The scale of GSK's involvement and timing looks to take advantage of the recent Schedule Y amendment in the Indian Drugs and Cosmetics Act 1940, that further streamlined clinical research.
P.T. Jyothi Datta
Mumbai, Nov. 21
AFTER the recent tie-up with Indian cancer institutes, GlaxoSmithKline Plc (GSK) is looking to spread the clinical research net to other segments as well.
GSK Plc has identified India as a hub for clinical research and it is in the process of identifying institutes for similar long-term collaborations, said Mr Kal Sundaram, GSK's Managing Director in India. Besides cancer, GSK will undertake research in segments such as the central nervous system, anti-infectives, respiratory, diabetes and metabolic disorders, he told Business Line.
GSK Plc was investing in terms of capability and infrastructure, he said explaining the significance of the agreement. Unwilling to quantify the commitment, he said it is a multi-million-dollar agreement. GSK Plc holds 50.7 per cent equity in GSK India.
The cancer trials are expected to commence in January 2006 and one of the molecules that GSK is researching is Lapatinib, a dual action treatment being developed for breast cancer.
The trials across the different products would be either in Phase III or Phase II, a GSK official said. Phase III trials are conducted on 1,000-5,000 patients to test the safety, efficacy and adverse reactions of a prospective drug.
Phase II is conducted on up to 500 patients to monitor drug and its targeted application.
Other multinational companies, such as Pfizer, Novartis, AstraZeneca and Eli Lilly, are also routing some of their global clinical research into India, observed an industry representative.
But the scale of GSK's involvement and timing looks to take advantage of the recent Schedule Y amendment in the Indian Drugs and Cosmetics Act 1940, that further streamlined clinical research.
GSK's initiative is also an indicator of its confidence in the recent product-patent regime, ensuring the protection of intellectual property, Mr Sundaram said.
This, in addition to the fact that India has the patient-pool and scientific resources, he added.
Late last week GSK and the University of Oxford announced its collaboration in cancer research to be done through clinical centres in India.