Cipla, Hetero Labs secure DCGI nod for Remdesivir to treat COVID cases

It is not recommended for those with severe renal impairment and high level of liver enzymes, pregnant and lactating women, and those below 12 years, the document on ''Clinical Management Protocols for COVID-19'' stated.

The drug, administered in the form of injection, should be given at a dose of 200 mg on day one followed by 100 mg daily for five days.

Cipla and Hetero Labs have already entered into non-exclusive licensing agreements with US pharma giant Gilead Sciences, which is the patent holder of the drug remdesivir.

Gilead Sciences had applied to the Indian Drug Regulatory Agency, CDSCO, for import and marketing of Remdesivir on May 29. After due deliberations, permission under emergency use authorization was granted by DCGI on June 1 in the interest of patient safety and obtaining further data.

Besides Hetero and Cipla, three other firms BDR, Jubilant, Mylan and Dr Reddy's Labs have also applied to CDSCO for permission to manufacture and market the drug in India and are still awaiting permission.

These applications are being processed by the CDSCO 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 health ministry had earlier said.

Being an injectable formulation, testing for assay, identity, impurities, bacterial endotoxin test and sterility become very critical for patient safety and this data need to be provided by the companies, the ministry had said. 

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