Clinical Trial Regulations In India : Past, Present and Future
Journal Title: Journal of Medical Sciences - Year 2017, Vol 20, Issue 1
Abstract
Clinical trials are the only way of establishing the safety and efficacy of any new drug before its introduction in the market for human use. Clinical trials (with safeguards) are necessary for the introduction of new drugs for a country like India, considering its disease burden and emergence of new variants of the disease. The regulatory bodies need to frame guidelines and regulatory approval processes on a par with international standards. Many of the new laws, guidance documents, notifications and initiatives for regulating the pharmaceutical industry were in the charts for quite a long time. Indian regulatory authorities have started looking into speedy implementation and providing support in terms of necessary infrastructure and investment.
Authors and Affiliations
Haroon Rashid
Keywords
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