The Drugs Controller General of India on Friday asked the Serum Institute of India to suspend recruitment in its clinical trials of AstraZe...
The Drugs Controller General of India on Friday asked the Serum Institute of India to suspend recruitment in its clinical trials of AstraZeneca’s potential coronavirus vaccine in the country until further orders, amid safety concerns, PTI reported.
Pharmaceutical company AstraZeneca on Tuesday had paused late-stage global trials of the vaccine in the wake of a suspected adverse reaction in a participant. The Serum Institute of India is developing the vaccine in collaboration with AstraZeneca and Oxford University.
In an order issued on Friday, VG Somani, the drugs controller general of India, asked for increased safety monitoring of those already vaccinated with the experimental vaccine. Somani asked the Serum institute to submit a plan and report on the same.
Besides this, the drug regulator body also asked the firm to submit clearance from the Data and Safety Monitoring Board in the United Kingdom as well as in India before resuming trials in the future.
The move places further restrictions on the trials, which were already been put on hold by the Serum institute on Thursday, after the DGCI had asked the vaccine maker for details on the suspension of trials overseas. In a show-cause notice to SII, the drug regulator had pulled up the institute for not informing it about...
