Cipla, Hetero gets DGCI’s nod to manufacture, sell Remdesivir drug

India’s top drug regulator “Drug Controller General of India” (DGCI) has approved two domestic pharmaceutical companies Cipla and Hetero to manufacture and sell the anti-viral drug.

Remdesivir is a broad-spectrum antiviral medication developed by the American Biopharmaceutical company Gilead Sciences. Gilead Sciences is the patent holder of the ant-viral drug Remdesivir.

As per the “Clinical Management Protocols for COVID-19” by Union Health Ministry, this anti-viral drug is recommended for use on patients in the moderate stage of the disease, that is, those on oxygen. The Remdesivir drug has been included as an “Investigational therapy” only for restricted emergency use purposes.

However, Remdesivir drug is not recommended for patients with severe renal impairment and high level of liver enzymes, pregnant and lactating women, and children below 12 years of age. The drug is administered via injection into a vein at a dosage of 200mg on day one followed by 100mg daily for five days.

Earlier, Central Drug Control Standard Organisation (CDCSO), office of DCGI had granted approval to Gilead Sciences for marketing authorization of its Remdesivir drug in India for restricted emergency use on hospitalized COVID-19 patients.

Gilead Sciences had earlier signed non-exclusive voluntary licensing agreements with five pharmaceutical companies Cipla, Hetero, Jubilant Life Sciences, BRD and Mylan to manufacture and distribute Remdesivir drug.

Following which, the six domestic pharmaceutical companies Cipla, Hetero Labs, BRD, Mylan, Jubilant Life Sciences, Dr Reddy’s Labs had approached the DGCI to make and sell Remdesivir drug in India.

However, DGCI has granted permission only to Cipla and Hetero, as they were ahead among other applicants. The Health Ministry has stated that the other applications are being processed by CDSCO under the laid down procedures. The official also added that some of 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 Pharma companies which got approval have been directed to get written consent from each patient before the use of Remdesivir. They are also requested to submit the results of additional clinical trials, active post-marketing surveillance data and reporting of serious adverse events.

As per the recent announcements, Hetero is said to launch the Remdesivir drug under the brand name “Covifor” in India.

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