CoviShield vaccine registered in violation of Ukrainian law
The Indian Serum Institute has no Ukrainian GMP certificate confirming that the pharmaceutical production meets the standard of good manufacturing practice
As reported by Glavred with reference to the UNIAN news agency, doctor-epidemiologist and director of the Institute of Vaccination Science and Immunobiological Preparations Serhiy Kravchenko has said that AstraZeneca and Oxford University, which developed the vaccine against coronavirus, do not control the quality of production of the Indian Serum Institute that produces the vaccine under the trade name CoviShield and supplies it to Ukraine.
According to him, instead of re-inspecting the production in India, the Health Ministry issued a special order, actually under the CoviShield vaccine, allowing its import to Ukraine. He cited another problem as a violation of existing legislation in the registration of the CoviShield vaccine in Ukraine.
“I am referring to the decree of the Cabinet of Ministers № 902, which defines the order of state quality control of medicines imported into our country. According to the decree, medicines have to undergo quality control and expertise. Do you think Ukraine has carried out laboratory quality control of this vaccine in our country? – No, it has not. Did the State Administration of Ukraine receive a package of documents from India to draw its conclusion about the confirmation of the Indian GMP certificate? – No, this has not happened”, – the epidemiologist stressed.
Kravchenko added that the Ministry of Health is obliged by law to hand over 3,000 vials of the Indian vaccine to the laboratory of the state expert centre for laboratory quality control of the vaccine.
“If they do not do this, they will violate the Cabinet order once again”, – the scientist said.