Ethical Toxicity Studies: Promoting Safe Practices

• Use of animals for experimentation in education, training & research.

• An integral part of the pharmacology education at medical colleges, pharmacy, veterinary institutes.

• An essential part of basic research & preclinical drug discovery process.

• Animal models are used to test possibilities that would be difficult or impossible to test using the target species

• It is mandatory to do extensive toxicological studies in animals before the candidate drug gets approval for clinical trials in humans.

• The Centre has CPCSEA approval for experiments of small animals.

• We have our own Institutional Animal Ethics Committee Regulated by CPCSEA New Delhi for ethical clearance of toxicity study. (Reg. no. 1938/PO/Rc/S/17/CPCSEA)

Toxicity Study and Facility

Clinical Toxicity Lab

• Acute toxicity study on rats and mice through injectable and oral dosage form (7 – 14 days period according to the CDSCO Schedule Y requirements of Drugs and Cosmetic Act, New Amendment and OECD guidelines, NDCT Rules 2019).

• Sub acute/ Sub Chronic toxicity study on rats and rabbits through injectable and oral dosage form (28 days period.

• Chronic Toxicity Study on rats, mice and rabbits (90 - 120 days period.

• Dermal, Skin Sensitization, Irritation Toxicity Study on Rabbits &Rats (patch test for 72 hours or subchronic for 28 days.

• Photo-Allergy Or Dermal Photo-Toxicity Study In Guinea Pig.

• Ophthalmic Toxicity Study on Rabbits and rats.