India to Require Recording of Informed Consent for Clinical Trials

In May 2013, India’s Drug Technical Advisory Board (DTAB) recommended requiring the audio or video recording of informed consent in Indian clinical trials. If approved by lawmakers, the new proposal will be inserted into Schedule Y of the Drugs and Cosmetics Rules. Currently, investigators obtaining informed consent must verbally provide information about their study to patients. They must also give patients clinical trial information sheets in non-technical, “intelligible” language.

However, DTAB members said they were disturbed by recent reports of clinical trials that provided little to no counseling for participants. In addition, Indian lawmakers have expressed outrage over a 2013 government study on Indian clinical trials. The study found that more than 2,500 Indians died from clinical trials involving new drugs from 2005 to 2012.

The DTAB said the new requirements for audio-visual recording would ensure proper counseling during clinical trials. The Board also said that such recordings would serve as evidence that patient participation is voluntary and that patients are aware of the risks.

India has experienced a rapid rise in the number of local clinical trials since the mid-2000s. However, in the last two years, that number has gone from 500 in 2010 to just 262 in 2012. Experts blame new requirements and stricter enforcement of existing rules.