The US-based CRO (clinical research Organisation) major Kendle International Inc. will start its India operations soon. The company has identified a place in Gurgaon to set up its India office and has started recruiting personnel for operations, confirmed reliable sources.

In India, Kendle will provide phase I through IV clinical development services. Globally, the company also provides services like regulatory and R&D strategic planning and execution, regulatory submission services, compliance, validation and audits for manufacturing operations and clinical trials, and information services and regulatory intelligence.

Kendle International's subsidiary, Kendle Asia already operates as a full- fledged CRO in Beijing, China. "With product patent regime approaching, MNCs are in constant lookout of launching innovative products in India. New product launches in the areas like CVS, oncology, anti-infectives, CNS, respiratory, gastrointestinal diseases and biotechnology are launched on a wider scale today compared to few years back. Subsequently, there is demand for good CROs, especially ones having international exposure," said a pharma consultant from Mumbai.

The current Indian CRO market is estimated at $ 70-100 million, which is growing at a rate of 60-80 per cent annually.

The advantage possessed by India to be an ideal market for clinical trials include the availability of large naïve and multiethnic population, cost effectiveness of the market, and wide spectrum of diseases.

Sources could not confirm whether Kendle will set up operations on its own or will tie up with local partners having a feel of the domestic market. However, many feel it will enter the market all alone.

"An international CRO like Quintiles preferred to set up its base all alone and it succeeded. However, another foreign CRO like Covance had to tie up with Indian CRO Siro Clinpharma to get comfortable with Indian conditions. So there have been examples either ways," said senior official with a Mumbai-based CRO.