Jan. 20, page 25: FDA has sent more than a “handful” of warning letters to Indian drug manufacturers in the past three years. Although C&EN could not obtain an exact figure, the agency tells C&EN that in the 12 months ending Sept. 30, 2013, seven of 26 warning letters sent to foreign drug producers went to Indian firms.
Feb. 24, page 6: A story about a visit to India by FDA Commissioner Margaret A. Hamburg incorrectly quoted Helena Champion, head of the consulting firm Drug Quality Assurance, as saying the European Medicines Agency put 19 Indian companies on a noncompliance list. In fact, she said EMA has posted 30 noncompliance reports involving Indian companies since January 2010.
“Welcome to the World’s Drugstore” contains numerous inaccuracies and quotes only Indian sources and a consultant who works for them (C&EN, Jan. 20, page 25).
My survey of the U.S. Food & Drug Administration website shows that more than 25 FDA warning letters were sent in the past three years to Indian drug companies, far more than the “handful” cited in your story. In the U.S. fiscal year that ended September 2013, seven out of 26 warning letters sent to foreign companies went to India alone.
The map caption on page 26 is inaccurate. FDA does not approve manufacturing plants—it approves an application for a specific drug at a specific plant after inspection. India might have many FDA registrations, but it has relatively few plants with successful FDA or European inspections.
The number of FDA warning letters for India and China understates quality problems for multiple reasons: Foreign inspections occur less frequently because they cost more, some foreign plants won’t allow FDA to inspect, and some avoid inspection by not registering.
The European Medicines Agency (EMA) lists 30 Indian and 19 Chinese drug companies on its Good Manufacturing Practices (GMP) noncompliance list out of 70 noncompliant companies worldwide as of the past three years. This designation is just as serious as receiving an FDA warning letter. The EMA list includes many companies not inspected by FDA owing to cooperation to avoid duplication of effort.
GMP failures by Indian (and Chinese) companies are serious and include such inadequacies as not following procedures to protect injectable drugs from contamination, data falsification, and fabrication (for example, underreporting microbiological contamination, recording false results, retesting failing products until passing results occur, and falsifying data concerning manufacturing and testing).
If a manufacturer falsifies or fabricates manufacturing and testing data and does not follow approved procedures, the product may not be safe and effective. If an antibiotic doesn’t work as intended or an injectable drug is not sterile, a patient could suffer. A generic drug that should be equivalent to the original drug may not be.
Anecdotally, my dog was treated three times for Lyme disease. The veterinarian dispensed Ranbaxy Laboratories drugs, but she didn’t know whether they came from one of the four Ranbaxy plants in India recently barred from exporting drugs to the U.S. as a result of data falsification.