A recent report in a financial daily has brought out some of the rarely known facts about what is going on in the name of clinical research in India. This dangerous new business of risking lives and health of thousands of illiterate and poor young men is spreading fast across the country in the absence of a comprehensive law. The top international companies like Pfizer, GSK, Novartis, Sanofi, Merck and a few other MNCs are already doing extensive clinical trials of various new chemical entities in India. Besides these, several international CROs and small time Indian operators have also ventured into this huge profit making business during the last five years. Increasing flow of this business to India from abroad is mainly on account of the cheap availability of investigators and human subjects for trials. The US and Europe have become extremely difficult regions for trials as subjects are hard to get or they and investigators are prohibitively expensive. Increased awareness of the risks involved in testing of drugs under development is another key reason for not getting adequate number of human volunteers there. It is estimated that as many as 200 drug trials are going in India for various chemical compounds at multi locations in India. It is reported that the office of DCGI receives about 30 applications every month for conducting clinical trials. Usually the phase I trials are done in utmost secrecy as the sponsors and CROs know that this activity, if not done ethically, amounts to human right violations. A bunch of agents operating in close coordination with large companies and CROs procure illiterate and uninformed subjects to parade before the so-called investigators. With the offer of a few thousands of rupees these healthy volunteers agree to undergo trials without understanding the consequences of such experiments. How many of these subjects die or face serious health problems during or after the trial is not known. Deaths or chronic ailments on account of such trials are not recorded or accounted for as there is no government machinery to track this business. The Central government is aware of the need for an effective law to regulate this new business for some years now. The Central Ethics Committee on Human Research of the Indian Council of Medical Research had laid down ethical guidelines for biomedical research on human subjects as early as September 2000. All institutions carrying out any form of biomedical research involving human beings are expected to follow these guidelines to protect the safety of these individuals. Now even after these guidelines were converted into Biomedical Research Human Subjects Promotion and Regulation Bill, no progress is made to covert that into a statute. The bill was cleared by the Union law ministry way back in January 2006 but the health ministry has not cared to send it for Cabinet approval which is the next step for making the same into an act. Unless the health ministry gets the bill passed in the parliament at the earliest and establish an appropriate machinery to track and monitor clinical trials in the country, the lives of several thousands of young Indians will be in danger.