In an attempt to make clinical trial approval procedures and monitoring mechanisms more accountable, the Centre has now made registration of Ethics Committee mandatory before it reviews and accords approval to a clinical trial protocol.

Amendments to the Drugs and Cosmetics Rules, 1954, make it mandatory that all Ethics Committees should be approved with the Licensing Authority before they accept any clinical trials for review, and all clinical trials would have to be registered at the Clinical Trials Registry of India before enrolling the first patient for the study.

The preliminary scrutiny of the applications will be done by a committee of officers of the Central Drugs Standard Control Organisation (CDSCO) who will ensure that it contains all the required administrative as well as technical information in proper manner as per the checklist. If the applications are not submitted in accordance with the format and the checklist, it will not be accepted by CDSCO for further examination.

The Ethics Committee will have to allow inspectors or officials authorised by the CDSCO to enter its premises to inspect any record, data or any document related to clinical trials and provide adequate replies to any query raised by the inspectors. The Committee will also have to inform in writing the Licensing Authority if there is any change in its membership.

If the Ethics Committee fails to comply with any of the conditions of registration, the Licensing Authority can after giving an opportunity to show cause, suspend or cancel its registration. The registration, unless suspended or cancelled earlier, shall be valid for three years.

Under the amended Rules, the Ethics Committee should comprise of medical, scientific, non-medical and non-scientific members, whose responsibility is to ensure the protection of the rights, safety and wellbeing of human subjects involved in a clinical trial and it shall be responsible for reviewing and approving the protocol, sustainability of the investigators, facilities, methods and adequacy of information to be used for obtaining and documenting informed consent of the study subjects and adequacy of confidentiality safeguards. The Committee should have seven members including a legal expert, a social scientist or a representative of a non-governmental organisation and a lay person from community.

The Ethics Committees will have to maintain a record for at least five years after the completion of the trial.

The annual status of each clinical trial, as to whether it is ongoing, completed or terminated, shall be submitted to the Licensing Authority and in case of termination, the details and reasons will also have to be informed.

In the case of any serious adverse event occurring to the clinical trial subjects during the trial, the Ethics Committee will inform the authorities within 10 days. In case of an injury to the subject, the applicant shall provide complete medical management and compensation.

As many as 436 lives were lost in the country last year during clinical trials of drugs, averaging more than eight deaths every week, but government is yet to ascertain how many of them were due to such tests. The number of such deaths in 2011 was 438 while in 2010 it was 668.

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