Journal Press India^®

Author Details ( * ) denotes Corresponding author

The study of Pharmacodynamic and Pharmacokinetic characteristics of new chemical entity (NCE), device on a specific kind of patient, different dose treatments, therapies and surgical procedures to observe behavioral changes due to drug, before making it publicly available. It also examines safety and efficacy of already marketed medication or device for a new indication. These studies help in ensuring the effectiveness of new medicine or device in comparison with the old ones. India emerged as the most suitable country in the world for clinical trial during 2006 and 2010. Many reasons and facilities attracted outsiders for clinical trial in India. Those were mainly big population, availability of new patients for diverse treatment, low cost of drug experimentation and speedy approval. This was a big advantage for our country in terms of financial and scientific gain especially for individual who could not afford for medicines because of poverty. However, unethical practices, noncompliance of regulatory guidelines and protocol, conduction of trials without the approval of ethics committee were some of the discrepancies which converted it from boon to bane. There were several reports of exploitation of the poor and illiterate Indians. It was assumed that they were treated as guinea pigs for clinical trials. Increasing reports of trial participant fatalities aroused the need of robust vigilance. In 2013, the Supreme Court of India took serious cognizance on the PIL filed by Non-Government Organizations. All trials of new drugs were subsequently put on hold and passed strict regulation of three tier screening of their clinical trial documents before supplying drugs to the market. DCGI and ethics committee are the supervisory body of clinical trial to ensure safety, efficacy and quality of trial.

Keywords

Pharmacokinetics; Pharmacodynamics; Clinical Trial; Safety and Efficacy; Public Interest Litigation (PIL); Ethics Ommittee; DCGI

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