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.
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