The Rajasthan Drugs Rules, 1954
Published vide Notification No. F. 16A(2)M-H./53/6430, dated 22.7.1954
Note. - The Drugs Act, 1940 and the Rules made thereunder have been enforced in the State of Rajasthan with effect from 16th July, 1959, vide Government Notification No. F.16(A)(2)MH/53, dated 4th July, 1959.2. Application of Rule 2 and Parts V to XII of the Drugs Rules, 1945. - Rule 2 and Parts V to XII of Drugs Rules, 1945 including the connected Forms and Schedules (herein appended) shall apply to the State of Rajasthan as they apply to the State of Delhi: Provided that all references in the said rules to the Central Government, Government of Chief Commissioner shall be deemed to be references to the State Government.
Note. - (1) Since the adoption of the Central Rules by the State Government, many changes have been made in the Central Rules. It is of no use to reproduce the Appendix which was appended to the above notification. In its place, for facility of reference to the readers, the Central Rules (complete), as amended upto date are being given in the. following pages.
AnnexureThe State Government also made certain additions and alterations to the Rajasthan Drugs Rules, 1954 which are given as under:-
No. 1In Schedule C(1) to the said rules, for items 1, 3, 5, 6 and 7, the following items shall respectively be substituted, namely:-
"1. Drugs belonging to the Digitalis group and the preparations thereof not in a form to be administered parenterally."
"3. Adronaline and the preparations thereof not in a form to be administered parenterally."
"5. Vitamins and the preparations thereof not in a form to be administered parenterally".
"6. Liver extract and the preparations thereof not in a form to be administered parenterally", and
"7. Hormones and the preparations thereof not in a form to be administered parenterally".
No. 2In Schedule F annexed to the said Rules, in Part XII, under the heading "D-Preparations containing any vitamins in a form not to be administered parenterally", in the sub-head relating to "Labelling" for entry 1, the following entry shall be substituted, namely:-
"1. The number of units and/or the actual weight of each vitamin per unit volume and/or weight shall be declared on the label".
No. 3In Schedule A to the said Rules, in Form 21 under the heading "Conditions of licence" after conditions 3, the following shall be inserted namely:-
"4. In the licensee wants to see, stock, exhibit for sale or distribute during the currency of the licence additional products specified in Schedule 'C' but included in this licence, he should apply to the Licensing Authority for the necessary permission. This licence will be deemed to the products in respect of which such permission is given. This permission should be endorsed on the licence by the Licensing Authority".
No. 4In the said rules, for rule 106, the following rule shall be substituted, namely-
"106. Diseases which a drug may not purport to prevent or cure. - No drug may purport or claim to prevent or to cure one or more of the diseases or ailments specified in Schedule J or to procure or assist to procure miscarriage in women."
No. 5For the heading to Schedule J annexed to the said Rules, the following shall be substituted, namely: -
"Diseases and ailments (by whatever name described) which a drug may not purport to prevent or cure."
No. 7In Schedule H to the said rules, to the entry beginning with the word "Para-aminobenzene-suphonamide" and ending with the words "their salts" the following shall be inserted, namely:-
"but excluding preparations and dressings containing these for external use."
No. 8In the said Rules-
In the first proviso to Rule 44. for the figure 14 in the two places where it occurs, the figure 15 shall be substituted.
No. 9In Schedule A, in clause (1) of form 9-
(a) After the figures "1945" the words "excepting Penicillin and preparation of Penicillin for parenteral administration and Streptomicin" shall be inserted.
(b) After the words "British India" the words "in the case of Penicillin and preparations of Penicillin for parenteral administration and streptomycin, the said applicant shall be an authorised Agent in India" shall be added.
No. 10In Schedule C-
(a) in item 11 for the "Penicillin" the words "Penicillin and preparations of Penicillin for parenteral administration" shall be substituted.
(b) (i) After item 11, the following item shall be inserted, namely:-
"12. Streptomycin" :
(ii) Items 12, 13 and 14 shall be renumbered as items 13, 14 and 15 respectively.
No. 11In Schedule C(1), after item 8, the following item shall be inserted, namely:-
"9. Preparations containing Penicillin not in a form to be ad ministered parenterally".
No. 12In Schedule E in the entry beginning with the words "Hydrofluoriacid" insert a semi-colon after the words "Sodium-silicofluoride".
Note. - It may be noted that the Central Government has amended the Rules several times after they were made by the State Government of Rajasthan. Due to amendments made by the Central Government in these rules, the amendments made by the State Government may have become redundant. The complete text of Rules made by the Central Government as amended is given hereinafter.