USFDA grants VAI classification to Torrent's Gujarat manufacturing site

The US health regulator has granted Voluntary Action Indicated classification to Torrent Pharmaceutical's manufacturing site in Dahej, Gujarat.

A VAI classification means objectionable conditions or practices were found but the agency is not prepared to take or recommend any administrative or regulatory action.

As per the information available on its website, the United States Food and Drug Administration (USFDA) has granted Voluntary Action Indicated (VAI) classification to the plant.

The Dahej site was earlier placed under 'Official Action Indicated (OAI)' classification based on a March 2019 inspection outcome.

OAI means "objectionable conditions were found and regulatory administrative sanctions by FDA are indicated" during inspections.

The Dahej site was re-inspected by the USFDA between May 17 and May 25, 2023 and the officials had issued Form 483 with two observations.

Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that in its judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

The VAI classification of the Dahej plant would be a great relief for the drug firm, which produces active pharmaceutical ingredients and formulations at the site. The classification indicates that the company will be now able to get approval for all pending ANDAs (Abbreviated New Drug Applications) from the site.

Shares of the company on Wednesday ended 2.13 per cent down at Rs 1,935.05 apiece on the BSE.