Section 85C(3) in The Drugs and Cosmetics Rules, 1945
(3)while applying for a license to manufacture a "New Homeopathic medicine", an applicant shall produce along with his application, evidence that the "New Homeopathic medicine" for the manufacture of which application is made has already been approved.Explanation. - The term "New Homeopathic medicine" in this rule shall have the same meaning as in rule 30-AA.