Huge Population, Low Costs Bring Clinical Trials to India

Home to a booming population and low costs, India is rapidly becoming a preferred destination for drug companies to conduct clinical trials quickly and cheaply. Performing the trials in India can be 50%-60% cheaper than in North America or Europe.

Other practical matters make India an attractive proving ground for drugs. A genetically diverse population of a billion people, suffering from every malady imaginable, allows researchers to find subjects several times faster than elsewhere. Furthermore, researchers have access to patients who have never received any treatment for their condition, thus making them more valuable as test subjects. English is widely spoken, and a significant number of Indian doctors have attended medical colleges in Britain or the U.S. Advanced telecommunications networks allow for rapid and easy transmission of data.

Ramananda S. Nadig, medical director at Eli Lilly’s Indian branch, explains the scenario succinctly, “The problem with the West is you can’t get enough numbers – and the cost is high.” He expects India to attract an even larger share of the clinical trial market in the future. Cognizant of such developments, India’s government has taken steps to promote itself as a clinical-trial locale by eliminating regulatory hurdles to more trials. A revised, Western-style patent code will be adopted next year, a step necessary to attract multi-nationals to India. Clinical trial sample medications can now be imported free of customs duties.

Performing clinical trials in India is not without complications. Of the country’s 500,000 doctors, only a small fraction has the expertise to conduct trials along internationally recognized standards. For drugs developed abroad, India does not allow the initial phase of trials, when drugs are tested for basic safety. Furthermore, ethics committees at Indian hospitals, which must approve new trials, sometimes fail to uphold Western standards.

Regardless of the obstacles, multinationals like Pfizer and Eli Lilly have established branches or subsidiaries in India. The story of Mucos Pharma, a German firm, signals the promise India holds for successful clinical trials. Mucos enlisted a local partner to help it find 650 of 750 patients for a study. The subjects were culled from five hospitals over 18 months. Finding the remaining 100 participants in Europe took twice as long and involved 22 hospitals.