Madras HC Issues Notice To SII, ICMR & India’s Drug Regulato
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The Madras High Court on Feb.19 issued notices to Pune-based Serum Institute of India (SII), Indian Council of Medical Research (ICMR), India’s drug regulator following a petition filed by a participant who had allegedly suffered serious adverse event in the Serum trial for its Covid-19 vaccine- Covishield.

“The court has admitted the case and given time to respondents to file a reply before the next date of hearing which is March 26,” Rajaram, the advocate in the case told. The respondents named in the petition also include AstraZeneca and chairman of the ethics committee. The participant has asked the court to grant an “interim injunction restraining the continuance of vaccine to the public” as the vaccine is “not safe” and could produce “severe adverse effect on people”.

The participant has also asked for constitution of an independent expert committee to look into his case. Along with this, the participant has also demanded compensation of Rs 5 crore "for the suffering and trauma that he and his family had to go through". Earlier in November the law firm representing this 40-year-old participant in the trials of Covishield – had sent a legal notice to the company and the drug regulatory authority.

The company had in response had said that it would seek 100 crore in damages for the allegations which said are “malicious” and “misconceived”. It said that there was no correlation with the vaccine trial and the medical conduction of the participant. It said that the volunteer was specifically informed by the medical team that the complications he suffered were independent of the vaccine trial he underwent.

Concerns have been raised by various public health experts and organisations like AIDAN on the issue of Serious adverse events following immunisation of the Covid-19 vaccine. The government has so far not put the details of the investigation following SEA in the public domain.

Source:
https://economictimes.indiatimes.com/industry/healthcare/biotech/healthcare/madras-hc-issues-notices-to-sii-icmr-indias-drug-regulator-on-a-petition-against-covishield/articleshow/81106706.cms
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