Ministry of Health and Family Welfare

18.05.2020

Civil

Central Government, hereby issues notification for the purposes of making available suitable vaccines to meet the requirements of emergency arising due to COVID-19

MANU/HFAM/0033/2020

1.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.

(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.

Tags : Notification Suitable vaccines Emergency COVID-19

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