India's Health Ministry strengthens the role of the Central Drug Authority
(CDA) with respect to regulating clinical research activities. The authority
will also get the power to prosecute CROs, investigators and Pharma
companies violating respective rules and regulations.
The proposed CDA is planned to be autonomous and will have separate, mostly
independent divisions. One of these will be responsible for clinical trials.
The CDA structure will be similar to that of the U.S. Food and Drug
Administration (FDA). It will also be the central agency for drug licensing.
India's Drug and Cosmetic Act needs to be amended accordingly.
The authority, to be assisted by an advisory board, would streamline the
process of drug manufacture in the country and also be an effective monitor.
There are also other important objectives of drug regulation like ensuring
Good Manufacturing Practices (GMP), combat manufacturing and distribution of
counterfeit drugs, monitoring adverse drug reactions (post-marketing
surveillance) the CDA would take care of.
The number of clinical trials conducted in India has been increasing in the
last years and might reach more than 20% of the world's clinical research in
the next 10 years.