Five sites across the country are ready for the third and final phase of human trials of the Oxford-AstraZeneca COVID-19 vaccine, Department of Biotechnology (DBT) Secretary Renu Swarup said ,
“This is an essential step because it is necessary to have data within the country before the vaccine is administered to Indians,” Swarup to media .
Meanwhile Union Minister for Chemicals and Fertilizers Shri DV SadanandaGowda launched today four schemes of Department of Pharmaceuticals for promotion of domestic manufacturing of bulk drugs and medical devices parks in the country . He said India is often referred to as ‘the pharmacy of the world’ and this has been proved true especially in the ongoing Covid-19 pandemic when India continued to export critical life saving medicines to needy countries even during the countrywide lockdown. However, despite these achievements, it is a matter of concern that our country is critically dependent on imports for basic raw materials. The list of 41 products contained in the scheme guidelines will enable domestic production of 53 bulk drugs. Financial incentives will be given to a maximum of 136 manufacturers selected under the scheme as a fixed percentage of their domestic sales of these 41 products manufactured locally with required level of domestic value addition.
The Serum Institute of India has been chosen by Oxford and its partner AstraZeneca to manufacture the vaccine once it is ready. Trials results for the first two phases were published earlier in July.
According to Swarup, the DBT is part of any COVID-19 vaccine effort in India “… whether it is funding, whether it is facilitating the regulatory clearances or whether it is giving them access to different networks which exist within the country.”
“The DBT is now setting up Phase 3 clinical sites. We have already started working on them and five sites are now ready to be available for Phase 3 trials,” Swarup said.
The Pune-based SII has also sought permission from the Drugs Controller General of India (DCGI) for conducting Phase 2 and 3 human clinical trials of the potential vaccine.
It had said earlier it will start manufacturing the vaccine even before the final nod so it is read