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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 Category | Uses |
| Rare Disease Drugs | Drugs used to treat rare diseases. |
| Gene and Cellular Therapy Products | Advanced therapies involving genes and cells. |
| Pandemic Situation Drugs | New drugs specifically used during pandemics. |
| Special Defence Purpose Drugs | Drugs developed for defence or military purposes. |
| Significant Therapeutic Advances | New 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.
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