Covid drug: Hetero, Cipla get DCGI nod to make Remdesivir for coronavirus treatment

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June 22, 2020 12:30 AM

The product is launched under a licensing agreement with US-based Gilead Sciences to expand the access to Covid-19 treatment in low and middle-income countries.

Besides Hetero, Cipla has also received approval to market Remdesivir for restricted emergency use on hospitalised Covid patients.Besides Hetero, Cipla has also received approval to market Remdesivir for restricted emergency use on hospitalised Covid patients.

Hyderabad-based Hetero has received the approval to manufacture and market the investigational antiviral medicine, Remdesivir, from the Drug Controller General of India (DCGI) for treatment of Covid-19. Hetero’s generic version of Remdesivir will be marketed under the brand name ‘Covifor’ in India. Besides Hetero, Cipla has also received approval to market Remdesivir for restricted emergency use on hospitalised Covid patients.

The product is launched under a licensing agreement with US-based Gilead Sciences to expand the access to Covid-19 treatment in low and middle-income countries. Gilead has decided to build a consortium of manufacturing partners to maximize global supply of Remdesivir. Covifor will be used on critically-affected Covid patients in hospitals.

While there is no comparison with other drugs, this product is expected to reduce hospital stay from 14 to 11 days. Sources in the know said this drug will be made available through institutional sales. While the price is yet to be determined by the government, industry sources said it could be in the range of between Rs 5,000 and Rs 6,000 per vial.

“The government is yet to decide on the pricing of the drug. It is expected during this week. Also, the royalty to Gilead and marketing plan will also be known after Gilead gets final approval from the USFDA,‘‘ sources added.

Following intense criticism from civil society groups, Gilead gave up a special designation from the USFDA that would have allowed for extended monopoly control over the 20-year patents it has filed for in more than 70 countries for Remdesivir.

“In the light of increasing Covid-19 cases in the country, the approval of ‘Covifor’ (Remdesivir) can prove to be a game-changer, given its positive clinical outcomes. Backed by strong backward integration capabilities, we can ensure that the product is immediately made available to patients across the country. We are prepared for ensuring enough stocks required to cater to the present needs. We will continue to work closely with the government and medical community to make a difference in the fight against Covid-19. This product is made indigenously in line with ‘Make in India’ campaign,” Dr B Partha Saradhi Reddy, chairman, Hetero group of companies, said.

Remdesivir has been granted approval by the DCGI for treatment of suspected or laboratory-confirmed cases of Covid-19 in adults and children, hospitalised with severe symptoms of the disease. Covifor (Remdesivir) will be available in 100 mg vial (injectable) which has to be administered intravenous in a hospital setting under the supervision of a healthcare practitioner.

Hetero is the world’s largest producer of anti-retroviral drugs. It has 36 state-of-the-art manufacturing facilities strategically located worldwide, approved by stringent global regulatory authorities. Its portfolio includes 300-odd products encompassing major therapeutic categories such as HIV/AIDS, oncology, cardiovascular, neurology, hepatitis, nephrology, urology, diabetes, ophthalmology, hepatology and immunology, etc.

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