The Ministry of health and family welfare vide its notification dated 18th May 2020 has allowed manufacturing and stocking the vaccine for COVID-19 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.
In case if a person intends to manufacture and stock a vaccine for COVID-19, which is under clinical trial for marketing authorization for sale or distribution, then, such person shall obtain permission in Form CT-06 to conduct a 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 the Drugs and Cosmetics Rules, 1945, to the concerned Licensing Authority appointed by the State Government along with the permission obtained for conducting a clinical trial in Form CT-06, for grant of license to manufacture and stock the vaccine for sale or distribution under the provisions of the Drugs and Cosmetics Act, 1940.
Further, 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 the 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.
The Central License Approving Authority may if satisfied with the requirements shall grant License to manufacture and stock the vaccine.
Click here to read the Notification.
