How India lets slip its clinical trials advantage, guinea pigs & all

The brouhaha over India’s emergence as a hub for conducting clinical trials seems to be dissipating with the rise of other countries in Asia and Europe, and challenges related to recruitment of trial subjects and investigators confronting the nascent industry in the country.

Just a few years ago, industry body Assocham had predicted that India’s clinical trials market would grow to $546 million by 2010, cornering 15% of the global market.

The ground reality in 2011 is quite different. (Table A for the drop in the number of trials in India, against China and South Korea. Table B points to the total trials done till date in countries emerging as trial hubs).

Going by experts, less than 2% of the global trials are conducted in India, while the bulk goes to the US, EU, Latin America, South East and East Asia.

Like India, other economies also hold advantages in terms of abundant patient population to conduct the trials, and provide cost advantages to companies performing the trials. By outsourcing to China, S Korea, Taiwan, companies stand to save up to 60% of costs — more or less the same if outsourced to India.

“China, Korea, Poland have certain distinct advantages in terms of strong intellectual property norms, better infrastructure over India. We are losing out to these countries,” said Ranga Iyer, advisor, Pharmaceutical Research and Manufacturers of America (PhRMA), which represents US companies.

Estonia, Poland, Hungary, Romania, Czech Republic, etc are other emerging destinations for trials, said Ranjit Shahani, vice chairman and MD, Novartis India, which is currently doing trials in India in cardiology, hypertension and ophthalmology.

“In places like South Korea, there is excellent infrastructure in place due to the efforts of the government. Then there are moves by the government to set up funds to finance the development of new medicines. These factors attract firms to such destinations,” said Shahani.

Issues like difficulty in recruiting subjects to participate in the trials and investigators to monitor the trials are major factors contributing to MNCs surpassing India for other countries.

Dr Suresh Advani, senior oncologist and principal investigator in clinical research, said that getting doctors, research nurses, coordinators who are trained specifically for conducting the trials is often a tough task.

“We have to limit the number of trials, as often, human resource required for carrying on the trials is in short supply.”

According to principal trial investigator and gastroenterologist Dr Philip Abraham, getting subjects to participate in the trials is another hurdle.

Experts say that recruitment of subjects for the trials is difficult because of the low awareness about the manner in which trials are conducted and the need for trials.

“Several people are unaware that participation in a trial is purely voluntary, does not involve any monetary incentive, and a subject can withdraw whenever he feels like, without a reason. There is also insurance cover provided for participants,” said Dr Abraham, adding that this unawareness results in subjects hesitating to participate in research.

Investigators say there are guidelines in India for the protection of the rights of participants in the research.  

“However, implementation of the guidelines is uneven. There is also a major need for monitoring the trials. Guidelines require that at the time of conclusion of the study, participants should be informed of the outcome of the study, and the benefits should be shared with the participants,” said Sandhya Srinivasan, executive editor of Indian Journal of Medical Ethics.
Srinivasan adds that often, medicines tested in India, when marketed, are priced exorbitantly, keeping them out of the reach of several patients. “These are moral issues that have to be dealt with immediately.”