In a significant development, India’s top drug regulator has given nod to two domestic pharmaceutical companies–Cipla and Hetero for marketing authorization of anti-viral drug Remdesivir only for “restricted emergency use” on Covid-19 patients with moderate disease (those on oxygen), a senior government official told ANI.
With this development, India is soon to begin the domestic production of anti-viral drug remdesivir which would have efficacy, stability, safety for “restricted emergency use” on Covid-19 patients, official added.
Earlier, this month ANI had reported that the Central Drug Control Standard Organisation (CDCSO) office of DCGI had granted its permission to US based Gilead Sciences for marketing authorization of its anti-viral drug Remdesivir in India for “restricted emergency use” on hospitalized Covid-19 patients in the wake of virus pandemic.
On Saturday, ANI reported reported that DCGI granted domestic firm Glenmark Pharmaceuticals the permission to manufacture and market anti- viral drug favipiravir.
Gilead had signed non-exclusive voluntary licensing agreements with five generic pharma firms — Cipla, Jubilant Life Sciences, Hetero, BRD and Mylan to manufacture and distribute remdesivir, a potential antiviral therapy for Covid-19.
Following which, the six domestic pharma giants–Cipla, Hetero Labs, BRD, Mylan, Jubilant Life Sciences, Dr. Reddy’s Labs approached to the India’s drug regulator to make and sell remdesivir in the country.
“Two pharma giants–Cipla and Hetero were ahead among the other applications. 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,” said official.
“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.CDSCO is awaiting the data and is providing complete support to these companies,” said the official.
Apart from this, pharma companies have been directed to take written informed consent of each and every patient, results of additional clinical trials to be submitted, active surveillance data of all treated patients to be submitted, risk management plan along with active post marketing surveillance and reporting of serious adverse events also to be submitted, said the official.
It has already waived off the requirement of local clinical trials for these companies by invoking emergency provisions. The regulatory processes are being facilitated and expedited by CDSCO, official said.
The union health ministry’s recent issued clinical management guidelines for Covid-19. In the latest protocol, the health ministry has described the use of Remdesivir drug as investigational therapy on coronavirus patient.
“Patient can be administered with 200 mg IV on day 1 followed by 100 mg IV daily for 5 days. The drug cannot be administered to a pregnant or lactating mother and children below age of 12years. The drug is not recommended to patient with liver problems and renal complications,” stated the clinical management protocol on Covid-19.