Executive Summary:
This notification, published in the Gazette of India on January 17, 2017, proposes amendments to the Drugs and Cosmetics Rules, 1945. It is issued by the Ministry of Health and Family Welfare, after consulting with the Drugs Technical Advisory Board. The public has 30 days from the date the draft rules are available to submit objections or suggestions.
Key Points / Main Content:
* **Amendment Purpose:** The notification outlines draft rules to further amend the Drugs and Cosmetics Rules, 1945.
* **Rule Implementation:** The Drugs and Cosmetics Amendment Rules, 2017 will be enforced upon their final publication in the Official Gazette.
* **Amendment Details:** In Rule 3A, subrule 8, clause b of the Drugs and Cosmetics Rules, 1945, the following will be inserted after item 5:
* Enzymes and Hormones: Streptokinase (Natural and Recombinant), Human Chorionic Gonadotropin (hCG), and Human Menopausal Gonadotropin (hMG).
* Bacterial vaccine: Bacillus Calmette-Guerin (BCG) vaccine.
* Viral vaccines: Live attenuated Measles vaccine, Live attenuated Rubella vaccine, and Cell culture Rabies vaccine.
Impact Analysis:
Government of India, Ministry of Health and Family Welfare:
* Impact: Responsible for considering objections/suggestions to the draft rules and finalizing/publishing the amendment.
* Action Required: Review and address any objections or suggestions received from the public, and proceed with the final publication of the amended rules.
Public and Affected Parties:
* Impact: Subject to the amended Drugs and Cosmetics Rules.
* Action Required: Review the draft rules and submit any objections or suggestions to the Under Secretary Drugs, Ministry of Health and Family Welfare, within 30 days of the draft rules being made available.
Drug Manufacturers:
* Impact: Required to comply with the updated regulations regarding the inclusion of specific enzymes, hormones, and vaccines in Rule 3A.
* Action Required: Understand and adhere to the new amendments, ensuring compliance in manufacturing and labeling processes.
Key Entities Referenced
Drugs and Cosmetics Rules, 1945: A set of rules related to drugs and cosmetics, which is being amended by this notification.
Drugs and Cosmetics Act, 1940: An act of the Indian Parliament that regulates the import, manufacture, distribution and sale of drugs and cosmetics.
Drugs Technical Advisory Board: A board consulted during the amendment process of the Drugs and Cosmetics Rules, 1945.
Ministry of Health and Family Welfare: The Indian government ministry responsible for health policy in India.
New Delhi: The location of publication, and address for correspondence related to the notification. New Delhi, Delhi, India
Drugs and Cosmetics Amendment Rules, 2017: The title of the rules that are being introduced through this notification.
Bacillus Calmette-Guerin BCG vaccine: A bacterial vaccine that will be inserted into the Drugs and Cosmetics rules
K. L. Sharma: Jt. Secy. who is issuing the notification.
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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. 39] NEW DELHI, TUESDAY, JANUARY 17, 2017/PAUSA 27, 1938
(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)ल ी, 17 जनवरी, 2017
सा.का.िन. 44(अ).—औषिध और (cid:7079)साधन साम(cid:7061)ी िनयम, 1945 का और संशोधन करने 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,ै उ(cid:7334) धारा 12 क(cid:7409) उपधारा (1) और धारा 33 क(cid:7409) उपधारा (1) क(cid:7409)
अपे(cid:6979)ानुसार 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 सूचना 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)ितया ं जनता को उपल(cid:7011)ध करा दी जाती ह,(cid:7289) तीस (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;
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 भेजे जा सकते ह (cid:7289)।
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 ।
281 GI/2017 (1)(cid:32)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
(cid:7079)ा(cid:7272)प िनयम
1. सिं (cid:6979)(cid:7385) नाम और (cid:7079)ारंभ.–(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) ये राजप(cid:7074) म(cid:7286) उनके अंितम (cid:7079)काशन क(cid:7409) तारीख को (cid:7079)वृ(cid:7275) ह(cid:7298)गे ।
2. औषिध और (cid:7079)साधन साम(cid:7061)ी िनयम, 1945 के िनयम 3क के उपिनयम (8) के खंड (ख) म(cid:7286) मद (5) और
उससे संबिं धत (cid:7079)िवि(cid:7397)य(cid:7298) के (cid:7021)थान पर िन(cid:7388)िलिखत अंतः(cid:7021)थािपत (cid:7408)कया जाएगा, अथा(cid:6981)त्:-
“(6) एज़ं ाइम और हाम(cid:7299)न, जसै े-
(क) (cid:7021)(cid:7069)े(cid:7009)टोकाइनेस (नैस(cid:7414)गक और (cid:7407)रकािं बन(cid:7286)ट);
(ख) (cid:7022)यूमैन को(cid:7407)रयोिनक गोनेडो(cid:7069)ो(cid:7408)फन (एच.सी.जी.);
(ग) (cid:7022)यूमैन मेनोपॉसल गोनडे ो(cid:7069)ो(cid:7408)फन (एच.एम.जी.) ।
(7) जीवाणु-सबं ंधी वै(cid:6989)सीन, जैसे –
बैिसलस कॉलमेट गुरीन (बी.सी.जी.) वै(cid:6989)सीन ।
(8) िवषाणु-सबं ंधी वै(cid:6989)सीन, जैसे –
(क) जीिवत तनूकृत खसरा व(cid:6989)ै सीन;
(ख) जीिवत तनूकृत (cid:7272)बेला वै(cid:6989)सीन;
(ग) कोिशका सवं धन(cid:6981) रेबीज़ वै(cid:6989)सीन ।”
[फा. सं. ए-11018/2/2016-डी.एफ.(cid:6989) यू.सी.]
कु(cid:7008) दन लाल शमा(cid:6981), सयं ु(cid:6989) त सिचव
(cid:7407)ट(cid:7009)प ण : 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 थ े और उनम (cid:7286) अंितम संशोधन सा.का.िन. 1041(अ), तारीख 4 नव(cid:7013)ब र, 2016
Fkk
(cid:7367)ारा (cid:7408)कया गया ।
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 17th January, 2017
G.S.R. 44(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 sections 12 and 33 of the Drugs
and Cosmetics Act, 1940 (23 of 1940), after consultation with the Drugs Technical Advisory Board, is hereby published
as required by sub-section (1) the said section 12 and sub-section (1) of section 33 for information of all persons likely to
be affected thereby; and notice is hereby given that the said draft rules will be taken into consideration on or after the
expiry of a period of thirty days from the date on which the copies of the Official Gazette containing these draft rules are
made available to the public;
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;¹Hkkx IIµ[k.M 3(i)º Hkkjr dk jkti=k % vlk/kj.k 3
The objections and suggestions which may be received from any person with respect to the said draft
rules within the period specified above, will be considered by the Central Government.
DRAFT RULES
1.(cid:32) (1) These rules may be called the Drugs and Cosmetics (______Amendment) Rules, 2017.
(2) They shall come into force on the date of their final publication in the Official Gazette.
2.(cid:32) In the Drugs and Cosmetics Rules, 1945, in rule 3A, in sub-rule (8), in clause (b), after item (5) and the
entries relating thereto, the following shall be inserted, namely:-
“(6) Enzyme and Hormones such as-
(a) Streptokinase (Natural and Recombinant);
(b) Human Chorionic Gonadotropin (hCG);
(c) Human Menopausal Gonadotropin (hMG).
(7) Bacterial vaccine such as-
(a) Bacillus Calmette-Guerin (BCG) vaccine.
(8) Viral vaccines such as-
(a) Live attenuated Measles vaccine;
(b) Live attenuated Rubella vaccine;
(c) Cell culture Rabies vaccine.”.
[F. No. A.-11018/2/2016-DFQC]
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
the 21st December, 1945 and last amended vide notification number G.S.R. 1041(E), dated 4.11.2016.
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and Published by the Controller of Publications, Delhi-110054.