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India's vast and diverse disease and patient populations provide an enormous clinical research opportunity. The cost of drug development is largely attributed to the cost of conducting clinical trials. Indian CROs have an opportunity to access the $10 billion market for clinical trials. The presence of a large talent pool of medical and para medical professionals is conducive to building a strong clinical development infrastructure. Government policy to permit Phase1-4 Clinical Trials is on the anvil and this will enable CROs to take advantage of the opportunity. ICH and GCP guidelines have already been prescribed by the Drugs Controller General of India. This sector will certainly play a major role in India's Biotech future. International CROs have already recognized this opportunity and have set up operations in anticipation of policy changes that will enable clinical trials to be carried out in India on equivalent lines of those conducted elsewhere. Quintiles is the major player which has shifted the bulk of its data processing activity to India. Revenues at Quintiles India is expected to grow exponentially once policy changes permit Phase1 clinical trials. Other international CROs include the Irish ICON, US CRO: Covance, European CRO Clintec and several others. Indian CROs have also emerged in this segment. The notable ones are Clinigene (promoted by Biocon), Lambda Labs (a division of INTAS pharmaceuticals) and Lotus Labs (An offshoot of EROS Pharma). China has made substantial investment in this segment.
Apart from Phase 1-4 clinical trials, Indian companies have a large commercial opportunity in Pre-clinical and "proof of concept" studies. A number of high quality Animal Houses are already availing of this opportunity.
Additionally, Indian Pharma majors like Ranbaxy , Dr. Reddys and Dabur are actively pursuing the development of new drug molecules which is generating a demand for clinical testing capabilities
within the country.
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