Regulations For Manufacture And Stock Of Vaccines For Covid-19

By Author: Dolly
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India's Ministry of Health and Family Welfare has granted permission to manufacturers to produce and stock vaccines for Covid-19 that are under clinical trials for getting marketing authorization for sale or distribution. Thus easing the drug license registration process. This regulation will accelerate the availability of the Covid-19 vaccine in the country sooner after they get approval post trials.

This is one of the welcomed and awaited movements by the Ministry during this tough pandemic time. It allows all manufacturers of vaccines to initiate the process of manufacturing synchronously with ongoing clinical trials. If the vaccine trial becomes successful, this movement by the Ministry of Health and Family will help in saving time and the public will get easy and quick access as the vaccine is available immediately after required regulatory permissions. The early launch of Covid-19 vaccine will help in rapid vaccination of Indian public.

As per the notifications issued by the Government, if any of the manufacturers keeps ...
... an intention to stock a vaccine for Covid-19 that is now under clinical trial then they should obtain permission through a form CT-06.

Then they should obtain permission for the vaccine through the form Clinical Trial 23 from the Central Licensing Authority under the new Drugs and Clinical Trial Rules, 2019. Afterwards, the person should make an application under rule 75 or rule 75A of the Drugs and Cosmetics Rules, 1945, to the required licensing authority appointed by the state government in addition to the permission obtained for the conductance of clinical trial through form CT-06 for grant of license to manufacture and stock the vaccine for sale and distribution under the provisions of the Drugs and Cosmetics Act, 1940.

As per the notification, it has also been high lightened that if there is any inconsistency between this notification and rule that has been made under Drugs and Cosmetics Act, the provision of this notification, it will conquer over such rule to meet any emergency that has arisen because of Covid-19 pandemic.

The order came into force on the date of its publication in the Official Gazette.