US-based contract research organisation (CRO) Quintiles Transnational has formed a partnership with Apollo Hospitals Group, the largest private hospital company in India, to set up a Phase I clinical trial unit in Hyderabad.

Scheduled to open in the first quarter of 2010, the new unit will conduct Phase I testing on compounds developed both in India and abroad. It will initially have some 50 beds, with plans to expand that capacity to 100 beds to meet predicted growth in demand. The combined investment by the two partners in the Hyderabad facility is expected to be around US$6 million.

Hyderabad will be Quintiles’ fifth Phase I site, joining a network of units in London (UK), Kansas (US), Lulea (Sweden) and Uppsala (also Sweden). The CRO already has offices in Mumbai, Ahmadabad, Bangalore and Delhi, India, offering clinical research, central laboratory, data management and electrocardiogram services.

Senior managers from Quintiles’ Phase I unit at Guy’s Hospital, London will set up operations in Hyderabad and mentor the management team there. Quintiles’ London personnel will also help to train staff for the Indian facility, which will be established in a building on Apollo’s hospital campus in Hyderabad.

Phase I studies have generally been excluded from the outsourcing boom that has seen a flood of clinical trials into India to take advantage of lower costs, qualified investigators, a large and diverse patient pool, and an improved legal and regulatory framework. Unless the sponsor wants to file data from another country and then repeat the study in India, Phase I trials are only permitted if the drug was discovered locally.

Last autumn, there were reports that the Central Drugs Standard Control Organisation was finally looking at easing these restrictions, as part of a wider package of check and balances for clinical trials in India, such as more stringent monitoring systems, registration of CROs and creating a databank of trial volunteers.

As they stood, though, the draft regulations on amending the Drugs and Cosmetics Act came with significant and potentially discouraging conditions on licensing and intellectual property attached.