Health Ministry has Issued Regulatory Pathway for Approving Foreign-Produced COVID-19 Vaccines in India

Delhi, 15 April 2021 – The union health ministry has issued regulatory guidelines for foreign-produced COVID-19 vaccines. Remember apart from COVAXIN and COVIShield, even Sputnik V, the Russian-made vaccine has been given approval for emergency use. And now there is a set of guidelines that have been issued by the Union Health Ministry for foreign-produced COVID-19 vaccines.

Very important guidance issued by Central Drugs Standard Control Organisation. And as you go through these guidelines. These guidelines have an assessment and are posted by a CDSCO on its website. And they have also mentioned the fact that the foreign applicants for grant of approval for the use in an emergency are allowed to submit their details to the same organization or Central Drugs Standard Control Organisation.

Also, what is important here is that foreign vaccines shall be used as per the guidelines prescribed under the massive COVID-19 vaccination program. The first 100 beneficiaries also such vaccines shall be accessed for seven days. Also, the application should conduct post-approval trials within 30 days of such approval. What is most important here is that after getting the application, the CDSCO will process the applications for registrations and then a certificate for the same and import license will be issued within three working days from the date of approval of restrictive use in an emergency.

Health Minister Harsh Vardhan has also confirmed this news from his twitter account.

After that now, these guidelines have been issued by the DCGI. The meeting also took place of CDSCO which was also headed by DCGI and then finally these guidelines have now been issued. What is most important here is after the approval is given within three working days from the date of approval, the license and certificate will be given to the applicants. These guidelines are very much important because we have seen how there is a shortage which has also been reported by a few states where we are saying that we are not able to get enough vaccine. That is why we need more and more vaccines.

The government will also approve more vaccines in the coming few days and looking at that the more vaccines should be here in the Indian market. That’s why these guidelines have an issue. So that more and more vaccines can come and maximum people can be vaccinated. The government is already vaccinating people who are above the age of 45 and looking for ways to make further plans to vaccinate the population. These important guidelines have now been issued by DCGI.

While these guidelines become extremely important also given the fact that India is now completely focused on expanding its vaccination Drive. Sputnik V has been approved five more vaccines at least are in the pipeline. Let’s see how this plays out.