of data, stability testing, emergency laboratory testing as per protocol etc. Being an injectable formulation, testing for assay, identity, impurities, bacterial endotoxin test and sterility become very 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 off the requirement of local clinical trials for these companies by invoking emergency provisions. The regulatory processes are being facilitated and expedited by CDSCO.”

It also informed, “Restricted Emergency Use of drugs in the country for treatment of suspected or laboratory-confirmed COVID-19 in adults and children hospitalised with severe disease is subject to the following conditions- Written informed consent of each patient required, results of additional clinical trials to be submitted, active surveillance data of all treated patients to be submitted, risk management plan along with active post-marketing surveillance and reporting of serious adverse events also to be submitted. Additionally, the first three batches of imported consignments are to be tested and reports submitted to the Central Drug Standard Control Organisation (CDSCO).”

CDSCO had granted Emergency Use Authorization to remdesivir on June 1, 2020, in the interest of patient safety and obtaining further data.