Conditions of licence

Section 85H of the Drugs and Cosmetics Act and Rules deals with 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;

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 1Inspector 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; 1. Amended by G. S. R. 444, dt. 28-4-1973. 2. Amended by F-1-14/ 68-D, dt. 26-10-1968. 3. Ins. by G.S.R. 13(E), dt. 7-1-1983. 1[(ea) no colour shall be added to any Homoeopathic medicines :

Provided that caramel may be added to combination of Homoeopathic preparations with syrup base;] (f) records shall be maintained of Homoeopathic medicines containing alcohol and the quantities sold together with names and addresses of parties to whom sold.2 [Such records shall be maintained for a period of five years.] 3[85HH. Additional information to be furnished by an applicant for the licence or a licensee to the Licensing Authority .- The applicant for the grant of licence or any other person granted a licence under this Part shall, on demand, furnish to the Licensing Authority, before the grant of the licence or during the period the licence is in force, as the case may be, documentary evidence in respect of the ownership or occupation in rental or other basis of the premises, specified in the application for licence or in the licence granted, constitution of the firm or any other relevant matters which may be required for the purpose of verifying the correctness of the statements made by the applicant or the licensee, while applying for or after obtaining the licence, as the case may be.] 85-I. Cancellation and suspension of licences .- (1) The Licensing Autority may, after giving the licensee an opportunity to show cause why such an order should not be passed, by an order in writing stating the reasons therefor, cancel a licence issued under this Part or suspend it for such period as he thinks fit, either wholly or in respect of some of the substances to which it relates if, in his opinion, the licensee has failed to comply with any of the conditions of the licence or with any provisions of the Act or Rules made thereunder. 4[(2) A licensee whose licence has been suspended or cancelled may, within three months of the date of the order under sub-rule (1), prefer an appeal against that order to the State Government, which shall decide the same.] PART VIII MANUFACTURE FOR EXAMINATION, TEST OR ANALYSIS

Section 85H, The Drugs and Cosmetics Act and Rules (Act 23 of 1940).