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This, after Western inspectors found that several dozen foreign drug makers faked data used by government to regulate the passage of these drugs in the market for public consumption.
Inspectors say foreign drug makers faked data deliberately
Authorities said they found evidence of important documents and data discarded in the trash, including proof of deleted computer records and falsified blood tests, just to name a few.
Health Canada’s director of drug establishment inspections Etienne Ouimett, said that they have reason to suspect that data fraud is happening across the international pharmaceutical industry and that data integrity has just been found to be a new but emerging issue.
Since imported drugs make up majority of the brands of drugs – 80 percent in Canada and 50 percent in the United States, both governments are hoping to crack down on these illicit activities by the drug-manufacturing firms.
A couple of months back, the World Health Organization and the Food and Drug Administration noticed some problems in one private research firm in India testing pills in humans for a wide variety of international drug companies.
Inspectors from WHO reported that they saw evidence of deliberate sampling manipulation which was claimed to be ‘common practice’ and indicates an existence of fraud.
The FDA, in another inspection said they observed employees of the drug company tampering with bioequivalence tests, which are designed to prove that new versions of the drugs have the same metabolic effect on the body.
While others, saw pieces of valuable test documents found ripped on the floor. Authorities are now demanding that tests be conducted by an independent group.
Impossible to trace origin
One of the biggest problems of medical authorities is that they find it impossible to trace the location where it comes from.and causes a dilemma among retailers who wouldn’t know where a certain drug came from.
Authorities now believe there is a need to delve deeply into the drug manufacturing industry to be able to get to the bottom of these activities.
The global drug manufacturing industry is hiding behind a cloak of secrecy, specifically in Canada, where it is believed to be protected by corporate confidentiality regulations and one which companies could manipulate and add make the supply chain more complex.
This includes the sourcing of raw materials anywhere in the world to safety testings contracted out to third parties in China and india, among others, which the inspectors admit is getting more difficult to connect the dots.
Authorities hope to pass a global initiative to place these manufacturers under careful scrutiny and hope to legislate laws to promote transparency in the drug industry, including sanctions once proven foreign drug makers faked data.
The post Inspectors Found Foreign Drug Makers Faked Data appeared first on NUTRITION CLUB CANADA.
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