Amendment status not verified — confirm the current text below against the official source.
Definition of new drug.- For the purpose of this Part, new drug shall mean and include- 1[(a) A drug, as defined in the Act including bulk drug substance 2[or phytopharmaceutical drug] 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: