Six Indian firms await regulatory nod for anti-COVID-19 drug

India may have given the go ahead for use of remdesivir in treatment of COVID-19 patients, it will be a while before the drug is available for patients who need them.

The Indian drug regulator has waived off the requirement for local clinical trials of the drug, but is awaiting reports on stability testing, emergency laboratory testing from domestic firms that have inked non-exclusive contracts with Gilead, the US-headquartered pharma major that has developed the drug.

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Remdesivir is yet to be granted market authorisation by the USFDA, which has allowed its use under Emergency Authorization Use. India, too has granted permission for Emergency Authorisation Use but is yet to grant permission to manufacture the drug in the country.

Six Indian companies – Hetero, Cipla, BDR, Dr Reddy’s Labs, Mylan, and Jubilant have applied for permission to manufacture and market the drug in India while five have already signed non-exclusive agreements with Gilead.

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“These applications are being processed by the Central Drug Standard Control Organisation (CDSCO) on priority and in accordance with the laid down procedures,” an official statement said.

It said that the companies are at various intermediate stages of inspection of manufacturing facilities, verification of data, stability testing, emergency laboratory testing as per protocol.

As remdesivir is an injectable formulation, testing for assay, identity, impurities, bacterial endotoxin test and sterility are very critical elements for patient safety and this data need to be provided by the companies.

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“CDSCO is awaiting the data and is providing complete support to these companies,” the official statement said.

Prior to administering the treatment, written informed consent of each patient would be required and the 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 need to be submitted to the CDSCO.