('ardiac SteJJls. Drug Eluting Slents. " (l(l(UCl f. V Cannulae. 13cillC Cements. Heart Valves. Scalp Vein Set. Orthopae
The Ministry of Health and Family Welfare, Govt. of India under following Gazette notifications has notified Ihef()Howing devices to be considered as drugs under Section 3, Clause (b) . Sub clause (iv) of the Drugs and Cosmetics Act: -
~at~i;i'"
Disposable
IIypodennic
Syringes
Notification Nnmber GSR 365 (E)
Disposable
IIypodermic
Needles
(-'SR ~6'5 l-'F') 1.. .).
17-03-1989
Disposable
Perfusion
GSH
17-03-1989
In vitro Di,lgnostic
Sets
Devices for HIV,
365 (E)
notification 17-03-19WJ
GSR 601(E)
27-08-2002
S,O, 1468 (l')
06-10-2U05
HBsAg and [ICV ('ardiac
SteJJls
Drug Eluting Slents "
(l(l(UCl
S.O. 1468 eE)
06-10-2005
S.0.1468(E)
06-1 (}-2005
S.O. 1468 (E)
06-10-2005
f. V Cannulae
S.O. 1468 (E)
06-10-200::'
13cillC Cements
S.(). 1468 (E)
06-! 0-200."
Heart Valves
S.O. 1468 (E)
06-10-2005
Scalp Vein Set
S.O, 1468 (1-:)
06-10-2005
Orthopaedic
S.O. 1468 (E)
06-10-:;005
S.O. 1468 (E)
06-10-2005
I
Implants
Prosthetic
Replacements
Note: Further, the following products are regulated as 'Drugs' Cosmdics Act & Rules there under: -
un~cr Drugs &
L Blood Grouping Sera 2. Ligatures, Sutures and Staplers 3. 4. 5. 6.
Intra Uterine Devices C:ondoms '1ubal Rings SurgicalDressings
(Cu-T)
7. Umbilicalfapcs 8.
BloodlBlood
Component
Bags ~.
U~~or~_W\{) (Dr. S. Eswara Reddy) Asst. Drugs Controller (1)
