CLINICAL TRIALS IN INDIA: COST EFFECTIVENESS
Cost of conducting clinical trials in US is as follows:
Phase-1-$5404
Phase-2-$6538
Phase-3-$7635
Clinical trial for one drug in US costs approximately $1 billion. US infrastructure for conducting clinical trials is for sure unbeatable till now. While US continue to conduct clinical trials in flow, India and China are now seen as potential targets to conduct clinical trials.
Potential contract research targets have been kept away from China owing to its week regulatory practices in the past, while with its recent entry into WTO; China is also considered as a platform for clinical research. China is a low cost hub for drug manufacturers.
Indian infrastructure cuts down the cost of conducting clinical trials of new drugs to almost 60% of the cost in first and second world countries.
The CRO business in India ranges between $100-$120m per year.. This is a huge factor which is making the pharmaceutical countries flock towards Indian CROs manage many functions of a sponsor, monitoring the work in phase II-IV. Currently, there are almost 30 CRO in India. India gives a low cost advantage with high quality fast output.
There has been a meteoric rise in the clinical research infrastructure in India as compared to early nineties, when there was negligible clinical research experience, improper documentation, poor infrastructure, and weak regulatory environment with non functional ethics committee.
The potential for good practices is being realized now and clinical research facilities are being centralized in hospitals. Sites with well equipped laboratories and good research facilities allow the implementation of new and standardized policies. Simultaneously, with these new approaches, the interest of sponsors for clinical research in India is also developing at an accelerating pace.
Above all, the investigators from different parts of the country are well trained in GCP compliant clinical research. Additionally, the availability of patients from different therapeutic areas and less time consumption add to the advantage of low cost clinical trials in India.
There is a symbiotic relationship between the Indian infrastructure and clinical research. As, the Indian services are beneficial for clinical trials in terms of quality , training and costs, it adds more incentives to Indian platform when the sponsors provide highly sophisticated instruments to ensure good trial standards. The funds from sponsors are utilized to raise the standard trial sites.
