PremiumNEW DELHI: The Drugs Controller General of India VG Somani will take a decision on giving emergency authorisation 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 oversees manufacturing site and the covid-19 vaccine, and its import license will be done within six working days, the health ministry said.
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The application can be submitted to the Central Drugs Standard Control Organization (CDSCO), which Somani heads, by the foreign manufacturer 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 authorisation applications for vaccines already authorised for emergency use by drug regulators in the US, UK, European Union and Japan or those that have been cleared by the WHO, making them eligible for use in India without having to conduct a local bridging trial.
Under the fast-tracked regulatory pathway for foreign vaccines authorised by the five regulators, the DCGI can clear the vaccine for restricted emergency use in India if 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 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 which is reeling under a second wave. As such vaccinations have become 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 authorisation process for foreign vaccines was aimed at facilitating quicker access to foreign vaccines and encourage 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 & 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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