Source: TH
Context: The Central Government of India has announced that it will waive the requirement for local clinical trials for certain new drugs if they have already been approved in select countries, including the United States, United Kingdom, Japan, Australia, Canada, and the European Union.
- This decision aims to make foreign-manufactured drugs more accessible and affordable in India.
The waiver applies to five categories of drugs: orphan drugs for rare diseases, gene and cellular therapy products, drugs used in pandemic situations, drugs for special defense purposes, and drugs that offer significant therapeutic advancements over existing treatments.
