Waiver for Clinical Trials in India
Red Book
Red Book

ForumIAS announcing GS Foundation Program for UPSC CSE 2025-26 from 10th August. Click Here for more information.

Source- This post on Waiver for Clinical Trials in India has been created based on the article “No clinical trial for drugs approved in select nations” published in “The Hindu” on 9 August 2024.

Why in News?

The Indian government has decided to waive off  the requirement for clinical trials within India for certain drugs if they are already approved in specific countries like the U.S., U.K., Japan, Australia, Canada, and the European Union.

About Waiver for Clinical Trials in India

1. Purpose of the Waiver: This waiver aims to make drugs manufactured outside of India more accessible and affordable for Indian patients.

2. Categories of Drugs Considered for Waiver: There are five drug categories:

Drug CategoryUses
Rare Disease DrugsDrugs used to treat rare diseases.
Gene and Cellular Therapy ProductsAdvanced therapies involving genes and cells.
Pandemic Situation DrugsNew drugs specifically used during pandemics.
Special Defence Purpose DrugsDrugs developed for defence or military purposes.
Significant Therapeutic AdvancesNew drugs that offer major improvements over current treatments.

Government Regulations for Waive off

Rule 101: The waiver is authorized under Rule 101 of the New Drugs and Clinical Trial Rules, 2019. This rule allows the government to exempt local clinical trials if the drug is already approved in the listed countries.

UPSC Syllabus: Governance

Print Friendly and PDF
Blog
Academy
Community