**Summary:**
This notification, S.O. 4206(E), issued by the Ministry of Health and Family Welfare, Department of Health and Family Welfare, on November 24, 2020, addresses the COVID-19 pandemic in India.
The Central Government, empowered by sections 6 and 26B read with section 33P of the Drugs and Cosmetics Act, 1940 (23 of 1940) and rule 3 of the Drugs and Cosmetics Rules, 1945, directs the National Institute of Biologicals, Noida, to function as a Central Drugs Laboratory for COVID-19 vaccines, in addition to its existing functions. The Director of the Institute will exercise the functions of the Director in respect of COVID-19 vaccine.
The notification aims to regulate the testing of COVID-19 vaccines to ensure their availability to the public during the pandemic. In case of inconsistencies with existing rules, this notification will prevail.
The order took effect upon its publication in the Official Gazette and remained in force until November 30, 2021.
The notification was issued under F. No. 18352020-DCDR and signed by Dr. Mandeep K. Bhandari, Jt. Secy.
Key Entities Referenced
COVID19: A pandemic disease caused by SARS-CoV-2.
Central Government: The Union Government of India.
Drugs Controller India: A regulatory authority in India responsible for drug control.
Drugs and Cosmetics Act, 1940: An act of the Parliament of India which 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 to regulate the import, manufacture, distribution and sale of drugs and cosmetics.
National Institute of Biologicals, Noida: An autonomous institution under the Ministry of Health and Family Welfare, Government of India, located in Noida, Uttar Pradesh.
Central Drugs Laboratory: A national statutory laboratory for quality control of drugs and pharmaceuticals.
Ministry of Health and Family Welfare: A ministry of the Government of India responsible for health policy in India.
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
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सी.जी.-डी.एलxx.x-GअI.D-E2x4x1x 12020-223288
CG-DL-E-24112020-223288
ऄसाधारण
EXTRAORDINARY
भाग II—खण्ड 3—ईप-खण्ड (ii)
PART II—Section 3—Sub-section (ii)
प्राजधकार स ेप्रकाजित
PUBLISHED BY AUTHORITY
स.ं 3703] नइ ददल्ली, मगं लवार, नवम्ब र 24, 2020/ऄग्रहायण 3, 1942
No. 3703] NEW DELHI, TUESDAY, NOVEMBER 24, 2020/AGRAHAYANA 3, 1942
स्ट्वास्ट््य और पररवार कल्याण मत्रं ालय
(स्ट्वास्ट््य और पररवार कल्याण जवभाग)
ऄजधसचू ना
नइ ददल्ली, 24 नवम् बर, 2020
का.अ. 4206(ऄ).—भारत और दजु नया भर म ेंकोजवड -19 महामारी का प्रकोप जवद्यमान ह;ै
और, केंद्रीय सरकार आस बात स े संतुष्ट ह ै दक महामारी कोजवड -19 के कारण ईत्पन्न होने वाली अपातकालीन
अवश्यकताओं की पूर्तत के जलए ईपयुक्त कोजवड -19 टीके ईपलब्ध कराना ऄजनवाय य ह ै और, ऄतः, सावयिजनक जहत म,ें
कोजवड -19 संक्रमण की रोकथाम और प्रबंधन के जलए कोजवड -19 टीके के परीक्षण को जवजनयजमत करन े के जलए यह
अवश्यक और समीचीन ह;ै
और, औषजध जनयंत्रक (भारत) के परामि य स,े केंद्रीय सरकार का जवचार ह ै दक कोजवड -19 टीकों की अपूर्तत
प्रभाजवत नहीं होनी चाजहए और टीके िनता के जलए ईपलब्ध रहन े चाजहए;
ऄतः, ऄब केंद्रीय सरकार, औषजध और प्रसाधन सामग्री ऄजधजनयम, 1940 (1940 का 23) की धारा 6 और 26ख
के साथ परित धारा 33त और औषजध और प्रसाधन सामग्री जनयम के जनयम 3 द्वारा प्रदत्त िजक्तयों का प्रयोग करत े हुए, यह
जनदेि देती ह ै दक राष्ट्रीय िैजवक संस्ट्थान, नोएडा, ऄपन े मौिूदा कायों के ऄलावा, केंद्रीय औषजध प्रयोगिाला के कायय को
कोजवड -19 टीके के संबंध में एक ऄजतररक्त फैजसजलटी के रूप म ें जनष्पाददत करेगा और कोजवड -19 टीकों के संबंध म ें
जनदेिक के कायों का वहन ईक्त संस्ट्थान के जनदेिक द्वारा दकया िाएगा।
2. आस ऄजधसूचना और ईक्त ऄजधजनयम के ऄधीन बनाए गए दकसी भी जनयम के बीच दकसी भी ऄसंगतता के मामले
म,ें आस ऄजधसूचना के प्रावधान सावयिजनक जहत म ें आस तरह के जनयम के बाविूद लाग ू होंगे तादक कोजवड -19 महामारी के
कारण ईत्पन्न हुइ अपातकाल की अवश्यकताओं को पूरा दकया िा सके।
5723 GI/2020 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)]
3. यह अदिे रािपत्र म ें आसके प्रकािन की तारीख को प्रवृत्त होगा ।
4. यह ऄजधसूचना 30 नवंबर, 2021 तक की ऄवजध के जलए लाग ूरहगे ी।
[फा. सं. 18-35/2020-डीसी/डीअर]
डॉ. मनदीप के भण्डारी, संयक्तु सजचव
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 24th November, 2020
S.O. 4206(E).—Whereas, there has been an outbreak of COVID-19 pandemic in India and
worldwide;
Whereas, the Central Government is satisfied that making available suitable COVID-19 vaccines is
essential to meet the requirements of emergency arising due to the pandemic COVID-19 and, therefore, in
public interest, it is necessary and expedient to regulate the testing of COVID-19 vaccine for prevention
and management of COVID-19 infection;
Whereas, the Central Government, in consultation with the Drugs Controller (India), is of the
considered view that the supply of COVID-19 vaccine must not get affected and the vaccine must remain
available to the public;
Now, therefore, in exercise of the powers conferred by sections 6 and 26B read with section 33P of
the Drugs and Cosmetics Act, 1940 (23 of 1940) and rule 3 of the Drugs and Cosmetics Rules, 1945, the
Central Government, hereby directs that the National Institute of Biologicals, Noida, in addition to its
existing functions shall perform the function of Central Drugs Laboratory as an additional facility in respect
of COVID-19 vaccine and the functions of the Director in respect of COVID-19 vaccine shall be exercised
by the Director of the said Institute.
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 requirements
of emergency which have arisen due to COVID-19 pandemic.
3. This order shall come into force on the date of its publication in the Official Gazette.
4. The notification shall remain into force for a period upto 30th November, 2021.
[F. No. 18-35/2020-DC/DR]
Dr. MANDEEP K BHANDARI, Jt. Secy.
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