BackForeign shots may get nod within 3 days of application
The entire process from application to issuance of certificate for registration of oversees manufacturing site and the covid-19 vaccine, and its import license will be done within six working days, according to the health ministry
PremiumDrugs Controller General of India V.G. Somani will decide on giving emergency authorization to foreign vaccines within three days of submission of application, the health ministry said on Thursday.
The entire process from application to issuance of certificate for registration of overseas manufacturing site and the covid-19 vaccine and its import licence will be done within six working days, the health ministry said.
The application can be submitted to the Central Drugs Standard Control Organisation (CDSCO), which Somani heads, through its Indian subsidiary or through its authorized agent in India, the government said. The new norms follow the health ministry’s announcement on Tuesday to fast-track emergency authorization approvals for vaccines already approved for emergency use by regulators in US, UK, European Union and Japan or those that have been cleared by the WHO.
Under the fast-tracked regulatory pathway for foreign vaccines authorized by the five regulators, DCGI can clear the vaccine for restricted emergency use in India if it meets three conditions—it will be used as per the national covid-19 vaccination guidelines; the first 100 beneficiaries of the vaccines will be assessed for seven days for safety before it is widely rolled out; and the company initiates post-approval bridging trials within 30 days of such approval.
When the vaccines are rolled out, each batch of the vaccine will be released by the Central Drugs Laboratory (CDL), Kasauli, after testing the vaccine, just like it happens for other vaccines.
The move comes at a time when India is facing an acute shortage of vaccines as both Serum Institute of India and Bharat Biotech International struggle to scale up production of Covishield and Covaxin, respectively, to meet domestic demand even as India topped the daily infection counts of other countries.
On Wednesday, India added more than 200,000 new cases, a new record for the country. Vaccinations have become a crucial weapon in curbing the spread of the disease. However, the shortage of vaccines has proved to be a hindrance.
The government’s move to fast-track the authorization process for foreign vaccines was aimed at facilitating quicker access to foreign vaccines and encouraging imports, including that of bulk drug material and optimal utilization of domestic fill and finish capacity.
The move could pave the way for the use of Pfizer, Moderna and Johnson and Johnson’s vaccines in India. Vaccines made by the three companies have proved to be the workhorses of the US government’s immunization drive.
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