Date: 2016-01-25Category: Extra OrdinaryState: Union GovernmentCountry: India
In pursuance of sub-clause iv of clause b of section 3 of the Drugs and Cosmetics Act, 1940 23 of 1940, the Central Government, after consultation with the Drugs Technical Advisory Board, hereby specifies the following device intended for use in human beings as drug with immediate effect
**Policy Summary:**
This notification, S.O. 237(E), issued by the Ministry of Health and Family Welfare, Department of Health and Family Welfare, Government of India, effective January 25, 2016, specifies Ablation Devices as drugs under the Drugs and Cosmetics Act, 1940 (23 of 1940). This specification is made in pursuance of sub-clause (iv) of clause (b) of section 3 of the aforementioned Act, and follows consultation with the Drugs Technical Advisory Board. The file number for this notification is F. NO. X-11035/275/2015-DFQC. The issuing authority is K. L. Sharma, Joint Secretary.
Key Entities Referenced
Ministry of Health and Family Welfare: The Indian government ministry responsible for health policy in India.
New Delhi: The capital city of India, where the notification was issued.
Drugs and Cosmetics Act, 1940: An act of the Parliament of India that regulates the import, manufacture, distribution and sale of drugs and cosmetics.
Central Government: The executive authority of the Union of India.
Drugs Technical Advisory Board: A statutory body under the Drugs and Cosmetics Act, 1940 that advises the Central Government and State Governments on technical matters arising out of the Act.
Ablation device: A medical device specified as a drug for use in human beings, as per the notification.
K. L. Sharma: The Joint Secretary who signed the notification.
Mayapuri, New Delhi: Location of the Government of India Press.
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PART II—Section 3—Sub-section (ii)
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No. 210] NEW DELHI, MONDAY, JANUARY 25, 2016/ MAGHA 5 , 1937
(cid:7021)व ा(cid:7021)(cid:7005) य और प(cid:7407)रवार क(cid:7016)य ाण म(cid:7074)ं ालय
((cid:7021)व ा(cid:7021)(cid:7005) य और प(cid:7407)रवार क(cid:7016)य ाण िवभाग)
अिधसचू ना
नई (cid:7408)द(cid:7016) ली, 25 जनवरी, 2016
का.आ. 237(अ).— के(cid:7008) (cid:7076)ीय सरकार, औषिध और (cid:7079)साधन साम(cid:7061)ी अिधिनयम, 1940 (1940 का 23) क(cid:7409) धारा 3
के खंड (ख) के उप-खंड (iv) के अनुसरण म,(cid:7286) औषिध तकनीक(cid:7409) सलाहकार बोड (cid:6981) से परामश(cid:6981) के प(cid:7019) चात ् िन(cid:7013) निलिखत युि(cid:7334) को
मानव(cid:7298) के (cid:7079)योग के िलए तरु ंत (cid:7079)भाव म(cid:7286) औषिध के (cid:7272)प म(cid:7286) िविन(cid:7416)द(cid:7020) ट करती ह ै;
“एबलेशन युि(cid:7334)”
[फा. सं. X-11035/275/2015-डी.एफ.(cid:6989) यू.सी.]
कुंदन लाल शमा,(cid:6981) संयु(cid:6989) त सिचव
MINISTRY OF HEALTH AND FAMILY WELFARE
(Deaprtment of Health and Family Welfare)
NOTIFICATION
New Delhi, the 25th January, 2016
S. O. 237(E).—In pursuance of sub-clause (iv) of clause (b) of section 3 of the Drugs and Cosmetics
Act, 1940 (23 of 1940), the Central Government, after consultation with the Drugs Technical Advisory Board,
hereby specifies the following device intended for use in human beings as drug with immediate effect,
namely:-
“Ablation device”
[F. NO. X -11035/275/2015-DFQC]
K. L. SHARMA, Jt. Secy.
397 GI/2016
Printed by the Manager, Government of India Press, Ring Road, Mayapuri, New Delhi-110064
and Published by the Controller of Publications, Delhi-110054.