The Serum Institute of India (SII) on Tuesday received permission from Drugs Controller General of India (DCGI) V G Somani to resume clinical trial of the Oxford COVID-19 vaccine in the country.
Although the DGCI had revoked its earlier order of suspending any new recruitment for phase two and three trial, it has set certain conditions that had been asked to be strictly followed by the pharmaceutical company.
During the trial phase, the firm has been asked to follow conditions like taking extra care during screening, providing additional information in informed consent and close monitoring for adverse events at the time of follow-up of the study.
SII has also been asked to submit to the DCGI’s office details of medication used in accordance with the protocol for the management of adverse events.
The firm, which has partnered with UK based company AstraZeneca for manufacturing the vaccine candidate for COVID-19, had recently paused the clinical trials of the vaccine in the country after receiving instructions from the DGCI.
Due to the report of unexplained illness in a study participant in the UK, AstraZeneca has halted global trials of its experimental coronavirus vaccine following which even the DGCI had directed SII to halt the clinical trial phase of the vaccine in India.
On Saturday, AstraZeneca and the University of Oxford said clinical trials for their coronavirus vaccine have resumed in the UK after the Medicines Health Regulatory Authority’s (MHRA) confirmed that the trials were safe.
The DGCI has also asked SII to submit approvals from Data Safety Monitoring Boards (DSMB) of India and the UK to resume the COVID-19 vaccine trial.
On Tuesday, the SII had submitted the recommendations of the DMSB of India and the UK and requested for permission to restart enrolment in the clinical trial.