Tide turns for pharma as US FDA concerns get addressed

On Monday, Divi’s Laboratories became the fourth company that claimed redressal of the US Food and Drug Administration (FDA) concerns this year. This indicates turn-of-the-tide of regulatory concerns raised by the US FDA in the last three years.

The Hyderabad-based company said the US FDA would lift import alert 99-32 issued in March on unit-II of its Visakhapatnam plant, though the import alert 66-40 on the unit stays. The regulator issued the alerts following an audit between November 29 and December 6, 2016. Alert 99-32 is issued when a firm refuses an FDA inspection of its facility, while alert 66-40 is issued to those that do not comply with good manufacturing practices.

“Though the issue has been resolved partially, the alacrity with which it has been done is a sign of changing times,” says Jagdish Dore, managing director at Sidvim Lifesciences, a firm that specialises in preparing Indian firms for FDA inspections.

The company claims to have taken appropriate remediation measures to address the other concerns raised by the FDA, too, and awaits its clearance.

In February, Cadila Healthcare got clearance for its Moraiya plant after an inspection. FDA issued a warning letter to the formulations facility in December 2015 for breach of good manufacturing practices. The clearance came after nearly 14 months.

In March, India’s largest drug maker Sun Pharmaceutical informed about the FDA lifting ban on its Mohali plant, paving the way for resumption of export to the US. The plant came to Sun along with three other facilities through its acquisition of rival Ranbaxy Laboratories in 2015. The FDA had banned Mohali and other Ranbaxy plants in 2013 as a part of a consent decree designed to ensure compliance of good manufacturing practices. Also Sun Pharma’s own plant at Halol continues to be under FDA’s watch. It first received a warning letter from the US regulator in 2015. The regulator found breaches at the plant even after remediation work by the company last year.

“Some of these companies have certainly fulfilled some of these requirements but it is certainly not indicative of the whole industry,” says Dore, adding that if the facilities are good, clearances are certainly coming faster now.

Hyderabad-based Dr Reddy’s Laboratories also saw signs of remediation efforts paying off at its three units that received warning letters from the FDA in November 2015. During the inspection early this year, all three plants again received concerns through Form 483.

However, the company has been able to quickly address the issues for its API (active pharmaceutical ingredient) plant at Miryalguda and got a final clearance.

“Our understanding of the Srikakulam Form 483 is that observations are addressable in a short period of time,” says Kunal Randeria, analyst with domestic brokerage Antique, indicating clearance for one more plant of the company this year.