Health Ministry eases norms for manufacture and stocking of new drugs (under Phase III clinical trials) for treating Covid-19 and related diseases
In light of the outbreak of COVID-19 which has resulted in the spread of dangerous infections like Mucormycosis, etc., there is a requirement for treatment and management of COVID-19 and related diseases. Therefore, with a view to make suitable drugs available to meet the emergency requirements arising due to COVID-19, the Health Ministry has relaxed norms around the manufacture and stocking of new drugs for treatment of COVID-19 which are under phase three of clinical trials.
For the purposes of making available suitable drugs to meet the requirements of emergency arising due to COVID-19, in exercise of the powers conferred by section 26 B of the Drugs and Cosmetics Act, 1940 (23 of 1940), the following is prescribed:
• Upon intending to manufacture and stock a new drug for Covid-19 (which is under clinical trial for marketing authorisation for sale or distribution), such person shall 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 under the New Drugs and Clinical Trials Rules, he shall make an application under Rule 69 or Rule 70A or Rule 75 or Rule 75A of the Drugs Rules, 1945 to the concerned Licensing Authority with 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.
• However, 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 the Central License Approving Authority or the State Licensing Authority (as the case may be), is 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, they may 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.
• 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.
A copy of the Notification is attached herewith for ease of reference.
Source: Ministry of Health And Family Welfare
