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Big business of clinical outsourcing

Clinical research is all set to be the next big opportunity sector after IT, not just in India, but abroad as well, says Radhika Sachdev.

india Updated: Mar 15, 2006 02:04 IST

Rakesh Gaikwad, a BSc in Chemistry, hated his job at a call centre before he was finally picked up by the Tata Memorial Hospital, Mumbai, as a Research Coordinator in their Clinical Trial Department.

This was the opportunity for which he had spent two years at Bhavan's College, Andheri.

In fact, along with doing night shifts at the call centre, he did an MSc in Clinical Research, and a Professor eventually got him the break with the Tata Memorial Hospital -- a break that Gaikwad was waiting for!

"Money was not important to me. But, it was indeed upsetting when I couldn't do what I was trained to do in college," he recalls.

According to a McKinsey report, the global clinical outsourcing opportunity for the Indian pharmaceutical industry is pegged at around Rs 5,000 crore by the year 2010, which means a requirement of about 50,000 clinical research professionals.

These are not small numbers. They represent huge opportunities for the 75,000 undergraduates in medical, life sciences and another 45,000 pharmacy students that India produces each year.

Earlier, if they couldn't become doctors, they ended up merely as teachers, chemists or medical representatives. There were no other career paths for them.

Today, with the cracking of the Human Genome Project and the recent amendments in the patents legislation, the climate is set just right for outsourcing heavy back-end clinical research projects and data warehousing to Indian Clinical Research Organisations (CRO) armed with the right skill sets. And herein hangs a tale...

We have very few institutes in the country, government or private, that offer specialised postgraduate training in Clinical Research, except for one private institute, the Institute of Clinical Research (ICR) that was set up in Dehradun in 2004 and has since moved its campuses to Delhi, Mumbai and Bangalore.

"The placement response from the industry is tremendous," explains SR Dugal, Chairman, ICR, "especially for the two-year classroom M Sc programme that's offered in combination with the MBA, done through distance learning."

The programme includes a six-month internship with a CRO or a pharma company and, "invariably, our students continue with the same organisation," informs Vijay Moza, Vice Chairman, ICR.

Take, for instance, the case of Madhuchanda Patnaik, a B Pharm from Utkal University, Orissa, "I had some exposure to clinical research in B Pharm (a minor subject at that time) and attended seminars and international meets where I heard about ICR. I liked their infrastructure and faculty and so enrolled for their M Sc programme."

Patnaik is currently working with international pharma major Pfizer, where she started her first job as an apprentice and is now on probation in Bangalore.

There are two career paths that you can take in this field. The medical stream starts with the profile of an Investigator-Project Leader-Medical Director, to finally being appointed as the CEO of a CRO.

The non-medical stream starts with a Clinical Research Associate-Clinical Research Manager-Project Manager-Regulator-Data Coordinator-Business Developer to finally, the Director of a Clinical Operation.

Adding to the human resource potential is the huge patient pool we have in India...45 million diabetes, 35 million cardio-vascular patients and one million psychiatric patients. They constitute what is medically known as the "naïve patient" pool, i.e. they have not been part of any medical intervention programme before.

"With legal and ethical controls gradually falling into place, patent regulation and our traditional stronghold in the English language, we have a tremendous edge over China, which is also fast coming up in the field of Clinical Research," informs Duggal.