The Hindu Business Line : Apollo plans tie-up to tap clinical trial potential

"We are actively looking at tying up with a CRO," said Ms Preetha Reddy, Apollo's Managing Director. Through clinical trials, already carried out in a small way at the hospital, Apollo would supplement revenue from its main hospital business.

New drugs need to be tested on human volunteers before they can be approved. Apollo's large volume of patients provide opportunities to recruit volunteers. Ms Reddy said a CRO that carries out the trials would have to pay the hospital a fee.

Currently, a new drug is estimated to cost about $ 800 million by the time it reaches the market. Clinical trials are the most time-consuming and expensive part of the development process.

Overseas drug companies have shown increasing interest in carrying out trials in India because it is cheaper, 50 per cent-75 per cent lower than the costs of a similar study in the US.

In this context, Biocon India's Chairman and Managing Director, Ms Kiran Mazumdar-Shaw, had earlier said, "India's advantage in clinical development is clearly speed of patient enrolment and shorter timelines for clinical trials."

Ms Reddy said Apollo had carried out about 65 trials so far, and the revenue was about Rs 4 crore-Rs 5 crore (Apollo's 2002-03 income was Rs 449 crore). But the hospital was upbeat about the potential of the business.

As the sensitive nature of clinical trials make it necessary for procedures to be strictly followed and volunteers to be adequately informed, Apollo uses another agency to keep an eye on the trials.

Spectra, a site management organisation that is largely owned by Apollo, monitors the trials carried out by the hospital. Ms Reddy said Spectra has an "arm's length" association with Apollo.

Indian clinical trials have stirred controversies in the past primarily because it was found that procedures had not been followed. Ms Reddy felt a trial's sponsor was the best check on its integrity because a drug company had a lot to lose if it was later found that procedures were violated.

At the moment, an ethics committee that is made up of members of its medical staff, a lawyer and a representative from the site management organisation supervises Apollo's trials.