Question
Pharmaceutical Jurisprudence Question on Drugs and Cosmetics Act 1940, Rules 1945, including New Drug applications
As per schedule 'Y' of the drugs and cosmetics act, the animal toxicity study requirements for marketing of a drug depends upon tentative route and duration of administration in humans. In This context, which one of the following statements is incorrect
Single dose human use-animal toxicity for 2 weeks in 2 species
Oral use for 2 weeks in humans- animal toxicity for 4 week in 2 species
Aerosol use by repeated use in humans- animal toxicity for 24 weeks in 2 species
Multiple daily ocular application for short duration-iregation test in 1 species for 3 weeks
Multiple daily ocular application for short duration-iregation test in 1 species for 3 weeks
Solution
The correct option is (D): Multiple daily ocular application for short duration-iregation test in 1 species for 3 weeks