About GCTRO
Advantages to conduct Clinical studies in India
India is emerging as a destination for Clinical Research Outsourcing (heavily populated 1.136 billion) because of the inherent advantages like ethnically diverse and a large pool of treatment naïve patient population, 700,000 specialty hospital beds, 221 medical colleges and skilled English-speaking medical personnel and timely completion of projects. Subject recruitment is the most common rate-limiting step in the drug development process. Sponsors normally cannot reduce study timelines without sacrificing quality and incurring increased costs. India offers sponsors the opportunity to recruit subjects quickly while maintaining a high level of quality. The relative cost savings result not only from shorter timelines but also from the low cost of performing studies in India. It is predicted that Clinical Trials revenue would grow to anywhere between $500 million and $1 billion by 2010. According to a market research data, it has been predicted that by 2011, India will be conducting more than 15 percent of total global clinical trials.
Seeing the business opportunity being offered to India in the field of Clinical Research, the Government of India has stepped up with a lot of new initiatives to make it lucrative for Pharmaceutical Companies to do their Clinical Research in India. It is also taking care that the Clinical Trials are done in an ethical fashion.
The clinical trial industry in India in general has been shaping up in the past few months, while the government has been tightening the regulation of clinical research activities. The Health Ministry recently proposed a draft bill, under which the Central Drugs Authority (CDA) would have the power to prosecute CROs, investigators and pharmaceutical companies who violate rules of clinical trials. Its increased regulatory control and acceptance of the International Conference on Harmonization (ICH) guideline for good clinical practice further enhances India's reputation as an ideal location to conduct clinical trials.
Advantages of conducting trials in India
A large pool of patients, from multiethnic and multiracial backgrounds
Rapid patient recruitment, which significantly reduces the clinical development process
A wide ranges of indications. Multidrug-resistant pneumonia, Hepatitis B, diabetes, and some cancers are far more prevalent in India than in any Western countries
Drug companies can save 30%-50% by conducting trials in India as compared to the Western countries
Data generated in India is accepted by all major conferences and journals # Investigators are mostly trained in the Western countries
All hospitals, private clinics and private institutions store comprehensive source data, mostly in English
