New Delhi: The Special Committee of the Central Drugs Standard Control Organization (CDSCO) has sought clarification from the Serum Institute of India (SII) on the application in which it has asked the Controller General of Drugs of India (DGCI) for another Covid-19 vaccine developed by Oxford and another Permission is sought for the third phase of testing.
Official sources gave this information on Wednesday. He said that the subject matter committee constituted on Covid-19 met on Tuesday to discuss the application of SII. In this, the company of Pune was asked to review the protocols prepared for the second and third phase of testing and with this some additional information was also sought. He said that on Wednesday evening, SII submitted the revised protocol to DGCI for testing.
“The company was asked on Tuesday to define the second and third stage test mentioned in the protocol and submit the application again to the SEC for evaluation,” official sources said. Sources said that the committee recommended distribution of medical examination sites across the country. Sources said, “He also did not provide clarification regarding the proposed 1,600 registered participants during the trial.” “We have submitted the revised protocol to the DGCI office this evening for further action by SEEC,” said Prakash Kumar Singh, additional director of government affairs at SII.
