Executive Summary:
This notification from the Ministry of Health and Family Welfare announces a draft of amendments to the Drugs and Cosmetics Rules, 1945. The amendments are made under the powers conferred by the Drugs and Cosmetics Act, 1940, and after consultation with the Drugs Technical Advisory Board. The public has 45 days from the date the draft rules are available to submit objections or suggestions to the Central Government.
Key Points / Main Content:
Amendments to the Drugs and Cosmetics Rules, 1945:
* These rules may be called Drugs and Cosmetics Amendment Rules, 2017.
* They shall come into force on the date of their final publication in the Official Gazette.
Changes to Rule 122 P:
* Addition of item xiv: Whole human blood and blood components may be transferred, under prescribed storage conditions, to another blood bank which have facilities to store and monitor blood distribution.
* Addition of item xv: The recipient blood bank shall not further transfer units obtained from another blood bank except to another blood storage centre or a patient.
Modifications to Schedule F, Part XII B:
* Insertion of item d: a licensed blood bank run by registered voluntary or charitable organization recognised by State or Union territory Blood Transfusion Council; or
* Insertion of item e: a private hospital blood bank.
Amendment to Schedule K, Item 5B:
* Condition 2 under the column relating to extent and conditions of exemption is omitted.
Impact Analysis:
Public:
* Impact: The public is potentially affected by the changes to regulations regarding drugs and cosmetics.
* Action Required: Review the draft rules and submit any objections or suggestions to the Under Secretary Drugs within 45 days of the Gazette being made available.
Blood Banks:
* Impact: Blood banks are affected by changes regarding blood and blood component transfers and storage.
* Action Required: Ensure compliance with the new rules regarding blood transfers, storage conditions, and distribution, and adjust operations accordingly.
Drug Manufacturers and Distributors:
* Impact: Drug manufacturers and distributors are affected by changes to regulations regarding drugs and cosmetics.
* Action Required: Review the updated rules, particularly concerning Schedule K, and ensure compliance with any changes to exemption conditions.
Healthcare Professionals:
* Impact: Healthcare professionals are affected by changes in regulations related to blood transfusions and blood bank operations.
* Action Required: Stay informed about the updated rules to ensure adherence to proper procedures for blood handling and distribution.
State and Union Territory Blood Transfusion Councils:
* Impact: They are now explicitly recognized as entities that can license blood banks run by registered voluntary or charitable organizations.
* Action Required: Ensure they recognize and appropriately license blood banks run by registered voluntary or charitable organizations.
Key Entities Referenced
Drugs and Cosmetics Rules, 1945: A set of rules in India that this notification proposes to amend.
Drugs and Cosmetics Act, 1940: An Indian Act that confers powers to the Central Government regarding drugs and cosmetics. Sections 12 and 33 of this act are mentioned as the source of power for the proposed amendments.
Drugs Technical Advisory Board: An advisory board that is consulted before making amendments to the Drugs and Cosmetics Rules, 1945.
Ministry of Health and Family Welfare: The Indian government ministry to which objections and suggestions regarding the draft rules should be addressed.
New Delhi, Delhi: The location of Nirman Bhawan, where the Under Secretary Drugs of the Ministry of Health and Family Welfare can be contacted.
Drugs and Cosmetics Amendment Rules, 2017: The name given to the rules being amended in the notification.
Official Gazette: The official publication in which the final version of the amended rules will be published.
Blood Transfusion Council: State or Union territory Blood Transfusion Council recognised by registered voluntary or charitable organization that runs a licensed blood bank.
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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. 78] NEW DELHI, THURSDAY FEBRUARY 2, 2017/MAGHA 13, 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)ली, 2 फरवरी, 2017
सा.का.िन.
101(अ).—vkS
षिध और (cid:7079)साधन साम(cid:7061)ी िनयम, 1945 का और संशोधन करन े के िलए कितपय
vkS
िनयम(cid:7298) का िन(cid:7388)िलिखत (cid:7079)ा(cid:7272)प, िजसे के(cid:7008)(cid:7076)ीय सरकार का षिध और (cid:7079)साधन साम(cid:7061)ी अिधिनयम, 1940 (1940
vkS
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, षिध तकनीक(cid:7409) सलाहकार बोड (cid:6981) से
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;
vkS
ऐसे आ(cid:6979)ेप और सुझाव, य़(cid:7408)द कोई ह(cid:7298), अवर सिचव ( षिध), (cid:7021)वा(cid:7021)(cid:7005)य और प(cid:7407)रवार क(cid:7016)याण मं(cid:7074)ालय,
भारत सरकार, कमरा सं. 414ए, डी. (cid:7410)वग, िनमा(cid:6981)ण भवन, नई (cid:7408)द(cid:7016)ली-110011 को भजे े जा सकते ह (cid:7289) या
drugsdv.mohfw@gov.in पर b Z मेल (cid:7408)कए जा सकत े 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 ।
(cid:7079)ा(cid:7272)प िनयम
vkS
1. (1) इन िनयम(cid:7298) का संि(cid:6979)(cid:7385) नाम षिध 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 ।
576 GI/2017 (1)(cid:32)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
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2. षिध 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
,a
122त म(cid:7286) मद (xiii) के प(cid:7391)ात् िन(cid:7388)िलिखत मद (cid:7286) अंतः(cid:7021)थािपत क(cid:7409) जा गी, अथा(cid:6981)त:् -
“ (xiv) संपूण(cid:6981) मानव र(cid:7334) और र(cid:7334) घटक(cid:7298) को िविहत भंडारण दशा(cid:7312) के अधीन ऐसे (cid:7408)कसी अ(cid:7008)य र(cid:7334)
ब(cid:7289)क म(cid:7286) अंत(cid:7407)रत (cid:7408)कया जा सकेगा िजसम(cid:7286) भंडारण और र(cid:7334) िवतरण को मािनटर करने क(cid:7409) सुिवधाए ं ह (cid:7289) ।
(xv) (cid:7079)ा(cid:7385)कता(cid:6981) र(cid:7334) ब(cid:7289)क, (cid:7408)कसी अ(cid:7008)य र(cid:7334) ब(cid:7289)क से अिभ(cid:7079)ा(cid:7385) यूिनट(cid:7298) को एक अ(cid:7008)य र(cid:7334) भंडारण के(cid:7008)(cid:7076) या
(cid:7408)कसी रोगी को अंत(cid:7407)रत करन े के िसवाय आगे अंत(cid:7407)रत नह(cid:7277) करेगा ।”
3. उ(cid:7334) िनयम(cid:7298) क(cid:7409) अनसु ूची च के भाग 12ख म(cid:7286), “II र(cid:7334) दान कै(cid:7013)प” शीष(cid:6981)क के अधीन, मद (ग) के प(cid:7391)ात्
िन(cid:7388)िलिखत मद अंतः(cid:7021)थािपत क(cid:7409) जाएगी, अथा(cid:6981)त:् -
“(घ) रा(cid:6996)य या संघ रा(cid:6996)य(cid:6979)(cid:7074)े र(cid:7334)ाधान प(cid:7407)रषद ् (cid:7367)ारा मा(cid:7008)यता(cid:7079)ा(cid:7385) रिज(cid:7021)(cid:7069)ीकृत (cid:7021)वैि(cid:6994)छक या पूत(cid:6981) संगठन
(cid:7367)ारा चलाया जाने वाला कोई अनु(cid:6980)(cid:7385) र(cid:7334) बैक; या
(ङ) (cid:7408)कसी (cid:7079)ाइवेट अ(cid:7021)पताल का र(cid:7334) ब(cid:7289)क ।”
4. उ(cid:7334) िनयम(cid:7298) क(cid:7409) अनुसचू ी ट क(cid:7409) मद 5(ख) म(cid:7286), छूट का िव(cid:7021)तार और शत(cid:7300) स े संबंिधत (cid:7021)तंभ के अधीन, शत(cid:6981) (2) का
लोप (cid:7408)कया जाएगा ।
[फा. सं.
,Dl-
11035/290/2015-डी.एफ.(cid:6989)य़ू.सी]
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 थ े और उनम(cid:7286) अंितम संशोधन अिधसूचना सं. सा.का.िन. 76(अ), तारीख 31 जनवरी,
2017, (cid:7367)ारा (cid:7408)कया गया था ।
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 2nd February, 2017
G.S.R.101(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 the 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 drugsdiv-mohfw@gov.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)
(cid:32)
1.(cid:32) (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.¹Hkkx IIµ[k.M 3(i)º Hkkjr dk jkti=k % vlk/kj.k 3
2.(cid:32) In the Drugs and Cosmetics Rules, 1945, (hereinafter referred to as the said rules) in rule 122 P, after item (xiii),
the following items shall be inserted, namely:-
“(xiv) The whole human blood and blood components may be transferred, under prescribed storage
conditions, to another blood bank which have facilities to store and monitor blood distribution.
(xv) The recipient blood bank shall not further transfer units obtained from another blood bank except to
another blood storage centre or a patient.”
3.(cid:32) In the said rules, in Schedule F, in Part XII B under the heading “II. BLOOD DONATION CAMPS”, after item
(c), the following items shall be inserted, namely:-
“(d) a licensed blood bank run by registered voluntary or charitable organization recognised by State or
Union territory Blood Transfusion Council; or
(e) a private hospital blood bank.”
4.(cid:32) In Schedule K to the said rules, in item 5(B), under the column relating to extent and conditions of exemption,
condition (2) shall be omitted.
[F. No. X.11035/290/2015-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
21st December 1945 and last amended vide notification number GSR 76(E) dated 31st January, 2017.
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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.