If tweets were indicative of general option, then the recall of blood pressure medications is owing to faulty manufacturing practices in China. However, this recall is only part of a far bigger problem in the global pharmaceutical industry: contamination of active ingredients/drugs and not following good manufacturing practices (GMP). As we will see from Bloomberg's investigative pieces, the issue is also not restricted to production in China. Several production facilities in neighbouring India had/have substandard laboratory practices, which came to light during the Food & Drug Administration (FDA) inspections.- In 2016, Hetero Labs Ltd./Camber Pharmaceuticals Inc. was found following substandard GMP for cleaning and maintaining equipment and having products with potential carcinogens. Two months ago, they too detected a potential carcinogen in their losartan batches.
- In 2017, employees at Dr Reddy’s Laboratories Ltd. plant in Andhra Pradesh were caught destroying computer files and documents (suspected to be relating to the production process).
- Ranbaxy Laboratories Ltd was found to have falsified data at two factories and was fined $500 million by the US Justice Department.
Such examples being from India and China, there arises an argument for boycotting products manufactured in such countries. However, the problem of contaminated drugs and bad GMP is not restricted to the economic South.
- In 2016, an inspection by the FDA found that production staff at the West Virginian facilities of Mylan (the second largest producer of generics) had recorded passing scores for drugs that failed tests and had destroyed documents (again relating to the production process). In 2018, they found evidence of bad manufacturing practices.
- Illinois-based Akorn was found to have submitted falsified data to the FDA when requesting an approval of their generic version of the antibiotic azithromycin. In addition, they did not follow good GMP, particularly in following cleaning, testing, and storage procedures for ensuring drugs are not contaminated.
This then leads to a potential hypothesis that the problem has to do with the manufacturers of generics. However, brand names are not immune, as seen when Pfizer Inc.'s Hospira facility in Tamil Nadu recorded wrong (passing) data regarding the quality of some active ingredients. When these failed when retested in front of FDA inspectors, Pfizer paused manufacturing and later ceased production due to "significant long-term loss of product demand".
Thus, the problem of contaminated drugs and active ingredients is not one specific to manufacturing in certain countries or the nature of the manufacturer (generics or brand name). How then can the problem be solved? The three remaining blog posts of this series will offer pointers to the main stakeholders concerned: regulators, pharmaceuticals, and the general public.
Sources:
https://www.bloomberg.com/news/articles/2019-03-27/tainted-generic-drugs-force-fda-to-tighten-safety-regulations
https://www.bloomberg.com/news/articles/2019-03-01/third-potential-carcinogen-found-in-blood-pressure-drugs
https://www.bloomberg.com/news/features/2019-01-31/culture-of-bending-rules-in-india-challenges-u-s-drug-agency
https://www.bloomberg.com/news/features/2019-01-30/chinese-heart-drug-valsartan-recall-shows-fda-inspection-limits
https://www.bloomberg.com/news/features/2019-01-29/america-s-love-affair-with-cheap-drugs-has-a-hidden-cost
https://www.bloomberg.com/news/articles/2018-08-09/red-flags-raised-at-chinese-heart-drug-maker-year-before-recall
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