India Is Becoming a Testing Ground for Pharmaceuticals
By Ray Marcelo
Financial Times
October 20, 2003
NEW DELHI — Clinical drug trials — the approval process for any new pharmaceutical — are time-consuming, expensive and ethically tricky. The task involves recruiting hundreds, often thousands, of sick people to volunteer for the testing of experimental medicines, with unknown side effects.
This makes India, with a population of more than 1 billion and no shortage of diseases, an attractive destination for contract research organizations, businesses that run clinical trials for pharmaceutical companies.
The aim is to reduce the time and money needed to turn new molecules into marketable drugs: a marathon process that can take 20 years and cost $800 million.
Peter Pfeiffer, associate principal with consultancy McKinsey, told an industry conference in New Delhi: "The overall cost advantage in bringing a drug to market by leveraging India aggressively could be as high as $200 million. India clearly provides an opportunity for Western pharmaceutical companies because of the availability of large patient populations, access to highly educated talent and a lower cost of operations."
These developments come when pharmaceutical companies are beginning to consider transferring parts of their research operations to India, which is attractive because of its many scientists and the fact that it is implementing tougher patent protection. The companies are searching for ways to increase the productivity of their research. Some executives think India could become as prominent in pharmaceuticals as it is in information technology.
In clinical trials, India, unlike the U.S., offers an enormous pool of what the industry calls "treatment-naive" patients — those who have not been tested with rival drugs. A larger pool of such people offers the prospect of faster patient enrollment in trials and thus more rapid drug development.
India has about 30 million people with heart disease, 25 million with Type 2 diabetes and 10 million with psychiatric disorders, according to Centerwatch, a trade magazine. The abundance of these supposedly "rich-world" diseases is regarded as a prize attribute for companies looking to test drugs destined for Western patients.
The world's largest contract research organization, U.S.-based Quintiles, began operations in India in 1997, and has recruited 6,400 patients for clinical trials in areas such as psychiatry, infectious diseases and oncology. Centerwatch estimates there are a dozen contract research organizations that have set up offices in India, up from three in 2001.
Mike Ryan, business development manager of New Jersey-based Pharmanet, which has been in India for about a year, says one of the country's attractions is that patients hold doctors in high esteem. As a result, patient compliance in trials is high, as opposed to the U.S., where subjects often drop out to seek second opinions.
Indian companies, too, are angling for a share of contract research. Cathy White, chief executive of Neeman Medical International, a U.S.-based subsidiary of India's Max Healthcare group, says companies can save 20% to 30% in drug development costs by outsourcing to India.
Most of these savings come from hiring clinical researchers, nurses and information technology staff at less than a third of Western wages.
Another factor underpinning the shift of drug testing to India is the recent change in medical research rules. India's health authorities this year adopted guidelines on "good clinical practice" in line with global norms.
Still, some inside the industry express caution. Urmilla Thattle, associate professor at Tamil Nadu's medical college, argues that if patients are illiterate there are serious ethical questions surrounding their consent in a drug trial. She says she has seen hospital ethics committees using photocopied consent forms irrelevant to the proposed drug trial.
Harmala Gupta, who runs a cancer patient care and counseling service in New Delhi, is worried that many patients have little say in their treatment.
"Patients with lower social status are treated as if they have a basic inability to understand or even have feelings," she says. "I've heard young doctors saying it's so easy to do research on these people. But if you don't see people as people, but as case studies, it becomes exploitative."
Allan Weinstein, vice president of clinical research and regulatory affairs with U.S. drug maker Eli Lilly, says: "India should not be a place to go just because there are a lot of fresh patients." He says there must be a likelihood that patients involved in a clinical trial will benefit from the drug. |
