New Delhi: Serum Institute of India, which has received a show-case notice from Drugs Controller General of India, has said it is following all safety protocols.
In a statement, it said, “We are going by DCGI’s direction and so far were not told to pause the trials. If DCGI has any safety concerns, we will follow their instructions and abide by the standard protocols.”
DGCI) has issued a notice to the Serum Institute of India, which is manufacturing the Oxford University’s Covishield vaccine and will hold the phase 3 clinical trials in India from next week.
Drugs Controller General of India Dr V G Somani has asked SII why the permission granted for conducting phase 2 and 3 clinical trials of the vaccine candidate in the country should not be suspended till patient safety is established.
“Serum Institute of India Pvt Ltd, Pune, till now has not informed the Central licensing authority regarding pausing the clinical trial carried out by AstraZeneca in other countries and also not submitted casualty analysis of the reported serious adverse event with the investigational vaccine for the continuation of phase 2 and 3 clinical trials of the subject vaccine in the country in light of the safety concerns,” stated the show-cause notice.
It added: “In view of the above, I, Dr V G Somani, Drugs Controller General of India and Central Licensing Authority hereby give you an opportunity to show cause as provided under rule 30 of the New Drugs and Clinical Trials Rules, 2019, why the permission granted to you August 2 shall not be suspended till patient safety is established.”
The DGCI sought an immediate reply saying else it “shall be construed that you have no explanation to offer and action deemed fit will be taken against you.”