THE GAZETTEOFINDIA EXTRAORDINARY

[PARTH—SEC 3(Q]

MINBTKYOFHEALTHANDFAMILYWELFARE

(Department of Health)

NOTIFICATION

New Delhi, the 4th April, 2002

G.S.R. 249(E).—Whereas a draft of certain rules further to amend the Drugs and Cosmetics Rules, 1945 was

published, as required by sections 12 and 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), in Part-II, Section 3, Sub-

section (i), of the Gazette of India, Extraordinary, dated the 9th November 2001, vide notification of the Government of

India m the Ministry of Health and Family Welfare (Department of Health), number GSR 841 (E), dated the 9th November

2001, inviting objections and suggestions from all persons likely to be affected thereby, before the expiry of a period of

forty-five days from the date on which copies of the Official Gazette containing the said notification were made available

to the public.

And whereas copies of the said Gazette notification were made available to the public on 10-11-2001,

And whereas objections and suggestions received from the public on the said draft rules have been considered

by the Central Government,

And whereas the Central Government is of the opinion that circumstances have arisen which render it neces-

sary to make rules without consulting Drugs Technical Advisory Board,

And whereas the Central Government proposes to consult the Drugs Technical Advisory Board within six

months of making these rules,

Now, therefore, in exercise of the powers conferred by sections 12 and 33 of the said Act, the Central Government

hereby makes the following rules further to amend the Drugs and Cosmetics Rules, 1945, namely —

1(1) These rules may be called the Drags and Cosmetics (1 st Amendment) Rules, 2002

(2) They shall come into force on the date of their publication in the Official Gazette

2 In the Drugs and Cosmetics Rules, 1945, in rule 3 A,—

(l) in sub-rule (1A), after item (b), the following item shall be inserted, namely —

"(c) The National Institute of Biologicals, NOIDA",

(u) after sub-rule (7), the following sub-rule shall be inserted, namely —

"(8) The functions of the Laboratory in respect of Blood Grouping reagents and diagnostic kits for Human

Immunodeficiency Virus, Heptatitis B Surface Antigen and Hepatitis C Virus shall be carried out at the

National Institute of Biologicals, NOID A and the functions of the Director in respect of the said drugs

shall be exercised by the Director of the said laboratory "

[F No X-11014/11/2001-DMS&PFA]

DEEPAK GUPTA, Jt Secy

Foot Note—The Principal rules were published m the Official Gazette vide notification No F 28-10/45-H(l), dated the21st

December,1945 and last amended vide GSR 909(E) dated20-12-2001

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