IOM Says Falsified and Substandard Drugs Problem Requires Global Solution

Falsified and substandard drugs are a global problem requiring action at an international level, according to a report by the Institute of Medicine (IOM), Countering the Problem of Falsified and Substandard Drugs, which was commissioned by the FDA. The report discusses two drug failures of public health concern: substandard drugs, which do not meet the specifications given in the accepted pharmacopeia or in the manufacturer’s dossier, and falsified drugs, which carry a false representation of identity or source or both.

Fungal Meningitis Outbreak

These drug failures are not an isolated problem affecting low-income countries; in October, contaminated steroid injections caused a multistate fungal meningitis outbreak in the U.S., which struck 704 people, including 46 deaths, in 20 states. In October the CDC advised medical professionals to stop using the products in question, and the compounding company, New England Compounding Center, issued a voluntary recall of all products currently in circulation that were compounded at and distributed from its Framingham, Mass., facility.

Effects of Falsified and Substandard Drugs

While falsified and substandard drugs may contain toxic ingredients, the more common problem is that the medicine does not work, according to the report. All drugs have the potential of being compromised, but inexpensive antimicrobial drugs in low- and middle-income countries frequently contain low and erratic drug doses or are diluted, which allows the growth of resistant organisms. The report cited drug-resistant staphylococcus infections as an emerging problem in India, Latin America, and sub-Saharan Africa.

In addition, these drugs increase costs to patients and health systems: they waste money on ineffective drugs, and lingering illnesses cause decreased productivity and require workers to pay for more treatment.


The report found that the root cause of substandard drugs is a failure to adhere to good manufacturing practices. Weak regulatory systems in places like India and China, knowledge gaps in poorer countries, and high demand contribute to both substandard and falsified drugs. It also noted that in the U.S., secondary wholesalers cause drug shortages and exploit those shortages for profit, and unscrupulous wholesalers can seek out states with lower accreditation standards for their headquarters.


The IOM issued a number of recommendations to combat the problem, including that (1) governments should strengthen or establish systems to detect substandard, falsified, and unregistered medicines; (2) governments in low- and middle-income countries should provide an environment conducive to the private sector establishing quality medicines retail in underserved areas; (3) the development of a central repository for innovative detection, sampling, and analytical technologies; and (4) Congress should authorize the FDA to establish a mandatory track and trace system. The report also recommended that the World Health Assembly create a voluntary international code of practice, which would encourage international action against falsified and substandard drugs.