In an effort to enhance clinical trial oversight, India’s drug regulator is reinforcing the existing framework in place regarding institutional ethical committees (EC). 

For a long time these ethical committees within organizations running clinical trials in India have fallen under a cloud of suspicion and they have had their accountability questioned quite often. According to probes that followed controversial trials, ECs were found to be either mostly defunct or simply present only in name sake in some institutions carrying out clinical studies.

The soon-to-be enforced Drugs and Clinical Trials Rules 2018 elaborates on the modified structure and functions of ethical committees.

The new guidance seeks to replace the old order with well-structured and functional ECs grounded upon a thorough understanding of regulatory requirements.

An ethical committee is the prime requirement for any institution that intends to conduct clinical trials or bioavailability and bioequivalence studies.

All ECs should have a minimum of seven members. The committees should constitute members belonging to medical, scientific and non-medical, non-scientific disciplines. ECs must also be represented by a layman and a woman member.

The guidelines make it clear that the ethics committee chairperson shall not be related in any manner with the institute or organization.

In order to ward off inefficiencies in the system and obviate any gaps in the smooth functioning of ECs, the rules require every member to undergo training and development programs specified by the India’s drug regulator authority. Those who have not successfully completed such developmental programs, shall be disqualified to hold the post.

In addition, the rules recommend that based on the requirement of research areas such as HIVand genetic disorders, specific patient groups may also be represented in the committees.
Aiming for greater transparency in the system, the guidance mandates that members of the committee sign a declaration to the effect that there is no conflict of interest in the study protocol being reviewed by the EC. Meanwhile, it puts in place required checks and balances: “While considering an application which involves a conflict of interest of any member of the Ethics Committee, such member may voluntarily withdraw from the Ethics Committee review meeting.”

The EC will be responsible for applying for registration with the central licensing authority, the Drugs Controller General of India, according to the draft rules published for public comments by the Ministry of Health. The registration granted shall remain valid for a period of three years from the date of its issue.

The EC will review and accord approval to a clinical trial protocol and other clinical trial related documents. At the same time, the EC will oversee the conduct of clinical trial safeguards including the rights, safety and wellbeing of trial subjects as per GCP guidelines. The committee can suspend a clinical trial at any stage of a study if it finds the trial is likely to compromise any of the above mentioned.

Reporting adverse events during the trial to the regulator also falls among the functions listed for ECs.

At the same time, ECs cannot review study protocol and related documents unless at least five of its members, including a medical scientist—preferably a pharmacologist—clinician, legal expert, social scientist or representative of a non-governmental voluntary agency or philosopher or ethicist or theologian and a lay person from the community, are present. It is also necessary that ECs maintain all the data and documents pertaining to the studies for a period of five years after completion of the clinical trial.

The licensing authority, however, holds the power to suspend or cancel the registration of ECs, if the agency is of the opinion that a particular EC fails to comply with any of the provisions of the act and rules, after serving a show-cause notice.

The draft of the new regulations is awaiting publication in the Gazette, a public journal and an authorized legal document of the government of India. It is a mandatory requirement before enactment of rules and regulations.

While India’s promising clinical research industry saw its growth stall over the last couple of years for various reasons, including bad press and subsequent stringency in regulations, recent industry updates, however, indicate that the CRO sector is repairing itself, aided by a spate of actions to make the regulatory climate friendlier. Regulatory moves such as simplifying and expediting the approval processes are among those initiatives.