This summer ended with one recall after the next for Indian pharmaceutical companies that export generic drugs to the United States.
Three of India’s most well known pharmaceutical companies have voluntarily recalled at least four drugs in a little over a month – one for dry eyes, a steroid treatment, a urinary tract infection medication and another drug used to treat Parkinson’s disease. Of the three, Aurobindo has voluntarily recalled two drugs in August and September. The other pharmaceutical companies to recall were Zydus Lifesciences and Sun Pharmaceuticals.
Last month, Sun Pharmaceuticals said it would recall 69,707 cartons of Cequa (cyclosporine ophthalmic solution) from the U.S. market, a droplet used to treat dry eye syndrome.
The company’s U.S. subsidiary said it was voluntarily recalling the product because it was not as potent as it should be. The FDA classified the recall as a Class III recall, meaning it is unlikely to cause harm.
But this is not exactly welcome news. This past April, eye drop medication imported from India from a company called EzriCare was contaminated with enough bacteria to cause blindness in some people. There were numerous news reports about this at the time. The FDA was quick to warn consumers against taking EzriCare product, known as Artificial Tears. This would have been a Class I recall, which means the product is dangerous and ineffective and probable to cause harm.
Meanwhile, Aurobindo Pharma is recalling 9,890 bottles of Rasagiline Tablets, a medication indicated for the treatment of Parkinson's disease, due to "failed dissolution specifications", the FDA said.
The FDA has classified the Parkinson’s drug recall as a Class II risk, meaning it might cause a temporary health problem, and can pose a slight threat of a serious nature.
Just two weeks ago, Aurobindo said that 1,626 vials of Triamcinolone Acetonide Injectable Suspension, a generic corticosteroid, should not be used. The medication was recalled by Eugia US, a subsidiary of Aurobindo here.
Also last month, Zydus Pharmaceuticals, the U.S. arm of Indian generic drugs lab Zydus Lifesciences voluntarily recalled 7,248 bottles of Oxybutynin pills, used mainly to treat urinary conditions. Zydus found that the pill did not dissolve properly. The medication was made in India and distributed in the U.S. by Zydus Pharmaceuticals.
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Earlier this year, CPA’s economics team did a report about America’s increasing dependence on imports, stating, “U.S. dependence on India for widely-used generic pharmaceuticals creates serious risks to national security and patient safety.”
Pharmaceutical imports are one of the main sources of the U.S. trade deficit and is categorically the biggest goods deficit month after month. Generic drug imports come mostly from China, India and Mexico, with branded drugs coming from Europe. India leads on generics, but China is gaining fast and dominates some segments entirely. (For example, China now accounts for 95 percent of imports of ibuprofen and 91 percent of imports of hydrocortisone.)
Generic drugs, like the ones recalled above, account for 90% of all prescriptions written in the U.S.
The FDA often faces a conundrum of allowing for the import of medication from labs that have failed inspection, or risk supply shortages due to placing restrictions on those labs. The FDA is also dependent on those foreign labs acting in good faith and recalling faulty products.
In March, FDA Commissioner Dr. Robert Califf told the House Appropriations Committee that he is “very concerned” about America’s current dependence on other countries for everyday medications—and that reshoring of domestic drug production must be part of the solution.
We are a group of doctors, patients, health care industry experts, and advocates fighting to ensure all generic medicines are safe, affordable, and always available. Unsafe generic drugs from foreign manufacturers in China and India have been sold in the U.S that have been contaminated with carcinogens and fake ingredients, fall apart when tested, and don’t work as they should. We are fighting back to ensure all generic medicines are safe, affordable, and always available. We want every American to be able to trust the generics they take—every pill, every vial, every time.