* Dept. of Pharmacology, Mahatma Gandhi Medical College & Research Institute, Pondicherry.
** Dept. of Forensic Medicine & Toxicology, Vinayaka Mission's Medical College, Karaikal.
*** Dept. of Forensic Medicine & Toxicology, SAIMS, Indore, Madhya Pradesh.
Ethics defines right and wrong behaviour in a civil society and comes from within. It is different from law which regulates the external behaviour. Clinical research is research involving human beings and is a multi-million dollar industry today. It is regulated by international guidelines on the conduct of clinical trials called ICH GCP guidelines, which direct that clinical trials on human subjects should be performed in an ethical manner. However, guidelines are only advisory in most cases and are yet to have the force of law in many countries. This is particularly relevant due to the alarming rise of ethical violations by pharmaceutical companies and research organizations wherein the safety and rights of clinical trial participants are jeopardized in their pursuit of commercial and scientific gains. Stronger regulatory framework, registration of trials and ethics committees, and above all, stronger enforcement of laws in such cases are the need of the hour.
