Conditional market authorisation was granted on Thursday by the Drugs Controller General of India (DCGI) to COVID-19 vaccines Covishield and Covaxin for use in adults. Announcing the decision, Union Health Minister Mansukh Mandaviya tweeted: “The @CDSCO_INDIA_INF has now upgraded the permission for Covaxin and Covishield from restricted use in emergency situations to normal new drug permission in the adult population with certain conditions.”
The conditions set down by the DCGI include supply for programmatic settings including registration on the CoWin platform and continued submission of safety data on a six-monthly basis, the Minister added, referring to rules under the New Drugs and Clinical Trials Rules, 2019. Adverse events following immunisation will continue to be monitored.
Conditional market authorisation is a new category of market authorisation that has emerged during the current global pandemic of COVID-19. The approval pathways through this route are fast-tracked with certain conditions to enhance the access to certain pharmaceuticals for meeting the emerging needs of drugs or vaccines, the Health Ministry explained.
Mr. Adar Poonawalla, CEO of Covishield manufacturers Serum Institute of India (SII) said, “We are delighted to receive the conditional market authorisation for Covishield from the DCGI. With this, our focus should be to reduce the gap between the 2nd and the 3rd dose to six months, as it is done globally. Our objective must be to get the population fully vaccinated to curb the spread of the pandemic.”
