DCGI’s instructions to SII on Oxford Corona vaccine trial

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Controller General of Drugs of India

New Delhi: The Controller General of Drugs of India (DCGI) has told the Indian Institute of Serum (SII) that it is looking for new candidates for Phase II and Phase III clinical trials in the wake of drug company AstraZeneca stopping the testing of the Corona vaccine in other countries. Stop recruitment till the next order.

The Controller General of Drugs, VG Somani, in an order on Friday also asked the Indian Institute of Serum (SII) to increase the safety monitoring of those who were still vaccinated during the test. Also present plans and reports. The PTI-language has received this order of the Controller General.

As per the order, Somani has also asked the company to submit approval from the Data and Safety Monitoring Board (DSMB) in the UK and India for prior approval from their office (DCGA) before making new recruits for future tests. . The DCGA issued a show cause notice to SII on September 9 for not providing information about AstraZeneca’s withholding of vaccines in other countries.

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