Executive Summary:
This notification from the Ministry of Health and Family Welfare announces draft rules to amend the Drugs and Cosmetics Rules, 1945. It invites objections and suggestions from the public, which must be submitted within forty-five days from the date the draft rules are available. The amendments involve changes to rule 24, rule 26, and Schedule A of the Drugs and Cosmetics Rules, 1945.
Key Points / Main Content:
* **General Information**
* These rules are called the Drugs and Cosmetics Amendment Rules, 2017.
* The rules will come into force on the date of their final publication in the Official Gazette.
* **Amendments to the Drugs and Cosmetics Rules, 1945**
* In rule 24, sub-rule 1, the phrase "and by an undertaking in Form 9 duly signed by or on behalf of the manufacturer" shall be omitted.
* In rule 26, clause i and entries related to it shall be omitted.
* In Schedule A:
* In Form 8, paragraph 3 shall be omitted.
* In Form 8A, paragraph 3 shall be omitted.
* Form 9 shall be omitted.
Impact Analysis
* **Manufacturers**
* *Impact:* Manufacturers are affected by the removal of the requirement for an undertaking in Form 9 and changes to rules and schedules.
* *Action Required:* Manufacturers need to be aware of the changes to ensure compliance with the updated Drugs and Cosmetics Rules, 1945.
* **Central Government**
* *Impact:* The Central Government is responsible for considering objections and suggestions from the public regarding the draft rules.
* *Action Required:* The Central Government must review and address any objections or suggestions received within the specified period before finalizing the amendments.
* **Public**
* *Impact:* The public is affected as these rules will be changed.
* *Action Required:* The public should submit any objections and suggestions regarding the draft rules to the Under Secretary Drugs, Ministry of Health and Family Welfare, within the specified time frame (45 days).
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 provides the central government with the power to make rules regarding drugs and cosmetics.
Drugs Technical Advisory Board: An advisory board consulted by the Central Government regarding the draft rules.
Ministry of Health and Family Welfare: The ministry responsible for health and family welfare policies in India, which is issuing the notification.
New Delhi: The location of Ministry of Health and Family Welfare.
Drugs and Cosmetics Amendment Rules, 2017: The name of the amendment rules being introduced.
K. L. Sharma: The Joint Secretary who signed the notification.
Nirman Bhawan, New Delhi: Location of the Under Secretary Drugs, Ministry of Health and Family Welfare.
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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. 38] 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. 43(अ).—ओषिध 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, ओषिध 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 करत े(cid:7263)ए, ओषिध तकनीक(cid:7409) सलाहकार बोड (cid:6981)स ेपरामश (cid:6981)करन े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) सभं ावना 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) वाल ेभारत के राजप(cid:7074) क(cid:7409) (cid:7079)ितया ं
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 ऐस े आ(cid:6979)ेप(cid:7298) और सझु ाव(cid:7298) पर, जो उ(cid:7334) (cid:7079)ा(cid:7272)प िनयम(cid:7298) के संबंध म(cid:7286) ऊपर िविन(cid:7416)द(cid:7397) अविध के
भीतर (cid:7408)कसी (cid:7390)ि(cid:7334) स े(cid:7079)ा(cid:7385) ह(cid:7298), िवचार (cid:7408)कया जाएगा ।
ऐसे आ(cid:6979)ेप और सझु ाव, य(cid:7408)द कोई ह(cid:7298), अवर सिचव (ओषिध), (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, िनमाण(cid:6981) भवन, नई (cid:7408)द(cid:7016)ली-110011 को भजे े जा सकत े ह (cid:7289)या rg.singh72@nic.in पर मले (cid:7408)कए जा सकत े
ह (cid:7289)।
(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 ओषिध और (cid:7079)साधन साम(cid:7061)ी (.......... सशं ोधन) िनयम,
2017 ह ै।
(2) य ेराजप(cid:7074) म (cid:7286)उनके अिं तम (cid:7079)काशन क(cid:7409) तारीख को (cid:7079)वृ(cid:7275) ह(cid:7298)गे ।
280 GI/2017 (1)(cid:32)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
2. ओषिध 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 24 के
उपिनयम (1) म (cid:7286) “और इसके साथ उ(cid:7334) िविनमा(cid:6981)ता (cid:7367)ारा (cid:7079)(cid:7272)प 9 म (cid:7286) िविनमा(cid:6981)ता या उसक(cid:7409) ओर स े िविधवत ह(cid:7021)ता(cid:6979)(cid:7407)रत एक
वचनबंध भी सलं (cid:7336) होगा” श(cid:7011)द(cid:7298) का लोप (cid:7408)कया जाएगा;
3. उ(cid:7334) िनयम(cid:7298) के िनयम 26 का खंड (i) और उसस ेसंबिं धत (cid:7079)िवि(cid:7397)य(cid:7298) का लोप (cid:7408)कया जाएगा;
4. उ(cid:7334) िनयम(cid:7298) क(cid:7409) अनसु ूची क म,(cid:7286)-
(क) (cid:7079)(cid:7272)प 8 म,(cid:7286) पैरा 3 का लोप (cid:7408)कया जाएगा;
(ख) (cid:7079)(cid:7272)प 8क म,(cid:7286) परै ा 3 का लोप (cid:7408)कया जाएगा;
(ग) (cid:7079)(cid:7272)प 9 का लोप (cid:7408)कया जाएगा ।
[फा. स.ं ए(cid:6989) स-11014/13/2016-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 एफ. 28-10/45-एच(1), तारीख 21 (cid:7408)दसम् 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. 43(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 shall 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, shall 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 rg.singh72@nic.in.
Draft rules
1.(cid:32) Short title and commencement.—(1) These rules may be called 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 (hereinafter referred to as the said rules), in rule 24, in sub-
rule (1), the words “and by an undertaking in Form 9 duly signed by or on behalf of the manufacturer”
shall be omitted;
3.(cid:32) In the said rules, in rule 26, clause (i) and the entries relating thereto shall be omitted;¹Hkkx IIµ[k.M 3(i)º Hkkjr dk jkti=k % vlk/kj.k 3
4.(cid:32) In the said rules, in Schedule A,-
(a) in Form 8, paragraph 3 shall be omitted;
(b) in Form 8A, paragraph 3 shall be omitted;
(c) Form 9 shall be omitted.
[F. No. X.-11014/13/2016-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.
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