Covid-19 Vaccine Side Effects: Is There Legal Recourse For Recipients? Check Here

As per the legal experts, the compensation mechanisms may differ for recipients in India depending upon the vaccine they inoculate.

REPRESENTATIONAL IMAGE (AFP)

Covid-19 Vaccination: With successful dry runs for Covid-19 vaccination last month and earlier in January, and the second dry being conducted on Friday, it’s time for us to be hopeful of inoculations in the coming months. India's central drug authority, Drugs Controller General of India has given approval for restricted emergency use to Oxford-AstraZeneca's Covishield and the indigenously developed Covaxin of Bharat Biotech in the country. Also Read: Covid-19 Vaccination: All You Need To Know About The Second Dry Run Kicking Off Across Nation Today The Drugs Controller General of India (DCGI) has given different kinds of approvals to Covishield and Covaxin. The DCGI has licensed the indigenous product developed by local firm Bharat Biotech for “emergency use in a clinical trial mode”.  It means the Covaxin’s use is an extension of its phase III trials. But if the recipient suffers from severe side effects after getting a Covid-19 vaccine then what’s the recourse? What do vaccine makers say? Serum Institute of India chief executive officer Adar Poonawalla wants makers of covid-19 vaccines to be indemnified from liability in case there are any serious adverse effects or any other claims. But, the Centre has not said anything on the matter so far. However, legal experts have stated that vaccine recipients still have some existing recourse in case of an adverse effect following immunisation (AEFI), as per a Business Standard report. What’s the recourse? According to the legal experts, the compensation mechanisms may be different for recipients in India depending upon the vaccine they inoculate. The regulator has given its approval to Covaxin in clinical trial mode, the recipients of the vaccine will qualify as trial volunteers and will be eligible to receive compensation in case of a vaccine injury under New Drugs and Clinical Trial Rules, 2019, highlights the report quoting legal experts. In such a case the recipient would be eligible for compensation, including meeting medical costs (medical management) and compensation for loss of livelihood (financial compensation), Kartik Ganapathy, partner - IndusLaw, told the publication. In such a case, if the volunteers experience AEFI, it is up to an ethics committee to give its opinion on appropriate compensation, the report suggested. On the other hand, the compensation regime for possible vaccine injuries caused by Covishield may be completely different. It is because the SII has received permission in Form CT-23 (permission for manufacture for sale and distribution) which doesn’t mention anything about clinical trials. As per the report in the business daily, those who get the SII vaccine will not be trial volunteers and therefore, do not have the protection of the New Drugs Rules, 2019, including care and compensation. However, if the vaccine recipients of Covishield experience adverse side effects they may approach the court on the grounds that the drug was spurious, mislabelled, adulterated, or had manufacturing defects, as per the report. The Drugs and Cosmetics Act addresses such an issue, it added. Also, a recipient can approach the court under the Law of Torts, which seek civil remedies, or the Consumer Protection Act if there are issues with the underlying formulation of the drug, the report quoted legal experts as saying.