International pharma firms who have approvals for their Covid-19 vaccines from regulators in specific countries will now be able to sell them in India almost immediately as they will not have to conduct post-launch bridging trials and get the quality and stability tested again in the country.
The Drug Controller General of India (DCGI), Dr V.G. Somani, said on Wednesday that post-approval bridging clinical trials can be exempted for vaccines with restricted use permissions from regulators including the US FDA, the European Medicines Agency and those in the UK and Japan and with WHO Emergency Use Listing clearance. Top pharma giants have been demanding the easing of import rules for Covid vaccines.
However, the companies will still have to ensure safety outcome assessments by conducting the drugs on 100 beneficiaries for seven days before rolling it out. But they do not have to get every batch of the vaccine tested by the Central Drugs Laboratory, provided it has been certified and released by the National Control Laboratory of the country of origin.
The decision was taken by the DCGI on the recommendations of the National Expert Group on Vaccine Administration for Covid-19. Another factor for speeding up the process was the huge demand for vaccination in India and the need to import them to bridge the gap in supplies.
At present, only two Indian companies manufacture Covid vaccines. And they are unable to meet the growing demand for the vaccines. (Courtesy Khaleej Times)