In a bid to boost the availability of COVID-19 vaccines in India, the government has decided to process the import licences and registration certificate applications of the foreign-made vaccines in just three days after they are given the emergency use authorisation, reports Times of India.
"CDSCO (Central Drugs Standard Control Organisation) will process applications for Registration Certificate (registration of oversees manufacturing site and product: in this case Covid vaccine) and Import License, within 3 working days from the date of approval of Restricted Use in Emergency Situation," the Health Ministry said on Thursday (15 April).
According to the Health ministry, this decision will facilitate quicker access to such foreign vaccines by India and would encourage imports including import of bulk drug material, optimal utilization of domestic fill and finish capacity etc., which will in turn provide a fillip to vaccine manufacturing capacity and total vaccine availability within the country.
The decision by Health Ministry comes after the government on Tuesday (13 April) waived the pre-condition of mandatory bridging trials on the local population for securing the grant of emergency use authorisation (EUA) for the vaccines which are already in use in the United States (US), the United Kingdom (UK), the European Union (EU) and Japan.
The government had also waived the requirement for vaccines which have been cleared by the World Health Organisation (WHO).
As per the new norms, such vaccines will have to rather undergo a parallel bridging trial upon launch in India.
The guidelines also state that the first 100 beneficiaries of such vaccines shall be assessed for seven days. The data for the same will have to be submitted to the Central Drugs Standard Control Organisation (CDSCO) for assessment, after which it would be reviewed by subject experts.
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