Please use this identifier to cite or link to this item: http://localhost:8080/xmlui/handle/123456789/1381
Title: Clinical Trials In India: Look Forward To Live Forward
Authors: Prof. (Dr.) Subhrangsu Shekhar Chatterji
Joydip Ghosal
Keywords: Amendments, Clinical Trial Rules, Drug Regulatory Process, New Drug Regulations
Issue Date: Jan-2024
Publisher: Centre for Health Law and Policy (CHLP)
Abstract: The concept of outsourcing the development and global testing of new drugs has become popular in the pharmaceutical industry due to its cost and uncertainty. Due to various factors, India is considered the preferred destination for clinical trials. These include its large indigenous treatment population, human resources, technical capabilities, adoption, amendment, implementation of laws by regulators and changing economic environment. There is a high potential for multinational pharmaceutical companies being attracted to conduct their clinical trials in India due to the availability of a highly skilled workforce concentrated in a few urban areas, a large population, and the prevalence of all major diseases. Unfortunately, there have been isolated cases of supposedly unethical and improperly conducted studies. The “New Drugs and Clinical Trials Rules, 2019”, notified by the Central Drugs Standard Control Organization, will help provide Indian people with quick access to new medicine and has a slew of new provisions.
URI: http://localhost:8080/xmlui/handle/123456789/1381
Appears in Collections:CHLP Article 4

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