MANU/HFAM/0033/2020

Ministry : Ministry of Health and Family Welfare

Department/Board : Health and Family Welfare

Notification No. : SO1511(E)

Date of Notification : 18.05.2020

Date of Publication : 18.05.2020

Industry: Health Care

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

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.........