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Doubts have arisen about the genuineness of Covishield reaching patients in India, with the country reporting circulation of fake vials of the covid-19 vaccine developed by Oxford-AstraZeneca and manufactured by Serum Institute of India (SII).

Despite the Union government’s efforts to provide genuine coronavirus vaccines through transparent procurement and supply systems and the technology-backed CoWin platform for administration, the World Health Organization’s (WHO) global surveillance and monitoring system for substandard and fake medical products identified fake Covishield in India and Uganda.

WHO on Tuesday issued a medical product alert referring to fake Covishield in South-East Asia and Africa. The fake products were reported to it in July and August, the apex global public health agency said. SII, the Indian producer of Covishield, had confirmed that some vaccine vials reported at the patient-level were fake, according to WHO.

The health agency urged India to increase vigilance on hospitals, clinics, health centres, wholesalers, distributors, pharmacies, and other suppliers of medical products. WHO has also asked for increased vigilance within supply chains of countries and regions likely to be affected by these fake products.

The products identified are confirmed as “falsified" on the basis that they deliberately or fraudulently misrepresent their identity, composition, or source.

In India, Covishield 2ml was identified though SII does not produce the vaccine in 2ml (four doses). In Uganda, Covishield with Batch 4121Z040 and the expiry date (10.08.2021) was found, which SII confirmed to WHO was fake.

“Genuine Covishield vaccine is indicated for active immunisation of individuals 18 years or older for the prevention of coronavirus disease caused by the SARS-CoV-2 virus. The use of genuine covid-19 vaccines should be in accordance with official guidance from national regulatory authorities," WHO said.

“Falsified covid-19 vaccines pose a serious risk to global public health and place an additional burden on vulnerable populations and health systems. It is important to detect and remove these falsified products from circulation to prevent harm to patients," it said.

The Union health ministry said it is investigating the matter. “Although we have a strong system to prevent such cases, with this development, the only thing we want to ensure is that no Indian received a fake vaccine. A vaccination certificate that we give has proper details about the vaccine administered such as batch number, manufacturing details, and adverse reactions. More so, the supply chains are also strictly monitored. We have not received any complaint from anywhere in India so far. We are investigating the matter," a senior health ministry official said on condition of anonymity.

SII declined to comment.

The CoWin platform is not equipped to handle the logistics of vaccine distribution. It only takes note of the batch number at the time of vaccination, which ensures that the beneficiary knows which vaccine has been administered.

SII is the world’s largest vaccine manufacturer by number of doses produced and sold globally. The company’s July monthly production capacity for Covishield was between 110 million and 120 million doses.

WHO has said all medical products must be obtained from authorized and licensed suppliers. The authenticity and physical condition of the product should be carefully checked. In case of doubt, advice should be sought from a healthcare professional, it said.

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