Foreign vaccine; Drugs Controller granting exemptions from norms

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New Delhi: The Drugs Controller has granted exemption to norms to ensure availability of foreign vaccines to expedite vaccination in the country. For this, the Drug Controller omitted the indigenous vaccine testing and the permission required by the Central Drugs Laboratory for each batch of vaccine.

Currently, vaccines need to be tested in the country before foreign vaccines can be approved for immediate use. However, the relaxation in the norms was allowed to ensure the availability of the vaccine in the country.

Drug controller exemptions are granted for vaccines approved at various levels, including the FDA in the United States, the European Medicines Agency, the UK MHRA, the PMDA Japan, and the World Health Organization’s Emergency Use List.