As for Serum Institute of India’s Covishield approval, the drug regulator has mentioned in conditions to be met that the firm has to submit an India-specific risk management plan
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Coronavirus Vaccine | Bharat Biotech
As the inoculation drive begins around the country, the drug regulator’s office is likely to conduct rolling reviews of any adverse event that may occur after a person has been vaccinated.
While the vaccine makers are unlikely to have any indemnity from the government in case of an adverse event, the Central Drugs Standards Control Organisation (CDSCO) will investigate if there are any causal links between the adverse event and the vaccine. “If a causal link is…