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, 2002
G.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 <A'
Heallh and Family Welfare (Department of Health), Number
G S R 86(E) dated 6th February, 2002 inviting objections
and suggestions from all persons likely to be affected
(hereby, 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 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 .—
1. (1) These rules may be called the Drugs and
Cosmetics (6th Amendment) Rules, 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"
|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.
504(E) dated 18-7-2002.
NOnFTCATTOJV
New Del ta, the 27th August, 2002
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
inserted, namely .—
"(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. Sew
PnnUJ 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