The Central Government is of the opinion that circumstances have arisen which render it necessary to make rules without consulting the Drugs Technical Advisory Board

The Gazette of India

EXTRAORDINARY

PART II -Section 3—Sub-section (i)

PUBLISHED BY AUTHORITY

No. 573] NEW DELHI, FRIDAY, NOVEMBER 9, 2001/KARTIKA 18,1923

MINISTRY OF HEALTH AND FAMILY WELFARE

(Department of Health)

NOTIFICATION

New Delhi the 9th November. 2001

G.S.R 841(E).—Whereas the Central Government is of the opinion that circumstances have arisen which render it necessary to make rules without consulting the 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 Drugs and Cosmetics Act, 1940 (23 of 1940), the following draft of certain rules further to amend the Drugs and Cosmetics Rules, 1945, is hereby published as required by th c said sections for the information of all persons likely to be affected thereby; and notice is hereby given that the said draft rules will be taken into consideration after the expiry of forty-five days from the date on which the copies of the Official Gazette in which this notification is published are made available to the public;

Objections or suggestions, if any, may be addressed to the Secretary, Ministry of Health and Family Welfare, Government of India, Nirman Bhavan, New Delhi-110011.

Any obj ection or suggestion which may be received from any person with respect to the said draft rules before the expiry period specified above will be taken into consideration by the Central Government.

DRAFTRULES

1. 0) These rules may be called the Drugs and Cosmetics (Amendment) Rules, 2001.

(n) They shall come into force on the date of theirpublication in the Official Gazette.

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

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

"(c) The National Institute of Biologicals, NOEDA";

(if) 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 Immuno Deficiency Virus, Hepatitis B Surface Antigen and Hepatitis C Virus shall be carried out at the National Institute of Biologicals, NOIDA and the functions of the Director in respect of the said drugs shall be exercised by the Director of the said Laboratory."

[No. X-l 1014/11/2001-DMS & PFA]

DEEPAK GUPTA, Jt Secy.