France and Italy ban products from Indian companies

While FDA regulatory action against Indian companies has drawn the media spotlight the last couple of years, European regulators also have been finding problems with some Indian plants. Both France and Italy took action against Indian drug manufacturers last month, finding them out of compliance and limiting product sales as a result.

France issued a statement of noncompliance and banned products from a Medreich plant in Andhra Pradesh following a May inspection, which was a follow-up to one the year before. According to the report, inspectors found 58 deficiencies, including one concerning data being faked that was classified as critical. Another 29 were classified as major and included a variety of problems related to cross-contamination, inadequate visual inspections, inadequate equipment maintenance, a "poor level of quality management," as well as with microbial testing. According to the report, the problems affected both sterile and nonsterile drugs.

The Italian Medicines Agency recommended products be banned from a Sri Krishna Pharmaceuticals facility in Hyderabad, also in Andhra Pradesh, after finding 10 issues that inspectors considered major. They discovered that employees were backdating testing equipment and writing over failed test results repeatedly until they got an acceptable result. "Notably, after subsequent investigation it was found that the Master Batch Record (version 0) had been back-dated by the most responsible persons within your firm's Quality and Manufacturing departments, which was confirmed by these persons during our inspection," the agency wrote to Sri Krishna.

The agency said it didn't believe any of Sri Krishna's products needed to be recalled since the company makes active pharmaceutical ingredients that will go through further processing. Later testing of finished products should pick up any problems, it said, but cautioned that if authorities determined no testing of the finished product was being done, then they might want to consider a recall.

Those findings were enough for Health Canada to take its own action. On Tuesday it announced that, based on information from trusted partners, it had requested importers to quarantine products made with active pharmaceutical ingredients from Sri Krishna, "due to data integrity concerns."

All of those actions followed similar responses by Germany and EU regulators in November to restrict some products manufactured at a Ranbaxy Laboratories facility in Dewas, a plant the FDA had banned from shipping to the U.S. more than 6 years ago. The European regulators limited its to the plant's injectable versions of cephalosporin antibiotics.

Ranbaxy is one of a number of large Indian drugmakers which have had plants banned by the FDA, both for quality lapses and for faking testing data. Some Indian government and industry officials have complained that the FDA has singled out India for unfair oversight and that FDA standards are too focused on process. During a meeting at the CPhI conference in Paris in October regulators and industry officials argued that the FDA's methods are sometimes out of step with EU regulations which focus on end products meeting specifications. Some of the same products the FDA has banned are fine as far as EU regulators are concerned, they pointed out.

- read the Medreich and Sri Krishna reports
- read the Health Canada announcement