Norms for clinical trials eased

With the aim to speed up innovation and research in India, the Health Ministry has amended the Drug and Cosmetics Act, exempting clinical trials conducted at academic institutions from taking the hitherto mandatory permission from the Drug Controller General of India (DCGI).

Background:

The latest amendment to the Drug and Cosmetics Act

follows recommendations by the Professor Ranjit Roy Choudhury Committee, which had suggested that academic research should be approved by the Institutional Ethics Committees.

• The once booming clinical trials in India came under the Supreme Court scrutiny in 2013, after at least 370 deaths were attributed to Serious Adverse Events (SEAs) during such trials.
• In September 2013, the apex court ruled that no new clinical trials be permitted until the regulatory mechanism was reformed.

Criticisms:

• Public health experts say the move is a setback for those working towards a safer, more transparent clinical trials regime.
• With the latest amendment chances of misuse are also higher. The only defence for this decision can be that this is academic, not commercial, research.

Violation of rights:

In 2013, the Supreme Court banned trials after a public interest litigation petition brought to light that trials conducted in various parts of the country had violated patient rights as informed consent was not taken, and the patients subjected to clinical trials included newborns, children, pregnant women and mentally challenged persons.