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), at page 2 in the Gazette of India, Extraordinary, Part II, Section 3, Sub section (i) dated the 6th February, 2002

REGD. NO. D L 33004/99 The Gazette of India

EXTRAORDINARY

PART II—Section 3—Sub-section (i)

PUBLISHED BY AUTHORITY

No. 397 \ NEW DELHI, TUESDAY, AUGUST 27, 2002/BHADRA5,1924

MINISTRY OF HEALTH AND FAMILY WELFARE

(Department of Health)

NOTIFICATION

New Delhi, the 27th August, 2002G.S.R. 600(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), at page 2 in the Gazette of India, Extraordinary, Part II, Section 3, Sub- section (0 dated the 6th February, 2002, under the 2680 012002 (1) 2 THEGAZErrEOFJNDlA^EXTRAORDINARy [PART 11—_SF.rJ"(i)] notific.iiion of ;hc Government iu India i>i the Miniati y

And whereas copies of the said Gazette were made

available to the public on 7-2-2002,

And whereas, objections and suggestions received from the public on the said draft rules heve been considered by the Central Government;

Now, therefore, in exercise of I he powers conferred

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 amend the Drugs and Cosmetics Rules, 1945, namely .—

NOnFTCATTOJV

1. (1) These rules may be called the Drugs and

Cosmetics (6th Amendment) Rules, 2002

New Del ta, the 27th August, 2002 (?) They shall come into force on the 1st

Sepiembcr, 2002.

2. In the Drugs and Cosmetics Rules, 1945, in

Schedule C( 1 ),'a(ler serial number 9, the following shall be inserted, namely :—

"10. In-vitro Blood Grouping Sera

11. In-vitio Diagnostic Devices for HIV, HbsAg

aiidllCV"

C.S.R. 60t(E).—In exercise of powers conferred by sub clause (iv) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1 'M0 (23 of 1940), the Central Government after consultation with the Drugs Technical Advisory Board hereby nuikes the following amendment to the notification of the Government of India, in the Ministry of Health and Family Welfare published in the Gazette of India, Extraordinary, Part-fl, Section 1, Sub-section (i) vide No. G S.R. 365(E) dated the 17thMaich, 1989, namely ;—

In the said notification.

1. after entry (iii), the following entry shall be |F. No.X-11014/13/2001-DMS & PIrA| DEEPAK GUPTA, Jt Secy. Foot Note: —The Principal Rules were published in the Official Gazette vide notification No. F 28- 10/45-HO) dated December 21, 1945 and last amended vide G S.R.

inserted, namely .—

504(E) dated 18-7-2002.

"(tv) In-vitro diagnostic devices for HIV, HbsAg &

- HCV"

2. This notification shall come inlo force on the 1st

September, 2002

[F. No X-UOI4/13/2OO1-DMS&PFA]

DEEPAK. GUPTA. Jt. SewPnnUJ by the Miuudu, Govi "f i""in Press, Rinr. Rond, Maynpun, New Delhi-] ]0(J(i4 mid Published hv Ihc Conlrollcr nl Puhlicitinns, Delhi-11005-4