Govt puts clinical research approvals on fast lane

The government has begun speeding up approvals in the area of clinical research which is set to boom in India, say top industry sources. The clinical research industry in India is currently USD 200 million, but is expected to reach USD 1.5 billion in just two years. “The government is proactively improving the regulatory framework to speed up approvals. So, the proper safeguards need to be in place to ensure this growth but also protect the people,” Drug Controller General of India (DCGI) Surinder Singh said. The government is also planning on introducing fingerprinting of clinical trial volunteers to ensure better data from the trails and also regularise insurance claims by these volunteers. Currently, only Indian pharma companies are allowed to conduct clinical trials from phase zero. Foreign firms are only allowed to conduct phase 2 and 3 trials in the country. With the DCGI planning on allowing foreign firms to conduct phase 0 and 1 trials in the country, it could definitely provide a boost to the industry and help it reach the projected number of USD 1.5 billion. The removal of service tax for CROs and customs duty on all imported drugs used in clinical trails has helped give this industry a boost and compared better on a cost platform to other countries. Suneela Thatte, utive director at Quintiles Research said, “The clinical research industry is growing faster than the pharmaceutical industry today. Research firms are getting into long-term partnering deals”. A Merill Lynch report has stated that India is a more economically viable destination to conduct clinical trials. The overall cost of conducting trails in the US is 2.5 times the cost in India. Phase 1 trails in India cost USD 12 million in March this year when compared to USD 25 million in the US. Phase 2 trails in India cost USD 25 million while the US was more than double at USD 60 million. Phase 3 trials in the US cost USD 110 million while it cost only USD 45 million in India. The increase in health and allied infrastructure and the implementation of good clinical practices (GCP) guidelines, is another reason why companies across the globe are looking at India as an attractive destination for clinical research. KPMG’s latest pharma report states that according to the US National Institutes of Health, about 272 trials are actively recruiting patients in India. Of this, 60% are phase 3 trails. In March 2008, about 80 hospitals (both government and private) were estimated to be involved in clinical trails apart from the 290 clinical research organisation in the country. Pratibha Pilgaonkar, chief utive officer of Rubicon Research said, “To reach the estimated target, the issue of qualified and adequate manpower needs to be addressed. Looking at the amount of outsourced work coming to India, we need to keep pace in terms of manpower, software skills and documentation process.” Indian companies have shifted from paper trails to electronic data capture (EDC) trails. But even this, industry sources say, needs to be improved to compete with countries like China which is also an aggressive player in the clinical research space.


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