The government in mid-April made it easier for foreign vaccines approved in the west and Japan to sell in India, though companies would still have to initiate a local clinical trial within 30 days of receiving emergency use authorisation.
Previously, companies were required to do the trial prior to approval. India has invited Pfizer, Johnson & Johnson and Moderna Inc to sell their vaccines to the country but none have applied to do so yet.
Pfizer, however, said it is holding fresh talks with the government after having withdrawn its initial application in February over the earlier local trial rule.
“Pfizer’s application for emergency use authorization was supported with data that shows an overall efficacy rate of 95% with no safety concerns,” a company spokeswoman said when asked if it had sought an exception even to the current trial rule in its discussions with the government.