India's Central Drug Authority Gets More Power to Control Clinical Trials

GMP News
4 October 2007

India's Central Drug Authority Gets More Power to Control Clinical Trials

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.

Hear essential aspects about the organisation and management of clinical trials, IMP distribution and things to consider during the study at the ECA Education Course

During this course, the important interfaces between GMP and GCP will be elaborated.

Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)

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