'India to get more foreign vaccines as govt has no issue in granting indemnity to manufacturers': Sources
New Delhi | Jagran News Desk: In order to fast-track the approvals for Moderna and Pfizer vaccines against COVID-19, the Union Health Ministry is considering providing indemnity from liability to both the vaccine manufacturers. Both Moderna and Pfizer have requested the government to grant them indemnity and waive off post-approval local trials during negotiations to supply imported vaccines to the country.
According to Union Health Ministry sources, as quoted by news agency ANI, India doesn't have any problem in granting indemnity or legal protection from any claims against the use of COVID-19 vaccine manufactured by foreign manufacturers.
"If these companies have applied for Emergency Use Authorisation in India, then we are ready to give them indemnity. It is expected that they will be granted indemnity against legal proceedings along the lines of what has been allowed in other countries for Pfizer and Moderna," the Health Ministry sources said.
In another major decision to cater to the vaccine demand in the country, the government has also waived off the requirement of India-specific trials for foreign vaccines approved by specific countries and WHO for emergency use.
In a letter, DCGI Chief VG Somani letter said that this will be applicable for vaccines that have already been approved for restricted use by the US FDA, EMA, UK MHRA, PMDA Japan or listed for Emergency Use by the World Health Organisation. Earlier, vaccines that had completed clinical studies outside the country were required to carry out "bridging trials" or limited clinical trials on the Indian population to know how the drug works on people of Indian origin.
However, despite these big concessions, it will take time for both Moderna and Pfizer to join India in its vaccination drive due to the huge demand of vaccine shots across the globe. Pfizer, who is ready to offer 5 crore vaccines to India, had earlier requested the government to provide the legal protection to its vaccine and shared efficacy trials and approvals for its vaccine in various countries and by WHO.
Meanwhile, India has not provided indemnity or legal protection to any COVID-19 vaccine manufacturer against the costs of compensation for any sevre side effects. "They have requested indemnity to all the nations including the country of origin. We are examining this request and will take a decision in the larger interest of people and on merits. This is under discussion and there is no decision as of now," Dr VK Paul, a NITI Aayog member, had said last month.
Posted By: Talibuddin Khan