In Thursday's Post, this column brought up recent investigations into the growing problem of counterfeit prescription and over-the-counter drugs.
Specifically, recent cases of fake drugs originating in India and intended for retail sale in the United States were mentioned.
More than 40 percent of the generic drugs sold in the United States this year will originate in India. An estimated $15 billion worth of drugs will be manufactured in 200 different factories that are approved by the FDA to manufacture generics.
In 2013, the Food and Drug Administration approved a little more than 300 Abbreviated New Drug Applications (ANDA's) and more than 110 of those originated with Indian owned companies.
According to some reported estimates from authorities including the World Health Organization, as many as 20 percent of the drugs manufactured in India are fake. Similar reports estimate that for China the fake drugs may be as high as 10 percent. Since only a portion of the counterfeits are discovered, these estimates may be substantially lower than the actual numbers.
While some manufacturers in these countries are exceptionally modern and rival any plant found in the United States or Europe, others are far less sophisticated.
The recent technology boom that has provided opportunities for drug counterfeiters to create bogus labels, including the ability to fake holograms and other sophisticated labeling techniques, makes it very difficult to prevent all fake drugs from reaching the market.
A number of companies in India have been found to be falsifying safety data to avoid fines and delays in getting their products into the U.S. market. Others have been caught generating counterfeit drugs.
As recently as last month the commissioner of the Food and Drug Administration, Dr. Margaret A. Hamburg, made a personal visit to India to communicate the seriousness of the concern that the FDA now has regarding drug manufacturing safety concerns. Regulators are now swarming throughout India in an effort to reign in the corrupt practices.
For the vast majority of consumers in the United States, currently there is little risk that fake drugs will be passed over the counter. However, it is important to realize that there is a growing problem with fake pharmaceuticals and consumers should take certain steps to minimize their risk.
There will always necessarily be a significant element of trust involved with the purchase of drugs. For example, when you make a purchase of a prescription at XYZ Pharmacy, you may not actually know where they import their generic drugs from.
A pharmacy may fill your prescription with pills made by AJAX company in India today and switch them with pills made by ACME company in China next month because they can save money, or perhaps one company is able to ship on time and the other isn't. Distributors and retailers may switch suppliers routinely without informing consumers.
Cheap generic drugs are imported from many countries other than India and China. Mexico, Poland, United Arab Emirates and other countries have also begin to receive closer scrutiny by the FDA.
However, considering that many popular drugs will soon be coming off patent and therefore flood into the generic market, there is considerable concern that regulatory resources may be insufficient to match the growing need for oversight.
If you elect to take a chance on internet drugs, your risk increases dramatically. Regulators estimate that as many as 50 percent of drugs now sold over the internet are fakes or poorly controlled adulterated or diluted versions of the real thing.
In other countries your risk of getting a fake are considerable as well. If you will be traveling, take your medications with you and avoid buying from unknown sources.
Recall from a previous column that generics may have up to 20 percent less or 20 percent more release of the active ingredient. There are also acceptable variations in the actual timing of release of the active ingredient and bioavailability.
If you notice that you do not respond to medications in the way that you have previously, you should contact your primary care provider to discuss the problem.