Clinical Drug Trials and Ethical Dilemma in the Indian Context

The world of Medicine is making progress in the diagnosis and treatment of many diseases, which have plagued mankind for centuries. The pace of progress is really overwhelming. New drugs are introduced continuously. The evaluation of their efficacy and safety is an arduous and costly process that involves laboratory work, animal studies and human trials. Someone must take a new drug first hence, human experimentation is unavoidable. Over the years, principles and rules have been introduced to guarantee respect for the individual. In our present state of knowledge, randomized clinical trials are necessary. They aim not only at the actual patients treatment, but also to serve future patients who will need the drug. The developed counties have established an ethical basis for the proper conduct of RCTs. This is a costly affair for pharmaceutical giants. So they are out sourcing clinical trials to developing nations to cut cost. But in India, in the absence of enforcement of law, the clinical trials are conducting in the most unethical manner and without the information and consent of the poor and illiterate patients. The Supreme Court recently issued notice on a PIL seeking a proper regulatory framework to check rampant illegal and unethical clinical trials on adults, children and even mentally ill persons in the country. A bench of Justice R.M. Lodha and Justice H.L. Gokhale sought the response of the government and the Medical Council of India (MCI) on the PIL filed by Indore-based NGO Swasthya Adhikar Manch. India was being used for conducting clinical trials by multinational corporations because of non-enforcement of laws. After the patent regime, the Government had amended the Drugs and Cosmetic Rules in 1995 to allow multi-centric trials. India had even permitted Phase-I trial which meant the trial of a medicine on a human being first. There were more than 100 Contract Research Organisations (CRO) in the country offering clinical trials at a low cost. A study had revealed that informed consent before trial was not being taken, compensation was being denied and the loopholes in the functioning of the Drug Controller General of India were being exploited. A Malayalam channel recently published documents in proof of unethical medical trials being mushroomed in India, particularly in Kerala without the consent of patients. Alarmed by the rise in illegal drug trials in the country and the lack of effective laws for their monitoring, the National Human Rights Commission (NHRC) is mulling guidelines for clinical trials.
drug trials fair to promote our pharmaceutical industry and at the same time to compensate the victims.

Lets look in to the need of legal and ethical frameworks to clinical

Prasad T S IIIrd Sem MBA (P T)