Why India?

Cost, timeline and profitability pressures have forced the global pharmaceutical industry to outsource research and development. A solution to this is conducting clinical trials that provide lower cost and faster recruitment without compromising the quality of the research. India clearly offers this solution.

The history of global clinical research in India really started in the mid 90’s, when some of the pharma companies and early starting CROs initiated international studies in India. During this period although selective international trials were permitted to be run in India there were few and far between.  The amendment to the Drugs And Cosmetics Act in 2003 to explicitly permitting part of global clinical studies in India was the main impetus for significantly increasing the clinical research activities in India. This followed by India’s acceptance of WTO compliant product patent regime in 2005 have boosted the clinical trial activity in India further.   

The regulators since then are proactively reviewing the system to reduce the time for regulatory permission; the Indian council of Medical Research is also proactively reviewing the Ethical and scientific aspects of clinical trials to make the system robust and make sure trained manpower is available for clinical research.    

Conducting clinical trials in India has many advantages

• The billion-plus population ensures availability of large numbers of treatment-naïve patients and vast genetic diversity in a variety of diseases.  For example, India has the largest pool of diabetic patients, with more than 20 million people suffering from the ailment.

• The cost of conducting clinical research in India is still significantly cheaper than Western countries. The indexed clinical trial costs are graphically presented here.

• Many Indian doctors have spent time in the USA or Europe broadening their training in world-renowned centres.  They are supported by facilities, such as nearly 700,000 specialty hospital beds, 221 medical colleges and skilled English-speaking research personnel.


• Availability of sophisticated technological infrastructure for conducting clinical research. This includes connectivity with remote locations. It is possible to conduct meetings/ training through audio-visual media. This infrastructure is ideal for eCRF studies which are also supported by a strong IT industry and the availability of IT skilled man-power.

• Recent reviews by the Indian council of Medical Research are ensuring higher GMP, GLP and GCP compliance. There is in fact the largest number of GMP approved plants outside the USA.

• Over the last 10 years there is an increasing presence of all major Pharma companies and  CRO’s, which has only improved the knowledge and conduct of clinical research, as well as increasing awareness in the population. This table lists New Drug Applications approved by the FDA which includes data generated from India.