New Delhi – The Union Health Minister has written a reply to a letter written by the Chattisgarh Health Minister to Union Health Minister Dr Harsh Vardhan on incomplete efficacy data, and lack of display of expiry date on the vials of COVAXIN.
“I have got the matter examined in the Ministry. I would like to inform you that as per New Drugs and Clinical Trials Rules, 2019 under the Drugs and Cosmetics Act. 1940 and in light of urgent need due to COVID pandemic in the country, Central Drugs Standards and Control Organization(CDSCO) Headed by the Drug Controller General of India (DCGI), the National Regulator, has granted permission to manufacture two COVID-19 vaccines based on the prescribed procedure and after due evaluation of pre-clinical and clinical trial data. Only those COVID-19 vaccines that have been granted permission for restricted use in an emergency situation by the DCGI i.e COVISHIELD & COVAXIN are being used for COVID-19 vaccination drive in the country. Both vaccines are safe and immunogenic and should be used expeditiously to rapidly confer protection to prioritized beneficiaries thereby mitigating the impact of the pandemic at the earliest.” said Dr Harsh Vardhan, Union Health Minister of Family and Welfare
The Union Health Minister has also said that the unavailability of expiry date on Covaxin is also completely unfounded, “Your concern regarding unavailability of expiry date on Covaxin vial is also completely unfounded and without basis, as same is mentioned on the label of the vials.”