The Department of Health and Family Welfare vide notification dated the 9th February, 2022 has relaxed the Drugs Rules, 1945 and New Drugs and Clinical Trials Rules, 2019, for the purposes of making available suitable drugs to meet the requirements of emergency arising due to COVID-19.
In case a person intends to manufacture and stock a new drug for COVID-19, which is under clinical trial for marketing authorization 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, he shall make an application 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.
The Central License Approving Authority or the State Licensing Authority, as the case may be, if satisfied that requirements under the provisions of the said Act and the Drugs Rules, 1945 and the New Drugs and Clinical Trials Rules, 2019 have been complied with, grant License 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.
