Sun Pharma not following procedures to prevent contamination of drug products; USFDA flags concern

New Delhi: In a major setback, country’s drug giant Sun Pharmaceutical Industries (Sun Pharma) is reported to have received four observations from the US health regulator for its Halol facility in Gujarat post inspection by the US Food and Drug Administration (USFDA).

According to a recent report by Business Standard, the USFDA has flagged that the facility is not following procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile.

The regulator has also observed that lab control mechanisms were not documented, design plans were inadequately established, and the processes whose results could not be fully verified by the subsequent inspection were not adequately validated.

As per the daily, the inspection at Halol started on June 3 and went on for at least seven days.

This is not for the first time that the facility has received observations from the US regulator. Prior to this, the unit had been issued a series of observations. Medical dialogues had earlier reported that shares of Sun Pharma had fallen, dropping almost 4 per cent after USFDA issued Form 483 with observations on inspection of its Halol facility in Gujarat. Further, objectionable conditions at the facility were also found by the US regulators, resulted in issuing Voluntary Action Indicated (VAI) status to the company’s plant.

Later in August, following its responses to six observations, the Halol facility had received an NAI status from USFDA, allowing Sun Pharma to continue manufacturing.

Also Read: USFDA for voluntary action by Sun Pharma’s on Halol plant observations

In spite of having a challenging regulatory record, the unit contributes as much as 10-15 per cent to the company’s US sales.

Presently, the drugmaker has reportedly received yet another four observations for the same facility.

In reaction to the recent observations, Sun Pharma told the daily that it will respond to the observations soon.

“Sun Pharma intends to implement promptly any corrective actions and improvements that may be necessary and remains committed to following the highest levels of quality and 24x7 cGMP compliance at all its manufacturing sites globally,” a spokesperson told Business Standard.

Drugmakers are provided with a window of 15 days to respond to such observations. Based on the responses, Sun Pharma's Halol facility may bag either of the statuses such as no action indicated, voluntary action indicated or official action indicated.

Despite being a routine inspection, the development had caused flutters among investors and analysts given Halol’s significance as Sun Pharma’s key unit that supplies products to the US.

Analysts believe the inspection was probably part of a pre-product approval. “It seems some products are up for approval. However, while it was a longer inspection, it has resulted in mostly routine observations which explain why the stock is up," an analyst told the daily.