Date:29/11/2004 URL: http://www.thehindubusinessline.com/2004/11/29/stories/2004112902190100.htm

Back Clinical research organisations see boom despite recent hiccups

Nithya Subramanian

New Delhi , Nov. 28

CLINICAL research organisations (CROs) are in the spotlight after generic companies like Ranbaxy and Hetero voluntarily withdrew their anti-AIDS drugs from the World Health Organisation's (WHO) list due to improper documentation of the bio-equivalence studies.

While senior officials at CROs preferred to call these "exceptional instances," they said that India is on the threshold of becoming a big player in the business. They also felt that these examples of poor documentation would not have an adverse impact on the business. However, Ranbaxy has shifted to a CRO in Europe, following the withdrawal action.

Speaking to Business Line, Mr Harpal Singh, Chairman, SRL Ranbaxy, said, "These are a few of the rare instances of poor quality service, but the serious players are quality-driven."

Added Mr S. Krishnakumar, General Manager - Business Development, Alkem Laboratories Ltd, "In India, CROs are on a learning curve. Except for a few well-established companies, all the others are in the process of learning. But the opportunity is here to stay."

However, the dropping of anti-retroviral (ARV) drugs of Cipla and Ranbaxy by the WHO has alerted not only the pharma industry, but also the CROs.

Mr Krishnakumar said, "Realising the importance of keeping pace with newer needs, CROs are upgrading their systems, improving infrastructure and educating staff. By doing so, India's huge potential in bio-equivalence studies, Phase I, II and III clinical trials and the outsourcing opportunity for research in its entire value chain can be exploited."

Mr Singh added, "Before the on-rush of clinical business, the market was estimated at Rs 1,000 crore. But now, it is very difficult to project how many folds it will grow to. We will get a clearer picture in the next 12-15 months," he said.

Meanwhile, his company is expanding its operations by setting up a new capacity for trials apart from lab work. It expects these facilities to be used to full capacity during the next three years.

"There is a need to ensure that trials are conducted properly, records are properly maintained and patients remain enrolled. Normally, there is little motivation for clinicians to conduct clinical trials. We ensure that the clinicians remain motivated and follow good clinical practices," said Dr Ashok Kumar Bantham, Vice-President, Neeman Medical International, a site management organisation offering study management services to the pharmaceutical, biotechnology, and CRO industries worldwide.

Pharmaceutical industry sources said that the CROs cannot be completely blamed for the earlier slippages. "When a pharma company hires a CRO, it is its responsibility to see that the CRO complies with Good Laboratory Practices and Good Clinical Practices. Clinical research is a joint programme of the sponsor and the CRO." To get quality work, pharma companies must give CROs adequate time and not indulge in cost-cutting methods, they added.