Clinical research in India has been fraught with ethical problems. Credit: AFP PHOTO/ Prakash SINGH

In Mumbai, a small firm that used to translate legal documents is making a fortune translating informed consent forms into a dozen local languages. Contract research organizations (CROs), which compete with each other to provide clinical trial services for pharmaceutical companies, are mushrooming across India. US companies are acquiring Indian CROs and turning them into hubs of their clinical research activities. These are just a few signs of the next trend in India—outsourcing of clinical trials.

“It is a business opportunity India cannot afford to miss,” says Vasudeo Ginde, who ran the Mumbai-based CRO DiagnoSearch until the US company iGATE acquired it six months ago.

A huge patient population, genetically distinct groups, specialty hospitals with state-of-the-art facilities, nearly 700,000 hospital beds and 221 medical colleges, and skilled, English-speaking investigators are India's trump cards. “Most importantly,” says Sudhakar Bangera, director of the Hyderabad-based company Asian Clinical Trials, “the trials can get done fast and at a cheaper cost than in the West.” In the US, trials for a single drug can cost about $150 million. Early estimates are that drugs could be tested in India at 60% of that price.

The authorities have been quick to respond to the trend. The Mumbai government's Cancer Research Institute has set up a clinical trial center linking major hospitals. The federal government has also shown support by exempting customs duty on research supplies and trying to set up the country's first Institute of Clinical Research.

With sponsors donating expensive equipment, the benefits for local hospitals extend beyond cash. For instance, Pfizer has donated $100,000 bone density–measuring instruments to six hospitals testing its new osteoporosis drug.

“Hospitals and research labs in the West earn 60 to 70% of their income by conducting clinical trials for the industry,” says Rupam Borgohain, a neurologist at Nizam's Institute of Medical Sciences in Hyderabad. “Why can't we do that?”

For the time being, at least, there are several reasons why not. Regulatory approvals in India can take three months or more, compared with 30 days in the US. Indian CROs have yet to learn to deliver data of international standards. More worrying is the lack of confidentiality. Unlike China, India does not yet grant protection for data gleaned from clinical trials, which makes it easy for generic drug makers to copy the drug under trial. “[India's] opportunities are limited unless you have a strong patent law and a mechanism to enforce it,” says Michael Alder, executive director of the Biotechnology Association of Alabama.

Clinical trials in India have a checkered past that could scare multinationals away (Nature 412, 466; 2001). The field is dogged by complaints that Indian trial investigators recruit patients unethically, exaggerate claims and downplay the risks of trial drugs. Institutional ethics committees aren't much help either. “The committees do not meet often or are staffed by the wrong people,” says one CRO official.

At the federal level, the central ethics committee at the Indian Council of Medical Research issues guidelines but has no policing powers. There are plans under way to convert the current ethical guidelines into law, says Vasantha Muthuswamy, the agency's deputy director general.

Under India's existing laws, only those drugs that have already passed phase 1 safety trials in the country of their origin can be tested on Indians. Raghunath Mashelkar, who chaired a panel to draft amendments to the law, says the committee has not recommended phase 1 trials of foreign drugs “as this will make our people, who are mostly illiterate, guinea pigs.”

Even once the myriad hurdles are resolved, India's potential as a host for clinical trials is limited. The US Food and Drug Administration does not approve data from trials in which more than 20% of subjects are from developing countries. Although the agency has inspected 64 trial sites outside the US, it has yet to inspect any clinical trial facilities in India.

“Clinical research outsourcing provides a big opportunity, no doubt, but India's business model for [information technology], which is based on cheap labor, may not work here,” warns William Rutter, chairman emeritus of Chiron Corporation. “What US companies look for is quality data, reliability and confidentiality—and not just low price.”