New Delhi: In a major development, India's drug regulator (DCGI) has approved Pharma giant Dr Reddy's proposal to conduct phase IV clinical trial of Favipiravir 200 mg tablets.
While giving the approval, Drug Controller General of India has asked the pharmaceutical company to include 50 per cent of the government site for the study.
"Physician actively involved in treating Covid19 patients to be included in the study at various levels. Standard of care across all the sites should be standardised as far as practicable," the DCGI said.
It further said that active monitoring of patient safety should be reported to the drug regulator.
Favipiravir is presently being used in the treatment of patients who have mild to moderate Covid-19 symptoms.
The DCGI has also allowed Hetero Labs Ltd for manufacture and marketing of Favipirnavir 600/800 mg tablets.
On Wednesday, DCGI allowed Serum Institute of India (SII) to resume phase 3 clinical trial of Oxford vaccine candidate ChAdOx1 after it was halted due to some issues detected in a volunteer in the UK.
Following the approval, the SII is likely to start the trial next week. The pharmaceutical company is in the completion of recruitment process of 1600 volunteers for the trial.
The DCGI, however, said that extra care should be given in screening for the trial process.
Meanwhile, in last 24 hours, as many as 82719 Covid 19 patients have been cured in across India which takes the total number of recovery to 4025079 at a rate of 78.64 per cent. A similar huge number of recoveries have been reported for the last two days.
Maharastra (17,559) contributed more than one-fifth of the new recoveries (21.22 per cent) while the states of Andhra Pradesh (10845), Karnataka (6580), Uttar Pradesh (6476) and Tamil Nadu (5768) contributed 35.87 per cent of the new recoveries.
India currently has 1009976 active cases with an increase of 14043 active Covid cases in the last 24 hours. Active cases, is, however, 19.73 per cent of total Covid cases in India. As many as 83198 people have also died due to the infection to date.
Significantly, close to half ((48.45 per cent) of the active cases are concentrated in three states namely Maharastra, Karnataka and Andhra Pradesh. And along with Uttar Pradesh and Tamil Nadu, these states contribute nearly 60 per cent of the active cases.
Meanwhile, Union Health Ministry has told in the Parliament that Hydroxy-chloroquine has shown no effect on mortality and other clinically meaningful outcomes.
Minister of State for Health and Family Welfare Ashwini Kumar Chaubey said that observational studies with severe methodologic limitations "have shown no effect on mortality or other clinically meaningful outcomes."
"Government has re-purposed the drugs for the treatment of mild and for moderate cases. It's now recommended for severe cases. However, Hydroxy-chloroquine has demonstrated in vitro activity against SARS-CoV-2 and was shown to be clinically beneficial in several small single centre studies though with significant limitations," said Chaubey.
He said that India has exported Hydroxy-chloroquine to more than 140 countries.
He said that all the state governments and UTs across India have enough quantity of Hydroxy-chloroquine drugs for their use.
As on date, the maximum number of 10111630 Hydroxy-chloroquine 200 mg tablets are available with Tamil Nadu Government followed by 7672950 tablets with West Bengal government and 5393200 tablets in possession of Delhi government.
ALSO READ: Covid vaccine to be available by 'start of next year': Harsh Vardhan
