Regulatory Focus™ > News Articles > Indian API Manufacturer Faces Canadian Quarantine Over Data Integrity Issues

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Posted 30 June 2015 | By Michael Mezher 

Indian API Manufacturer Faces Canadian Quarantine Over Data Integrity Issues


After Slovenian inspectors uncovered serious issues at Indian active pharmaceutical ingredient (API) manufacturer Polydrug Laboratories, Health Canada has issued a voluntary quarantine for all products containing APIs sourced from the company.


On 18 March 2015, inspectors from Slovenia's drug regulator JAZMP uncovered evidence of serious good manufacturing practice (GMP) deficiencies at Polydrug's facility in Maharashtra, India.

In their report, filed to the European manufacturing and distribution database EudraGMDP, the inspectors cited Polydrug for 17 GMP violations, mostly concerning the manufacturer's data integrity practices. Of these violations, five were considered to be major:

  • "Customer complaints deliberately unregistered in the official logbook"
  • "Storage of quality documents in an uncontrolled location, involving staff from QC, QA, maintenance and production"
  • "Deficient management of paper documents"
  • "Deficient management of the computerised system"
  • "Failure to address risks of cross contamination for APIs sent out to micronisation subcontractor."

These issues, the inspectors said, represent "a critical deficiency leading to a potential risk for the patient." Following the inspection, In-Pharma Technologist reports, the European Directorate for the Quality of Medicines and Healthcare (EDQM) suspended Polydrug's certificates of suitability (CEP) for all seven APIs manufactured by the company.

Quarantined in Canada

In response to the Slovenian inspection report and EDQM's actions, Health Canada announced that all importers and distributors of drugs containing Polydrug APIs must cease distribution until further notice.

Health Canada says that no risk to patient health has been identified, and the regulator is issuing the quarantine as a precautionary measure. Patients are advised to continue taking any affected medicines as prescribed, unless instructed to do otherwise by their doctor. Health Canada says it will continue to update the public on the situation through its inspection tracker.

Echoing GVK Suspension

The situation involving Polydrug is reminiscent of EMA's recommendation to

-GVK-Data-Integrity-Issues/">suspend all drugs that relied on studies conducted by GVK Biosciences last year, after French inspectors uncovered evidence of data manipulation at their Hyderabad, India site.

While there was no evidence that any drugs affected in the GVK scandal were unsafe or lacked effectiveness, EMA upheld its suspension for more than 700 medicines whose authorizations relied on studies conducted by GVK.

Health Canada, EudraGMDP


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