Saturday, February 25, 2012

New Guidelines to Tighten Indian Clinical Trials Industry by RNCOS E-Services Pvt. Ltd.

According to our latest research report “Booming Clinical Trials Market in India”, the number of clinical trials has increased in the country supported by both domestic as well as global participation. These clinical trials have got the support of regulatory bodies in the country through faster review and other imperative activities. Support from the government has come in the form of duty free drug imports and bioequivalence studies data for export.

Rapid growth of the sector in recent years has prompted concerns about lax oversight of clinical trials and CROs. Resultantly, India’s Central Drugs Standard Control Organization (CDSCO), in a recent move, has issued guidance for regulators and sponsors on clinical trial inspection procedures that covers all sites and sponsor/contract research organization (CRO) facilities involved in clinical studies of drugs, biologicals, and medical devices regulated by the India’s Drugs & Cosmetics Act. The guidance is in line with the wider government efforts to tighten up the regulatory framework for clinical research in India.

Besides, we have presented the key factors that will continue to serve as growth driver for the market during the forecast period (2011-2013). We have identified that the country has managed to position itself as one of the leading destinations for clinical trials during the past few years. Availability of world-class healthcare infrastructure, skilled medical professionals, and low cost for patients and volunteers are some of the main factors driving growth in this industry. The market is expected to perform well in future also and will reach US$ 768 Million by 2013, registering a CAGR of 29% since 2009.

Our report “Booming Clinical Trials Market in India” provides an extensive research and rational analysis along with reliable statistics of the Indian clinical trial market. It studies the emerging market trends, recent developments, and their impact on the market. Besides, the report provides complete details of the cost involved in various phases of clinical trials in the country. In addition, an in-depth analysis of the patient pool availability in India along with infrastructure and expertise has been elucidated in the report. The report also reveals about the contribution of the government regulations in the growth of the country’s clinical trial industry. Further, the report has also identified risk factors that can affect the future growth of the industry. Competitive landscape is also presented in the report to enable clients understand future market structure and growth potential.

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