The Madras High Court on Friday issued notice to the Centre and others, including Serum Institute of India, on a plea from a man who alleged serious side effects after being administered the Covishield vaccine last year during trial.
In his plea, which came up before Justice Abdul Quddhose, the petitioner sought a declaration that the traumatic health issues he faced following vaccination was a ‘serious adverse event’ as defined in the New Drugs and Clinical Trial Rules (NDCTR), 2019.
The Covishield vaccine should hence be declared ‘not safe’ he pleaded and also sought a direction to the SII to provide him a compensation of Rs five crore.
The petitioner, 41-year old Asif Riaz, also sought an interim injunction restraining the Central government and the Drugs Controller General of India from continuing with administering Covishield vaccine, pending disposal of his petition.
According to him, he volunteered in the phase-III trial of the vaccine and he was inoculated on October 1 last year at Sri Ramachandra Institute of Higher Education and Research here.
He experienced severe trauma due to acute neuro encephalopathy, a severe neurological disorder from October 11 to 26 and this was a serious adverse event as defined in NDCTR.
To his legal notice seeking compensation,SII replied last December that his condition was not related to the trial vaccine and the firm offered no proof to support such a view, he said.
The Director General of the Indian Council of Medical Research, in reply to his legal notice, merely stated that any serious event is compensated as per the NDCTR.
Despite request, he received no reply from the Drugs Controller of India on the report of an independent committee it appointed, which said the adverse event he went through had no link to the vaccine.
This panel neither heard him nor physically examined him before submitting its report, he said and sought constitution of an expert committee to go into records and give its view.
The petitioner said he has “…no end in sight for complete recovery,” from the side effects following the vaccination.
The court ordered notice to the Union Health Secretary, DCGI, Director General of ICMR, and CEO of SII and chief of the Sri Ramachandra’s ethics panel.
The matter has been posted for March 26.