Richard T
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- Mar 25, 2018
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No they do not regulate them effectively. It helps, but there are still quality concerns. Below is an article where the FDA found serious lies at their India plant. Wondering how many they did not find?The key with generics is the regulation and the price. If India makes them cheaper, that is a good thing, but the manufacturing process and final product have to be regulated. Both the EU and the FDA, on behalf of the USA, do this quite effectively. Reshoring generic production will only add to costs. Stockpiling is an answer to the wartime scenario, these things are not space intensive.
The Massive Failures of India’s Drug Regulatory System
Recurring exposés reveal massive gaps in drug safety in India’s pharma industry, as regulatory failures, lax laws, loopholes and lobbying leave millions in India, Southasia and the world at risk In...
FDA warning letter reveals quality control, data integrity issues at Viatris plant in India
Following Viatris’ December announcement that a manufacturing plant in India had been written up by the FDA, a document published by the U.S. | Following Viatris’ December announcement that a manufacturing plant in India had been written up by the FDA, a document published by the U.S. regulator...
Not All Generics Are Created Equal: Study Exposes a 54% Higher Risk in Indian-Made Drugs
A new study reveals that generic drugs made in India are linked to a significantly higher number of severe adverse events, including hospitalizations and deaths, compared to their U.S.-made counterparts. Researchers uncovered this by matching drugs to their specific manufacturing plants, somethin
scitechdaily.com
Stockpiling is good, but all drugs have expiry dates. Drug manufacturing is fairly automated. We should bring more manufacturing back in this area for security and for safety. We need an FDA that is funded though of course.
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