Executive Summary:
This notification, issued by the Ministry of Health and Family Welfare, amends existing regulations pertaining to drugs and cosmetics. It addresses the distribution and sale of Oxytocin formulations and introduces further amendments to the Drugs and Cosmetics Rules, 1945. The Drugs and Cosmetics Seventh Amendment Rules, 2018, come into force on September 1, 2018.
Key Points / Main Content:
Oxytocin Formulations:
* Oxytocin formulations manufactured by public sector companies or undertakings licensed under the Drugs and Cosmetics Rules, 1945, shall be distributed or sold in accordance with such rules.
Amendments to the Drugs and Cosmetics Rules, 1945:
* The Drugs and Cosmetics Rules, 1945 are further amended.
* These amendments are called the "Drugs and Cosmetics Seventh Amendment Rules, 2018."
* These rules come into force on September 1, 2018.
Schedule Changes:
* In Schedule H, the entry at serial number 382 relating to Oxytocin is omitted.
* In Schedule H1, after entry at serial number 46, the following entry is inserted: "47. Oxytocin."
Impact Analysis:
Public Sector Companies/Undertakings Licensed Under the Drugs and Cosmetics Rules, 1945:
* Impact: These entities must ensure that their distribution and sale of Oxytocin formulations comply with existing rules.
* Action Required: Adhere to all applicable rules regarding the distribution and sale of Oxytocin formulations.
Manufacturers and Distributors of Drugs and Cosmetics:
* Impact: Must be aware of the changes to Schedule H and H1 of the Drugs and Cosmetics Rules, 1945, concerning Oxytocin.
* Action Required: Update practices to reflect the omission of Oxytocin from Schedule H and its inclusion in Schedule H1.
Regulatory Bodies:
* Impact: Must enforce the amended rules and regulations.
* Action Required: Update regulatory oversight to reflect the changes to the schedules.
Key Entities Referenced
Drugs and Cosmetics Act, 1940: An Indian law that regulates the import, manufacture, distribution and sale of drugs and cosmetics.
Ministry of Health and Family Welfare: A ministry in the Government of India responsible for public health in India.
G.S.R. 411E: A notification number related to amendments in the Drugs and Cosmetics Rules.
Oxytocin: A drug formulation regulated under the Drugs and Cosmetics Act.
Drugs and Cosmetics Rules, 1945: Rules formulated under the Drugs and Cosmetics Act, 1940 to regulate drugs and cosmetics.
Drugs Technical Advisory Board: A statutory body advising the Central Government on technical matters related to drugs and cosmetics.
Drugs and Cosmetics Seventh Amendment Rules, 2018: Rules that further amend the Drugs and Cosmetics Rules, 1945.
New Delhi: The location where the notification was issued. New Delhi is the capital of India.
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अअअअििििधधधधससससचचूूचचूू ननननाााा
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उ(cid:30) अिधसूचना म,. पैरा 1 के उप-पैरा 5 के खंड (v) एवं (vi) को िन0िलिखत खंड से (cid:15)ित(cid:11)थािपत (cid:4)कया जाएगा,
अथा3त, ् —
“(v) औषिध और (cid:15)साधन साम(cid:20)ी िनयम, 1945 के अंतग3त लाइसस. (cid:15)ा9 साव3जिनक :े, क(cid:24) कंपिनय(cid:31) या उप;म(cid:31)
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[फा. सं. ए>स .-11014/3/2018-डीआर]
सुधीर कुमार, संयु(cid:30) सिचव
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(cid:27)ारा अिं तम बार संशोिधत (cid:4)कया गया था।
4878 GI/2018 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 21st August, 2018
G.S.R. 794(E).—In exercise of the powers conferred by section 26A of the Drugs and Cosmetics Act,
1940 (23 of 1940), the Central Government hereby further amends the notification of the Government of
India, Ministry of Health and Family Welfare (Department of Health and Family Welfare)
No. G.S.R. 411(E), dated 27th April, 2018 published in Part II - Section 3 - Sub-section (i) of the Gazette of
India, Extraordinary, namely,—
In the said notification, in para 1, in sub-para 5, for clauses (v) and (vi), the following clause shall be
substituted, namely,—
“(v) The Oxytocin formulations manufactured by the public sector companies or undertakings
licensed under the Drugs and Cosmetics Rules, 1945 shall be distributed or sold in accordance with
such rules.”
[F. No. X.-11014/3/2018-DR]
SUDHIR KUMAR, Jt. Secy.
Note : The principal notification was published in the Gazette of India Extraordinary, Part II, Section 3,
ub-section (i) vide number G.S.R. 411(E), dated the 27th April, 2018 and was last amended vide
notification number G.S.R. 602(E), dated the 29th June, 2018.
अअअअििििधधधधससससचचूूचचूू ननननाााा
नई (cid:4)द(cid:6)ली, 21 अग(cid:11)त, 2018
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का (cid:15)ाEप, औषिध और (cid:15)साधन साम(cid:20)ी अिधिनयम, 1940 (1940 का 23) क(cid:24) धारा 12 और धारा 33 क(cid:24) अपे:ानसु ार
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िनPन िलिखत िनयम बनाती ह,ै अथा3त,्—
1. (1) इन िनयम(cid:31) का संि:Kत नाम औषिध और (cid:15)साधन साम(cid:20)ी (सातवां संशोधन) िनयम, 2018 ह।ै
(2) ये िनयम 1 िसतPबर, 2018 को (cid:15)वृO त ह(cid:31)गे।
2. औषिध और (cid:15)साधन साम(cid:20)ी िनयम, 1945 म. —
(क) अनुसूची ‘ज’ म .;म संCया 382 पर ऑ>सीटोसीन से सPबिं धत (cid:15)िविX का लोप (cid:4)कया जाएगा;
(ख) अनसु ूची ‘ज1’ म. ;म संCया 46 (cid:15)िविX के बाद अंत म. िन0िलिखत (cid:15)िविX का समावेश (cid:4)कया जाएगा, अथात3 ,्—
"47. ऑ>सीटोसीन " ।
[फा. सं. ए>स .-11014/3/2018-डीआर]
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(cid:15)कािशत (cid:4)कए गए थे और अिधसूचना संC या सा.का.िन. 521(अ), तारीख 1 जून, 2018 (cid:27)ारा अंितम बार
संशोिधत (cid:4)कया गया था।
NOTIFICATION
New Delhi, the 21st August, 2018
G.S.R. 795(E).—Whereas a draft of certain rules further to amend the Drugs and Cosmetics Rules,
1945 was published as required under sections 12 and 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940),
vide notification of the Government of India in the Ministry of Health and Family Welfare (Department of
Health and Family Welfare) number G.S.R. 763(E), dated the 10th August, 2018, in the Gazette of India,
Extraordinary, Part II, Section 3, Sub-section (i), inviting objections and suggestions from persons likely to be
affected thereby, before the expiry of a period of 7 days from the date on which the copies of the Official
Gazette containing the said notification were made available to the public;
And whereas, copies of the Gazette were made available to the public on the 10th August, 2018;
And whereas, objections and suggestions received from the public on the said rules have been
considered by the Central Government;
And whereas, circumstances have arisen making it necessary to publish this notification without prior
consultation of the Drugs Technical Advisory Board and the consultation shall be made in accordance with
section 12 and section 33 of the said Act.
Now, therefore, in exercise of the powers conferred under sections 12 and 33 of the Drugs and
Cosmetics Act, 1940, the Central Government 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 (Seventh Amendment) Rules, 2018.
(2) They shall come into force on the First day of September, 2018.
2. In the Drugs and Cosmetics Rules, 1945, —
(a) In Schedule H the entry at serial number 382 relating to Oxytocin shall be omitted;
(b) In Schedule H1 at the end after entry at serial number 46 the following entry shall be inserted,
namely,—
“47. Oxytocin ”.
[F. No. X.-11014/3/2018-DR]
SUDHIR KUMAR, Jt. Secy.
Note : The principal rules were published in the Gazette of India vide notification number F.28-10/45-H(1),
dated the 21st December, 1945 and was last amended vide notification number G.S.R. 602(E), dated
the 29th June, 2018.
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.