India issues draft clinical trials rules 2018

India issues draft clinical trials rules 2018

The Ministry of Health and Family Welfare in India has issued the draft Clinical Trials Rules 2018. It applies to all new drugs, investigational new drugs for human use, clinical trial, bioequivalence study, bioavailability study and Ethics Committee. It will come into force after its final publication in the Official Gazette.

The new rules clearly defines features of an academic study, role of central licensing authority, trial protocol, biomedical and health research.

Further it has detailed about clinical trial in relation to a new drug or investigational new drug in human subjects to generate data for discovering or verifying its pharmacological interactions including pharmacodynamics, pharmacokinetic and adverse effects. The objective is to determine the safety, efficacy or tolerance of new drugs, stated the regulatory authority.

Hopefully the new rules will help to overcome the current problems with clinical trials performed in India, e.g. lack of standardisation of the regulatory review process.


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