SII directed to suspend recruitment for Oxford vaccine trial
Drugs Controller General of India (DCGI) which is country’s apex drug regulator has directed Serum Institute of India SII to suspend the new recruitments which were about to happen for recent phase 2 and 3 clinical trials of the Oxford COVID-19 vaccine till further orders.
Why the SII is asked to suspend recruitment for vaccine trial?
AstraZeneca a drug manufacturing company which in collaboration with Oxford University is involved in the clinical trial of the vaccine. Recently during one of its trial the company faced a huge blow when one of the volunteers in the UK experienced some unknown illness in his body. This resulted in the issuance of the show-cause notice to AstraZeneca and all its trial operation was paused. The company halted all its vaccine trial across four countries, the UK, US, South Africa and Brazil. The halt will remain till the company investigates the recipient’s “potentially unexplained” illness and find out whether it is a side effect of the vaccine shot.
What was DCGI’s order?
Dr VG Somani the Drugs Controller General of India (DCGI) in his recent order asked the Serum Institute of India to suspend any new recruitment in phase 2 and 3 clinical trials for the COVID-19 vaccine till further orders. The order was ruled under Rule 30 of the New Drugs and Clinical Trials Rules, 2019
A major point in DCGI order
The aped drug regulator directed SII to increase the safety monitoring of the volunteers who have already been vaccinated with the vaccine under trial and submit the plan and report. DCGI also directed the Serum institute to submit clearance from DSMB UK and DSMB India to obtain clearance from this office prior to the resumption of future recruitment in the trial.
Drugs Controller General of India is a department of the government of India who is responsible for all the regulatory work related to the drug in the country. DCGI is also responsible for setting standards for manufacturing, sales, import, and distribution of drugs in India. VG Somani is the current head.