Health Ministry issues guidelines for foreign-produced COVID-19 vaccines' approval

The Union Health Ministry on Thursday has issued regulatory pathways for foreign-produced COVID-19 vaccines. The development comes after India gave a nod for foreign-made and approved vaccines following the alarming rise in the number of COVID-19 cases. As per the government, the decision will fast-track India's access to foreign COVID-19 vaccines. In addition, it will also boost imports for bulk drug material, as per the government. The Regulatory Pathway has been issued for vaccines for restricted use by US FDA, EMA, UK MHRA, PMDA Japan or which are listed in WHO Emergency Use Listing (EUL).

As per the Central Drugs Standards Control Organization (CDSCO), the pathway will ensure that vaccines will be used as per the government National Covid-19 Vaccination Programme guidelines. In addition, it also states that first 100 beneficiaries of the vaccines will be assessed for seven days for safety outcomes before a further roll-out. The pathway also states that the applicant shall initiate conduct of post-approval bridging clinical trials within 30 days of such approval.

Moreover, each batch of the COVID-19 vaccines will be released by the Central Drugs Laboratory(CDL), Kasauli before it can be used. Moreover, CDSCO will review the safety data submitted by the applicant and once found satisfactory, will authorise the applicant to use the vaccine. Here's the full regulatory pathway as issued by the Union Health Ministry:

HFW COVID Vaccines Regulatory Pathways by Republic on Scribd

India fast-tracks emergency approvals for foreign-made  vaccines

The Centre had on Tuesday decided to fast-track Emergency Approval for vaccines produced outside India which have been granted Emergency Utilisation Authorisation (EUA) in other countries. This came after Russia's Sputnik V received the SEC & DCGI's nod earlier on Monday and Tuesday for emergency use. With this decision, it is expected that India will have quicker access to foreign-made vaccines. In addition, import of bulk drug material optimal utilization of domestic fill and finish capacity will also be encouraged. As per the development, India will receive vaccines from four additional manufacturers which include Johnson & Johnson's vaccine (with Biological E), Novovax (with SII, as mentioned above), Zydus Cadila's vaccine and an intranasal vaccine by Bharat Biotech. 

The number of new coronavirus cases in India hit a record daily high with over 2 lakh infections being reported in a day, while the active cases surpassed the 14-lakh mark, according to the Union Health Ministry data updated on Thursday. With the new cases, the total tally of COVID-19 cases in the country rose to 1,40,74,564.

A total of 2,00,739 new COVID-19 cases have been registered in a span of 24 hours, while death toll increased to   1,73,123 with 1,038 daily new fatalities, the highest since October 3, 2020, the data updated at 8 am showed.

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