India is fast becoming one of the biggest hubs for conducting global clinical trials. In 2007, the country conducted around 220 clinical trials, making up for less than 2 percent of the global clinical trials. But, according to a new research report, a number of factors such as low cost, large patient pool, easy recruitment, strong government support and strengthening of its intellectual property environment will enable India to conduct nearly 5 percent of the global clinical trials by 2012. The industry will spend 1500 crore plus on clinical trials in India, as per Goldman Sachs, Centre watch, Goldman Sachs and McKinsey.

What has led to this dramatic shift in the location of clinical trials? The change was made in response to vociferous demands from multinational drug companies and private organizations that conduct clinical research for a relaxation of the rules for drug trials — those necessary hurdles whose price tags can run to 40 percent of the cost of drug development. It has become increasingly difficult to test drugs in Western countries, with their strict regulations, elaborate safety and compensation requirements, and small populations, all of which make the recruitment of research subjects slow and expensive.

India is a particularly attractive site for such trials because of its genetically diverse population of more than 1 billion people with patient pollution suffering from infectious diseases to chronic illnesses. As most of the healthcare costs in India are paid 'out of pocket', a large patient population continues to have unmet medical needs. As a result, they may readily volunteer to participate in clinical trials to get free treatment. Virtually all Indian doctors speak English, and may have acquired postgraduate qualifications abroad, primarily in Britain or the United States. Added to these attractions are cheap labor and low infrastructure costs, which can reduce expenditures for clinical trials by as much as 60 percent. We, as clinicians, are interested in bringing more clinical trials to India as, study of pharmacogenomics gives evidence that drug response and adverse effects are based on one’s genes.  

In January 2005, the government of India enacted a new rule that allows foreign pharmaceutical companies and other interested parties to conduct trials of new drugs in India at the same time that trials of the same phase are being conducted in other countries. This new rule supersedes a directive of India's Drugs and Cosmetics Rules that required a "phase lag" between India and the rest of the world. According to the old rule, if a phase 3 study had been completed elsewhere, only a phase 2 study was permitted in India. Even under the new rule, phase 1 trials will not normally be permitted in India. The old rule was designed to protect Indians from being used as guinea pigs in the testing of unproved drugs of foreign origin; trials of domestically discovered drugs were not subject to this provision.

Despite the availability of infrastructure and demand in India, the area of Clinical Research (CR) is still in its infancy here. The country has more than half a million practicing doctors, but fewer than 200 investigators have been trained in good clinical practice in regards to CR. Among some 14,000 general hospitals, no more than 150 have the adequate infrastructure to conduct trials, and there are fewer than a dozen pathology laboratories that meet the criteria for compliance with good laboratory practice. Only about half of the large hospitals have institutional review boards, and even these boards have not yet formulated standard operating procedures — and they, too, often lack the expertise with which to evaluate protocols. Information about conflicts of interest is neither sought nor voluntarily provided by investigators. Furthermore, the Drugs Controller General of India (DCGI) — the equivalent of the U.S. Food and Drug Administration (FDA) — is understaffed and lacks the expertise to evaluate protocols.

In 2001, self-styled researchers working in their own clinics formulated "vaginal pellets" of erythromycin and tried them as contraceptive agents in more than 790 poor, illiterate, rural women in West Bengal. In 2003, letrozole, an anticancer drug, was tested in more than 430 young women at a dozen private clinics to find out whether it promoted ovulation. All these trials took place without regulatory approval. Adverse coverage in the media, that trials in India are illegal and unethical trials, could mean a loss of opportunity for India to make a mark on the CR industry.

This calls for the development of its capacities and capabilities in terms of infrastructure, regulatory structure, and formulation of specialized pool of research investigators. The aim by Indian Council of Medical Research is to generate such professionals who can represent India in good light, which attracts further international collaborations. Also, this will help to organize this sector in a well-defined mould, whose interests will have to be catered at both local and international level. This will go a long way in launching and boosting India as a major player in this area of research and ensure that it does not lag behind for want of trained manpower.

Currently, per a central registry for all clinical trials, there are 2208 clinical trials in Gynecology and 128 trials in Obstetrics, with 7 being done in India. There are over 31 pregnancy registries with minimal inputs from obstetricians from India. While we as Investigators in developing countries could benefit from rigorous training in the design, conduct, and ethical oversight of trials, which would allow us to engage more fully in multinational clinical research at a leadership level, pressures at work and time constraints may limit us from attending professional courses.
In following few months I wish to share some topics which could help some reader’s take active part in this interesting field. The topics I have in mind are starting with some common terminologies used in clinical research, responsibilities of an Investigator, training of staff, FDA rules pertaining to an investigator, registering a trial, ethical review committees and any other topic requested by reader’s.


A K Nair (2009) Retrieved on 23 Feb 2009 from

Samiran Nundy, M.Chir, Chandra M. Gulhati (2005).A New Colonialism? — Conducting Clinical Trials in India. New England Journal of Medicine. Volume 352, Number 16:1633-1636

Seth W. Glickman et al.( 2009) Ethical and Scientific Implications of the Globalization of Clinical Research. New England Journal of Medicine. Volume 360, Number 8 :816-823



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