The outbreak of Covid-19 pandemic has made it necessary to regulate the manufacture, stock, sale or distribution of new drug for prevention and treatment of associated infections,” the union health ministry notification stated.
Union health ministry has notified provisions under Drugs Rules, 1945 and New Drugs and Clinical Trials (NDCT) Rules, 2019, to manufacture, stock, sale and distribution of new drugs in the wake of Covid-19 pademic. The provisions have been notified to stock and sale the drugs subject to condition of obtaining permission as per the regulations.
“The outbreak of Covid-19 pandemic throughout India has made it 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 infections,” the union health ministry notification stated.
As per the notification, in order to make suitable drugs available to meet the requirements of emergency arising due to COVID-19, the union health ministry has notified the following in exercise of the powers conferred by section 26B of the Drugs and Cosmetics Act, 1940 (23 of 1940)-
(a) In case a person intends to manufacture and stock a new drug for COVID-19, which is under clinical trial for marketing authoisation for sale or distribution, then, manufacturer shall have to obtain permission in Form CT-06 to conduct clinical trial of such drug. On successful completion of the clinical trial and after obtaining permission in Form CT-23 from the Central Licensing Authority (CLA) under the NDCT Rules, 2019, he 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 NDCT 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 (23 of 1940) (hereinafter referred to as the said Act) and the rules made thereunder:
Provided that the requirement of prior permission from the CLA under rule 81 of the NDCT 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 NDCT Rules, 2019.
(b) The CLA or the State Licensing Authority (SLA) if satisfied that requirements under the provisions the Drugs Rules, 1945 and the NDCT Rules, 2019 have been complied with, grant license to manufacture and stock the new drug. This is also 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 CLA under the NDCT Rules, 2019.
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,” said the notification.
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