Updated on 15 October 2012
The Ethics Committee is comprised of a team of 5 to 12 persons, consisting of doctors, the institution, independent observers, ethicists and lawyers. If an institution does not have an Ethics Committee, the protocol approved by the Ethics Committee of another institution would be applicable to it, and in case neither of the institutions have an Ethics Committee, a protocol accepted by the Investigator and approved by the DCGI would be sufficient to initiate the clinical trials. The Rules also recognize that special studies will have to be carried out with regard to dosage. However, this regime is far from satisfactory. The Rules do not prescribe any mechanism to ensure the effective and transparent implementation of the safeguards, so that a meaningful consent is obtained and the subject has been provided adequate information.
There has been a rise in the number of trials being conducted. India's patient's diversity and availability, and other conditions have attracted Corporations, but not researchers, what the Ethics Committees lacks are transparency. In a country where poverty is high, as is the lack of literacy, implementation of regulation is not easy. There has been a history of concern on conducting tests on impaired and challenged humans. There is no interface of the Committee with other agencies or engaging in advocacy. This inwardness has to change in order to benefit all stakeholders.