Safety Issues about drugs from India

[Paul Edwards]

With the high cost of cancer drugs that are not covered by the Australian Pharmaceutical Benefits Scheme, some patients are getting prescriptions filled by Indian Online Pharmacies.

 

A recent article in the New York Times raises concerns about drugs from India.

 

The article reported that the United States Food and Drug Administration is conducting increased scrutiny of drugs made in India following lapses in quality, falsified drug test results and selling fake medicines.

 

“India’s drug industry is one of the country’s most important economic engines, exporting $15 billion in products annually, and some of its factories are world-class, virtually undistinguishable from their counterparts in the West. But others suffer from serious quality control problems. The World Health Organization estimated that one in five drugs made in India are fakes. A 2010 survey of New Delhi pharmacies found that 12 percent of sampled drugs were spurious.”

 

Under US laws a drug must meet the requirements as to safety and must have the identity and strength, and have meet the quality and purity characteristics, which the drug purports or is represented to possess.   Last year Ranbaxy, one of India’s biggest drug manufacturers, pleaded guilty to charges brought by the US FDA including adulterated drugs and paid a $500 million fine.

 

One of the breaches by Ranbaxy was that supposed sterile environments in which drugs were being produced were contaminated with flies “too numerous to count”.

 

The article also tells the story of how the Uganda Cancer Institute stopped buying cancer drugs from India because it had received shipments of drugs that turned out to be counterfeit and inactive.  “Chemotherapy patients... showed none of the expected responses to the drugs and ... had none of the usual side effects.”