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Outsourcing Of Indian Clinical Trials Clinical trials indicate the research and study that is conducted by several pharmaceutical firms in order to arrive at advanced treatment methods and diagnosis procedures to treat patients ailing from chronic diseases. Simultaneously, in an effort to introduce advance medical drugs to others, leading pharmaceutical players are leveraging the best of all medical opportunities that are coming up today. With this increasing medical opportunities and scopes rising in India, practices are being encouraged to advance the clinical research procedure and outsource the same.

Reasons For Clinical Research Outsourcing In India

The clinical research focus in India has been moving from cost efficiency to quality and quick responses. India has the second largest population globally and is undergoing through an upheaval socially, economically and scientifically. The increased awareness of Good Clinical Practices (GCP) along with a desire for global acceptability of medical researches conducted in India has ushered positive changes in the attitude of Indian medical professionals taking part in clinical researches. Multiple investigators are willing to participate in GCP clinical trials and to comply to the restraints of the protocol as well. The present clinical trial practices in India are approximately around Rs.13.5 billion and is expected to increase in the forthcoming years.

Going by the statistics accumulated by the Indian Council of Medical Research the overall earning from clinical researches in India back in 2003 was Rs.2.25 billion. Around 800 people work as full time employees and other thousands of people are appointed as site staff. Presently, the total number of patients taking part in clinical trials is around 10,000. The clinical trials are regulated by schedule Y of Drugs and Cosmetics Act in India. Furthermore, the Ministry of Health in addition to ICMR and DCGI also have guidelines for clinical research in human subjects. These guidelines are formulated based on Declaration of Helsinki, WHO guidelines and ICH requirements for GCP. Simultaneously, the Department of Science and Technology has taken the attempt for setting up quality requirements by establishing the National Board for Accreditation of Testing and Calibration Laboratories for bio-clinical laboratories.

In the recent past, various clinical research organizations (CRO’s) have strengthened their base in India in terms of conducting clinical trials and researches as well as other medical studies. These CRO’s have a


strategic alliance with esteemed medical institutions and hospitals. This helps the CRO’s to have access to huge patient databases that spans across various therapeutic areas and other related proprietary diagnostics and therapies.

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Outsourcing Of Indian Clinical Trials