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| Centre may grant indemnity to COVID vaccine manufacturers Pfizer and Moderna: Sources | | | Agencies
NEW DELHI: In order to strengthen the fight against Coronavirus, the Centre is expected to grant indemnity to leading anti-COVID vaccine manufacturers like Pfizer and Moderna, sources said on Wednesday.
Quoting government sources, the news agency ANI said that like other countries, the Indian government is also likely to grant indemnity to these companies if they apply for Emergency Use Authorisation (EUA).
Granting indemnity is like giving a concessional request of legal protection from any claims linked to the use of their Covid-19 vaccines in India. India has so far not given an indemnity to any COVID vaccine manufacturer against the costs of compensation for any severe side effects so far.Meanwhile, the Drugs Controller General of India (DCGI) has done away with specific trials of COVID-19 vaccines that have been approved by other international regulatory bodies - a big move likely to clear the way for foreign vaccines like Pfizer and Moderna for the country`s urgent requirement.
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.
"In light of the huge vaccination requirements and the need for increased availability of imported vaccines,... it has been decided that for approval of COVID-19 Vaccines in India for restricted use in emergency situation which are already approved for restricted use by US FDA, EMA, UK MHRA, PMDA Japan or which are listed in WHO Emergency Use listing," he said.
Somani added that for the vaccines that are well established from the standpoint that millions have already been vaccinated with the said vaccines, the requirement for conduction post-approval bridging clinical trials and the requirement of testing of every batch of the vaccine by the Central Drugs Laboratory (CDL), Kasauli can be exempted, if the vaccine batch/lot has been certified and released by the National Control Laboratory of the Country of Origin.
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. |
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