Section 85C in The Drugs and Cosmetics Rules, 1945
85C. Application to manufacture "New Homeopathic medicines"
.-Subject to the other provisions of these rules,-(1)No "New Homeopathic medicine" shall be manufactured unless it is previously approved by the licensing authority mentioned in rule 21;(2)the manufacturer of "New Homeopathic medicine", when applying to the licensing authority mentioned in sub-rule (1) shall produce such documents and other evidence as may be required by the licensing authority for assessing the therapeutic efficacy of the medicine including the minimum proving carried out with it;(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.
