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Knowing where all our ingredients come from is the first step toward improving drug quality.
Medicines have to pass through a rigorous series of clinical trials to prove their efficacy and safety; by bypassing systems that are in place, the manufacturers of counterfeit medicines are not only illegally profiting from others' endeavors--they are also putting patients' lives at risk.
The Avandia issue has shed light on important issues in FDA regulation, including politics and regulating the practice of medicine.
Counterfeit drugs have contaminated India's pharmaceutical supply, putting the entire Indian medical system at risk, and can only be stopped by a broader political effort.
Policies enacted over the last few decades have systematically eroded the ability of manufacturers to earn returns on certain drugs, especially older parenteral drugs sold as generics. We need to reform the policies governing these markets if we're going to lure investment back into these important areas.
Worldwide attention by regulatory authorities on the contribution of genetic factors to drug response has increased. This is reflected by a developing regulatory framework that facilitates PGx integration into drug development such as Voluntary Exploratory Data Submissions in the USA and Japan, as well as the more recent, formal biomarker qualification by the regulators.
New research indicates that many drugs bought by developed-world governments and NGOs fail crucial quality tests.
Drugs purchased by government aid agencies and NGOs using taxpayer dollars are often substandard and dangerous.





