Clinical Trials--In India

Regulatory Affairs Focus magazine (what, you're not a subscriber?) published an interesting article on the future of regulatory and clinical trial issues in India.

The need to cut costs is persuading US and Western European firms to seek alternative destinations such as China and India for clinical trials. Another factor in this decision is that India and China have joined the World Trade Organization (WTO), which has invigorated both countries� economies. As a result, clinical trials conducted in these countries are no longer confined to evaluating new medicines for their own markets. India and China have opened up new opportunities for US and Western European firms to expand their pharmaceutical and biotechnology product markets substantially. In 2006, the global clinical trials sector is estimated to be about $10 billion and has the potential for considerable growth over the next few years.

Wired Magazine has a more somber outlook, their article, A Nation of Guinea Pigs is worth looking into

Kalantri is uneasy about his clinical success. "Patients here are very passive," he reflects. "They will almost never question their doctor." Indeed, one woman who joined the trial six months ago sits patiently for more than an hour while Kalantri translates my questions, before revealing that she is suffering from aches and fever that are likely malaria. Such deference is hard to imagine in US patients - a querulous lot - and it makes Kalantri's position tricky. "Nine out of 10 times," he says, "the patient will just ask me to make the decision about the trial for him. So what role do I play? Am I a physician, concentrating on what's best for the patient? Or am I a researcher interested in recruiting patients? I try to balance the two sides, but ..." He shrugs. "It's a dichotomy." Kalantri began worrying

And more recently they reported that

Companies are attracted to India not only because of the huge patient pool and skilled workers, but also because many potential study volunteers are "treatment naïve," meaning they have not been exposed to the wide array of biomedical drugs that most Western patients have, said Stefan Ecks, a lecturer in social anthropology at the School of Social and Political Studies in Edinburgh who recently published a paper on the marketing of antidepressants in India.

Our humble experience note: We actually spoke with some industry figures in Boston while they were on a trade mission from the state of Gujarat. According to them, the press is naturally going to blow a lof of the outlier claims out of proportion. Perhaps this is an opportunity for India to participate in cutting edge research and have a population that can benefit from promising drugs. Hey, while we they are at it---we don't mind the oversight!

And for the conspiracy theorists