The Indian drug regulator—the Drugs Controller General of India—has waived off the requirement of a bridging trial in India for foreign vaccines that have received clearance from WHO and health regulators of specific countries. The move is being seen as a major step by the government to pave the way for the entry of foreign vaccine makers such as Pfizer and Moderna amid a major crisis of COVID-19 vaccines in India.
Notably, the US-based pharmaceutical giants had asked the government for multiple waivers such as indemnity and relaxation from a post-approval local trial. While the government has waived off the need for a local trial, it is yet to take a call on indemnity.
However, media reports suggested that the government is likely to grant indemnity to companies at a time when it desperately wants to scale up the vaccination drive that is moving slower than expected due to a shortage of vaccines.
The companies have been seeking legal protection from any claims linked to the use of their COVID-19 vaccines before the jabs are rolled out in India.
What DCGI said
The DCGI chief VG Somani said, “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 (EUL) and which are well-established vaccines from the standpoint that millions of individuals have already been vaccinated with the said vaccines, the requirement of conducting 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 National Control Laboratory of the country of origin.”
Vaccination drive in India
India’s vaccination drive that began in January is moving at a slower-than-expected pace. Only three vaccines—Covishield, Covaxin and Sputnik V—have been approved for use in the country. So far 21.85 crore doses of the vaccines have been administered. Of it, 17.34 crore are people who have taken their first dose, whereas only 4.51 crore people have taken both doses of the vaccines.
However, the Union government has said that it will complete the vaccination of all people who are eligible to take it by December-end.
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