CoviShield vaccine produced by Serum Institute of India does not have the Ukrainian national GMP certification and it cannot be used in the territory of Ukraine as Chairman of the National Medical Chamber of Ukraine Serhiy Kravchenko reported on Facebook.
“Serum Institute of India’s National Ukrainian GMP certificate has expired about a year-year and a half ago,” Kravchenko noted.
According to him, the Ukrainian inspectors came to the production and defined about six comments from critical to minor concerning the pharmaceutical production of the Institute. Only the last week, the Serum Institute of India has filed to the Ukrainian Health Ministry the grounded answers to the comments of the inspectors and provided documentary evidence on the elimination of the defects.
“Only the next week, the Health Ministry of Ukraine should prepare the order on the confirmation of the plan, order and terms of the commission inspection by employees of the Ukrainian Institute of Pharmaceutical Quality of the State Service of Ukraine on Medicines and Drugs Control of the pharmaceutical production of the Serum Institute of India to confirm the correspondence with GMP standard,” Kravchenko noted.
According to him, this process might take about three weeks.
GMP (Good Manufacturing Practice) is the practices required in order to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of the products. These guidelines provide minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality, from batch to batch, for their intended use.
On February 21, the Health Minister reported that in India, the first 500,000 doses of the AstraZeneca-CoviShield vaccine have started their way to Ukraine.
Today, February 22, President of Ukraine Volodymyr Zelensky announced the efficacy level of CoviShield, calling its one of the best vaccines.