BENGALURU (Reuters) – The U.S. Food and Drug Administration (FDA) has raised doubts about Strides Pharma Sciences Ltd’s quality-control practices after finding adulteration and evidence of “uncontrolled shredding of documents” at one of its plants.
The FDA found “significant violations” of current good manufacturing practice (CGMP) regulations at Strides Pharma’s plant in Puducherry in southern India, the drug regulator said in a warning letter (https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/strides-pharma-science-limited-576722-07012019) that was made public on Tuesday.
Shares of the Bangalore-based company, which fell as much as 8% to a near one-year low earlier on Wednesday, were trading down 3.2% at 0757 GMT.
Last month, Aurobindo Pharma Ltd was warned (https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/aurobindo-pharma-limited-577033-06202019) by the FDA for ignoring impurities in an active ingredient it produced. Hyderabad-based Aurobindo recalled contaminated valsartan in January and in March.
The destruction of quality-control paperwork by Strides and a lack of adequate documentation that its medicines are safe “raise questions about the effectiveness” of Strides’s quality unit “and the integrity and accuracy” of its data, said Francis Godwin, director of the FDA’s Office of Manufacturing Quality, in the letter.
The regulator said an investigator found a binder containing CGMP records, including batch records for U.S. drug products, discarded with other records in a 55-gallon drum in Stride’s scrap yard.
“CGMP documents in the binder were dated as recently as January 21, 2019: seven days before our inspection. Your quality unit did not review or check these documents prior to disposal,” Godwin said in the letter, addressed to Strides Chief Executive Officer Arun Kumar.
On July 2, Strides shares slumped after it said it received a warning letter from the U.S. FDA, it did not disclose the content of the letter at that time.
A Strides spokesman said on Wednesday the company won’t be making any further comments.
Strides bought a unit of Vivimed Labs Ltd in January. Vivimed manufactures losartan, a drug that is part of a wider recall in the United States.
The FDA’s warning letter dated July 1 comes months after several Indian drugmakers including Sun Pharmaceutical Ltd and Dr.Reddy’s Laboratories Ltd were named in a U.S. lawsuit against Israeli drugmaker Teva Pharmaceutical Industries Ltd accusing it of conspiring to inflate drug prices and stifle competition for generic drugs.
(Reporting by Chandini Monnappa in Bengaluru; editing by Gopakumar Warrier)