India's poor susceptible to pharmaceutical gaints

 

Lured by the money being offered by dozens of international pharmaceutical companies carrying out clinical trials in India, human guinea pig M. Mahesh is testing his sixth drug-this time helping in the search for a cure for asthma.

 

Dressed in a green hospital gown, Mahesh, a welder, has no knowledge at all about the drugs he has allowed doctors to introduce into his body over the past two years.

 

For now, he has no regrets.

 

"So far, no drug has had an adverse impact on my health. I will continue to do this for the money I get, "27 year old Mahesh said, disclosing that for the lastest test he will be paid an equivalent of C$150 by the research firm. His 19-year-old friend, Bala Kumar, an electrician, said the 5,000 rupees he would be paid for testing the drug on himself for 48 hours was more than his monthly takings.

 

Mahesh and Kumar are among 1000's of volunteers who are driving India's nascent clinical research industry, which has attracted global pharmaceutical firms such as Aventis, GlaxoSmithKline, Novartis and Pfizer.

According to a report by consultants McKinsey and Co, the Indian clinical research industry can earn revenues of US$1.5 (C$1.7) billion by 2010, at which time the country will need 50,000 professionals and about 300,000 'subjects' or patients.

 

Critics say India's huge illiterate population is in danger of being misused by unethical firms to test suspect drugs. But industry officials say each trial follows a strict code of ethics.

 

"The volunteers undergo health tests such as blood, urine, chest X-rays and heart check-up. If they fail we do not enroll them for the test," says Sandhya Ravi, chief of clinical services of Lotus Labs. "Strict protocols for safety are followed and the trial is monitored by an ethics committee comprising doctors, lawyers and even housewives."
 

Under Indian laws, only testing of new and generic drugs which have gone off patent and are manufactured in the country are permitted. All other pre-clinical trials, except those on rodents, are banned.

 

But as soon as pre-clinical trials on animals are over in a foreign country and the new drug has been tested on healthy volunteers in that nation, the drug can be used in India for so-called second and third phase trials.

Industry officials say it costs upwards of US$1 billion to make a new drug, with clinical trials accounting for almost two-thirds of the cost. Carrying out trials in India can cut costs by more than 55 percent, due to cheap and skilled scientific manpower and the availability of volunteers.