The Gazette of India
EXTRAORDINARY
PART II—Section 3—Sub-section (i)
PUBLISHED BY AUTHORITY
No. 22] NEW DELHI, SATURDAY, JANUARY 17, 1981/PAUSA 27, 1902 Separate paging is given to this Part in order that it may be filed as a separate compilation
•4S T HE GAZETTE OF INDIA • EXTRAORDINARY LPARI 1I-—SEC 3a)]And whereas the said Gazette were made available to the public on the 10th March, 1980 and the 30th August, 1980 respectively ,
And whereas the objections and suggestions leceived from the public on the said draft mles have been considered by the Central Government ;
Now, therefore, in exercise of the powers confened by sections 12 and 33 of the said Act, the Central Government, after consultation with the Drugs Technical Advisory Board, hereby makes the following rules further to ameny the Drugs and Cosmetics Rules, 1945, namely :—•
1 (I) These rules may be called the Dmgsi and Cosmetics ("Amendment) Rules, 1981.
(2) Rule 2(b), rule 2(c), in so fur as it relate to the piovision of '"preparations containing any drug speci- fied m Schedule W as the single active ingredient", and mle 3, shall come into force on the 1st day of August, 1981, and the remaining provisions of these rules shall come into force on the date of their publication in the Official Gazette.
* - 2. fn 'the Drugs and Cosmetics Rules, 1945 (hereinafter ^efe/redjo asf #15 said rules), in lule 96, in sub-rule (1). in clause (f),—
fe) tor the words "For this purpose," the brackets letter and words "(A) For this purpose," shall be substitu- ted1 ?
CO after sub-clause (A) as so numbered, the following sub-clause shall be inserted, namely :—
"(B) The following preparations shall be labelled only with proper name of the drug and not with any trade name :—
(i) Preparations containing any new drug as the single active ingredient and approved under rule 30A. 69B or 75B by the licensing authority subject to the condition that such preparations should be marketed under a generic name only.
MINISTRY OF HEALTH AND FAMILY WELFARE
(ii) Prepaiations containing any drug specified in Sche- (Department of Health)
NOTIFICATION
New Delhi, the 17th January, 1981
GJS.R. 27(E).—Whereas certain draft rules further to amend ihe Drugs and Cosmetics Rules, 1945, were published, as required by section 12 and 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), at pages 347 and 1864 of the Gazette of India, Part IT," Section 3, Sub-section U), dated the 23rd February, 1980 and the 16th August, 1980 respectively, under the notifications of the Government of India in the Ministry of Health and F-amily VVJelfare (Department of Health), Nos. OS.R. 216, dated the 8th Februaiy, 1980 and G.S.R. 864, dated the 8th August, 1980 respectively, inviting objections and suggestions from all persons likely to be affected thereby, before the expiry of ninety days from the date on which the copies of the Official Gazette containing the said respectively notifications were made available to the public :
dule W as the single active ingredient".
3 In the said rules, after Schedule V. the following Sche- dule shall be inserted, namely :—
SCHEDULE W
LSee rule 96(1)(i) (B)l
Name of the drugs which shall be maiketed under genenc names only
1 Analgin. 2 Aspirin and its salts 3. Chlorpromazine and its salts 4. Ferrous Sulphate. 5. Piperazine and its salts.
[No X 11013/7/79-D&MS]
C V. S M \NI, Addi. Secy.