In another indication of growing interest in India as a destination for early-stage clinical trials, US-based contract research organisation (CRO) QPS has taken a majority stake in Bioserve Clinical Research, a full-service Phase I CRO based in Hyderabad.
The announcement came just a couple of days after Quintiles officially opened its new Phase I research facility in Hyderabad, India, set up in partnership with Apollo Hospitals Group.
No financial terms were disclosed for the QPS/Bioserve deal, under which the latter will now operate as QPS-Bioserve India. Suneil Reddy remains managing director of the Indian business.
The existing Bioserve infrastructure includes a 92-bed unit for Phase I trials and a bioanalytical lab equipped with multiple LC/MS/MS (liquid chromatography-tandem mass spectrometry) systems for small molecule bioanalysis.
Over the past six years, Bioserve has conducted more than 500 studies, leading to “numerous” product approvals, and has been inspected by the US Food and Drug Administration, the UK’s Medicines and Healthcare products Regulatory Agency, the World Health Organization and the Drugs Controller General of India, the new partners noted.
Ben Chien, chairman, president and chief executive officer of QPS, said the deal “further expands QPS’ global range of linearly integrated services”, giving clients a third more Phase I beds (400 in total) as well as increased bioanalytical capacity and “access to another facility, located in India, with a reputation for outstanding performance and a record of timely approvals”.
Established in 2004, Bioserve has been growing at a rate of over 50% per year and now has a staff of more than 100, the companies said. Clients include large Indian as well as multinational pharmaceutical players.
Phase I restrictions
India revised its Schedule Y regulations on clinical trials in 2005 to bring them into line with international standards and eliminate ‘phase lag’. Previously, sponsors could only start a clinical trial in India once the relevant phase had been completed in another market.
Phase I trials remained a sticking point, though, unless the drug was discovered locally or the sponsor wanted to file data from another country and repeat the study in India. Persistent concerns about Indian volunteers being used as guinea pigs for untried foreign drugs have complicated moves towards liberalisation.
In the last couple of years, though, there have been discussions about further amendments to the Schedule Y regulations that would ease restrictions on Phase I and Phase 0 microdosing trials in India.
Notably, it has been suggested, these amendments could include arrangements for licensing of associated intellectual property or joint development of the drug in question; or, alternatively, permitting Phase I trials of drugs discovered abroad where the sponsor had a permanent establishment in India.
CROs from outside India are not the only parties beefing up their Phase I capacity in the country. Earlier this month, Bangalore-based Ecron Acunova said it had expanded its Mangalore Clinical Pharmacology Unit to an 80-bed facility, citing the growing needs of its global client base for pharmacokinetic and pharmacokinetic studies.
Ecron Acunova now has a total capacity of 176 beds at research centres in Mangalore, Manipal and Bangalore, India.