At a time when the government is facing heavy criticism over the glitches in the COVID-19 vaccine rollout due to short supplies, the administration is set to fast-tracked emergency approval for foreign-produced jabs that have been granted similar clearances in other countries.
Till now India has been depending on the Oxford AstraZeneca vaccine made in India by Serum Institute under the name Covishield and homegrown Bharat Biotech's Covaxin to inoculate its population.?
On Monday, the DCGI (Drugs Controller General of India) cleared the Russian Sputnik V for use in the country, making it only the third covid vaccine in India.?But both SII and Bharat Biotech have been struggling to scale up their production to meet the rising demand from the government.
Several states have been complaining that they running out of shots and requested the Center to increase supplies.
Now the government has accepted the recommendation of an expert panel which said that COVID-19 vaccines which have been developed and are being manufactured in foreign countries and which have been granted emergency approval for restricted use by authorities in the US, Europe, the UK, Japan or which are listed in the WHO Emergency Use Listing may be granted emergency use approval in India.
The expert panel also mandated the requirement of post-approval parallel bridging clinical trial in place of conduct of local clinical trial.
"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 for domestic (use)," the ministry said.
According to the Union Health Ministry, 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.
Though this, in theory, will help India to get more vaccine shots it is still unclear how much the country will be able to procure from the international market.?
That is because makers of the other COVID-19 vaccines that have been cleared around the world are also struggling to meet their own existing commitments, mostly in the US, UK and EU.