•4S

THE GAZETTE OF INDIA • EXTRAORDINARY

LPARI 1I-—SEC 3a)]

MINISTRY OF HEALTH AND FAMILY WELFARE

(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,

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 :

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

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 ?

<b) for the words "the proper name of the drug shall be

g|ven v in an equally conspicuous manner as

the

trade name, if any, and shall be", the words "the

proper flame of the drug shall, be printed or wrjtten

in a more conspicuous manner than the trade name,

if any, which shall be shown immediately after or

under the proper name and shall be" shall be substi-

tuted ;

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

marketed under a generic name only.

(ii) Prepaiations containing any drug specified in Sche-

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.

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AND PUBLISHED BY THE CONTROLI>R OF PUBLICATIONS, DrI HI-1 10054, 1981