Stories
India Proposes Major Overhaul of Animal Testing Rules for Drug Research
- •The Centre has proposed a new framework to simplify animal experiment approvals for academic institutions, research bodies, and pharmaceutical industries.
- •Registered Institutional Animal Ethics Committees would gain the authority to approve a wider range of experiments, reducing reliance on the Central Control and Supervision of Experiments on Animals.
- •A new four-tier risk-based classification system is introduced based on expected pain and suffering, categorized as mild, moderate, severe, and non-recovery.
- •The draft formally incorporates the 3Rs principles of replacement, reduction, and refinement to strengthen safeguards for laboratory animal welfare.
- •Additional proposed safeguards include annual audits for high-containment labs, digital record-keeping, and dedicated registers for euthanasia.
Key Questions Answered
The Centre has proposed a draft framework to replace older rules from 1968 and 1998, shifting from an animal-size-based system to a four-tier risk-based classification covering mild, moderate, severe, and non-recovery experiments. Registered Institutional Animal Ethics Committees would be empowered to approve mild and moderate studies, reducing the clearance burden on the Central Control and Supervision of Experiments on Animals.
Under the proposed framework, experiments involving severe pain or classified as non-recovery, as well as those involving animals other than rodents and lagomorphs for certain high-risk categories, remain subject to additional approval requirements from the Central Control and Supervision of Experiments on Animals.
The draft incorporates the 3Rs principles—replacement, reduction, and refinement—and mandates safeguards such as proper animal housing, veterinary supervision, staff training, digital record-keeping, dedicated euthanasia registers, and annual audits for high-containment laboratories. Additionally, ethics committees must submit their meeting minutes within 15 days.
