P.T. Jyothi Datta

Mumbai , July 24

THE world's biggest medicine makers are in India with plans to increase their clinical trial activities, involving the testing of medicines on humans. Not oblivious to this, the Centre too is tightening regulations to prevent the local population from being exploited. But what could trip-up this line of scientific activity is the shortage of investigators, say scientific heads in the clinical research space.

"There is a shortage of trained manpower. India has about 500-1,000 investigators in the country, as compared to the United States that has 50,000 investigators," says Dr Arun Bhatt, President, ClinInvent Research Pvt Ltd, a clinical research organisation (CRO) that is part of the Purnendu Chatterjee Group.

An investigator is a medical professional, usually a physician, under whose direction an investigational drug is administered to a human volunteer. A principal investigator is responsible for the overall conduct of the clinical trial at his/her site.

Underlining the significance of the investigator's role, Dr Bhatt says: "The ethics are quite different for a doctor who acts as an investigator. The patient trusts the investigator, as he takes a risk in participating in an experiment that the investigator is conducting on behalf of a sponsor." The ethics here are a different ball game, he says.

Endorsing this view is Dr Swati Piramal, Director (Strategic Alliances) with Nicholas Piramal India Ltd. "In Wellquest we train people for three months and they are offered double the salaries by other CRO and they go. There is problem and for the love of money, I cannot get a good bio-analyst," she points out.

There is a shortage of not just investigators, bio-analytical scientists, pharmacokinetic experts etc., she added. Wellquest is a CRO from the NPIL stable.

While authentic figures are hard to come by, estimates from the industry put the Indian clinical trial market at $100 million, with the prospects of touching $300 million by 2010. "By these estimates, India would need about six times its present number of investigators," says Dr Bhatt.

More optimistic estimates by McKinsey expect clinical trials in India to touch about $1.5 billion in the same period. This would require a 10-fold increase in the existing number of investigators, he points out.

According to Dr Piramal, the industry has been the training ground for investigators. But some efforts have been taken to address the problem, she said. For instance, Maharashtra has recently started the Biotech Commission at the KEM Hospital to train people.

This year, the Government, along with the World Health Organisation, conducted training workshops for investigators, ethics committees and pharma companies, says a principal investigator, who has participated in several clinical trials. Dr Bhatt points out that there are reputed institutions for training such as the Academy for Clinical Excellence and Institute of Clinical Research India.

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