India-sourced drugs run afoul of FDA, Health Canada

A messy situation is getting messier for Indian manufacturers, in particular those producing generics for export. On Sept. 22, FDA added more drugs from Apotex’ Bangalore, India, facility to ongoing “detention without physical examination” restrictions; in effect, these Apotex drugs are banned from importation. That action motivated Health Canada to do more or less the same, even though it had given Apotex an all-clear in an inspection earlier this year. “Health Canada last inspected the [Bangalore] facility in February 2014 with an international regulatory partner. The visit resulted in a compliant rating. The FDA had issued a compliant rating to the same facility following its own inspection in 2013,” said Health Canada in a Sept. 24 statement. However, that import ban was preceded by an increasingly contentious debate in Canada’s Parliament, since FDA’s inspection of the same facility in June resulted in a warning letter citing numerous deficiencies in quality assurance and recordkeeping. "Health Canada is not on top of drug safety," the Toronoto Star quoted a government minister saying.

Also this week, Roger Bate, a visiting scholar at the American Enterprise Institute, and collaborators from academic centers in the US and Canada, stepped up their ongoing examination of the Indian pharmaceutical industry. A new study, “Poor Quality Drugs and Global Trade: A Pilot Study,” published by the National Bureau of Economic Research, looked at a cross-section of antibiotics and tuberculosis drugs manufactured by 17 different firms in India, and then collected and analyzed from locations from several Africa nations, China, Russia, Turkey, Brazil and elsewhere. Drugs were purchased with legitimate prescriptions from apparently legitimate pharmacies (this collecting and analysis is part of ongoing work Bate and others have done to study counterfeit or substandard medicines around the world.)

Lab analysis shows that drug quality varies based on the amount of active API in the samples; the lowest-quality products tended to be gathered in Africa; and drugs exported to non-African nations exceeded even the quality of drugs gathered inside India. “One likely explanation is that Indian pharmaceutical firms and/or their export intermediaries do indeed differentiate drug quality according to the destination of consumption,” the report concludes.

Apotex’s woes have been going on for years with FDA—the Toronto-based company lost a suit filed under the North American Free Trade Agreement that claimed that Apotex’s products were unfairly being restricted from the US market. But it is by no means alone; Ranbaxy, Wockhardt and Sun Pharmaceuticals are among those recently tagged by FDA warning letters and restrictions. Various Indian officials have claimed that the country’s industry is being unfairly targeted, but the warning letters from FDA keep coming.