Executive Summary:
This notification announces the Drugs and Cosmetics Eighth Amendment Rules, 2017, further amending the Drugs and Cosmetics Rules, 1945. These amendments address the transfer of blood and blood components between blood banks and storage centers, and modify rules related to blood donation camps. The rules take effect upon publication in the Official Gazette on April 3, 2017.
Key Points / Main Content:
Blood Transfer Amendments:
* Whole human blood and blood components may be transferred to another blood bank with storage and monitoring facilities.
* Recipient blood banks cannot further transfer units obtained from another blood bank, except to a blood storage center or a patient.
Blood Donation Camp Amendments:
* Licensed blood banks run by registered voluntary or charitable organizations recognised by State or Union territory Blood Transfusion Council can conduct blood donation camps.
* Private hospital blood banks can conduct blood donation camps.
Schedule K Amendment:
* In Schedule K, item 5B, condition 2 regarding extent and conditions of exemption is omitted.
Impact Analysis:
Blood Banks:
* Impact: Blood banks can now transfer blood and blood components under specified conditions, allowing for better resource management. Recipient blood banks are restricted in further transferring units, except to storage centers or patients.
* Action Required: Blood banks must ensure compliance with the new transfer rules, including storage conditions and restrictions on further transfer.
Blood Storage Centers:
* Impact: Blood storage centers can receive blood units from recipient blood banks.
* Action Required: Ensure they are able to store blood received from blood banks.
Hospitals and Healthcare Providers:
* Impact: Private hospitals can operate blood banks that may now run blood donation camps.
* Action Required: Ensure compliance with all requirements for operating donation camps and changes in Schedule K.
Voluntary and Charitable Organizations:
* Impact: Registered voluntary or charitable organizations recognised by State or Union territory Blood Transfusion Council can operate blood banks that may now run blood donation camps.
* Action Required: Ensure compliance with all requirements for operating donation camps and changes in Schedule K.
Regulatory Bodies:
* Impact: Responsible for enforcing the amended rules and guidelines.
* Action Required: Update regulatory frameworks and ensure compliance monitoring to reflect the changes.
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.
Drugs and Cosmetics Act, 1940: An act of the Parliament of India that regulates the import, manufacture, distribution and sale of drugs and cosmetics.
Ministry of Health and Family Welfare: A ministry of the Government of India responsible for health policy in India.
New Delhi: The capital of India, where the notification was issued.
Drugs Technical Advisory Board: A statutory body under the Drugs and Cosmetics Act, 1940 that advises the Central Government on technical matters related to drugs and cosmetics.
Drugs and Cosmetics Eighth Amendment Rules, 2017: An amendment to the Drugs and Cosmetics Rules, 1945.
Official Gazette: A public journal, a gazette is an official journal of record.
Union territory: One of the type of administrative divisions in the Republic of India.
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REGD. NO. D. L.-33004/99
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EXTRAORDINARY
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PART II—Section 3—Sub-section (i)
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PUBLISHED BY AUTHORITY
la- 261] ubZ fnYyh] lkseokj] vizSy 3] 2017@pS=k 13] 1939
No. 261] NEW DELHI, MONDAY, APRIL 3, 2017/CHAITRA 13, 1939
स्वास्थ्य और पिरवार कल्याण म(cid:7074)ं ालय
(स्वास्थ्य और पिरवार कल्याण िवभाग)
अिधसूचना
नई िदल्ली, 3 अ(cid:7079)ैल, 2017
सा.का.िन. 328(अ).— औषिध और (cid:7079)साधन साम(cid:7061)ी िनयम, 1945 का और संशोधन करने के िलए कितपय
िनयम(cid:7298) का (cid:7079)ारूप औषिध और (cid:7079)साधन साम(cid:7061)ी अिधिनयम, 1940 (1940 का 23) की धारा 12 और धारा 33 की
अपेक्षाऩुसार भारत के राजप(cid:7074), असाधारण, भाग II, खंड 3, उपखंड (i), तारीख 2 फरवरी, 2017 म(cid:7286) (cid:7079)कािशत
भारत सरकार के स्वास्थ्य और पिरवार कल्याण मं(cid:7074)ालय (स्वास्थ्य और पिरवार कल्याण िवभाग) की अिधसचू ना
सं. सा.का.िन. 101(अ), तारीख 2 फरवरी, 2017 (cid:7367)ारा (cid:7079)कािशत िकया गया था िजसके (cid:7367)ारा उन सभी (cid:7390)ि(cid:7334)य(cid:7298)
स,े िजनके उनसे (cid:7079)भािवत होने की संभावना ह,ै उस तारीख से, िजसको उ(cid:7334) अिधसूचना वाले भारत के राजप(cid:7074) की
(cid:7079)ितयां जनता को उपलब्ध करा दी गई थ(cid:7277), प(cid:7289)तालीस िदन की अविध की समाि(cid:7385) से पूवर् आक्षेप और सुझाव आमंि(cid:7074)त
िकए गए थे;
और उ(cid:7334) मूल राजप(cid:7074) की (cid:7079)ितयां जनता को तारीख 2 फरवरी, 2017 को उपलब्ध करा दी गई थ(cid:7277) ।
और केन्(cid:7076)ीय सरकार (cid:7367)ारा उ(cid:7334) िनयम(cid:7298) के संबंध म(cid:7286) जनता के (cid:7079)ा(cid:7385) आक्षेप(cid:7298) और सुझाव(cid:7298) पर िवचार िकया
गया ह ै।
अतः, अब, केन्(cid:7076)ीय सरकार, औषिध और (cid:7079)साधन साम(cid:7061)ी अिधिनयम, 1940 (1940 का 23) की धारा 12
और धारा 33 के अधीन शि(cid:7334)य(cid:7298) का (cid:7079)योग करते हुए, औषिध तकनीकी सलाहकार बोडर् से परामशर् करने के प(cid:7391)ात्,
औषिध और (cid:7079)साधन साम(cid:7061)ी िनयम, 1945 का और संशोधन करने के िलए िन(cid:7388)िलिखत िनयम बनाती ह,ै अथार्त्:-
1. (1) इन िनयम(cid:7298) का संिक्ष(cid:7385) नाम औषिध और (cid:7079)साधन साम(cid:7061)ी (आठवां संशोधन) िनयम, 2017 ह ै।
(2) ये राजप(cid:7074) म(cid:7286) उनके (cid:7079)काशन की तारीख को (cid:7079)वृ(cid:7275) ह(cid:7298)गे ।
1881 GI/2017 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)]
2. औषिध और (cid:7079)साधन साम(cid:7061)ी िनयम, 1945 (िजन्ह (cid:7286) इसम(cid:7286) इसके प(cid:7391)ात् उ(cid:7334) िनयम कहा गया ह)ै के िनयम
122त म(cid:7286) मद (xiii) के प(cid:7391)ात् िन(cid:7388)िलिखत मद (cid:7286) अंतःस्थािपत की जाएगी, अथार्त्:-
“ (xiv) संपूणर् मानव र(cid:7334) और र(cid:7334) घटक(cid:7298) को िविहत भंडारण दशा(cid:7312) के अधीन ऐसे िकसी अन्य र(cid:7334) ब(cid:7289)क म(cid:7286)
अंतिरत िकया जा सकेगा िजसम(cid:7286) भंडारण और र(cid:7334) िवतरण को मािनटर करने की सुिवधाएं ह (cid:7289)।
(xv) (cid:7079)ा(cid:7385)कतार् र(cid:7334) ब(cid:7289)क, िकसी अन्य र(cid:7334) ब(cid:7289)क से अिभ(cid:7079)ा(cid:7385) यूिनट(cid:7298) को एक अन्य र(cid:7334) भंडारण केन्(cid:7076) या िकसी
रोगी को अंतिरत करने के िसवाय आगे अंतिरत नह(cid:7277) करेगा ।”
3. उ(cid:7334) िनयम(cid:7298) की अनुसूची च के भाग 12ख म(cid:7286), “II र(cid:7334) दान कैम्प” शीषर्क के अधीन, मद (ग) के प(cid:7391)ात्
िन(cid:7388)िलिखत मद अंतःस्थािपत की जाएगी, अथार्त्:-
“(घ) राज्य या संघ राज्यक्षे(cid:7074) र(cid:7334)ाधान पिरषद ्(cid:7367)ारा मान्यता(cid:7079)ा(cid:7385) रिजस्(cid:7069)ीकृत स्वैिच्छक या पूतर् संगठन (cid:7367)ारा
चलाया जाने वाला कोई अनुज्ञ(cid:7385) र(cid:7334) ब(cid:7289)क; या
(ङ) िकसी (cid:7079)ाइवेट अस्पताल का र(cid:7334) ब(cid:7289)क ।”
4. उ(cid:7334) िनयम(cid:7298) की अनुसूची ट की मद 5(ख) म(cid:7286), छूट का िवस्तार और शत(cid:7300) से संबंिधत स्तंभ के अधीन, शतर् (2) का
लोप िकया जाएगा ।
[फा. सं. 11035/290/2015-डीएफक्य़ूसी]
कुन्दन लाल शमार्, संयु(cid:7334) सिचव
िटप्पण: मूल िनयम भारत के राजप(cid:7074) म(cid:7286) अिधसूचना सं. एफ. 28-10/45-एच(1), तारीख 21 िदसम्बर, 1945
(cid:7367)ारा (cid:7079)कािशत िकए गए थे और उनम(cid:7286) अंितम संशोधन अिधसूचना सं. सा.का.िन. 303 (अ), तारीख 30 माचर्,
2017 (cid:7367)ारा िकया गया था ।
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 3rd April , 2017
G.S.R. 328(E).— Whereas the draft of certain rules further to amend the Drugs and
Cosmetics Rules, 1945 was published as required by sections 12 and 33 of the Drugs and
Cosmetics Act, 1940 (23 of 1940) in the Gazette of India, Extraordinary, Part II, Section 3,
Sub-section (i), dated the 2nd February, 2017 vide notification of the Government of India in
the Ministry of Health and Family Welfare, number G.S.R. 101(E), dated the 2nd February,
2017 for inviting objections and suggestions from all persons likely to be affected thereby
before the expiry of a period of forty-five days from the date on which copies of the Official
Gazette containing the said notification was made available to the public;
And whereas the copies of the said Gazette were made available to the public on 2nd
February, 2017;
And, whereas, objections and suggestions received from the public on the said rules
have been considered by the Central Government.¹Hkkx IIμ[k.M 3 (i)º Hkkjr dk jkti=k % vlk/kj.k 3
Now, therefore, in exercise of the powers conferred by sections 12 and 33 of the said
Act, the Central Government, after consultation with the Drugs Technical Advisory Board,
hereby makes the following rules further to amend the Drugs and Cosmetics Rules, 1945,
namely:-
1. (1) These rules may be called Drugs and Cosmetics (Eighth Amendment) Rules, 2017.
(2) They shall come into force on the date of their publication in the Official Gazette.
2. 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 banks shall not further transfer units obtained from
another blood bank except to another blood storage centre or a patient.”
3. 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. 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 G.S.R. 303 (E) dated 30th March, 2017.
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.