Section 122E(a) in The Drugs and Cosmetics Rules, 1945
(a)[ A drug, as defined in the Act including [or phytopharmaceutical drug] [Substituted by G.S.R. 591(E), dated 17.8.1999 (w.e.f. 17.8.1999).] which has not been used in the country to any significant extent under the conditions prescribed, recommended or suggested in the labelling thereof and has not been recognized as effective and safe by the licensing authority mentioned under rule 21 for the proposed claims:
