The Wall Street Journal, Asian edition, on February 17, 2014 had an article written by Gardiner Harris from New Delhi titled “Medicines from India set off safety fears”. This is a hotly debated issue. On the one side, India’s pharmaceutical industry is coming under scrutiny from American regulators looking into prescription drugs. The concern for the American consumer is whether or not there are “safety lapses, falsified drug testing results and the sale of fake medications”. From the American Food and Drug Administration comes an “unease” because of a “handful of pharmaceutical firms” with “recent lapses in quality” according to Dr. Margaret Hamburg. From India, a top drug regulator, Mr. G. N. Singh, was quoted as saying at an interview “If I have to follow U.S. standards in inspecting facilities supplying to the Indian market, we will have to shut down almost all of those.”
One quote stated that during an inspection a pharmaceutical company was “repeatedly been lying to the F.D.A. and found to have conditions such as flies “two numerous to count” in critical plant areas, according to the article. Several drugs were listed as being of concern. They included the “acne drug Accutane, the pain reducing drug Neurontin and the antibiotic Cipro”.
Apparently, “one widely used antibiotic was found to contain no active ingredient after being randomly tested in a government lab.”
India is concerned that a few “bad apples” in the Indian pharmaceutical industry and questionable motives behind the F.D.A. may be painting an inappropriate tarnished view of the situation overseas. Mr. Singh has “warned in meetings with the F.D.A. of the risk of overregulation.”
Indian drug companies “estimate that routine F.D.A. inspections add about 25% to overall costs.”
The problem is likely not isolated to India, as you can well imagine. “China is the source of some of the largest counterfeit manufacturing operations that we find globally,” said John P. Clark, Pfizer’s chief security officer.
Folks from India say the F.D.A. motives are to boost sales of drugs within the U.S.A.
Bottom line: Buyer beware. Consumers be prudent. Patients be cautious.