India's Central Drugs Standard Control Organisation (CDSCO) says Pfizer officials failed to turn up to meetings after the company's application was made in early December and wants India to order its COVID-19 vaccines without any local trials.
Pfizer was the first company to seek emergency-use authorisation (EUA) for a COVID-19 vaccine in India.
But India's Central Drugs Standard Control Organisation (CDSCO) says Pfizer officials failed to turn up to meetings after the company's application was made in early December.
The regulator has also declined to accept the company's request for approval without a small local trial on the vaccine's safety and immunogenicity for Indians, Reuters has reported.
"The data collected has been endorsed by various regulatory agencies (including the most evolved) and they have given EUA [based on] ... that data," Pfizer said in an emailed response to questions, including on India's demand for a local trial.
According to data from the V...