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Foreign vaccines such as Pfizer, Moderna with no Key India one step closer.

Foreign vaccines such as Pfizer and Moderna are one step closer to India\\\'s major exemption.

Thursday, 3rd June 2021

In a big move to pave the way for foreign vaccines like Pfizer and Moderna, the Medicines Agency has lifted the requirements for India-specific studies. Foreign vaccines approved for emergency use by certain countries and the WHO no longer require bridge testing in India. said the Comptroller General of Drugs of India (DCGI) in an attempt to speed up imports of doses needed to boost vaccines.

Pfizer and Moderna were among the companies that applied to the government for exemptions such as compensation and local post-approvals. The government has yet to decide on compensation or mandatory compensation for serious side effects.

Also Read : Pfizer Insists on Its High Effectiveness on Current SARS-Cov-2 Strain Found in India Now and Seeks Indemnity.

A letter from DCGI states that it has waived the obligation of foreign companies to conduct “post-launch bridge studies” and test the quality and stability of their vaccines in India if they have approvals from certain countries or health authorities. DCGI chief VG Somani said in the letter that the decision was made "given the huge vaccination needs in India following the recent surge in COVID-19 cases and the need for increased availability of imported vaccines".

This has been recommended by the National Group of Experts on Vaccine Administration for COVID-19 or NEGVAC, US FDA, EMA, UK MHRA, PMDA Japan or those on the WHO Emergency Use List (EUL) and from the point of view that millions of people have already been vaccinated with such vaccines, well-established vaccines are approved, bridging clinical trials, and the requirement that the Central Drug Laboratory (CDL) test every batch of the vaccine, Kasauli can be exempted if the batch / batch of the vaccine is dated National Control Laboratory of the country has been certified and approved of origin, "said Dr. Somani in the letter. No completed overseas clinical trials were required to conduct “bridge studies” or limited clinical trials in the Indian population to find out how the drug works in people of Indian descent in a local context.

The government has promised to vaccinate all of India by December, which would require a massive increase in the number of shots fired. Vaccines have been slowed down or stopped in many states due to dose shortages.

The government expects to have a billion doses a day by July. Foreign vaccines are likely to play an important role in this. Vaccinate all of India by December, which would require a massive increase in the number of injections.

Vaccinations have slowed or have been suspended in many states due to dose shortages. The government expects a dose of crore per day in July: Foreign vaccines are likely to play a major role in this.

The News Talkie Bureau



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