An evaluation of drug lag for new drugs approved by the Indian regulator relative to the United States, European Union, and Japanese regulatory agencies: A 15-year analysis (2004-2018).

Background: The approval process of every drug regulatory agency differs, and hence, the time required for the approval of a new drug varies. This results in a drug lag and India is no exception to this phenomenon. A drug lag precludes Indian patients from accessing new medicines at the same time as they are approved elsewhere.

Audiovisual recording of the consenting process in clinical research: Experiences from a tertiary referral center.

The quality of the written informed consent process is one of the most important aspects of clinical research, as it is the single tool that serves as a metric of autonomy. Several challenges have been identified with the informed consent process in developing countries the most important of which is the ability to assimilate and understand the information presented in the consent form. In India, a unique aspect of the informed consent process is the need for audio-video [AV] recording of the process for vulnerable populations and new chemical entities.