Form 483 action looms over Sun's Halol plant

The recent US Food and Drug Administration (FDA) surprise visit at Sun Pharmaceutical Industries's Halol facility may lead to an issuance of Form 483, potentially a precursor to an import alert.

The US FDA last week conducted a surprise inspection at company's Halol facility in Gujarat, which contributes nearly 15-20% to Sun Pharma's US sales. Recalls of various drugs made at the unit was seen as a trigger for the inspection.

According to an industry expert, US FDA now has its office in India and a surprise inspection in any facility of any pharma company is therefore a possibility now. The whole motive is to check whether these companies are maintaining the manufacturing and quality standards as laid out by the FDA, the expert said.

FDA issues Form 483 to a company at the conclusion of inspection in which the investigators observe conditions that they think violate the Food Drug and Cosmetic Act and related Acts. Form 483 notifies the company of objectionable conditions.

The company is encouraged to respond with a corrective action plan followed by its implementation. Else, an import alert could be issued against the company. "What we understand is that FDA has made certain observations which include some data and record related observation as well. Some deviations may have occurred in relation to documentations. If FDA thinks these are serious in nature, it may lead to a Form 483," said another industry expert.

Hitesh Mahida, analyst with Antique Stock Broking, said, "The facility was last inspected in 2012. So in that sense the FDA inspection is not something unusual, since FDA can carry out such inspections once in every two years. But if they are not satisfied with the manufacturing standards and have witnessed deviations, it might then lead to a Form 483. Halol is one of the major facilities for Sun Pharma and a warning letter will cause a major setback for the company."

Sun Pharma's Karkhadi facility, also in Gujarat, is under import ban from FDA. Though the impact is insignificant in terms of sales but the observations were serious in nature. FDA has identified violations of current good manufacturing practice (CGMP) regulations for its finished pharmaceuticals and deviations from CGMP for the manufacture of APIs in the facility.

"If the deviations or the violations observed in case of Halol are similar in nature to what it was with Karkhadi, then it can lead to a serious impact going forward," said another sector analyst. Sun Pharma in April announced its intent to acquire Ranbaxy Labs, which is facing import ban from FDA on four of its plants in India.

"With Sun acquiring Ranbaxy, FDA is also more likely to keep a close watch on the former," said an expert. In a latest update on BSE, Sun Pharma has said that it will seek shareholders' approval to raise Rs 12,000 crore via qualified institutional placement. It will also seek a similar approval for borrowing, in tranches, for up to Rs 50,000 crore.

Mahida said, "The company wants shareholders' approval so that it can raise and utilise the money for any future expansion and M&As."