Executive Summary:
This notification announces a draft of amendments to the Drugs and Cosmetics Rules, 1945, regarding Etizolam. It is issued by the Ministry of Health and Family Welfare. The public has forty-five days from the date the draft rules are available to submit objections or suggestions for consideration by the Central Government.
Key Points / Main Content:
* **Amendments to Drugs and Cosmetics Rules:**
* The notification concerns draft rules to further amend the Drugs and Cosmetics Rules, 1945.
* These amendments are made in exercise of powers conferred by section 12 and section 33 of the Drugs and Cosmetics Act, 1940, and in consultation with the Drugs Technical Advisory Board.
* **Effective Date:**
* The rules will come into force on the date of their final publication in the Official Gazette.
* **Specific Amendment:**
* In Schedule H of the Drugs and Cosmetics Rules, 1945, Etizolam is added after serial number 536 with the serial number 537.
* **Public Input:**
* Objections and suggestions are invited from those affected by the draft rules.
* Submissions must be addressed to the Under Secretary Drugs, Ministry of Health and Family Welfare.
* Submissions can be sent to Room No. 414 A, D Wing, Nirman Bhavan, New Delhi 110011 or via email to rg.singh72nic.in.
Impact Analysis:
* **Drug Manufacturers and Distributors:**
* *Impact:* Will need to comply with the updated regulations regarding Etizolam, including any new requirements for manufacturing, labeling, and distribution.
* *Action Required:* Review the draft rules, assess the impact on their operations, and submit objections or suggestions to the Ministry of Health and Family Welfare within the specified timeframe if necessary.
* **Healthcare Professionals (Doctors, Pharmacists):**
* *Impact:* Will need to be aware of the updated regulations regarding Etizolam, including any changes to prescribing or dispensing guidelines.
* *Action Required:* Review the draft rules to understand the implications for their practice.
* **Patients:**
* *Impact:* May be indirectly affected by changes in the availability or regulation of Etizolam.
* *Action Required:* No direct action required, but may want to stay informed about changes to drug regulations.
* **Central Government (Ministry of Health and Family Welfare):**
* *Impact:* Responsible for reviewing and considering public feedback on the draft rules, finalizing the amendments, and publishing them in the Official Gazette.
* *Action Required:* Review and consider all objections and suggestions received, finalize the amendment rules, and publish the final rules in the Official Gazette.
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: The Act that confers powers to the Central Government to make rules regarding drugs and cosmetics.
Drugs Technical Advisory Board: An advisory board consulted by the Central Government when making rules under the Drugs and Cosmetics Act.
Ministry of Health and Family Welfare: The ministry responsible for health and family welfare in India, which is issuing the notification.
Nirman Bhavan, New Delhi: Location of the Ministry of Health and Family Welfare, where objections and suggestions can be addressed.
Drugs and Cosmetics Amendment Rules, 2017: The title of the rules that are being amended in this notification.
Etizolam: A substance being added to Schedule H of the Drugs and Cosmetics Rules, 1945.
K. L. SHARMA: Joint Secretary who signed the notification.
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EXTRAORDINARY
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PART II—Section 3—Sub-section (i)
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No. 37] 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. 42(अ).—vkषS िध 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, vkSषिध 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, vkSषिध तकनीक(cid:7409) सलाहकार बोड (cid:6981) स े
परामश(cid:6981) करने के प(cid:7391)ात,् 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 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)ि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 (vkSषिध), (cid:7021)वा(cid:7021)(cid:7005)य और प(cid:7407)रवार क(cid:7016)याण म(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 सकत े ह (cid:7289) या
rg.singh72@nic.in पर मेल (cid:7408)कए जा सकते ह (cid:7289)।
279 GI/2017 (1)(cid:32)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
(cid:7079)ा(cid:7272)प िनयम
1 संि(cid:6979)(cid:7385) नाम और (cid:7079)ारंभ – (1) इन िनयम(cid:7298) का संि(cid:6979)(cid:7385) नाम vkषS िध 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. vkSषिध और (cid:7079)साधन साम(cid:7061)ी िनयम, 1945 क(cid:7409) अनुसूची ज म(cid:7286), (cid:7059)म सं(cid:6990)याकं 536 और उससे सबं ंिधत
(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)त्:-
“537. ऐटीज़ोलम” ।
[फा. सं. ए(cid:6989) स-11014/11/2016-डी.आर.एस.]
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(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 सशं ोधन सा.का.िन. 1041(अ), तारीख 4 नव(cid:7013)ब र
Fkk
2016 (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. 42(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), in 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 the 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 send on
email rg.singh72@nic.in .
DRAFT RULES
1.(cid:32) Short title and commencement.-(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 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.
Foonote.- The principal rules were published in the Official Gazette vide notification number F.28-10/45-H
(1), dated the 21st December, 1945 and last amended vide notification number G.S.R. 1041(E), dated the
4th November 2016.
(cid:32)
(cid:32)
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.