Abstract
With the harmonization of patent laws in the post-WTO scenario, like many other developing countries India became one of the preferred destinations for carrying our clinical trials (CTs) of new drug molecules. To facilitate the emerging demands of the CT industry, several amendments were made in the existing Schedule Y under the Drugs & Cosmetics Act and rules in 2005. The upcoming CT industry witnessed a sudden surge in its activities both in number of trials and economics. However, soon it was realized that there were lapses in the conduct of CTs including violations of Good Clinical Practices (GCP), functioning of the ECs and CROs, and flouting of the regulatory requirements. New amendments were enacted in 2013 to enhance the public confidence and faith in CTs. In line with these amendments, CDSCO upgraded and optimized the regulatory requirements and policies so as to have predictable, transparent, and effective regulations for CTs to enable faster accessibility of new drug molecules in the country. The New Drugs and Clinical Trials Rules 2019 is a step in that direction. This chapter attempts to give an overview of the regulatory developments in the context of changed scenario in clinical research in India.
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George, B., Kulkarni, S.K., Kshirsagar, N.A. (2021). Regulatory Requirements and Quality Standards in India’s Clinical Trials Journey. In: Dikshit, M. (eds) Drug Discovery and Drug Development. Springer, Singapore. https://doi.org/10.1007/978-981-15-8002-4_12
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