Last Updated on July 1, 2021 by The Health Master
In a bid to reduce the burden on Central Drugs Laboratory (CDL), Kasauli in Himachal Pradesh, the department of biotechnology (DBT) under the science and technology ministry has taken initiative to operationalize two more vaccine testing laboratories — National Centre for Cell Sciences (NCCS) in Pune and the National Institute of Animal Biotechnology (NIAB) in Hyderabad.
Currently, CDL approved by the World Health Organization (WHO), is the only laboratory testing the batches of C-19 vaccines as well as other vaccines. So far CDL has cleared more than 37 crore vaccine doses including 32 crore doses of Covishield, 3.94 crore doses of Covaxin and 1.5 lakh doses of Sputnik V, according to official data.
Over the next few months, a significant amount of C-19 vaccines is expected to be produced in the country, which will increase the pressure on CDL.
The government expected about 216 crore doses of C-19 vaccines to be available in the country between August-December 2021. These include mRNA vaccines of Pfizer and Moderna, DNA vaccine of Zydus Cadila and the protein subunit vaccine of Biological E, a nasal vaccine from Bharat Biotech and mRNA vaccines from Genova Pharmaceuticals.
Hence additional vaccine testing facilities are required to handle the increased load.
Taking serious note of this, DBT has stepped up efforts to start two more testing laboratories for vaccines in Hyderabad and Pune which are the hub of two C-19 vaccines– Covaxin and Covishield respectively, said government sources.
The Pune based NCCS and Hyderabad based NIAB, selected by DBT for testing and approval of vaccines, are likely to start operation over the next couple of months, added sources.
When contacted Dr Renu Swarup, secretary via email, DBT, she did not respond at the time of going to press. According to sources at NCCS, the joint inspection by CDSCO, CDL and state drug authority was being conducted at the facility to check its vaccine testing preparedness.
NCCS is close to Serum Institute of India (SII), which commenced production of American vaccine Novavax’s Indian version Covovax, apart from AstraZeneca-Oxford University’s Covishield. SII has also received approval from the Drugs Control General of India (DCGI) to manufacture Russian vaccine Sputnik V.
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. NCCS is recognised as an ICMR-approved bio-repository.
In April 2021, NCCS invited applications for various positions for its vaccine facility centre being set up along with Pune Municipal Corporation. The positions open for recruitment include veterinary pathologist, junior scientist, technical officer, laboratory and office assistant, data entry operator, helper, in-charge (clinical virologist) and process consultant.
When contacted, Dr Manoj Kumar Bhat, director, NCCS has refused to comment on the upcoming facility at his institute. Sources at NIAB said the Hyderabad based institute is also undergoing inspections for its vaccine testing preparedness.
Hyderabad has emerged as the vaccination capital of the world by producing one-third stock of the global vaccine. It takes approximately 30-45 days to dispatch vaccine lots to CDL, Kasauli from Hyderabad for testing which is a time consuming and expensive affair.
Once NIAB gets operationalized, it will cut down time and cost on vaccine rollout. When contacted, Dr Subeer Kumar Majumdar, director NIAB, refused to comment on the vaccine testing facility being set up at the institute.
It is not the first time that the Centre has taken steps to put in place an additional laboratory for testing C-19 vaccines.
Earlier a notification was issued by the government on November 24, 2020 allowing the Noida-based National Institute of Biologicals (NIB) to function as an additional facility for testing vaccines.
The NIB is known for performing quality control tests of biologicals such as insulin, blood products, and diagnostic kits among others.