Import alert issued on plant in Karkhadi.
By Deepak Chitnis
WASHINGTON, DC: The Indian pharmaceutical industry is getting hit again by the US Food and Drug Administration (FDA), which has announced that its slamming Sun Pharmaceutical with an import alert on its plant in Karkhadi, Gujarat.
The alert comes after the FDA inspected the plant last year, and adds Sun Pharmaceutical to the growing list of India-based drug companies that have come under the hammer of the US watchdog agency, such as Ranbaxy, Aurobindo, Wockhardt, and RPG Life Sciences. According to information released by the company, the Karkhadi plant was not in compliance with the current Good Manufacturing Practice (cGMP) regulations imposed by the FDA.
“The company remains fully committed to compliance and has already initiated several corrective steps to address the observations made by the US FDA,” said Sun Pharmaceutical. “The contribution of this facility to Sun Pharma’s consolidated revenues is negligible. Sun Pharma maintains its FY [Fiscal Year] 2013-14 consolidated sales growth guidance.”
Analysts confirm that the Kharkadi plant closing will have very little impact on Sun Pharmaceutical’s bottom line, reducing sales by somewhere around just 1%. Despite the company’s assurances, however, shares of Sun Pharmaceutical fell 6.4% on Thursday, to Rs. 574, after the FDA alert issuance was announced. Sun Pharmaceutical has 25 manufacturing plants around the world, 11 of which are in India. Three of those are in Gujarat, one of which is the Karkhadi plant.
This is not Sun Pharmaceutical’s first experience with bad publicity in recent times. The company recalled more than 2,500 bottles of Glumetza, a generic diabetes drug that it produces, after it was discovered that certain seizure medications had been mixed into some bottles that were on pharmacy shelves. The reason for that, as well as several oversights at pharmaceutical manufacturing plants, is because the first company to debut a generic drug is allowed a six-month exclusivity period, which boosts revenue considerably.
For now, Sun Pharmaceutical has said that it has begun taken “several corrective steps” to come into compliance with FDA regulations, and hopes to have the Kharkadi plant up to standard in due time.