US Regulator Warns Sri Krishna Pharma, Citing Drug-Data Manipulation

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Mumbai: Sri Krishna Pharmaceuticals, a supplier of paracetamol and other drugs to more than 60 countries, has been warned by the US Food and Drug Administration (FDA), which cited manipulation of its test results at a plant.

The company, based in Hyderabad, is the latest drug maker in the country to get such a warning. Similar data-integrity issues found by the FDA at other Indian drug firms have led to dozens of manufacturing plants being banned in recent years.

Staff at one of the company’s plants in Hyderabad deleted unfavourable test results and manipulated records to show products it made there adhered to quality standards, the FDA found during an inspection in December 2014.

The agency listed its findings in a “warning letter” dated April 1 and addressed to Krishna Pharma chairman V V Subba Reddy, a copy of which was posted on the FDA website on Tuesday.

Officials at privately-owned Krishna Pharma did not respond to requests for comment on Wednesday morning.

The FDA warning comes a year after Canada’s health regulator said it stopped importing raw materials from Sri Krishna Pharma over data integrity concerns.

The company supplies several drugs such as anti-diabetic glipizide, the stomach disorder drug domperidone, and the diuretic furosemide, to the United States and Europe, among other countries.

While the company responded to the FDA’s concerns in 2014 with a plan to fix the issues, the agency said in the letter that it found the plan to be lacking. “None of your explanations justify your failure to maintain complete records, nor do they support your practice of repeating tests or deleting test results.”

The violations could impact medicines sold by other pharmaceutical firms for which it acts as a contract manufacturer, the FDA warned. It wasn’t immediately clear which companies could be impacted.