Failed Dissolution Test with Active Content Within Limit Is a Minor Defect, No Grounds for Prosecution Under Drugs & Cosmetics Act: Rajasthan High Court

In a significant ruling, the Rajasthan High Court has quashed a complaint filed under the Drugs and Cosmetics Act, following the discovery of a minor defect in a drug’s dissolution test. The court found that the active pharmaceutical ingredient (API) in the drug was within the prescribed standard limits, and the failure to pass the dissolution test did not render the drug ineffective. This decision comes as a relief to…