New Delhi: The Narendra Modi government is planning to authorise Pune-based National Centre for Cell Science (NCCS) to test and approve Covid-19 vaccines, ThePrint has learnt.
Currently, Central Drugs Laboratory (CDL) — the country’s apex vaccine testing laboratory in Kasauli, Himachal Pradesh — is the only lab testing the batches of all Covid-19 vaccines. The central government has now begun inspections at NCCS, an autonomous organisation aided by the Department of Biotechnology.
The lab was undergoing inspection Wednesday involving officials from the state drug controller’s office, officers from Central Drugs Standard Control Organisation (CDSCO), the country’s apex drug regulatory authority, and CDL.
“Apart from the brilliance of the resources at NCCS that can be utilised in vaccine testing, the other objective behind evaluation is its proximity with Serum Institute of India (SII), which will be manufacturing two other Covid-19 vaccines in the coming future apart from the country’s largest available Covishield,” said a government source privy to the development.
Pune-based SII will be manufacturing the Russian vaccine Sputnik V, American vaccine Novavax’s Indian version Covovax, apart from AstraZeneca-Oxford University’s Covishield.
“If NCCS is approved after all the audits, checks and inspections, it will also reduce the travel time of transporting the consignments to Himachal Pradesh,” the officer said, adding that reducing the burden on CDL is important as it is also responsible for testing other vaccines which are used in the national immunisation programme.
Till 15 June, CDL Kasauli has tested and released 32.7 crore Covid-19 vaccines.
NCCS part of group monitoring SARS-CoV-2 genomic sequences
NCCS, known for conducting research in cell biology and working as a national animal cell repository, was among the first government laboratories designated to test SARS-CoV2 samples.
It is also a part of the Indian SARS-CoV-2 Genomic Consortium (INSACOG) to monitor the genomic variations in the SARS-CoV-2 through a multi-laboratory network.
According to NCCS’ website, it has also established a biobank of Peripheral Blood Mononuclear Cells (PBMCs) and plasma from Covid-infected and convalescent patients for research purposes, in association with the B.J. Medical College in Ahmedabad. NCCS is recognised as an ICMR-approved bio-repository.
The centre also deals with research in diverse fields of cell biology, especially for health issues such as cancer, metabolic disorders, infectious diseases, and regenerative medicine.
Another additional lab not put in use yet
It is not the first time that the central government has decided to create an additional laboratory for testing Covid-19 vaccines.
In November last year, the Noida-based National Institute of Biologicals — an autonomous institute under the health ministry — was approved to function as an additional facility for testing vaccines.
According to a gazette notification issued on 24 November “…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 (CDL) as an additional facility in respect of COVID-19 vaccine”.
While the notification remains in force till 30 November 2021, NIB hasn’t started functioning fully yet.
The NIB is known for performing quality control tests of biologicals such as insulin, blood products, and diagnostic kits among others.