Executive Summary:
This document is a notification regarding proposed amendments to the Drugs and Cosmetics Rules, 1945, under the Drugs and Cosmetics Act, 1940. It invites objections and suggestions from the public, which will be considered by the Central Government. The draft rules will be considered after a 30-day period following the publication of the notification.
Key Points / Main Content:
* **Proposed Amendments:**
* The Drugs and Cosmetics Rules, 1945, are to be amended.
* **Rule Changes:**
* In rule 43A, the word "Tuticorin" shall be substituted with "Tuticorin and Kamrajar Port."
* In rule 43A, the word "Gandhinagar" shall be substituted with "Gandhinagar and Mundra Port."
* **Rule Title and Commencement:**
* The amended rules are called the Drugs and Cosmetics Amendment Rules, 2018.
* The rules will be effective upon their final publication in the Official Gazette.
* **Public Consultation:**
* The notification is published to inform all persons likely to be affected by the draft rules.
* Objections and suggestions will be considered if received within 30 days of the Gazette's publication.
* Objections and suggestions can be sent to the Under Secretary Drugs, Ministry of Health and Family Welfare, or emailed to drugsdivmohfwgov.in.
Impact Analysis:
**General Public:**
* Impact: The general public is affected as the notification is for proposed amendments to the Drugs and Cosmetics Rules, 1945.
* Action Required: The public can submit objections and suggestions regarding the proposed amendments within 30 days of the notification's publication.
**Central Government:**
* Impact: The Central Government, specifically the Ministry of Health and Family Welfare, is responsible for reviewing and considering the feedback received.
* Action Required: The Central Government must consider the objections and suggestions received and finalize the amendments.
**Drugs Technical Advisory Board:**
* Impact: The Board was consulted regarding the amendments.
* Action Required: No action specified.
**Drug Manufacturers/Cosmetics Manufacturers:**
* Impact: These stakeholders are impacted by changes to which ports are listed in rule 43A.
* Action Required: Review amendments and ensure alignment.
Key Entities Referenced
Drugs and Cosmetics Rules, 1945: A set of rules in India governing the import, manufacture, distribution, and sale of drugs and cosmetics. This notification proposes amendments to these rules.
Drugs and Cosmetics Act, 1940: An act of the Parliament of India that regulates the import, manufacture and distribution of drugs and cosmetics.
New Delhi: The location where the notification was issued.
Ministry of Health and Family Welfare: The Indian government ministry responsible for health policy in India.
Drugs Technical Advisory Board: A board that is consulted regarding amendments to the Drugs and Cosmetics Rules.
Tuticorin, Tamil Nadu: A port city in the state of Tamil Nadu, India, mentioned in the proposed amendment to the Drugs and Cosmetics Rules.
Gandhinagar, Gujarat: The capital city of Gujarat, India, mentioned in the proposed amendment to the Drugs and Cosmetics Rules.
Drugs and Cosmetics Amendment Rules, 2018: The name given to the rules that may be introduced as a result of the notification.
jftLVªh laö Mhö ,yö&33004@99 REGD. NO. D. L.-33004/99
vlk/kj.k
EXTRAORDINARY
Hkkx II—[k.M 3—mi&[k.M (i)
PART II—Section 3—Sub-section (i)
izkf/dkj ls izdkf'kr
PUBLISHED BY AUTHORITY
la- 757] ubZ fnYyh] lkseokj] vDrwcj 22] 2018@vkf'ou 30] 1940
No. 757] NEW DELHI, MONDAY, OCTOBER 22, 2018/ASVINA 30, 1940
(cid:1)(cid:1)(cid:1)(cid:1)ववववाााा(cid:1)(cid:1)(cid:1)(cid:1)(cid:4)(cid:4)(cid:4)(cid:4)यययय औऔऔऔरररर पपपप(cid:10)(cid:10)(cid:10)(cid:10)ररररववववाााारररर कककक(cid:12)(cid:12)(cid:12)(cid:12)ययययााााणणणण मममम(cid:16)(cid:16)ंं(cid:16)(cid:16)ंं ााााललललयययय
(((((cid:2)(cid:2)(cid:2)(cid:2)ववववाााा(cid:2)(cid:2)(cid:2)(cid:2)(cid:5)(cid:5)(cid:5)(cid:5)यययय औऔऔऔरररर पपपप(cid:11)(cid:11)(cid:11)(cid:11)ररररववववाााारररर कककक(cid:13)(cid:13)(cid:13)(cid:13)ययययााााणणणण ििििववववभभभभाााागगगग))))
अअअअििििधधधधससससचचूूचचूू ननननाााा
नई (cid:4)द(cid:6)ली, 22 अ(cid:10)त बू र, 2018
ससससाााा....ककककाााा....ििििनननन....1111000055551111((((अअअअ)))).–औषिध और (cid:18)साधन साम(cid:22)ी िनयम, 1945 का और संशोधन करने के िलए कितपय
िनयम(cid:24) के िन(cid:27)िलिखत (cid:18)ा(cid:29)प, िजसे क ! सरकार औषध तकनीक" सलाहकार बोड’ के परामश’ से औषिध और
(cid:18)साधन साम(cid:22)ी अिधिनयम, 1940 (23 के 1940) क" धारा 12 और धारा 33 1ारा (cid:18)द2 शि3य(cid:24) का (cid:18)योग करत े
5ए, इसके 1ारा (cid:18)भािवत होने क" संभावना वाले सभी ;ि3य(cid:24) क" जानकारी के िलए (cid:18)कािशत (cid:4)कया जाता ह ै और
एतद1् ारा सूचना दी जाती ह ै (cid:4)क उ(cid:10) त (cid:18)ा(cid:29)प िनयम(cid:24) पर उस तारीख स े तीस (cid:4)दन(cid:24) क" अविध समा?त होने पर या
उसके बाद िवचार (cid:4)कया जाएगा िजस तारीख को इन (cid:18)ा(cid:29)प िनयम(cid:24) वाले भारत के राजप@ क" (cid:18)ितयां जनता को
उपलAध कराई जाएगी।
क ! सरकार 1ारा उपयु’3 िनDदE अविध के भीतर (cid:4)कसी भी ;ि3 से (cid:18)ाF होने वाली आपि2य(cid:24) और
सुझाव(cid:24) पर िवचार (cid:4)कया जाएगा।
आपि2यां और सुझाव, य(cid:4)द कोई ह(cid:24), तो अवर सिचव, (औषिध), IवाIJय और पKरवार क(cid:6)याण मं@ालय,
भारत सरकार, कमरा सं. 414ए, डी Mवग, िनमा’ण भवन, नई (cid:4)द(cid:6)ली - 110011 को अ(cid:22)ेिषत (cid:4)कया जाए अथवा
drugsdiv-mohfw@gov.in पर ई-मेल (cid:4)कया जाए।
(cid:18)(cid:18)(cid:18)(cid:18)ाााा(cid:19)(cid:19)(cid:19)(cid:19)पपपप ििििननननययययमममम
1. (1) इन िनयम(cid:24) को औषिध एवं (cid:18)साधन साम(cid:22)ी (…… संशोधन) िनयम, 2018 कहा जाएगा।
(2) ये सरकारी राजप@ म इसके अंितम (cid:18)काशन क" ितिथ से लागू ह(cid:24)गे।
6169 GI/2018 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
2. औषिध और (cid:18)साधन साम(cid:22)ी िनयम, 1945 के िनयम 43क म, "तूतीकोKरन" शAद के Iथान पर "ततू ीकोKरन
एवं कामराजार बंदरगाह" और "गाँधीनगर" शAद के Iथान पर "गाँधीनगर एवं म!ुं ा बंदरगाह" शAद(cid:24) को
Qमशः (cid:18)ितIथािपत (cid:4)कया जाएगा।
[फा. सं. ए(cid:10)स .11014/25/2018-डीआर]
सुनील शमा,’ संयु(cid:10) त सिचव
(cid:10)(cid:10)(cid:10)(cid:10)टटटट(cid:23)(cid:23)(cid:23)(cid:23)पपपपणणणण:::: मुल िनयम(cid:24) को (cid:4)दनांक 21 (cid:4)दसSब र, 1945 क" अिधसूचना सं0 एफ.28-10/45-एच (1) के तहत सरकारी
राजप@ म (cid:18)कािशत (cid:4)कया गया और अंितम बार अिधसूचना स.ं सा.का.िन. ………(अ),
तारीख.............. के तहत संशोिधत (cid:4)कया गया।
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 22nd October, 2018
G.S.R.1051(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 thirty 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 Bhavan, New Delhi - 110011 or emailed at
drugsdiv-mohfw@gov.in.
DRAFT RULES
1. (1) These rules may be called the Drugs and Cosmetics (………. Amendment) Rules, 2018.
(2) They shall come into force on the date of their final publication in the Official Gazette.
2. In the Drugs and Cosmetics Rules, 1945, in rule 43-A, for the word “Tuticorin” the words “Tuticorin and
Kamrajar Port”; and for the word “Gandhinagar” the words “Gandhinagar and Mundra Port” respectively shall
be substituted.
[F. No. X.11014/25/2018-DR]
SUNIL SHARMA, Jt. Secy.
Note: The principal rules were published in the Official Gazette vide notification No.F.28-10/45-H (1), dated
21st December, 1945 and last amended vide notification number G.S.R ………… (E), dated …………..
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.