Quintiles marks a decade in India with new central laboratory
A new central laboratory in Mumbai is the latest chapter in contract research organisation (CRO) Quintiles Transnational’s 10-year history of operations in India.
Dedicating the new facility, which will extend both the US CRO’s global central laboratory network and the range of services offered by Quintiles in India to support international and regional clinical trials, chairman and chief executive officer Dennis Gillings said the laboratory “symbolises the rapid growth and achievement of our team here, as well as the acceptance of India as a centre for clinical research”.
Quintiles has been something of a pioneer in the Indian market, first setting up an office in Ahmedabad 10 years ago. Since then it has added offices in Mumbai and Bangalore with a full complement of services, expanded its clinical research staff in India to 750 and conducted more than 700 global trials across business lines.
The Mumbai laboratory will provide access to Quintiles laboratory kits, ensure all study samples are processed in a consistent and timely manner, and oversee data transfer for inclusion in the Quintiles Laboratory Information Management System and the protocol-specific database, the CRO noted.
According to Shamiq Hussain, the Institute for Clinical Research’s (ICR) new country manager for India, the sector only really started to take off in 2001, with some 20 to 25 CROs setting up shop over the last two to three years. A recent addition to this community was US-based INC Research, which entered the market through a 50:50 joint venture with India’s GVK Biosciences. The newly formed INC GVK BIO Private Limited will have the capability to run full-service Phase I-IV clinical trials in India for its pharmaceutical and biotech clients.
The financial advantages of shifting clinical research to India can be overstated, Hussain told PharmaTimes recently. Trial costs are probably 30-40% below those of more established markets, rather than the 60-70% sometimes quoted. But there are many other reasons for CROs to be in India, he pointed out. Not least of these is the pace of recruitment, in some cases three to four times faster than in the west.
There is also a huge population, often with very limited access to medical care and presenting a mixture of tropical and – increasingly – diet- and lifestyle-related western diseases. Moreover, Hussain noted, the regulatory environment is improving. For example, more acceptance of foreign clinical data is starting to resolve the ‘phase lag’ whereby companies were obliged to conduct Phase II trials in India before moving onto Phase III.
Alan Boyce, chief operating officer at Synexus Clinical Research, says India wants to run clinical trials and is adapting its regulations accordingly. Timelines for study approval are now down from six months or over to three months, he told PharmaTimes. And the trials are flooding in. According to Boyce, the number of studies conducted in India has grown by roughly a factor of five since 2000 and is expected to increase tenfold over the next five years.