| If good manufacturing standards are followed, abortion pills are as safe as many other commonly available drugs, clinical evidence shows. But the consequences of taking a poorly made pill — one that doesn't have enough active ingredient, for example — can be dire. Particularly in low-income countries, where the abortion drug misoprostol is also used to prevent hemorrhaging after childbirth, taking a product that fails to stop bleeding can be fatal. There are many high-quality manufacturers of the medicine. But in a Bloomberg investigation[[[LINK]]] my colleagues and I found that one of the major distributors of abortion pills to low-income countries is buying a fifth of its products from a company with a record of making substandard drugs. DKT International, a Washington DC-based nonprofit with major donors like the Bill & Melinda Gates Foundation, relies on Synokem Pharmaceuticals, headquartered in Delhi, as a key supplier. That's in part because the company's drugs are cheaper than alternatives vetted by stricter regulators such as the US Food and Drug Administration. But more than 30 samples of drugs made by the manufacturer — including generic abortion pills, an antibiotic and anti-seizure medicines — have failed quality tests conducted by Indian regulators and public health researchers since 2018, according to government records and data reviewed by Bloomberg News. The samples contained impurities, lacked the right amount of active ingredient or failed to meet other international standards designed to ensure that medicine is safe and effective, the records show. Chris Purdy, DKT's chief executive officer, said his organization takes quality seriously and that DKT has not received any complaints from pharmacies, hospitals or other customers.
Some DKT abortion pills made by Synokem are now entering the US even though they haven't been approved by the FDA. The medication is being purchased through underground online pharmacies unaffiliated with DKT, as court rulings and new laws restricting access to abortions force women to look elsewhere. Synokem abortion pills haven't been linked directly to any deaths or serious injuries. But the company's product failures, all detected after the drugs had been sold to pharmacies and other distributors, suggest the company's internal quality assurance system is not working, medical experts told us. DKT's willingness to buy medicine from a company that has repeatedly failed quality tests highlights a key weakness in the world's drug supply chain: There's always a buyer lined up if the price is low enough, and those who make dangerous or ineffective drugs rarely face serious penalties. Bloomberg Investigations is digging into medicine quality as part of an ongoing series (sign up for updates here). We'd love to hear from you if there are issues you think we should be reporting on. You can reach us at badmedicine@bloomberg.net — Kendall Taggart[[[ADD BIO LINK]]] | 
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