Industry experts have sought clarification from the DCGI on why ongoing trials of Covishield has not been halted in India, even after reports of an adverse event.
A Covishield clinical trial volunteer has demanded Rs five crore as compensation after reporting major neurological disorder after taking a dose during the clinical trial proceedings. However, Serum Institute of India stated his claims were “malicious and misconceived in nature” and has countered his complaint with Rs 100 crores as damages to the company’s reputation.
However, some industry observers and experts have raised their concerns on this issue and opine that such reactions from pharma companies will discourage people from participating in clinical trials. Hence, they have asked for the transparency in the generated clinical trial data irrespective of COVID-19 Vaccine trials and suggested to follow the global compensation practices for such victims.
Amar Jesani, Editor, Indian Journal of Medical Ethics said, “It is a sad thing to see that Serum Institute of India has threatened the participated volunteer of COVID-19 vaccine clinical trial. He was a healthy participant during the enrolment process of the said clinical trial, if he was not healthy, then he wouldn’t have participated in the clinical trial. Although, after a fortnight of participation in the trial, he started developing the serious adverse event related to neurology disorder.”
He continued, “This is the similar kind of neurology event which was reported in the UK and due to which the global clinical trial was halted in the UK, the US, Brazil and in India for a few days. When a similar major neurologic event was reported in India, then why was the trial not halted? This time, the DCGI should take immediate action and should instruct to stop the clinical trial immediately till the time facts and evidence related to the participant’s claim is evaluated.”
He also questioned whether Indian participants are less important than the ones in the UK trial or any other country in the world?
Bejon Kumar Misra, Founder Director, Patient Safety and Access, expressed, “The defamation suit filed by Serum Institute of India is not in the right spirit because it will discourage honest feedback from the participants who have given their consent in the manner required as per law, to be part of the clinical trial. The law is very clear in our country. If any participant becomes a victim, there is a well laid out norm on how to compensate the victim. I strongly feel there must have been a communication gap due to which the participant had to knock the door of the judiciary for compensation. All clinical trials which are undertaken globally must try their best to compensate such victims as per the law, without the victims having to go through the legal process.
He said, “In my view, the regulator, CDSCO plays a very pivotal role and should immediately intervene in all such matters in order to build the trust of volunteers who participate in such clinical trials.”
Responding to a query on whether the clinical trial should be stopped in India or not, he mentioned that it is the sole prerogative of the regulator (CDSCO) to take the decision whether to stop the clinical trial or continue it, based on facts and evidence put before them as per global best standard and practices.
Malini Aisola, Co-Convenor, AIDAN said, “We are shocked at this blatant attempt at intimidation of a clinical trial participant by Serum Institute. Serum Institute is attempting to divert public scrutiny of its trial. Bear in mind that in Serum’s Phase II/III trial, safety is one of the primary endpoints in addition to immunogenicity. An ICMR official has gone on record to say that a decision on the SAE from DCGI/CDSCO is awaited. Given that the SAE took place in October, it is of serious concern that CDSCO did not pause the trial to investigate the SAE when it was reported. The silence from the CDSCO which granted permission for the trial is deafening. And Serum’s attempt to threaten a trial participant in this manner is unacceptable. The trial was recruiting healthy volunteers and a participant who received a first dose in the trial has and continues to suffer neurological problems. The participant has not received any formal communication from any party. The CDSCO must inform the public as to why the trial was not and has not been halted while it is contemplating the serious adverse event. We would also like to know what protocols are being followed to investigate the SAE and reach a conclusion and inform about the role of the institutional ethics committee, DSMB, SEC and CDSCO in this process.”
“The Serum Institute and ICMR, co-sponsors of the trial, must inform all trial participants about the handling of SAEs and simultaneously release the detailed protocol of the trial, along with any amendments made to the protocol, in the public domain immediately,” she added.
The DCGI did not respond till the time the story was filed/ published.