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THE PHARMA REVIEW (MAY 2009)

Clinical Trials in India: Current Scenario and Future Outlook

D. Sreedhar, Manthan D Janodia, Virendra S Ligade, Ajay Pise and N. Udupa

Abstracts: Clinical trial may be defined as “A systematic study of drug(s) in human subject(s) to generate data for discovering and / or verifying the clinical, pharmacological and /or adverse effects with the objective of determining drug(s) safety and / or efficacy”.

It is mandatory to conduct the pre clinical and clinical trials for approval of drugs by any regulatory authority. Most importantly the clinical trial data will be accepted by the regulatory authority if it is been conducted in a registered clinical trial centre. Clinical trials were primarily conducted in the United States. There was paradigm shift from the west to east for conducting the clinical trials because of the cost factor. Developing countries such as India, China and South East Asian countries have tapped the very potential clinical trial market. India has exploited the potential for clinical research by attracting various international and domestic pharmaceutical companies.
 
Scenario
India presently occupies only a small quiche of the global market. The total numbers of clinical trials conducted in India were 221 in 2007 and had increased to just over 700 trials in 2008. Although there was an increase of 65%, it associates to only single digit percentage of the global clinical trial market. The country is projected to conduct nearly 5% of the global clinical trials by 2012. However, to achieve its goal of becoming a global center of clinical trials, the country has to overcome few challenges.
 
Clinical trials and research is now a major business in India. Over 100 companies are currently conducting the clinical trials in India. Top multinational pharmaceutical companies like Pfizer, Glaxo Smith Kline, Aventis, Novartis, Novo Nordisk, Astra Zenica, Eli Lilly are conducting clinical trials in India apart from the Indian companies like Dr. Reddys, Nicholas Piramal, Cipla and Lupin.
 
Advantage India
India has an advantage of having huge population, well equipped hospitals, trained doctors, government initiatives and low cost. Population of over 1 billion with a life expectancy of 65 years, large number of patients who are suffering from various diseases, heterogeneous and high enrolment rates provides opportunity for clinical trial organization. More than 15000 hospitals provide the opportunity to select the best with well trained doctors of over 500,000 and nurses of 737,000. Increased awareness among various health care professional regarding ICH–GCP (The International Conference on Harmonisation-Good Clinical Practice) guidelines for conduct of clinical trials. Large pool of scientifically trained, English speaking personnel who can be involved in clinical trials. Government has taken initiatives like regulations in data protection and data exclusivity. Import duty on clinical trials is exempted. Availability of infrastructure required for conducting clinical research which includes connectivity with remote locations. It is now possible to conduct meetings/training through strong networking facilities provided by Information technology sector. Overall cost of conducting clinical trials is low in India when compared to US, it is estimated to be half the cost (See Table 1). Cost of drug research and development is high, hence, pharmaceutical companies are attempting to reduce the Cost and time required to bring a new drug to the market. Lower cost is a combination of clinical researchers cost, nurses cost, doctors cost, cost of infrastructure facilities and cost of subjects recruited for clinical trials. 

 

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