Mumbai : In a bid to facilitate smooth supply of Covid vaccines in the country, the Union health and family welfare ministry has designated National Centre for Cell Science (NCCS), Pune as Central Drugs Laboratory (CDL) for testing and approval of Covid-19 vaccine batches for a year.
Currently, Kasauli based CDL approved by the World Health Organization (WHO), is the only laboratory testing the batches of Covid-19 vaccines as well as other vaccines.
Over the next few months, a significant amount of Covid vaccines is expected to be produced in the country. It will increase the pressure on CDL, which usually gets 7,000 batches of vaccines yearly for testing.
With an aim to reduce the burden on the existing CDL, the health ministry in a notification on June 28, 2021 directed NCCS to perform the function of CDL as an additional facility in respect of Covid-19 vaccines for a period of twelve months. The functions of the director in respect of Covid-19 vaccines shall be exercised by the director of the said institute, stated the notification.
“Making available suitable Covid-19 vaccines is essential to meet the requirements of emergency arising due to pandemic Covid-19, and in public interest it is necessary and expedient to regulate the testing of Covid-19 vaccines for prevention and treatment of Covid-19 infection. In order to ensure uninterrupted supply of Covid-19 vaccines to the public, NCCS, Pune has been tasked to test and approve Covid vaccine lots for a period of one year,” said joint secretary, Union health ministry, Dr Mandeep Bhandari.
The government expected about 216 crore doses of Covid-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.
The joint inspection by CDSCO, CDL and state drug authority was conducted at NCCS, Pune to check its vaccine testing preparedness. Following this, it has been given an additional responsibility of testing and approval of Covid jabs.
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.
Besides NCCS, the ministry is in process of designating National Institute of Animal Biotechnology (NIAB) in Hyderabad as an additional laboratory for testing and approval of Covid vaccines.