REGISTERED NO. D-(D)-72
The Gazette of India
EXTRAORDINARY
PART II-Section 3—Sub-section (i)
PUBLISHED BY AUTHORITY
No. 44] NEW DELHI, THURSDAY, FEBRUARY 5, 1976/MAGHA 16, 1897
Separate paging is given to this Part in order that it may be filed
as a separate compilation
MINISTRY OF HEALTH AMD FAMILY PLANNING
(Department of Health)
NOTIFICATION
New Delhi, the 5th February 1976
G.S.R. 64(E).—The following draft of certain rules further to amend the Drugs and Cosmetics Rules, 1945, which the Central Government proposes to make, after consulta- tion with the Drugs Technical Advisory Board, in exercise of the powers conferred by sections 12 and 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940) is published, a* Required by the said sections for the information of persons likely to be affected thereby.
Notice is hereby given that the said draft rules will be taken into consideration after three months from the date on which the copies of the Official Gazette in which this notification is published are made available to the public.
Any objection or suggestion which may be received from any person with respect to the said draft rules before the expiry of the period so specified will bo taken into consi- deration, by the Central Government.
1- (1) These rules may be called the Drugs and Cosmetics (Amendment) Rules, 1976. (2) They shall come into force on the date of their publication in the Official Gazette.
2. In the Drugs and Cosmetics Rules, 1945 (hereinafter referred to las the said r u l e ), for rule 55 the following rule shall be substituted namely:—
"55, Form of receipts for seized drug, cosmetic, record, register, document or any other material object—A receipt by an Inspector for the stock of any drug or cosmetic or for any record, register, document or other material object seized under clause (c) or clause (cc) of sub-section (1) of section 22 of the Act, shall be in Form 16".
(193)
194 ™B GAZETTE OF INDIA EXTRAORDINARY LPm i i~3. In rule 65 of the said rules,
(i) in condition (3), for clause (d), the following clause shall bo substituted, namely:—
"(d) the name and address of the patient, or the name and address of the owner of the animal if the drug supplied is for veterinary use",;
(ii) In condition (10), for clause tb), the following clause shall be substituted, namely:—
"(b) specify the name and address of the person for whose treatment it is given, or the name and address of the owner of the animal if the drug is meant for veterinary use.";
(iii) after condition (19), the following condition shall be inserted, namely:—
"(20) Medicines for treatment of animal kept in a retail shop or premises and labelled with the words "Not for human use—for treatment of animals only" shall be stored—
(a) In a cupboard or drawer reseWed solely for the storage of veterinary drugs, or
(b) in a part of the premises separated from the remainder of the premises to which customers are not permitted to have access"-
4. In rule 66 of the said rules, for sub-rule (2), the following sub-rule shall be sub- stituted, namely:—' 1
;
"(2) A licensee whose lic"nc© has been suspended or cancelled may within three months of tha dat" of the order under sub-rule (1), prefer an appeal against that order to the State Government, which shall decide the same.
5- In rule 67—H, for sub-rula (2), the following sub-rule shall be substituted, namely:— "(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.".
6. In rule 71 of the said rules, for condition (4), the following Condition shall be substituted, namely:—
,
\
"(4) The applicant shall provide and maintain adequate staff, premises and labora- tory equipment for carrying out tests of the strength, quality and purity of the substances at a testing unit. The testing unit shall be separate from the manufacturing unit and the head of the testing unit shall b© independent of the head of the manufacturing unit:
Provided that in the case of manufacturing units, which before the ConMaento- ment of the Drugs and Cosmetics ( Amendment) Rules, 1975<, were making arrangements with institutions approved by the licensing authority for such tests to be carried out on their behalf may continue such arrangements up to the 31st December, 1976:
provided further that for tests requiring sophisticated instrumentation techniques or biological or microbiological methods the licensing authority may per- mit such tests to be conducted by institutions approved by it for this purpose."-
7. In rule 71A of the said rules, for condition (3), the following condition shall b© substituted, namely:—
"(3) the applicant shall have adequate arrangements in his own premises for carry- ing out tests for the strength, (Quality and purity of the drugs at a testing unit which shall be separate from the repacking unit:
Provided that in the case of repacking units, which, before the commencement of the Drugs and Cosmetics ( Amendment) Rules, 1975, were making arrangements with institutions approved by the licensing authority for1 such tests to be carried out on their behalf, may continue such arrangements upto the 31st December, 1976".
Provided further that for tests requiring sophisticated instrumentation techniques or biological or microbiological methods the licensing authority may per- mit such test to be conducted by institutions approved by it for this purpose.".
Sic. 3(i)] THE GAZETTE OF INDIA EXTRAORDINABY
,195
8. In rule 76 of the said rules, for condition (4), the following condition shall be substituted, namely:—
{
"(4) The applicant shall provide and maintain adequate staff, premises and labora- tory equipment for carrying out such tests of the strength, quality and purity of the substances as may be required to be carried out by him under the provisions of Part X of t'nesc rules including proper housing for animals used for the purposes of such tests. The testing unit shall be separate from the manufacturing unit and the head of the testing unit shall be independent of the head of the manufacturing unit:
Provided that in the case of manufacturing umits which before the commence- 1 "ment of the Drugs and Cosmetics ( Amendment) Rules, 1975, were making arrangements with institutions approved by the licensing authority for such tests to be carried out on their behalf may continue such arrangements upto the 31st December, 1976:
Provided further that for tests requiring sophisticated instruments techniques or biological or microbiological methods the licensing authority may permit such tests to be conducted by institutions approved by it for this purpose.".
9. In rule 85 of the said ruels. for sub-rule (2), the following sub-mile shall be sub- stituted, namely:—
'
"(2) A licensee whose licence has been suspended or cancelled may, within three months of the date of the order under sub-rule fl). prefer an appeal against that order to the State Government, which shall decide the same.".
10. Tn rule 85-1 of the said rules, for sub-rulo (2), the following sub-rule shall be substituted, namely:—
"(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.'.
11. In Schedule A to the said rules, for Form 16, the following Form shall be sub- stituted, namely:—
"FORM 16
(See Rule 55)
Receipt for stock of drug, or cosmetics or for record mister, d"cum
obiect "hud under section 22(1) (c) or (cc) of the Drugs and Cosmetics
Act, 1940.
i
The stock of drugs ov cosmetics or records, rasters, documents or material objects
saw S2S.W a-w^ffi -" ™ the premises of -situated at - Date -Inspector-
Details of drugs, cosmetics, records, registers, documents or material ob,ects seized.
Datc Inspector—
12. In Schedule K to the said rule,—
(a) against entry 12, under the hcadins "Extent( a n d M o t i on o f ^ ^ n d n ^ n"
stocking or selling such substances", shall be inserted,
(c) after entry 19, the following entry shall be inserted, namely:-
"20. Radio P h a r m a c e u t i c a l !! the provisions of CJnpter IV of the Act and the rules made thereunder,".
[No. X. 11014/2/72-D] SHRAVAN KUMAR, It. Secy.
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