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– Unreliable lab records, data at issueCanada (vancouversun.com) – The federal government has halted the importation of several drugs and drug ingredients from two Indian factories,Penn State Nittany Lions Jerseys, as concern grows about Canadian health products sourced in the burgeoning South Asian pharmaceutical industry.Health Canada said another government had passed on worries about “data integrity” at the plants, and Canadian importers – mostly generic pharmaceutical companies – agreed to quarantine the products indefinitely.The 16 affected medicines range from blood-pressure pills to chemotherapy drugs,Joe Paterno Penn Jersey, anti-psychotics and opioid painkillers.But one expert on pharmaceutical regulation is questioning why Health Canada has not blocked the sale of those medicines that had arrived on shelves earlier from the factories.“How can the product be too dangerous to import,Carmelo Anthony Syracuse Jersey, but safe enough to go down a Canadian’s throat?” asked Amir Attaran,Melvin Gordon Wisconsin Jersey, Canada research chair in law and population health at the University of Ottawa. “This makes no sense. … What about the doses already sitting in warehouses,Tavon Austin West Virginia Jersey, what about the doses already sitting on pharmacy shelves?”He said the integrity problems could range from relatively innocuous data-entry shortcomings to clearly fraudulent behaviour – such as fudging results on drug-stability tests.Canada’s increasing use of Indian-made medications,Karl Joseph West Virginia Jersey, coupled with India’s antiquated regulatory system,LaMarcus Aldridge Texas Jersey, points to the need for more drastic action, such as barring all imports if the country fails to modernize its rules, Attaran said.Health Canada said it has identified “no immediate risk” to Canadians’ health from the products, and urged patients not to change their medication without consulting their doctors.A spokesman said the data-integrity issues ranged from the spectrum of poor record keeping to intentional falsification,Jalen Hurd Tennessee Jersey, calling into question the reliability of lab data the facilities provided to regulators.Health Canada says it has engaged provinces and territories to share information on the situation. A newspaper in India reported that inspectors from the U.S. Food and Drug Administration had earlier found problems at the plants – Dr. Reddy’s Laboratories in Srikakulam and IPCA Laboratories in Pithampur.Health Canada quietly posted a notice about the voluntary quarantine of products from the factories two days before Christmas.The importers were 11 generic pharmaceutical companies, including giants Teva Canada and Sandoz Canada.Officials for either Dr. Reddy’s or IPCA could not be reached for comment. A spokesman for Dr. Reddy was quoted in India as saying the flagged products “pose no risk to the health and safety of the Canadian people,Rod Wilks Tennessee Jersey,” and that the company is working to resolve the issue.An IPCA factory and two owned by Canada’s Apotex in India were subject to a similar ban announced in September. The government later allowed the drugs through, as long as they passed independent tests. |
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