Bare ActsThe drugs and cosmetics act, 1940

Section 85H

Conditions of licence

Amendment status not verified — confirm the current text below against the official source.

Conditions of licence.–A licence in Form 25-C shall be subject to the conditions stated therein and to the following further conditions, namely : (a) the licensee shall provide and maintain staff and premises as specified in Rule 85-E; (b) the licensee shall allow an 1[Inspector appointed under the Act] to enter, with or without prior notice, any premises where the manufacture of a Homoeopathic medicine in respect of which the licence is issued is carried on, to inspect the premises and to take samples of the manufactured Homoeopathic medicines; (c) the licensee shall allow an Inspector to inspect all registers and records maintained under these rules and shall supply to the Inspector such information as he may require for the purpose of ascertaining whether the provisions of the Act and the rules made thereunder have been observed; 2[(d) the licensee shall maintain an Inspection Book in Form 35 to enable an Inspector to record his impressions and defects noticed;] (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 3[for a period of five years]; (ii) the total solids in the mother tincture shall be determined and records of such tests shall be kept 3[for a period of five years]; (iii) the alcohol content in the mother tincture shall be determined and records of the same shall be maintained 3[for a period of five years]; (iv) the containers of mother tinctures shall preferably be of glass and shall be clean and free from any sort of impurities or 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 Homoeopathic principles;

Section 85H – The drugs and cosmetics act, 1940 | DailyLaw.ai