Global Vaccine Makers Breathe Sigh Of Relief As India Exempts Post-Approval Bridging Trials

In a major push to the innoculation policies which can push forward the vaccination drive in populated country like India, the Drugs Controller General of India on Wednesday said that the foreign made vaccines for Covid-19 can now be launched in the country without the requirement of post approval clinical trials and testing every batch of the vaccine.

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In a notice released today, the DGCI said that vaccines which have been approved for restricted use by US FDA, EMA, UK MHRA and PMDA Japan and under the WHO Emergency Use Listing (EUL) and where millions of individuals have been vaccinated, the requirement of conducting post approval clinical trials and the requirement of testing every batch of the vaccine by Central Drugs Laboratory (CDL), Kasauli can be exempted if the vaccine batch has been certified and released by National Control Laboratory of country of origin.

The body however clarified that the scrutiny and review of their summary lot protocol and certificate of analysis of the batch shall be undertaken by CDL, Kasauli for batch release as per standard procedures. It added that the requirement of assessment of the first 100 beneficiaries for first 7 days for safety outcomes before the vaccine rolled out for further immunisation programme and other procedures for applications will remain the same.

This nod is likely to apply first to Pfizer and Moderna vaccines. AstraZeneca’s Covishield and Russia’s Sputnik have already been approved. It is not clear whether the Chinese vaccines will come under this ambit or they will apply in India.

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The cumulative number of COVID-19 vaccine doses administered in the country exceeded 21.85 Crore on Wednesday morning. Bihar, Delhi, Gujarat, Haryana, Karnataka, Madhya Pradesh, Maharashtra, Rajasthan, Tamil Nadu, Uttar Pradesh and West Bengal have administered more than 10 lakh beneficiaries of the age group 18-44 years for the first dose of COVID vaccine.

(With inputs from IANS)

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