Executive Summary:
This notification from the Ministry of Health and Family Welfare publishes draft amendments to the Drugs and Cosmetics Rules, 1945. It invites objections and suggestions from the public, which will be considered by the Central Government. The deadline for submitting feedback is forty-five days from the date the notification is made available to the public.
Key Points / Main Content:
* **Amendment Purpose:** The notification announces proposed changes to the Drugs and Cosmetics Rules, 1945.
* **Rule Changes:**
* Rule 96, sub-rule 1, clause i, sub-clause A is amended.
* The proper name of drugs or fixed-dose combination drugs (excluding vitamin combinations or combinations with three or more drugs) must be printed conspicuously, in the same font but at least two font sizes larger than the brand name or trade name.
* In other cases the brand name or the trade name, if any, shall be written in brackets below or after the proper name and shall be.
* **Public Consultation:** The Central Government will consider objections and suggestions received from the public.
* **Submission Details:** Feedback should be addressed to the Under Secretary Drugs, Ministry of Health and Family Welfare, or sent via email to drugsdiv@mohfw.nic.in.
* **Reference Information:** The principal rules were published on December 21, 1945.
Impact Analysis
Stakeholders Impacted:
* Drug Manufacturers:
* Impact: Revised labeling requirements for drug names, potentially requiring changes to packaging and printing processes.
* Action Required: Review and adapt labeling processes to comply with the new font size and placement rules for drug names.
* Public:
* Impact: Increased clarity in drug labeling, potentially reducing medication errors.
* Action Required: Review the draft rules and submit any objections or suggestions to the Ministry of Health and Family Welfare within the specified timeframe.
* Ministry of Health and Family Welfare:
* Impact: Responsible for reviewing and incorporating feedback on the draft rules.
* Action Required: Collect, review, and address public feedback on the draft amendments before finalizing the rules.
Key Entities Referenced
Drugs and Cosmetics Rules, 1945: A set of rules in India related to the regulation of drugs and cosmetics.
Drugs and Cosmetics Act, 1940: An act of the Parliament of India that regulates the import, manufacture, distribution and sale of drugs and cosmetics.
Drugs Technical Advisory Board: A statutory body in India that advises the Central Government and State Governments on technical matters related to drugs and cosmetics.
Ministry of Health and Family Welfare: A ministry of the Government of India responsible for health policy in India.
New Delhi, Delhi: The capital city of India, where the notification was issued and where the Ministry of Health and Family Welfare is located.
Drugs and Cosmetics Amendment Rules, 2017: Amendments to the existing Drugs and Cosmetics Rules, 1945.
K. L. Sharma: Jt. Secy., likely a Joint Secretary in the Government of India involved in the notification process.
Nirman Bhawan, New Delhi: Location of the office of Ministry of Health and Family Welfare.
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EXTRAORDINARY
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No. 240] 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. 302(अ).—औषिध और (cid:7079)साधन साम(cid:7061)ी िनयम, 1945 का और संशोधन करन े के िलए कितपय
िनयम(cid:7298) का िन(cid:7388)िलिखत (cid:7079)ा(cid:7272)प, िजसे के(cid:7008)(cid:7076)ीय सरकार का, औषिध और (cid:7079)साधन साम(cid:7061)ी अिधिनयम,1940 (1940
का 23) क(cid:7409) धारा 12 और धारा 33 (cid:7367)ारा (cid:7079)द(cid:7275) शि(cid:7334)य(cid:7298) का (cid:7079)योग करते (cid:7263)ए, औषिध तकनीक(cid:7409) सलाहकार बोड (cid:6981) स े
परामश(cid:6981) करने के प(cid:7391)ात्, बनाने का (cid:7079)(cid:7021)ताव ह,ै उन सभी (cid:7390)ि(cid:7334)य(cid:7298) क(cid:7409) जानकारी के िलए (cid:7079)कािशत (cid:7408)कया जाता ह,ै
िजनके उनसे (cid:7079)भािवत होने क(cid:7409) संभावना ह ै और यह सचू ना दी जाती ह ै (cid:7408)क उ(cid:7334) (cid:7079)ा(cid:7272)प िनयम(cid:7298) पर उस तारीख स,े
िजसको इन (cid:7079)ा(cid:7272)प िनयम(cid:7298) वाले भारत के राजप(cid:7074) क(cid:7409) (cid:7079)ितयां जनता को उपल(cid:7011)ध करा दी जाती ह,(cid:7289) प(cid:7289)तालीस (cid:7408)दन
क(cid:7409) अविध क(cid:7409) समाि(cid:7385) पर या उसके प(cid:7391)ात् िवचार (cid:7408)कया जाएगा;
के(cid:7008)(cid:7076)ीय सरकार (cid:7367)ारा ऐसे आ(cid:6979)ेप(cid:7298) और सुझाव(cid:7298) पर, जो उ(cid:7334) (cid:7079)ा(cid:7272)प िनयम(cid:7298) के सबं ंध म(cid:7286) ऊपर िविन(cid:7416)द(cid:7397)
अविध के भीतर (cid:7408)कसी (cid:7390)ि(cid:7334) से (cid:7079)ा(cid:7385) ह(cid:7298), िवचार (cid:7408)कया जाएगा ।
ऐसे आ(cid:6979)ेप और सुझाव, य़(cid:7408)द कोई ह(cid:7298), अवर सिचव (औषिध), (cid:7021)वा(cid:7021)(cid:7005)य और प(cid:7407)रवार क(cid:7016)याण मं(cid:7074)ालय,
भारत सरकार 414-ए, डी (cid:7410)वग, िनमा(cid:6981)ण भवन, नई (cid:7408)द(cid:7016)ली-110011 को भेज े जा सकते ह (cid:7289) या drugsdiv-
mohfw@nic.in पर मेल (cid:7408)कए जा सकते ह (cid:7289) ।
1787 GI/2017 (1)(cid:32)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
(cid:7079)ा(cid:7272)प िनयम
1. इन िनयम(cid:7298) का संि(cid:6979)(cid:7385) नाम औषिध और (cid:7079)साधन साम(cid:7061)ी ( संशोधन) िनयम, 2017 ह ै ।
2. औषिध और (cid:7079)साधन साम(cid:7061)ी िनयम, 1945 (िज(cid:7008)ह (cid:7286) इसम(cid:7286) इसके प(cid:7391)ात् उ(cid:7334) िनयम कहा गया ह)ै के िनयम
96 के उपिनयम (1) के खंड (i) के उपखंड (अ) म(cid:7286), “इस (cid:7079)योजनाथ”(cid:6981) श(cid:7011)द(cid:7298) स े आरंभ होने वाल े और “नीच े दशा(cid:6981)या
जाएगा, और” श(cid:7011)द(cid:7298) से समा(cid:7385) होने वाले भाग के (cid:7021)थान पर “इस (cid:7079)योजनाथ,(cid:6981) औषिध या िवटािमन वाले िनयत
खुराक संयोजन(cid:7298) स े िभ(cid:7382) िनयत खुराक संयोजन(cid:7298) और ऐसे अ(cid:7008)य िनयत खरु ाक संयोजन(cid:7298) का, िजनम(cid:7286) तीन या अिधक
औषिधयां ह,(cid:7289) समुिचत नाम सहजद(cid:7019)ृ य रीित म(cid:7286) मु(cid:7408)(cid:7076)त (cid:7408)कया जाएगा या िलखा जाएगा, जो (cid:7408)क आकार म(cid:7286) उसी फ(cid:7298)ट
म(cid:7286), (cid:7408)क(cid:7008)तु (cid:7081)ांड नाम या (cid:7390)ापार नाम से, य(cid:7408)द कोई ह,ै कम से कम दो फ(cid:7298)ट बड़ा होगा और अ(cid:7008)य दशा(cid:7312) म(cid:7286) (cid:7081)ांड नाम
या (cid:7390)ापार नाम, य(cid:7408)द कोई ह,ै समुिचत नाम के नीच े या उसके प(cid:7391)ात् को(cid:7399)क(cid:7298) म (cid:7286) िलखा जाएगा, और” श(cid:7011)द रखे
जाएगं े ।
[फा. सं. ए(cid:6989)स.11014/5/2017-डी.आर.एस.]
कु(cid:7008)दन लाल शमा(cid:6981), संयु(cid:7334) सिचव
(cid:7407)ट(cid:7009)पण : मूल िनयम भारत के राजप(cid:7074) म(cid:7286) अिधसूचना सं. 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 संशोधन अिधसूचना सं. सा.का.िन. . . . . . . . (अ), तारीख. . . . ,
(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.302(E).—The following draft of certain rules further to amend the Drugs and Cosmetics Rules, 1945
which the Central Government proposes to make in exercise of the powers conferred by section 12 and section 33 of the
Drugs and Cosmetics Act, 1940 (23 of 1940), after consultation with the Drugs Technical Advisory Board, is hereby
published for information of all persons likely to be affected thereby and notice is hereby given that said draft rules will
be taken into consideration on or after the expiry of a period of forty-five days from the date on which copies of the
Gazette of India containing these draft rules are made available to the public.
Objections and suggestions which may be received from any person within the period specified above will be
considered by the Central Government.
Objections and suggestions, if any, may be addressed to the Under Secretary (Drugs), Ministry of Health and
Family Welfare, Government of India, Room No. 414 A, D Wing, Nirman Bhawan, New Delhi – 110011 or sent on
email drugsdiv-mohfw@nic.in.
(cid:97)(cid:68)(cid:114)(cid:102)(cid:101)(cid:108)(cid:115)(cid:117)(cid:32)(cid:116)(cid:114)(cid:32)
1.(cid:32) These rules may be called the Drugs and Cosmetics (______Amendment) Rules, 2017.
2.(cid:32) In the Drugs and Cosmetics Rules, 1945 (hereinafter referred to as the said rules), in rule 96, in sub-rule (1), in
clause (i), in sub-clause (A), for the portion beginning with the words “For this purpose” and ending with the
words “name and shall be”, the words “For this purpose, the proper name of the drug or fixed dose combination
drug other than fixed dose combinations of vitamin and other fixed dose combinations containing three or more
drugs, shall be printed or written in a conspicuous manner which shall be in the same font but at least two font¹Hkkx IIµ[k.M 3(i)º Hkkjr dk jkti=k % vlk/kj.k 3
size larger than the brand name or the trade name, if any, and in other cases the brand name or the trade name, if
any, shall be written in brackets below or after the proper name and shall be” shall be substituted.
[F. No. X.11014/5/2017-DRS]
K. L. SHARMA, Jt. Secy.
Note : The principal rules were published in the Gazette of India vide notification No. F.28-10/45-H (1) dated
21st December 1945 and last amended vide notification number G.S.R. (E) dated.
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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.