Strides Arcolab is now under the US FDA scanner following the regulatory authority sighting violations at its injectable facility of its subsidiary Agila in Bengaluru. Now Strides is the fourth Indian pharma company to come under the surveillance of US FDA after Ranbaxy, Wockhardt and Hospira.
An FDA Form 483 is issued to a company after an inspection and communicates concerns discovered during the production plant audit. After the receipt of a Form 483, a company has to respond to the concerns within 15 days. If FDA is not satisfied with the response, the issue might lead to a warning letter and subsequently, snowball into an import alert.
According to Arun Kumar, vice-chairman and managing director Strides Arcolab stated, "We confirm that as part of periodic US FDA inspection of one of our units in June 2013, the company received a 483, which is an observational document issued by the US FDA post inspection. The company has responded to the observations within the stipulated period and awaits response from US FDA."
“Further we wish to mention that the Strides Arcolab has a strong track record of FDA approvals. The company had 15 inspections in the past at its various facilities. While seven of them had zero 483s, the rest of them had observations. We have addressed all these observations at all times to the satisfaction of US FDA,” clarified the company in a statement.
The 483 communication comes at a time when the company is in the midst of a deal with US drug major Mylan. In fact it was in February this year that Strides Arcolab entered into a definitive agreement for the sale of its specialties subsidiary, Agila Specialties Private Limited and its overseas specialties subsidiary, Agila Specialties Asia, Singapore to Mylan Inc. The transaction is subject to customary conditions, including receipt of required regulatory approvals. Now industry observers are have stated that this US FDA safety concerns could further lead to delay in the outcome of the deal.
But the company has confirmed to its investors that the Mylan acquisition of Agila was awaiting the clearance of the Foreign Investment Promotion Board, according to a media report.
US FDA has been has been issuing warnings to Indian companies: On May 13, this year, Ranbaxy was the first company that paid $500 million fine over charges related to drug safety at two of its India plants at Dewas and Ponta Sahib. This was followed by Wockhardt which received a US FDA alert on its Aurangabad unit and then Hospira too received a warning letter which was a drug safety alarm at its finished formulations facility at Sriperumbudur in Tamil Nadu.