GlaxoSmithKline plans to outsource more knowledge-based and value-added services like clinical data management, analysis and packaging to India.
Addressing a press conference in Bangalore on Tuesday, Dr Hans Ludwig Bock, vice-president and director, clinical R&D and medical affairs at GSK, said the parent company, recognising India's strength, has scaled up operations from the data entry level to clinical data management services.
The company began its Clinical Data Management Centre, India in 1996 in a small way and from then "operations grew in stature and importance, and now increasingly so, after merger which created GlaxoSmithKline. The parent company is now investing in infrastructure to cater to its global needs," he added.
With Bangalore centre becoming operational, it would be GSK's seventh after two groups in US, two in the UK and one each in Canada and Italy. "The India centre will not service country (India) needs but will service parent company's global work," said Penny Clarke of Biomedical Data Sciences GSK.
GSK plans to house both the CDMCI and Biomedical Data Sciences India in Bangalore as the city has huge a number of statisticians biometricians and clinical data reviewers and scientific writers, said Ashwini Mathur, general manager, GSK pharmaceuticals.
CDMCI, over the past nine years, has handled data entry operations of over 2.2 million subjects data sheets and provided clinical operations support to 400 clinical trials for vaccines business of GSK.
BDSI, co-located with CDMCI in 2001 post the GSK merger, has handled proprietary research molecules in therapy areas like CNS, CVS and metabolic disorders. "To date, the group has supported more than 100 clinical studies of pharma products of GSK," said Clarke.
CDMCI, since its inception has helped many global clinical trials. Latest being vaccines for gasteroentrities. "India was part of the 60,000 infants who took part in phase III trials," said Bock. The drug is awaiting DGCI approval for conducting further tests and launch in India.
According to S Kalyanasundaram, managing director, GSK India has slowly gained in importance.
"So far India has been part of nine global trials and is helping market intelligence group located in Europe, and has successfully set up third party centralised packaging system in Hyderabad. With India entering product patent regime, it has allowed us to increase our market presence in bringing in more vaccines and drugs for tropical diseases," he further added.
Allaying fears of GSK moving the bulk of its manufacturing to China, Kalyanasundaram said, "GSK point of view is that it is India and China and not India vs China. In India the company has begun to associate more with government schemes and is looking for partnering in vaccination drives.
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