Drugs Controller General of India initiates probe into complaint

The Drugs Controller General of India (DCGI) has initiated probe into the complaint  by a  Chennai-based volunteer about alleged adverse complications  reported in a CoviShield vaccine trial.  While the volunteer has demanded  Rs 5 crore compensation for causing medical complications, the  Serum Institute of India (SII) has also served a legal notice seeking damages of Rs 100 crore from him,  calling his compliant “malicious.”

According to reports, the 40-year-old Chennai-based business consultant, who was a volunteer for the third phase of the vaccine trial conducted by Pune-based Serum Institute of India (SII), has sought Rs 5 crore compensation for allegedly suffering serious neurological and psychological symptoms after taking the dose.

 He was administered the shot at Chennai’s Sri Ramachandra Institute of Higher Education and Research (SRIHER), one of the trial sites on October 1.

Now on his behalf, a law firm has  sent a legal notice to Director General, ICMR, Drugs Controller General of India,  DCGI, CEO, Astra Zeneca UK, Professor Andrew Pollard, Chief Investigator, Oxford Vaccine Trial and Vice Chancellor of Sri Ramachandra Higher Education and Research.

The man has sought a compensation of Rs 5 crore and that the testing, manufacturing and distribution of the vaccine be stopped immediately. The SII has partnered with British-Swedish biopharmaceutical giant AstraZeneca AstraZeneca for manufacturing the Oxford vaccine candidate for Covid-19.

On its part, issuing notice against the complainant, SII refuted the allegation, terming his claims “malicious and misconceived in nature”. The Pune-based pharma giant claimed that “there is absolutely no correlation with the vaccine trial and the medical condition of the volunteer”.

“The allegations in the notice are malicious and misconceived. While the Serum Institute of India is sympathetic with the volunteer’s medical condition, there is absolutely no correlation with the vaccine trial and the medical condition of the volunteer.

The volunteer is falsely laying the blame for his medical problems on the Covid vaccine trial,” the SII held.

Meanwhile,  Dr Samiran Panda, who heads the Epidemiology and Communicable  Diseases (ECD) division of the ICMR, said the causal link, if any, of the serious adverse events with the investigational product is objectively assessed in any clinical trial following a pre-defined scientific pathway and within a stipulated period.

 “Any hurried inquiry or inference is prone to be wrong. Both the institutional ethics committee and the DCGI are investigating the causal links, if any, between the adverse events and investigational product, which is an anti-coronavirus vaccine,” Dr Panda said.

 The DCGI had on September 11 directed SII (SII) to suspend any new recruitment in phase 2 and 3 clinical trials of the Oxford COVID-19 vaccine candidate till further orders in the backdrop of pharma giant AstraZeneca pausing the clinical trials in other countries because of ‘’an unexplained illness’’ in a participant in the study.

However, on September 15 it permitted the SII to recommence the trial.

Seeking a  financial compensation of Rs. 5 crores within two weeks from the receipt of this notice, the legal firm on behalf of the Chennai resident said that testing, manufacturing and the distribution of the vaccine should also be stopped immediately, “failing which he has no other option except to take appropriate legal action against all the concerned parties, who would be made responsible for all the costs and consequences”.