This notification, S.O. 648(E), issued by the Ministry of Health and Family Welfare, Department of Health and Family Welfare, Government of India, effective April 1, 2020, specifies that certain devices intended for use in humans or animals are to be classified as drugs under the Drugs and Cosmetics Act, 1940 (23 of 1940). This specification, made after consultation with the Drugs Technical Advisory Board, encompasses all devices, including instruments, apparatus, appliances, implants, materials, or other articles (including software and accessories), intended by the manufacturer for use in humans or animals. These devices do not achieve their primary intended action through pharmacological, immunological, or metabolic means but may assist in their function through such means, for the specific purposes of: (i) diagnosis, prevention, monitoring, treatment, or alleviation of any disease or disorder; (ii) diagnosis, monitoring, treatment, alleviation, or assistance for any injury or disability; (iii) investigation, replacement, modification, or support of the anatomy or a physiological process; (iv) supporting or sustaining life; (v) disinfection of medical devices; and (vi) control of conception. The notification is referenced as F.No. X.11035/28/1/2018-DRS and is issued by Dr. Mandeep K. Bhandari, Jt. Secy.
Key Entities Referenced
Drugs and Cosmetics Act, 1940: An act of the Central Government of India, under which certain devices are specified as drugs.
New Delhi: The location of the notification, presumably New Delhi, Delhi, India.
Central Government: The governing body issuing the notification.
Drugs Technical Advisory Board: The advisory board consulted by the Central Government regarding the devices to be specified as drugs.
Ministry of Health and Family Welfare: The ministry responsible for the Department of Health and Family Welfare, which issued the notification.
Department of Health and Family Welfare: The department within the Ministry of Health and Family Welfare that issued the notification.
Dr. Mandeep K. Bhandari: The Joint Secretary who signed the notification.
The Gazette of India: Official government publication in which the notification is published.
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. NO. D. L.-33004/99
सी.जी.-डी.एल.-अ.-11022020-216073
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CG-DL-E-11022020-216073
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असाधारण
EXTRAORDINARY
भाग II—खण् ड 3—उप-खण्ड (ii)
PART II—Section 3—Sub-section (ii)
प्राजधकार स ेप्रकाजित
PUBLISHED BY AUTHORITY
स.ं 591] नई दि्ली, तगं लवार, फरवरी 11, 2020/ताघ 22, 1941
No. 591] NEW DELHI, TUESDAY, FEBRUARY 11, 2020/MAGHA 22, 1941
स्ट्व ास्ट्् य रर पिरवार क्य ाण तरं ालय
(स्ट्व ास्ट्् य रर पिरवार क्य ाण जवभाग)
अजधसचू ना
नई दि् ली, 11 फरवरी, 2020
का.आ. 648 (अ).—केंद्रीय सरकार, ओषजध रर प्रसाधन सातग्री अजधजनयत, 1940 (1940 का 23) की
धारा 3 के खंड (ख) के उप-खंड (iv) के अनुसरण त,ें ओषजध तकनीकी सलाहकार बोडड के साथ परातिड के पश् चात
तारीख 1 अप्रलै , 2020 स े तानव या पिुओं त ें उपयोग करन े के जलए आिजयत जनम्न जलजखत युजतत यक को ओषजध के
रूप त ेंजवजनर्िषड ट करती ह,ै अथाडत:―
उपकरण, साजधर, साधन, इम् पलांट, सातग्री या अन् य वस्ट् तओंु को सजम् तजलत करते ए ए सभी युजतत यां, चाह े
अकेले या सजतश्रण के रूप तें प्रयोग की िाती ह,ै जिसके अंतगडत साफ्टवेयर या उपसाधन भी ह,ै उसके जवजनताडता
द्वारा उनका जवजिष्ट त: तानवक या पिुओं के जलए प्रयोग दकया िाना आिजयत ह ै िो दकसी भेषिगुणजवज्ञानीय या
प्रजतरक्षाजवज्ञानीय या चयापचय साधनक द्वारा तानव िरीर या पिुओं तें या पर प्राथजतक आिजयत दिया नहीं करता
ह,ै लेदकन िो जनम्न जलजखत एक या अजधक जवजनर्िष्ड ट प्रयोिनक के जलए ससे साधनक द्वारा आिजयत कृत् यक तें सहायता
करेंगे―
(i) दकसी रोग या जवकार का जनिान, जनवारण, तानीटरी, उपचार या उपितन;
(ii) दकसी क्षजत या अितत ता का जनिान, तानीटरी, उपचार, उपितन या उसके जलए सहायता;
823 GI/2020 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)]
(iii) िरीर रचना जवज्ञान या िारीिरक प्रदिया का अनुसंधान, प्रजतस्ट् थापन या उपांतरण या सहयोग;
(iv) िीवन सतथडक या संपोषक;
(v) जचदकत् सा युजतत यक का जवसंिातण; रर
(vi) गभडधारण का जनयंरण।
[फा. स.ं एत स-11035/281/2018-डीआरएस]
डॉ. तनिीप के. भंडारी, संयुत त सजचव
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 11th February, 2020
S.O. 648(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 devices intended for use in human beings or animals as drugs with effect from the
1st day of April, 2020, namely:―
All devices including an instrument, apparatus, appliance, implant, material or other article, whether
used alone or in combination, including a software or an accessory, intended by its manufacturer to be used
specially for human beings or animals which does not achieve the primary intended action in or on human body
or animals by any pharmacological or immunological or metabolic means, but which may assist in its intended
function by such means for one or more of the specific purposes of ―
(i) diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder;
(ii) diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability;
(iii) investigation, replacement or modification or support of the anatomy or of a physiological
process;
(iv) supporting or sustaining life;
(v) disinfection of medical devices; and
(vi) control of conception.
[F.No. X.11035/281/2018-DRS]
Dr. MANDEEP K. BHANDARI, Jt. Secy.
Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064
and Published by the Controller of Publications, Delhi-110054.