Executive Summary:
This notification from the Ministry of Health and Family Welfare announces amendments to the Drugs and Cosmetics Rules, 1945. The amendments follow a draft publication on January 17, 2017, consideration of public feedback, and consultation with the Drugs Technical Advisory Board. These amendments are referred to as the Drugs and Cosmetics Sixth Amendment Rules, 2017 and come into force on the date of their publication in the Official Gazette on March 30, 2017.
Key Points / Main Content:
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 Sixth Amendment Rules, 2017.
* The rules come into force on the date of their publication in the Official Gazette.
Schedule H Amendment:
* In Schedule H of the Drugs and Cosmetics Rules, 1945, Etizolam is added after serial number 536.
* The new entry is assigned serial number 537.
Impact Analysis:
Central Government:
* Impact: Exercises powers conferred by sections 12 and 33 of the Drugs and Cosmetics Act, 1940 to amend the Drugs and Cosmetics Rules, 1945 after consulting with the Drugs Technical Advisory Board.
* Action Required: Implement and enforce the amended rules.
Drug Manufacturers and Distributors:
* Impact: Must comply with the updated regulations, including the addition of Etizolam to Schedule H.
* Action Required: Update product information and ensure compliance with the amended Drugs and Cosmetics Rules, 1945.
Regulatory Bodies:
* Impact: Responsible for enforcing the updated rules and guidelines.
* Action Required: Update inspection procedures and ensure compliance by drug manufacturers and distributors.
Key Entities Referenced
Drugs and Cosmetics Rules, 1945: A set of rules related to drugs and cosmetics, which is being amended.
Drugs and Cosmetics Act, 1940: The Act under which the Drugs and Cosmetics Rules are framed and amended.
Ministry of Health and Family Welfare: The government ministry responsible for health and family welfare in India, which published the notification.
New Delhi: The location where the notification was issued.
Drugs Technical Advisory Board: An advisory board consulted by the Central Government for amending the Drugs and Cosmetics Rules.
Drugs and Cosmetics Sixth Amendment Rules, 2017: The name given to the specific set of amendments made to the Drugs and Cosmetics Rules in 2017.
Etizolam: A substance added to Schedule H of the Drugs and Cosmetics Rules, 1945.
Mayapuri, New Delhi: Location of the Government of India Press.
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EXTRAORDINARY
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PART II—Section 3—Sub-section (i)
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PUBLISHED BY AUTHORITY
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No. 241] NEW DELHI, THURSDAY, MARCH 30, 2017/CHAITRA 9, 1939
(cid:7021)वा(cid:7021)(cid:7005)य और प(cid:7407)रवार क(cid:7016)याण म(cid:7074)ं ालय
((cid:7021)वा(cid:7021)(cid:7005)य और प(cid:7407)रवार क(cid:7016)याण िवभाग)
अिधसचू ना
नई (cid:7408)द(cid:7016) ली, 30 माच(cid:6981) , 2017
सा.का.िन. 303(अ).— औषिध और (cid:7079)साधन साम(cid:7061)ी िनयम, 1945 का और सशं ोधन करने के िलए
कितपय िनयम(cid:7298) का (cid:7079)ा(cid:7272)प औषिध और (cid:7079)साधन साम(cid:7061)ी अिधिनयम, 1940 (1940 का 23) क(cid:7409) धारा 12 और
धारा 33 क(cid:7409) अपे(cid:6979)ाऩुसार भारत के राजप(cid:7074), असाधारण, भाग II, खंड 3, उपखंड (i), तारीख 17 जनवरी, 2017
म(cid:7286) भारत सरकार के (cid:7021)वा(cid:7021)(cid:7005)य और प(cid:7407)रवार क(cid:7016)याण मं(cid:7074)ालय ((cid:7021)वा(cid:7021)(cid:7005)य और प(cid:7407)रवार क(cid:7016)याण िवभाग) क(cid:7409) अिधसचू ना
सं. सा.का.िन. 42(अ), तारीख 17 जनवरी, 2017 (cid:7367)ारा (cid:7079)कािशत (cid:7408)कया गया था िजसके (cid:7367)ारा उन सभी (cid:7390)ि(cid:7334)य(cid:7298)
से, िजनके उनसे (cid:7079)भािवत होने क(cid:7409) संभावना ह,ै उस तारीख से, िजसको उ(cid:7334) अिधसूचना वाले भारत के राजप(cid:7074) क(cid:7409)
(cid:7079)ितयां जनता को उपल(cid:7011)ध करा दी गई थ(cid:7277), प(cid:7289)तालीस (cid:7408)दन क(cid:7409) अविध क(cid:7409) समाि(cid:7385) से पूव(cid:6981) आ(cid:6979)ेप और सुझाव आमंि(cid:7074)त
(cid:7408)कए गए थ;े
और उ(cid:7334) मूल राजप(cid:7074) क(cid:7409) (cid:7079)ितयां जनता को तारीख 17 जनवरी, 2017 को उपल(cid:7011)ध करा दी गई थ(cid:7277) ।
और के(cid:7008)(cid:7076)ीय सरकार (cid:7367)ारा उ(cid:7334) िनयम(cid:7298) के संबंध म(cid:7286) जनता के (cid:7079)ा(cid:7385) आ(cid:6979)ेप(cid:7298) और सुझाव(cid:7298) पर िवचार (cid:7408)कया
गया ह ै ।
अतः, अब, के(cid:7008)(cid:7076)ीय सरकार, औषिध और (cid:7079)साधन साम(cid:7061)ी अिधिनयम, 1940 (1940 का 23) क(cid:7409) धारा
12 और धारा 33 के अधीन शि(cid:7334)य(cid:7298) का (cid:7079)योग करते (cid:7263)ए, औषिध तकनीक(cid:7409) सलाहकार बोड (cid:6981) से परामश(cid:6981) करने के
प(cid:7391)ात्, औषिध और (cid:7079)साधन साम(cid:7061)ी िनयम, 1945 का और संशोधन करन े के िलए िन(cid:7388)िलिखत िनयम बनाती ह,ै
अथा(cid:6981)त्:-
1. (1) इन िनयम(cid:7298) का संि(cid:6979)(cid:7385) नाम औषिध और (cid:7079)साधन साम(cid:7061)ी (छठा संशोधन) िनयम, 2017 ह ै ।
(2) ये राजप(cid:7074) म(cid:7286) उनके (cid:7079)काशन क(cid:7409) तारीख को (cid:7079)वृ(cid:7275) ह(cid:7298)गे ।
1788 GI/2017 (1)(cid:32)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
2. औषिध और (cid:7079)साधन साम(cid:7061)ी िनयम, 1945 क(cid:7409) अनसु ूची ज म(cid:7286), (cid:7059)म सं(cid:6990)याकं 536 और उससे संबंिधत
(cid:7079)िवि(cid:7397)य(cid:7298) के प(cid:7391)ात् िन(cid:7388)िलिखत (cid:7059)म सं(cid:6990)यांक और (cid:7079)िवि(cid:7397) जोड़ी जाएगी, अथा(cid:6981)त:् -
“537. ऐटीज़ोलम” ।
[फा.सं. ए(cid:6989) स-11014/11/2016-डी.आर.एस. ]
कुंदन लाल शमा(cid:6981), संयु(cid:6989) त सिचव
पाद (cid:7407)ट(cid:7009)प ण:- मूल िनयम, भारत के राजप(cid:7074) म,(cid:7286) अिधसूचना सं(cid:6990) यांक एफ. 28-10/45-एच(1), तारीख 21 (cid:7408)दस(cid:7013) बर,
1945 (cid:7367)ारा (cid:7079)कािशत (cid:7408)कए गए थे और उनम(cid:7286) अंितम बार संशोधन सा.का.िन. 102 (अ), तारीख
15 माच(cid:6981) , 2017 (cid:7367)ारा (cid:7408)कया गया था ।
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 30th March, 2017
G.S.R. 303(E).— Whereas the 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) in the Gazette of India, Extraordinary, Part II, Section 3,
Sub-section (i), dated the 17th January, 2017 vide notification of the Government of India in
the Ministry of Health and Family Welfare, number G.S.R. 42(E), dated the 17th January,
2017 for inviting objections and suggestions from all persons likely to be affected thereby
before the expiry of a period of forty-five days from the date on which copies of the Official
Gazette containing the said notification was made available to the public;
And Whereas the copies of the said Gazette were made available to the public on
17th January, 2017;
And, Whereas, objections and suggestions received from the public on the said rules
have been considered by the Central Government.
Now, therefore, in exercise of the 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.(cid:32) (1) These rules may be called Drugs and Cosmetics (Sixth Amendment) Rules, 2017.
(2) They shall come into force on the date of their publication in the Official Gazette.¹Hkkx IIµ[k.M 3(i)º Hkkjr dk jkti=k % vlk/kj.k 3
2.(cid:32) In the Drugs and Cosmetics Rules, 1945, in Schedule H, after serial number 536 and
entries relating thereto, the following serial number and entry shall be added, namely:-
“537. Etizolam”.
[F.No. X 11014/ 11/2016-DRS]
K. L. SHARMA, Jt. Secy.
Foot-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 lastly amended vide notification number G.S.R.
102(E) dated the 15th March, 2017.
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.