DCGI reviews COVID-19 drugs of six domestic pharma giants

DCGI has asked six major pharmaceutical companies of the nation to submit their final papers for different drugs to cure the dreadful coronavirus infection. These Pharma giants include Mylan, Cipla, Jubilant, Hetero Labs Ltd and Biosphere Clinical Research Pvt Ltd.

New Delhi:With an aim for speedy approval of COVID-19 drugs, India's apex drug regulator Drugs Controller General of India (DCGI) has asked six pharma giants including Mylan, Cipla, Jubilant, Hetero Labs Ltd and Biosphere Clinical Research Pvt Ltd to submit their final papers for different drugs.

The Subject Expert Committee (SEC) of DCGI in a recent meeting asked Mylan and Jubilant to submit the Post Marketing Surveillance (PMS) protocol as per the condition of market authorisation for further review of Remdisivir 100mg/vial (lyophilised) injections.

In the meeting, Cipla presented the protocol for the PMS of Remdisivir 100mg/vial injection. "After detailed deliberations, the committee recommended for the conduct of proposed study subject to the condition that follow-up period should be up to 28 days for all the subjects," officials in the DCGI said.

The SEC, however, denied permission for Laxai Life Science's drugs including Umifenovir, Nafamostat, 5-ALA as these are not yet approved in India for any purpose.

The expert committee further recommended for the conduct of PMS of Remdisivir 100mg/vial injection proposed by Hetero Labs Ltd. The SEC also recommended for phase II clinical trial of PNB001 drugs proposed by Biosphere Clinical Research Pvt Ltd.

The SEC has also recommended AIIMS, Raipur to conduct the proposed clinical trial of Angiotensin Receptor Blockers for COVID-19 respiratory disease by enrolling mild and moderate cases.

Meanwhile, Bharat Biotech's COVAXIN phase I trial has demonstrated protective efficacy and immunogenicity in non-human primates.

Bharat Biotech said that the vaccine candidate was found to generate robust immune responses, thus preventing infection and disease in the primates upon high amounts of exposure to live SARS-CoV-2 virus.

The Hyderabad-based pharma giant now is all set to start the Phase II human clinical trials.

It may be mentioned here that COVAXIN which has been tagged as a promising domestic COVID-19 vaccine has already got DCGI's approval for phase II clinical trial. Another domestic COVID-19 vaccine of Zydus Cadila is also in the phase II trial.

However, the phase III clinical trial of much-hyped Oxford vaccine candidate ChAdOx1 has been put on hold following some difficulties in volunteer after they were vaccinated.

Meanwhile, India on Saturday witnessed another highest-ever single day recovery of 81,533 patients in last 24 hours taking the total recovery number to above 36 lakhs at a rate of 77.77 per cent.

60 per cent of the total recoveries are concentrated in given states namely Maharashtra, Tamil Nadu, Andhra Pradesh, Karnataka and Uttar Pradesh. Ironically, 60 per cent of the total COVID positive cases reported in India is coming from these five states.

In the past 24 hours, 1201 deaths have been registered in India. 69 per cent of India's total COVID-19 deaths are accounted from Maharashtra, Tamil Nadu, Andhra Pradesh, Karnataka and Delhi.

India till date has registered total deaths of 77,472. Against a total COVID-19 case of 46,59,984, India at present has 9,58,316 active COVID cases.

Read:|India's Covid vaccine set for second clinical trial