In terms of vaccine approvals, India has reached uncharted territories. Never before have vaccines been developed at such pace and approved by regulators in such haste. Serum Institute of India (SII) Adar Poonawalla has previously claimed that he wants the government to indemnify vaccine makers from liability.
The Center did not say anything about the matter. However, regardless of the government’s position on compensation, vaccine recipients also have some current redress in the event of an adverse effect following immunization (AEFI) according to legal experts.
The experts agree that the reimbursement systems can be different depending on the vaccine they inoculate for recipients in India.
Covishield and Covaxin have been authorized by the Drugs Controller General of India (DCGI). For “emergency use in clinical trial mode,” the DCGI has approved the indigenous product produced by Bharat Biotech. This has made it clear to the government that the use of Covaxin is an extension of Phase III studies.
As the regulator approved Covaxin in the clinical trial mode, the jab recipient will be liable, in compliance with the 2019 New Drugs and Clinical Trial Regulations, for trial volunteer work and be entitled to obtain compensation for a vaccine injury, according to the study citing legal experts.
The recipient would thus be entitled to compensation, covering medical costs (medical management) and compensation for loss of living (financial compensation), according to a report from the publication issued by Kartik Ganapathy, partner – IndusLaw.
In such a situation, if the volunteers experience AEFI, it is up to the Ethics Committee to give its opinion on acceptable compensation, as suggested in the study.
The reimbursement regime for potential vaccine injuries caused by Covishield could be entirely different, as the SII requested permission in Form CT-23 (permission to produce for sale and distribution) does not mention clinical trials. This indicates that those receiving the SII vaccine will not be trial volunteers and thus do not have the security of the New Drugs Rules, 2019, including treatment and reimbursement, the report said.
However, if Covishield vaccine recipients suffer adverse side effects, they may appear before the court on the grounds that the medication was counterfeit, mislabelled, adulterated, or had manufacturing defects as stated in the study. The Drugs and Cosmetics Act addresses this problem, it added.
The recipient can also have recourse to the court under the Law of Torts seeking civil remedies or the Consumer Protection Act if something is wrong with the underlying formulation of the medication, according to a study from legal experts.