Section 122DA(4) in The Drugs and Cosmetics Rules, 1945
(4)[ No permission for conduct of clinical trial intended for academic purposes in respect of approved drug formulation shall be required for any new indication or new route of administration or new dose or new dosage form where,-(a)the trial is approved by the Ethics Committee; and(b)subject to the provisions of sub-rule 5, the data generated is not intended for submission to licensing authority.
