Experts say more clinical trials are needed in India for those who’ve exhausted available treatment, and to help establish therapies that work best for Indians. But hurdles remain.
The Drug Controller General of India has in the past rejected several applications from other drugmakers, including Dr Reddy Laboratory and Natco Pharma.
Several of SII's volunteers are healthcare workers who will be eligible for getting the vaccine now. Unblinding phase 3 trial data will let them know if they are already vaccinated.
As India gears up to roll out a national vaccination programme, Bharat Biotech and Serum Institute's barbs at each other will only add to vaccine hesitancy.
The company has been asked to submit the safety data of M1 adjuvant — the patented technology of Novavax made to enhance the immune response — along with published literature.
IJMR article says 42 trials used modern medicine, 13 were ‘miscellaneous’ — including nutraceuticals, process-of-care changes and non-Covid patient management.
According to the CDSCO panel, the pharma company has to conduct both phase 2 and 3 clinical trials and cannot directly hold phase 3 trial for the vaccine in India, a source said.
Even if an effective Covid vaccine is licensed, the manufacturing of doses for administration to world’s population will need collaboration among manufactures.
MoSPI proposes to remove closed factories from IIP sample, aiming for truer picture of India’s industrial health in upcoming 2022–23 base series. Plan open to public feedback until 25 November.
Bihar is blessed with a land more fertile for revolutions than any in India. Why has it fallen so far behind then? Constant obsession with politics is at the root of its destruction.
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