Wednesday, May 20, 2009

Clinical Research in India

Clinical research in India is developing day by day, having number of pharmaceutical or biotechnological companies. This pharmaceutical industries works on researching new drugs not only for tropical diseases, but also for universal diseases such as cancer, aids, diabetes, etc. Since the western medical fraternity is poor in researching numerous Indian diseases, they are attracted to build their establishment in India and competing in the global market. There are certain Contract Research Organizations or Clinical Research Organizations (CROs) which offer their clients with many services which include development of the product, formulation and ultimate production in spite of sponsor.   

A wide range of outsourcing services related to pharmaceutical research are offered by numerous Indian CROs to their clients to aid in the medical device research, drugs and development process. That means a legal person or a corporation as an independent contractor takes the contract from a client along with the sponsor designs some rules, investigates, evaluate reports, prepare materials and submits to FDA (Food and drug administration) or their clients. The number of services offered includes: development of the product, formulation of the product and manufacturing of the product.

For medical research, Clinical Research Organizations conducts clinical trials to provide safety and effective data for new drugs. Once acceptable information is gathered about the quality of the product and its clinical and non-clinical safety and approval from health authority or ethics committee of India is granted this trials takes place. Professionals of these research organizations initially hire or enroll patients and/or volunteers depending on the stage of development and type of the product and then they compare the new product with the ongoing prescribed treatment by performing large scale and final studies in patients.

There are number of medical research centers or CROs in India whose main motive behind the clinical research is to provide quality clinical research support to the biotechnical and pharmaceutical industries. This will lead to research of novel drug delivery system; evolve innovative therapies, development of new chemical entities, and taking care keeping safety of patient. There are numerous clinical research organizations which are providing superb scientific expertise, benchmark ethical practices and quality commitment, and caring out clinical research development of new novel therapies and molecular entities much faster also with high level of accuracy. So there is many clinical research organizations performing clinical trials at lower cost compared to wester countries CROs, within lesser time to complete the medical project. Even there are some institutes in India which works on researches for new generic and special drugs and new technology of medical treatments; they are AIIMS (e.g. All India Institute of Medical Science, New Delhi), the research materials are outsourced by many biotechnical and pharmaceutical companies of India and they finally produces drugs.

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