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Regulatory Focus™ > News Articles > Indian Regulators Release Draft Clinical Trial Rules

Indian Regulators Release Draft Clinical Trial Rules

Posted 06 August 2012 | By Ansis Helmanis

India's Ministry of Health has released three new draft rules governing the approval of clinical trials in India, the registration of ethics committees in charge of reviewing and approving investigation protocols and the compensation payable to patients enrolled in clinical trials in the case of injury or death.

Clinical trials must first be registered with India's Clinical Trial Registry before patient enrollment can proceed.  The trial sponsor or clinical trial organization must then allow inspection of trial sites without notice by the Central Drugs Standard Control Organization (CDSCO).  The CDSCO may, "Seize any record, data, document books, [or] investigational drugs" related to clinical trials during the inspection.

Draft rules for ethics committees set forth the required composition of an ethics committee and lists the information that must be included in the registration application, such as whether the committee has been audited or inspected and if so by whom.  The CDSCO is to verify compliance with the rules governing ethics committees.

The final draft released by the Ministry of Health covers covers all trials conducted on drugs and medical devices, as well as bioavailability and equivalence studies, and provides a formula for determining the level of compensation payable to patients injured or killed in the course of a trial.  The formula factors age, income and the severity of the disease the patient was suffering at the time of the clinical trial.

All drafts are subject to a comment period.

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