India has exempted foreign-made Coronavirus disease (Covid-19) vaccines from conducting local bridging studies before seeking emergency-use authorisation, provided they have received approval from any of the major regulators globally, the government announced on Tuesday.
The move is a part of the centre's efforts to fast track emergency approvals for foreign-produced Covid-19 vaccines (that have been granted approval in other countries) to expand the basket of vaccines for domestic use, and hasten the pace and coverage of Covid-19 vaccination.
"The National Expert Group on Vaccine Administration for Covid-19 (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," said the Union health ministry in a statement.
The expert vaccine panel also suggested that the first 100 beneficiaries of such foreign vaccines shall be assessed for seven days for safety outcomes before further immunisation takes place within the country.
"The Union government, after due consideration, has accepted the recommendation of NEGVAC. This decision will facilitate quicker access to such foreign vaccines by India & would encourage imports including import of bulk drug material, optimal utilisation 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 statement further read.
In May 2020, India constituted a task force headed by principal scientific advisor, K Vijay Raghavan, to encourage research and development for vaccine manufacture, and also constituted an expert group called NEGVAC in August 2020.
The matter of augmenting the basket of vaccines available for fighting the pandemic as well as to accelerate the pace and coverage of domestic vaccination programme was discussed in the 23rd meeting of NEGVAC on April 11, chaired by Dr VK Paul, member (health), Niti Aayog.
On Monday, an expert panel of India's drugs regulator recommended emergency-use approval of Russia's Sputnik V coronavirus vaccine, according to officials, paving the way for the country to have access to a third vaccine at a time when several regions are reporting shortage.
Experts welcomed Monday's development, saying any additional dose to be cleared will be a big boost for India's coronavirus vaccination programme. "All additional vaccines will help the programme. It is the number of doses we will get, rather than the efficacy numbers from clinical trials, that matter," said Dr Gagandeep Kang, one of the top vaccine experts in India.
Since January 16, India has given out close to 106 million doses to become the country with the fastest vaccination drive. But the country has one of the largest populations to reach in the world, a challenge that became stark in recent weeks as a surge in cases drove people to vaccination centres, many of which ran out of doses.