CDSCO Update on Biopharmaceutical systems

CDSCO Update on Biopharmaceutical systems

CDSCO has released the ninth amendment in Drug and Cosmetics rules on April 03, 2017

CDSCO has made following changes in Drug and Cosmetics rules, 1945 as G.S.R 327 (E)

  1. In D & C rule, 1945, in rule 2 after clause (a), CDSCO has given classification of biopharmaceutical system based on solubility and permeability of drugs. They are as follows category I- high solubility and high permeability, category II- low solubility and high permeability, category III- high solubility and low permeability, and category IV- low solubility and low permeability.
  2. In rule 74, after clause (p), clause (q), In rule 74B, after clause (7), clause (8), In rule 76, after clause (9), clause (10), In rule 78, after clause (q), clause (r), In rule 78A, after clause (8), clause (9) following clause has been added “The applicant shall submit the result of bioequivalence study referred to in Schedule Y, along with the application for grant of a license of oral dosage form of drugs specified under category II and category IV of the biopharmaceutical classification system.”

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