With the aim to fast track the approvals for the foreign manufacturers to commercially market their Covid-19 vaccine in the country, the centre Tuesday announced that vaccines that have been granted emergency approvals by US, UK, Japanese regulators, including those listed by the WHO may be granted emergency use approvals in India.
The centre said that decision will facilitate quicker access to such foreign vaccines by India & would encourage imports including import of bulk drug material, optimal utilization of domestic fill, and finish capacity. “…which will, in turn, provide a fillip to vaccine manufacturing capacity and total vaccine availability for domestic,” the centre said.
With the change in the rules, the centre said that the first 100 beneficiaries of such foreign vaccines shall be assessed for seven days for safety outcomes before it is rolled out for further immunization programme within the country.
Tuesday’s decision came after the matter of augmenting the Basket of Vaccines available for fighting the pandemic as well as accelerating the pace & coverage of the domestic vaccination programme was discussed in the meeting of the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC).
“The NEGVAC, after comprehensive deliberation, recommended that vaccines for COVID-19, which have been developed & are being manufactured in foreign countries and which have been granted emergency approval for restricted use by USFDA, EMA, UK MHRA, PMDA Japan or which are listed in WHO(Emergency Use Listing) may be granted emergency use approval in India, mandating the requirement of post-approval parallel bridging clinical trial in place of conduct of local clinical trial as per the provisions prescribed under Second Schedule of the New Drugs & Clinical Trials Rules 2019,” the Minister of Health and Family Welfare said.