Contract Research Organizations (CROs) in India: A Clinical Approach

Disease has always plagued man. In the 21^st century, mankind is confronted with various new afflictions/diseases. This situation poses a challenge to the healthcare sector and the pharmaceutical industry. The need and demand for effective cures for various diseases, hitherto unknown, is testing the limits of science and technology development. These newer diseases further challenge the pharmaceutical industry because of the lack of effective and appropriate drugs for treatment and control. The human factor in such a situation becomes increasingly important because of the evolution and thrust given to clinical trials by the pharmaceutical industry in recent years. The Human Genome project of 2003 stimulated research on diseases like AIDS, cardiovascular diseases, oncology, Alzheimer and Parkinson based on the genetic makeup of the human body.

Consider these figures: The global clinical trials market is expected to be worth US$16 billion by 2007, up from US$10 billion in 2005. This market is registering a growth of 15-18%. Clinical research industry in India touched US$140 million in 2006, up from US$70-80 million in2001-02 and is likely to touch US$200 million by 2007 and US$500-600 m by 2010. So what is a clinical trial? A clinical trial is a research study, comprising human volunteers, to test the effectiveness of a new drug. Clinical trials are carried out to find out if proposed treatments work on human beings. A clinical trial comprises three stages all of which are closely-monitored and evaluated by investigators, physicians, nurses and para-medical staff. A critical function discharged by these professionals is the recording of data for regulatory purposes. These trials could take anywhere between nine to ten years before a new drug can be brought out in the market for popular consumption. This process could cost anywhere between US$350 and US$500 million.

To counter the cost factor, while not losing out on the all important factor of research and development (R&D), around 30% of clinical trials are now outsourced to Contract Research Organisations (CROs).CROs performs tasks like conducting clinical studies, monitoring the use of a new drug, regulatory and compliance services for new drug                                                                     

development, medical devices and biologics and combination of products. CROs also provide clinical testing services to the pharmaceutical industry for prescription, consumer and over-the counter medications. Thus CROs are rapidly establishing themselves as essential cogs in the drug discovery and development process.

.India has become a favoured destination for the establishment of such CROs, with 20 to 30 percent of the clinical development activity getting outsourced here. The main factor working in India’s favour is the cost issue. The cost of conducting clinical trials in India, for instance, is 20 to 60 per cent of the cost in developed countries. Other factors working in India’s favour is the existing infrastructure from world class hospitals and state of the art laboratories, from viable research infrastructure facilities to qualified and skilled nurses, doctors, researchers and technicians and a Government that recognizes the importance of research in health and medicine. The large and diverse population of India constitutes a larger pool of diseases and its various strains that can further research. This large human presence also ensures a bigger number of treatment naïve patients, thus giving impetus to conduct varied research on a particular drug. The presence of English speaking researchers also helps the growth and development of the CRO industry in India. Favorable Regulatory and IPR environment and the huge cost advantage in clinical trials compared with Western countries also make India a favored destination for CROs and clinical trials. Also, the growth of clinical trial industry is directly linked to the growth of health care industry in India as well as world over. All these factors put across a bright scenario with regards to the CRO industry in India and it remains to be seen the kind of growth and employment this sector will generate in the next few years