Government eases the norms of manufacturing, stocking, sale or distribution of new drugs under phase III clinical trials, for the treatment of Covid-19 and related diseases. The provision is made to stock the drugs with a condition that it will sell the new drug only after obtaining permission as per the regulations.
The Central Government notified that there is an outbreak of COVID-19 pandemic throughout India, resulting in dangerous and opportunistic infections, disease like Mucormycosis and due to which emergency has arisen to make available new drugs for treatment or management of COVID-19 and related diseases.
The Central Government is satisfied that making available suitable new drugs 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 such new drugs for prevention and treatment of COVID-19 and associated infection.
In case a person intends to manufacture and stock a new drug for COVID-19, which is under clinical trial for marketing authorisation for sale or distribution, then, such person shall have to obtain permission in Form CT-06 to conduct clinical trial of such drug 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.
Then applicant shall make an application under rule 69 or rule 70A or rule 75 or rule 75A of the Drugs 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 drug for sale or distribution under the provisions of the Drugs and Cosmetics Act, 1940.
Notification further said that, 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 new drug 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.
If Central License approving authority or the State Licensing Authority satisfied with the requirements as per act, they grant License in accordance with the provisions of the Drugs Rules, 1945 to manufacture and stock the new drug subject to the condition that the licensee shall sell or distribute the new drug only after obtaining permission for such new drug in Form CT-23 from the Central Licensing Authority under the New Drugs and Clinical Trials Rules, 2019.
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