Section 85H(e) in The Drugs and Cosmetics Rules, 1945
(e)the licensee shall comply with the following conditions in respect of mother tinctures manufactured by him:-(i)the crude drug used in the manufacture of the mother tincture shall be identified and records of such identification shall be kept [for a period of five years] [Added by G.S.R. 13(E), dated 7.1.1983 (w.e.f. 7.1.1983).];(ii)the total solids in the mother tincture shall be determined and records of such tests shall be kept [for a period of five years] [Added by G.S.R. 13(E), dated 7.1.1983 (w.e.f. 7.1.1983).];(iii)the alcohol content in the mother tincture shall be determined and records of the same shall be maintained [for a period of five years] [Added by G.S.R. 13(E), dated 7.1.1983 (w.e.f. 7.1.1983).];(iv)the containers of mother tinctures shall preferably be of glass and shall be clean and free from any sort of impurities of adhering matter. The glass shall be neutral as far as possible;(v)in the process of manufacture of mother tinctures hygienic conditions shall be scrupulously observed by the licensee. Storage and handling conditions shall also be properly observed by the licensee according to Homeopathic principles;(ea)[ no colour shall be added to any Homeopathic medicines: [Inserted by G.S.R. 680(E), dated 5.12.1980 (w.e.f. 5.12.1980).]
