Executive Summary:
This notification, issued by the Ministry of Health and Family Welfare on May 18, 2020, regulates the manufacture and stock of COVID-19 vaccines to address the emergency situation caused by the pandemic. It outlines procedures for manufacturers seeking to produce and stock vaccines, including requirements for clinical trial permissions and licenses. The notification prioritizes public interest and aims to expedite vaccine availability.
Key Points / Main Content:
Manufacturing and Stocking of COVID-19 Vaccines:
* Individuals intending to manufacture and stock COVID-19 vaccines undergoing clinical trials for marketing authorization must have permission in Form CT06 for conducting clinical trials.
* Upon successful trial completion and obtaining permission in Form CT23 from the Central Licensing Authority, an application must be made under Rule 75 or 75A of the Drugs and Cosmetics Rules, 1945, to the State Government appointed Licensing Authority.
* The application must include the clinical trial permission in Form CT06 to obtain a license for manufacturing and stocking the vaccine for sale or distribution under the Drugs and Cosmetics Act, 1940.
Waiver and Deferral:
* The requirement for prior permission from the Central Licensing Authority under Rule 81 of the New Drugs and Clinical Trials Rules, 2019, to manufacture the vaccine as required under Rule 83, is deferred.
* Permission under Rule 81 must be obtained after successful completion of the clinical trial and submission of application, fees, data, and particulars as per the New Drugs and Clinical Trials Rules, 2019.
License Granting and Conditions:
* The Central License Approving Authority may grant a license under Rule 68A of the Drugs and Cosmetics Rules, 1945, if requirements under the Drugs and Cosmetics Act, 1940, Drugs and Cosmetics Rules, 1945, and New Drugs and Clinical Trials Rules, 2019, are met.
* The licensee can only sell or distribute the vaccine after obtaining permission in Form CT23 from the Central Licensing Authority under the New Drugs and Clinical Trials Rules, 2019.
Precedence and Effective Date:
* In case of inconsistencies, this notification takes precedence over any conflicting rules made under the Drugs and Cosmetics Act, 1940.
* The notification is effective from the date of its publication in the Official Gazette.
Impact Analysis:
Vaccine Manufacturers:
* Impact: Need to comply with the new procedures for manufacturing and stocking COVID-19 vaccines, including obtaining necessary permissions and licenses.
* Action Required: Obtain permission in Form CT06 for clinical trials, apply for permission in Form CT23 post-trial, and apply for a manufacturing license under Rule 75 or 75A with the State Government appointed Licensing Authority. They must also apply under Rule 81 after successful trials.
Licensing Authorities (Central and State):
* Impact: Responsible for processing applications and granting licenses for manufacturing and stocking COVID-19 vaccines according to the new guidelines.
* Action Required: Review applications, ensure compliance with regulations, and grant licenses under Rule 68A of the Drugs and Cosmetics Rules, 1945, as appropriate.
Public:
* Impact: Benefits from expedited availability of COVID-19 vaccines due to streamlined regulatory processes.
* Action Required: No direct action required.
Key Entities Referenced
COVID19: The disease caused by the SARS-CoV-2 virus, which led to a global pandemic.
Drugs and Cosmetics Act, 1940: A legislative act in India that regulates the import, manufacture, distribution, and sale of drugs and cosmetics.
Drugs and Cosmetics Rules, 1945: Rules framed under the Drugs and Cosmetics Act, 1940, providing detailed regulations for drugs and cosmetics.
New Drugs and Clinical Trials Rules, 2019: A set of rules in India that govern the approval and conduct of clinical trials for new drugs.
Central Licensing Authority: The authority responsible for granting permissions and licenses related to drugs and clinical trials, as defined in the New Drugs and Clinical Trials Rules, 2019.
Ministry of Health and Family Welfare: A government ministry in India responsible for public health.
Form CT06: A form used to obtain permission to conduct clinical trials for vaccines, according to the New Drugs and Clinical Trials Rules, 2019.
Form CT23: A form used to obtain marketing authorization for new drugs, including vaccines, from the Central Licensing Authority, according to the New Drugs and Clinical Trials Rules, 2019.
रजजस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
xxxGIDHxxx
सी.जी.-डी.एलxx.x-GअI.D-E1x8x0x 52020-219415
CG-DL-E-18052020-219415
असाधारण
EXTRAORDINARY
भाग II—खण्ड 3—उप-खण्ड (ii)
PART II—Section 3—Sub-section (ii)
प्राजधकार स ेप्रकाजित
PUBLISHED BY AUTHORITY
स.ं 1350] नई दद्ली, सोमवार, मई 18, 2020/वि ाख 28 , 1942
No. 1350] NEW DELHI, MONDAY, MAY 18, 2020/VAISAKHA 28, 1942
स्ट्व ास्ट्् य रर पिरवार क्य ाण मरं ालय
(स्ट्व ास्ट्् य रर पिरवार क्य ाण जव भाग)
अजधसचू ना
नई दद् ली, 18 मई, 2020
का.आ. 1511(अ).—जबदक, केंद्र सरकार सहम त ह दक कोजवड-19 महामारी के कारण उत् पन्न ुईई आपात जस्ट्थजत
की आवश् यकतां को पूरा करने के जलए नए ीीक की उपल् धता अजनवायय ह, रर कोजवड-19 संक्रमण की रोकथाम,
उपचार के जलए ीीक की जब क्री या जवतरण के जलए जव जनमाय ण रर भंडारण को जवजनयजमत करना जनजहत म ें आवश् यक
रर प्रासंजगक ह;
अब, इसजलए, केंद्र सरकार रषजध रर प्रसाधन सामग्री अजधजनयम, 1940 (1940 का 23) की धारा 26ख द्वारा
प्रदत् त िजतियय का प्रयोग करत े ुईए, रषजध रर प्रसाधन सामग्री जनयम, 1945 रर नए रषजध रर नद ाजनक परीक्षण
जनयम, 2019 म ें जनजहत दकसी त्य के बावजूद, कोजवड-19 के कारण उत्पन्न आपात जस्ट्थजत की अपेक्षां को पूरा करने के
जलए उपयतियु ीीके उपल्ध कराए जाने के प्रयोजन से एतदद्व् ारा जनम्नजलजखत अजधसूचना जारी करती ह, अथाय त :-
(क) यदद कोई व् यजतिय, कोजवड-19 के जलए दकसी ीीके, जो जबक्री या जवतरण के जलए जवपणन प्राजधकार हते ु न दाजनक
परीक्षण के अधीन ह, के जवजनमाय ण एवं भंडारण का इच् छुक ह तो वह उस ीीके के न दाजनक परीक्षण के जलए रामय सीीी-06
के रूप म ें अनुमजत ल े चुका होगा रर न दाजनक परीक्षण के सरल समापन के बाद रर नए रषजध रर न दाजनक परीक्षण
जनयम, 2019 के अंतगय त केन् द्रीय लाइसें सग प्राजधकरण से रामय सीीी-23 म ें अनुमजत प्राप् त करन े के बाद वह रषजध रर
प्रसाधन सामग्री अजधजनयम, 1940 (1940 का 23) (जजन् ह ें इसके बाद उतिय अजधजनयम कहा गया ह) रर उसके तहत
बनाए गए जनयम के प्रावधान के अंतगय त ऐसी जबक्री एवं जवतरण हते ु ीीके के जवजनमाय ण एवं भंडार के जलए लाईसेंस प्रदान
दकए जाने के जलए रषजध रर प्रसाधन सामग्री जनयम, 1945 के जनयम 75 या जनयम 75क के अंतगय त, ज सा भी मामला
हो, नए रषजध रर न दाजनक परीक्षण जनयम, 2019, के अंतगय त राम य सीीी-06 में नद ाजनक परीक्षण करने के जलए प्राप्त
अनुमजत के साथ आवेदन करेगा।
2075 GI/2020 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)]
बिते दक नए रषजध रर न दाजनक परीक्षण जनयम, 2019 के जनयम 81 के अंतगय त केन् द्रीय लाईसें सग प्राजधकरण
से ीीके के जवजनमाय ण की पूवय -अनुमजत की आवश् यकता, ज सा दक उतिय जनयम के जनयम 83 के तहत अपेजक्षत ह , कोजवड-19
से उत्पन्न आकजस्ट्मक जस्ट्थजत स े जनपीन े के जलए जनजहत में, आस्ट्थ जगत होगी रर व् यजतिय, न दाजनक परीक्षण के सरल समापन
रर नए रषजध रर न दाजनक परीक्षण जनयम, 2019 के अनुसार ि्ु क रर डेीा तथा जववरण के साथ आवेदन प्रस्ट् तुत
करने के बाद उक्त अनुमजत प्राप्त करेगा।
(ख) केन् द्रीय लाइसेंस अनुमोदन प्राजधकरण, यदद संतुष्ट ह दक उतिय जनयम रर रषजध रर प्रसाधन सामग्री जनयम, 1945
तथा नए रषजध रर न दाजनक परीक्षण जनयम, 2019 के अतं गय त जन धाय िरत प्रावधान के अनसु ार, अपक्षे ां का अनुपालन
दकया गया ह तो रषजध रर प्रसाधन सामग्री जनयम, 1945 के जनयम 68क के तहत ीीके के जवजनमाय ण रर भडं ारण के
जलए इस ितय के अधीन लाईेसेंस प्रदान कर सकता ह दक उक्त ीीके (नई रषजध) के संबंध में नए रषजध रर न दाजनक
परीक्षण जनयम, 2019 के अंतगय त केन् द्रीय लाईसें सग प्राजधकरण स े रामय सीीी-23 में अनुमजत प्राप् त करन े के बाद ही
लाइसेंसधारी द्वारा ीीके की जबक्री रर जवतरण दकया जायेगा।
2. इस अजधसूचना रर उतिय अजधजनयम के अंतगय त बनाय े गय े दकसी जनयम के बीच कोई असंगजत होन े के मामल े में,
कोजवड-19 महामारी के कारण उत्पन्न आपात जस्ट्थजत से जनपीने के जलए जनजहत में, ऐसे जनयम के स्ट् थान पर इस
अजधसूचना के प्रावधान प्रभावी ह गे।
3. यह आदिे राजपर में प्रकािन की तारीख से लागू होगा।
[रा. सं. एक् स-11014/02/2020-डीआरएस]
डॉ. मनदीप के. भण्डारी, संयुक् त सजचव
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 18th May, 2020
S.O. 1511(E).—Whereas, the Central Government is satisfied that making available suitable
vaccines is essential to meet the requirements of emergency arising due to pandemic COVID-19, and in
public interest it is necessary and expedient to regulate the manufacture and stock for sale or distribution of
vaccines for prevention and treatment of COVID-19 infection;
Now, therefore, in exercise of the powers conferred by section 26B of the Drugs and Cosmetics
Act, 1940 (23 of 1940), the Central Government, hereby issues the following notification, notwithstanding
anything contained in the Drugs and Cosmetics Rules, 1945 and New Drugs and Clinical Trials Rules,
2019, for the purposes of making available suitable vaccines to meet the requirements of emergency arising
due to COVID-19, namely:―
a) In case a person intends to manufacture and stock a vaccine for COVID-19, which is under clinical
trial for marketing authorisation for sale or distribution, then, such person shall have obtained permission in
Form CT-06 to conduct clinical trial of such vaccine and on successful completion of the clinical trial and
after obtaining permission in Form CT-23 from the Central Licensing Authority under the New Drugs and
Clinical Trials Rules, 2019, he shall make an application under rule 75 or rule 75A of the Drugs and
Cosmetics Rules, 1945, as the case may be, to the concerned Licensing Authority appointed by the State
Government along with the permission obtained for conducting clinical trial in Form CT-06 under the New
Drugs and Clinical Trials Rules, 2019, for grant of license to manufacture and stock the vaccine for sale or
distribution under the provisions of the Drugs and Cosmetics Act, 1940 (23 of 1940)(herein after referred to
as the said Act) and the rules made thereunder:
Provided that the requirement of prior permission from the Central Licensing Authority under rule
81 of the New Drugs and Clinical Trials Rules, 2019 to manufacture the vaccine as required under rule 83
of the said rules shall be deferred in public interest to meet the emergent situation arisen out of COVID-19
and such person shall obtain the said permission after successful completion of the clinical trial and
submission of application along with fees, data and particulars in accordance with the provisions of the
New Drugs and Clinical Trials Rules, 2019.[भाग II—खण् ड 3(ii)] भारत का राजपर : असाधारण 3
(b) The Central License Approving Authority may, if satisfied that requirements under the provisions of
the said Act and the Drugs and Cosmetics Rules, 1945 and the New Drugs and Clinical Trials Rules, 2019
have been complied with, grant License in accordance with the provisions of rule 68A of the Drugs and
Cosmetics Rules, 1945 to manufacture and stock the vaccine subject to the condition that the licensee shall
sell or distribute the vaccine only after obtaining permission for such vaccine (new drug) in Form CT-23
from the Central Licensing Authority under the New Drugs and Clinical Trials Rules, 2019.
2. In case of any inconsistency between this notification and any rule made under the said Act, the
provisions of this notification shall prevail over such rule in public interest so as to meet the emergency
which has arisen due to COVID-19 pandemic.
3. This order shall come into force on the date of its publication in the Official Gazette.
[F. No. X.11014/02/2020-DRS]
Dr. MANDEEP K. BHANDARI, Jt. Secy.
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.