Human Clinical Trials Started After June 15 Need to be Registered

The Drugs Controller of India has announced that all new clinical trials conducted on humans for new drugs, treatments, therapies, surgical procedures and new medical devices must be registered.

This move is designed to make the whole process ethical as well as transparent. The registration drive also means unnecessary force will not be used to coerce participants during the trial. This means that all interventional clinical trials conducted in India and involving Indian participants must be registered with the DCGI.

Clinical Trials | Drug Trials - Types Protocol Development and Approval FAQs
Clinical trials are experiments that yield useful information to clinicians if a particular treatment is of any value to a patient.

"Over the last five years there has been accelerated growth in the number of clinical trials in India. There is a need to improve transparency and accountability in this field both for ethical and scientific reasons," the Drugs Controller General of India (DCGI) said.

Furthermore the Indian Council of Medical Research has been asked by the DCGI to request institutions or companies to get their trials registered when permission is granted for a specific trial.

Clinical Trials and Its different Phases
Clinical trials serve as a vital component for improving the treatment of medical conditions as they lead to higher standards of patient care.

Source-Medindia
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