New Delhi: India's Drug Regulator on Saturday gave permission to Hetero and Cipla to manufacture and market antiviral drug remdesivir for "restricted emergency use" on hospitalised COVID-19 patients.
This comes a day after the Drug Controller General of India (DCGI), considering the emergency and unmet need for medicines in light of the coronavirus outbreak, granted domestic firm Glenmark Pharmaceuticals the permission to manufacture and market favipiravir for "restricted emergency use" in mild to moderate cases.
Hetero's generic version of Remdesivir will be marketed under the brand name 'Covifor' in India.
The drug will be available in 100 mg vial (injectable) which has to be administered intravenously in a hospital setting under the supervision of a healthcare practitioner, it said.
Asked about the price of the drug, Hetero Group of Companies MD Vamsi Krishna Bandi told PTI it will be in the range of Rs 5,000-6,000 per dose.
Currently, the drug is being manufactured at the company's formulation facility in Hyderabad. The active pharmaceutical ingredient (API) is being made in the firm's Visakhapatnam facility, he added.
The drug will be available only through hospitals and government, and not the retail channel, Vamsi said.
The drug has been granted approval by DCGI for the treatment of suspected or laboratory-confirmed cases of COVID-19 in adults and children, hospitalised with severe symptoms of the disease, the company said.
"Backed by strong backward integration capabilities, we can ensure that the product is immediately made available to patients across the country," Hetero Group of Companies Chairman B Partha Saradhi Reddy said.
The product is being launched under a licensing agreement with Gilead Sciences Inc to expand access to COVID-19 treatment in low and middle-income countries, Hetero said.
Written informed consent of each patient is required before the use of remdesivir and results of additional clinical trials, active post-marketing surveillance data and reporting of serious adverse events have to be submitted.
The Union health ministry, in its 'Clinical Management Protocols for COVID-19', recommended the use of the remdesivir on patients in moderate stage of the disease that is, those on oxygen. The drug has been included as an "investigational therapy" only for restricted emergency use purposes.
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.
In May, domestic pharma firms Hetero, Cipla and Jubilant Life Sciences had entered into non-exclusive licensing agreements with drug major Gilead Sciences Inc for manufacturing and distribution of Remdesivir.
The medicine has been issued an Emergency Use Authorization (EUA) by the United States Food and Drug Administration (USFDA) to treat COVID-19 patients.
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 June1 in the interest of patient safety and obtaining further data.
Domestic pharma firm Glenmark Pharmaceuticals had on Saturday launched antiviral drug Favipiravir, under the brand name FabiFlu, for the treatment of patients with mild to moderate COVID-19 at a price of about Rs 103 per tablet.
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.
(PTI report)
