India's Cadila Healthcare is the latest in a long line of Indian pharma manufacturers to receive a warning letter from the U.S. Food and Drug Administration. The company disclosed the notice on Dec. 31 and said it covered a formulation plant in Moraiya and an API plant in Ahmedabad.
The FDA inspected the company's Moraiya facility more than a year ago and said it had problems with the plant's operations, but its findings were kept from the public. Cadila said in October it had fixed the issues, but the warning disclosed on New Year's Eve could mean the agency is not satisfied with the company's fixes, said Siddhant Khandekar, an analyst at ICICI Direct, according to a report in The Economic Times.
"The company's future sales are definitely going to take a hit," Khandekar said in the report.
"We take quality and compliance matters very seriously and stand by our commitment to fully comply with current good manufacturing practice regulations quality standards across all our facilities," the company said in a statement to the Bombay Stock Exchange, as reported by The Telegraph. "The company is working hard to ensure that the commitments made to the FDA are fully completed. The company will continue to take all necessary steps to ensure that the FDA is fully satisfied with our remediation of the above facilities. We will respond to FDA to address the observations within the statutory time permitted in the letter. We are committed to resolve all the issues and revamp our quality systems and processes as the top most priority."
Indian pharma analysts say they expect the FDA to maintain a tight grip on inspections throughout 2016; the FDA is under pressure from Congress to rein in quality-control problems both in India and China.
Meanwhile, India's Orchid Pharma said it received an Establishment Inspection Report (EIR) from the FDA following an inspection of its formulation plant in the state of Tamil Nadu. EIRs are issued when the agency completes a plant inspection and the inspection is "successfully" closed, according to a report in The Economic Times.