The Drug Controller General of India (DCGI) is considering a licensing system for ethics committees in institutions conducting clinical trials. The move is to bring in certain amount of accountability to these bodies, which are expected to oversee the trials.

Currently, although the country is set to offer promising opportunities in the area of clinical research for domestic as well as multinational pharma research institutions and companies, it is yet to take adequate safeguards and precautions for the same while considering bioethical issues.

At the same time, it is mandatory under the national and international laws that all proposals on biomedical research involving human subjects should be reviewed and cleared by an appropriately constituted Independent Ethics Committee (IEC) in order to protect the welfare and rights of the participants. Further, IEC has also the responsibility of monitoring a project for the compliance with the guidelines till the project is completed. However, at present there is no formal recognition required while constituting an ethics committee though the written clearance from such monitoring committee is considered necessary when the drug comes for approval or further development projects.

Therefore, according to informed sources, there is a need felt at the regulatory level that to introduce a system by which the ethics committees should be recognized formally as per the criteria fixed by the government. So that, the government can ensure that the committee is constituted appropriately and they can be held responsible for both fair and unfair (if any) issues involved in the human trails.

It is also learnt that, before introducing a licensing system, the government has to work out a regulatory code for the same and also to decide on the regulatory body, which has the expertise to handle the portfolio within existing drug regulatory system.

As per International guidelines, an IEC needs to be independent from political, institutional, professional and market influences. There should be no conflict to interest; whatsoever. At the same time, the Committee needs to demonstrate a high level of competency and responsibility. Ethics committee has the responsibility of safeguarding the rights, safety and well-being of human subjects involved in biomedical and health research projects including clinical trials of drugs and their formulations.