India beckons as a test-bed for western drug companies
By Ray Marcelo
Financial Times; Oct 14, 2003
Harmala Gupta runs a cancer patient care and counselling service in New Delhi, but she 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."
Ms Gupta's concern for her patients serves as an ethical reminder for multinational pharmaceutical companies that hope to cut drug development costs by recruiting Indian patients for clinical trials.
The reality of clinical trials - the approval process for any new pharmaceutical - is that they 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 1bn and no shortage of diseases, an attractive destination for contract research organisations, businesses that run trials for pharmaceuticals groups.
The aim is to reduce the time and money needed to turn new molecules into marketable drugs: a process that can take 20 years and cost $800m (£480m).
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 $200m.
"India clearly provides an opportunity for western pharmaceuticals companies . . . because of the availability of large patient populations, access to highly educated talent and a lower cost of operations."
These developments come when pharmaceuticals companies are beginning to consider transferring parts of their research operations to India. It is attractive because of its many scientists and the fact that it is implementing tougher patent protection. The companies are keenly searching for ways to increase the productivity of their research. Some executives believe India could become as prominent in pharmaceuticals as it is in information technology.
In clinical trials, India, unlike the US, offers an enormous pool of what the industry calls "treatment-naïve" patients - those who have not been tested with rival drugs. A larger pool of such people offers the prospect of faster patient enrolment in trials and thus more rapid drug development.
India has about 30m people with heart disease, 25m with type-II diabetes and 10m 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 consumers.
The world's largest CRO, US-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 CROs that have set up offices in India, up from three in 2001.
Mike Ryan, business development manager of New Jersey-based CRO 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 US, 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 US-based subsidiary of India's Max Healthcare group, says companies can save 20-30 per cent in drug development costs by outsourcing to India.
Most of these savings come from hiring clinical researchers, nurses and IT 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.
Allan Weinstein, vice-president of clinical research and regulatory affairs with US drugmaker 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. |
