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– Unreliable lab records,San Francisco Giants Ricky Romero Jersey, data at issueCanada (vancouversun.com) – The federal government has halted the importation of several drugs and drug ingredients from two Indian factories, 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,Washington Nationals Jayson Werth Jersey, 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, 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,Washington Nationals Max Scherzer Jersey, but safe enough to go down a Canadian’s throat?” asked Amir Attaran, 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, 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,St. Louis Cardinals Stephen Piscotty Jersey, coupled with India’s antiquated regulatory system, points to the need for more drastic action, such as barring all imports if the country fails to modernize its rules,Chicago Cubs Trevor Cahill Jersey, Attaran said.Health Canada said it has identified “no immediate risk” to Canadians’ health from the products,Chicago Cubs Justin Grimm Jersey, 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,St. Louis Cardinals Jonathan Broxton 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,Washington Nationals Michael Taylor Jersey, 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,” 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,Cleveland Indians Manny Ramirez Jersey, as long as they passed independent tests. |
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