Noida-based National Institute of Biologicals (NIB), a top autonomous institute under the Union health ministry, shall function as an additional facility for testing of COVID-19 vaccines, according to a gazette notification issued on Tuesday.
At present, all types of vaccines are being tested for lot release purposes at the Central Drugs Laboratory (CDL), Kasauli.
The aim is to expedite the testing process of COVID-19 vaccines as and when they become available to ensure their supply does not get affected, an official said. The NIB is performing primary statutory function of quality control of biologicals such as insulin, blood products and diagnostic kits among others.
The notification issued by the health ministry stated that making available suitable COVID-19 vaccines is essential to meet the requirements of emergency arising due to the pandemic and therefore, in public interest, it is necessary and expedient to regulate the testing of vaccine for prevention and management of the infection.
“Whereas, the central government, in consultation with the Drugs Controller (India), is of the considered view that the supply of COVID-19 vaccine must not get affected and the vaccine must remain available to the public.
“Now, therefore, in exercise of the powers conferred by sections 6 and 26B read with section 33P of the Drugs and Cosmetics Act, 1940 and rule 3 of the Drugs and Cosmetics Rules, 1945, the Central Government, hereby directs that the National Institute of Biologicals, Noida, in addition to its existing functions shall perform the function of Central Drugs Laboratory as an additional facility in respect of COVID-19 vaccine,” the notification read.
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 requirements of emergency which have arisen due to COVID-19 pandemic, the notification stated.
The notification shall remain into force for a period up to November 30, 2021.
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