After waiving the tests, the Center may grant legal indemnity to Pfizer, other
In addition to waiving the need for local clinical trials by foreign vaccine companies, the Union Health Department would have “no problem” in granting liability compensation as well, a claim Pfizer had made in the past
To accelerate the availability of Pfizer and Moderna in India, the government has not been content to forego India-specific trials for these foreign vaccines approved by specific countries and the WHO for emergency use. He would have “no problem” in awarding compensation or legal protection as well as against any claims related to a company’s use of a company’s COVID-19 vaccine, media said.
Citing sources from the Ministry of Health, NDTV signaled that the government could grant another important concession requested by Pfizer in the past – which is a liability indemnity.
Sources from the Union Health Ministry said “there was no problem” in awarding compensation or legal protection against any claims related to the use of a COVID-19 vaccine from a maker. “If these companies have applied for an emergency use authorization in India, we are prepared to pay them compensation,” the sources reportedly said. According to these sources, other countries have also awarded compensation against the lawsuits.
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However, NITI Aayog member Dr Paul said last month Pfizer had requested compensation from all nations, including the home country, and India was considering their claim and would make a decision. The decision will be taken after consideration of the merits and taking into account the broader interests of the population. “This is under discussion and there is no decision at this time,” said Dr Paul, NDTV reported.
Meanwhile, Live Mint focused on a letter from the head of the Comptroller General of Medicines of India (DGCI), VG Somani, who said the regulatory agency had removed the rule that required foreign manufacturers to conduct bridging trials or limited clinical trials on the Indian population. know their effect on people of Indian origin.
However, this exemption will only apply to vaccines that have already been approved for restricted use by agencies such as the US FDA, EMA, UK MHRA, PMDA Japan or if it has been listed for use. emergency use by the World Health Organization.
Read also : Pfizer vaccine: company seeks compensation for all claims in India
The head of the DGCI had also added that this exemption applied to vaccines “well established” with millions of people having already been vaccinated by them. The requirement to conduct post-approval bridging clinical trials and the requirement to test every vaccine lot by Kasauli’s Central Drugs Laboratory (CDL) can be ignored.
Exemption can be granted if the lot / lot of vaccine has been certified and released by the National Control Laboratory of the country of origin. The decision to forgo the trials was made “in light of the huge vaccine needs and the need for increased availability of imported vaccines,” Somani said in the letter.
The NDTV report added that despite all these concessions and concessions, Pfizer and Moderna vaccines will take a long time to reach India. They must meet global demand for their vaccines to be used to fight the pandemic.
Pfizer, while agreeing to give India 5 crore doses between July and October, had told the government it needed compensation and would share efficacy trials and approvals for its vaccine in various country. This vaccine manufacturer cannot be sued in the United States if someone who has taken their vaccine suffers from adverse effects. India has so far not awarded any compensation to the manufacturer for being sued for the side effects of the vaccines.