Can EC take decision to pay financial compensation on its own or only act when the patient asks for it? Is it necessary to inform the DGHS regarding the amount of compensation we seek from the sponsor?

As per Compensation Rule, the sponsor has to give the patient financial compensation over and above expenses incurred on the medical management of the subject. Also EC has to opine on causality and compensation. Hence, EC has to take the responsibility of deciding compensation, even if the patient does not make a claim. The EC decision should be conveyed to DGHS/CDSCO.

See relevant excerpt from Rule 122 DAB.

In case the injury occurring to the trial subject is related to the clinical trial, such subject shall also be entitled for financial compensation as per order of the Licensing Authority defined under clause (b) of rule 21, and the financial compensation will be over and above any expenses incurred on the medical management of the subject.

In case of serious adverse event, other than death occurring to the clinical trial subject, the Ethics Committee (EC) shall forward its report on the serious adverse event after due analysis along with its opinion on the financial compensation, if any, to be paid by the sponsor or his representative, whosoever had obtained permission from the Licensing Authority for conducting the clinical trial, to the Licensing Authority within twenty one calendar days of the occurrence of the serious adverse event."

Is it necessary to inform the sponsor about compensation? Can the sponsor challenge EC decision on compensation? Who will fight on behalf of the patient? Whether it is EC or Licensing Authority? What is the role of chairperson of EC in this legal battle if any?

The Rule 122DAB is a gazette order, which is now part of amended Schedule Y. Also, the sponsor has to give an undertaking along with the application for clinical trial permission to the Licensing Authority to provide compensation in the case of clinical trial related injury or death for which subjects are entitled to compensation.

In case the sponsor fails to provide medical management for the injury to the subject and/or financial compensation to the trial subject for clinical trial related injury or financial compensation, the CDSCO has the power to suspend, or cancel the clinical trial and/or restrict sponsor including his representative(s) to conduct any further clinical trials in the country or take any other action deemed fit under the rules.

The EC has to inform its opinion on the SAE - causality/compensation chairman of the Expert Committee and CDSCO in case of death; and to CDSCO in case of injury. The EC does not have to send its report to the sponsor/the investigator.

Although the EC may recommend compensation, the final recommendation is made by the Expert Committee. Hence, the sponsor cannot challenge EC's recommendation, as it is not a final order.

The sponsor has not been given any option under this rule of taking legal recourse. The final order is passed by CDSCO. Hence, theoretically, the sponsor can challenge the CDSCO order legally. But the sponsor would hesitate from taking such an action due to long term adverse impact of such an action on its business.

The purpose of the rule is to protect the rights, safety and well being of patient, without any need for him/her to fight a legal battle.

As the undertaking for EC registration is signed by the chairman and the member secretary, they are legally responsible for all actions of EC.

What is clause (b) of Rule 21. [permission from Licensing Authority as defines under rule 21(b)]

The rule is part of Drugs & Cosmetics Rule, which defines the Licensing Authority.
21 (b) “licensing authority” means the authority appointed by the Central government to perform the duties of the licensing authority under these Rules and includes any person to whom the powers of a licensing authority may be delegated under Rule 22.

We plan to submit a clinical trial proposal to govt body. Do we need DCGI approval?

As per CDSCO Actions on Recommendations of Prof. Ranjit Roy Chaudhury Expert Committee, academic clinical research may be approved by the Institutional Ethics Committee (lEC). However, if a new drug is being evaluated or a new use for an existing drug is being evaluated, then approval of the DCGI is needed as per D&C Rules. Such requirement will continue.

Can independent EC review a phase IV study which observational in nature? if yes, then can it review all the sites of one state or only local sites?
Dr. Mansi Pandya

The EC registration permits independent ECs to review and approve BE studies. The independent EC cannot approve any clinical trial including phase IV.
As per CDSCO checklist, the EC should be from the same area where the site is located. This means that EC can only approve local sites in the same city.