New Delhi: India's apex drug regulator, Drug Controller General of India (DCGI), has asked Serum Institute of India (SII) for more data of Phase III clinical trials of Covid19 vaccine.
DCGI, while reviewing the vaccine of six Pharma majors under accelerated approval process has asked Dr Reddy's to submit Phase III clinical trial protocol with adequate sample size and clearly defined inclusion-exclusion criteria, primary and secondary endpoints etc.
The firm presented its proposal for 2-Deoxy-D-Glucose oral powder along with the executive summary. In its recommendations, the subject expert committee of DCGI said that Phase II trials results have shown efficacy with an optimum dose of 90 mg/kg.
"However, the sample size was small in the phase II study for grant of market authorisation," the DCGI said.
The Pune based Serum Institute of India, presently doing Phase III clinical trial of Oxford vaccine, has approached the DCGI seeking approval for changes to its protocol to broaden the limit of the trials by including people with health conditions and from different age groups in the trial.
The Pharma giant had presented its proposal for amendment in their clinical protocol on October 6.
After detailed deliberations, the committee recommended for approval of the proposed amendments subject to conditions that the inclusion and exclusion criteria are same as that of AstraZeneca/Oxford trial with regard to the history of Covid19 infection. The findings should be submitted to the central drug standard control organisation (CDSCO).
The committee also recommended for approval of the amendment in the clinical protocol of Piramal and Cadila Healthcare Limited.
Pharmaceutical company Piramal presented their proposal for clinical trial amendment protocol of Sphaeranthus Indicus extract whereas Cadila Healthcare presented their proposal for Adalimumab 40 mg/0.8 mL pre-filled syringe.
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The committee, however, did not recommend for approval of the protocol amendment for Otilimab drugs to PPD pharmaceuticals and noted that the justification presented by the firm was not adequate. The committee has also asked the JSS pharmaceuticals to submit more data regarding their drug Opaganib.
Meanwhile, in a positive development, India's Covid19 doubling time has reached to 73 days.
"India is reporting a progressively high increase in the recoveries and a persistent decline in the percentage of active cases. Ad a result, the doubling time of the infection has reached to 74 days," the health ministry said.
In mid-August, India's doubling rate was 25.5 days. As many as 81,514 people have been recover3d from the disease in the last 24 hours taking the total recovery number to nearly 64 lakh with a rate of 87.36 per cent.
At present India has a total of 8,12,390 active cases whereas 67,708 cases have been reported in the last 24 hours. Interestingly, 10 states have accounted for 77 per cent of the new active cases.
Ironically, 10 states and UTs in India still account 80 per cent of the total casualties (111266) due to the pandemic.
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