New Delhi: Even as the country’s drug regulator has approved Glenmark’s FabiFlu, the generic version of antiviral drug Favipiravir, CSIR (Council of Scientific and Industrial Research) and Cipla will carry out a larger, multi-centre clinical trial of the drug to check its efficacy and safety among Covid-19 patients.
The CSIR is also going to submit before the Drug Controller General of India (DCGI) new proposals to conduct trials on combination drugs, Director General-CSIR Dr Shekhar Mande told News18.
The autonomous body under the Ministry of Science and Technology has focused on repurposing of existing drugs that have been used globally as antiviral medicine. The CSIR has partnered with pharmaceutical companies such as Cipla and Sun Pharma. The scientific body and its partners have got clinical trial approvals for four repurposed drugs – Sepsivac, ACHQ (a phytopharmaceutical plant based drug), Favipiravir and Umifenovir. Sepsivac and Favipiravir are in Phase III of the trials.
“Results on repurposed drugs are showing promise and we have some good leads. Cipla is already carrying out Favipiravir trials. The earlier trials had a limited number of people. But now we need a much larger trial on 600-700 people and we will approach the DCGI on that issue,” said Dr Mande.
“In addition, we have also prepared proposals on trials about three to four combinations of drugs. Our emphasis from now on will be on combinations. One of the drugs would be an antiviral drug. We will be submitting these proposals to the DCGI in the coming days to seek approvals for trials,” Dr Mande added.
As per the Clinical Trials Registry – India website Glenmark Pharmaceuticals Ltd. is carrying out a randomised open-label study to evaluate efficacy and safety of Favipiravir and Umifenovir combination as compared to Favipiravir alone. This is being tested on moderate hospitalized adult Covid-19 patients.
Meanwhile, Cipla is currently in Phase-3 of Favipiravir trials which are being carried out in eight centres in the country. Five of these eight centres have approved the Phase-3 trials. These randomised, open label, prospective, comparative parallel group clinical trials will evaluate efficacy and safety of Favipiravir with supportive care versus supportive alone among patients with mild to moderate Covid-19.
While Glenmark worked independently, CSIR worker on the research and actual synthesis of Favipiravir drug. “Favipiravir is a compound and to make the chemical structure in large quantities you need key starting materials. Through a series of chemical synthesis steps, you have to generate the final compound. We generated the end-to-end process and it was handed over to Cipla,” Dr Mande said.
“We understand our limitations of scaling up beyond our labs while companies can scale up but they need our technical know-how. This is a perfect win-win situation,” he added.