Subject`s consent for drug trial to be recorded
Institutions conducting drug trials have been asked to carry out audio and video recording of process of taking written consent from subjects after making them aware of the circumstances of the test.
New Delhi: Institutions conducting drug trials have been asked to carry out audio and video recording of the process of taking written consent from the subjects after making them aware of the circumstances of the test.
The direction was issued recently by Central Drugs Standard Control Organisation (CDSCO), the national regulatory body for pharmaceuticals and medical devices in the country.
CDSCO has sought opinion and suggestions from various stakeholders in this regard by month-end, an official of the organisation told.
The directive states that the order has been issued by CDSCO Directorate General with regard to the Supreme Court order of October 22 last year for drug testing.
While recording the consent, it should be ensured that the subject has understood the process, the directive said, adding that confidentiality should be followed.
Besides, all documents related to the recording have to preserved.
The institutions have also been told to inform about their agreement with the sponsors, fees and other payments involved.
The directive states that the institution conducting the trial will have to enter into a legal agreement with the sponsor and disclose the nature of relationship between them.
Further, the clinical trial applicants have been informed that testing of drugs can be done only under Section 21 (B) of Drug and Cosmetic Act and a written permission from the authority concerned is needed for this.
Around 2,234 people have died in the course of drug testing during the last four and half years in the country, according to information accessed through an RTI application.