Analyse der Proben aus Hyderabad im Labor in Leipzig

Global Risk Deadly Superbugs from Pharmaceutical Factories

Stand: 01.07.2018 17:16 Uhr

Pharmaceutical manufacturers appear to be contributing to the development and global spread of dangerous, multidrug-resistant pathogens. This reveal the broadcasters NDR and WDR together with the daily "Süddeutsche Zeitung".

Large pharmaceutical manufacturers appear to be contributing to the development and global spread of dangerous, multidrug-resistant pathogens, according to reporting by German broadcasters NDR and WDR together with the daily "Süddeutsche Zeitung". In conjunction with an infectious disease specialist from the University Hospital in Leipzig, reporters took samples from bodies of water surrounding pharmaceutical factories in the city of Hyderabad in India. Our reporting found that almost all large German generic drugs manufacturers, including Ratiopharm, Hexal, 1A Pharma and Stada, produce active pharmaceutical ingredients in the city.

Extreme Pollution from Pharmaceutical Industry Wastewater

The scientists and reporters involved undertook an investigation of suspicions that pharmaceutical factories were illegally disposing of significant quantities of antibiotics. The samples were taken in November 2016 and tested by the Institute for Biomedical and Pharmaceutical Research (IBMP) in Nuremberg for residue from a total of 25 different drugs. The results of that analysis have further fueled the suspicions.

Probennahme an einem See in Hyderabad
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The samples were taken in Hyderabad.

Scientists found concentrations of antibiotics in some of the bodies of water that were several hundred times, or even several thousand times, higher than the levels predicted to select for resistance. Renowned Swedish environmental pharmacologist Joakim Larsson says that many of the measured values are so high that industrial wastewater is the only reasonable explanation.

Antibiotics in the Environment Are a "Time Bomb"

The head of IBMP, Fritz Sörgel, says the findings represent a "time bomb." When antibiotics find their way into the environment, he says, bacteria living there develop defense mechanisms to protect themselves from the substances. In the Leipzig university hospital’s microbiology institute, researchers were able to isolate dangerous, multidrug-resistant pathogens in all of the samples. That, says Lübbert, is extremely alarming - particularly because bacteria don't stay in one place. They spread.

Drug-Resistant Pathogens Are Spreading Around the World

Medical doctors such as Dr. Lübbert say they are encountering an increasing number of patients who bring home drug-resistant bacteria from abroad and many of the pathogens can potentially lead to harmful infections. Operations and chemotherapy likewise present an extreme risk in cases where antibiotics are no longer effective against the highly resistant bacteria. The World Health Organization (WHO) has identified multidrug-resistant pathogens as one of the most acute threats facing global health. Already, some 700,000 people around the world die each year from infections against which medicines have no effect.

Christoph Lübbert, Fritz Sörgel (Mitte) und Christine Adelhardt
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The head of IBMP, Fritz Sörgel (m.), says the findings represent a "time bomb."

Pharmaceutical Companies Point to Standards and Monitoring

It is estimated that at least 80 to 90 percent of all antibiotics are now produced in China and India. According to reporting by NDR, WDR and the "Süddeutsche Zeitung", almost all large German pharmaceutical companies are supplied with antibiotics and antifungal medications from Hyderabad. All of them, however, declined requests for interviews.

Stada as well as Teva, Ratiopharm's parent company, confirmed in writing that they receive antibiotics from the Indian metropolis, but declined to name their suppliers. Sandoz, which belongs to Novartis, as does Hexal and 1A Pharma, continues to operate its own production sites in Austria and Slovenia. In response to our query, a company spokeswoman replied that 90 percent of its antibiotic agents come from those sites but added that they also had other suppliers. "Regardless of who these suppliers are and where they are located, our same standards are applied worldwide," the Sandoz/Hexal spokeswoman said. Other companies also referred to applicable standards and to their own monitoring or to inspections carried out by the authorities responsible.

Association Criticizes Pricing Pressures

The pharmaceuticals production association Pro Generika responded by saying it had issued a public warning several months ago pertaining to Germany's dependence "that has developed due to the extremely high share of production of antibiotic agents outside of the EU" and to the associated risks. The companies are demanding a debate focusing on the low prices charged for antibiotics, which can be as cheap as just a few cents per daily dose. "At this price level, the costs of production in Germany or the EU cannot be covered," Pro Generika writes. The association is critical of public health insurance companies, which, it says, only reward rebate contracts based on the lowest price. Instead, the association says, they should also consider social and environmental factors.

Public health insurance companies reject the criticism, saying they are bound by law to operate efficiently. Barmer, one of Germany's largest health insurance providers, writes that it expects its contractual partners - the pharmaceutical companies - to maintain strict environmental standards. Barmer adds that the producers and government authorities are responsible for monitoring compliance, adding that insurance companies are not able to do so. The company says it is "alarming if production conditions exist somewhere in the world that worsen the problem of antibiotics resistance in the short or long term."

Federal Environment Agency Demands Strengthening of EU Regulations

Germany's Federal Environment Agency (UBA) is demanding the expansion of the European Union's "Good Manufacturing Practice" (GMP) guidelines. All producers of drugs and active pharmaceutical ingredients that import their products to Europe must adhere to the GMP guidelines. Their fulfillment is monitored by European agencies which perform on-site inspections at factories - such as those in India. Every few months, German GMP inspectors likewise travel to Hyderabad. But the focus is exclusively on the quality of the pharmaceutical products being produced and the protection of EU consumers. Environmental factors do not play a role. Indeed, inspectors are currently not allowed to scrutinize the disposal of wastewater due to the lack of a legal framework for doing so. UBA is thus demanding that environmental criteria be included in the GMP guidelines, a proposal already made by the Swedish government several years ago.

Handeslwege der Pharma-Produzenten in Indien
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Hyderabad is one of the biggest centers for drug manufacturers.

Health Minister: "Urgent need" to develop environmental standards

German Health Minister Hermann Gröhe, of the conservative Christian Democrats (CDU), stresses there is an "urgent need" to develop industry and environmental standards and to monitor them locally. Companies everywhere must not be allowed to pollute water with harmful substances, he says, adding that it is important to work toward that goal within international bodies. "It is imperative that pharmaceutical companies process their waste water accordingly - everywhere, including in developing nations."

But Gröhe does not believe that tightening GMP guidelines is the appropriate method for doing so because drug agency inspectors, he says, do not possess the necessary expertise. Furthermore, he says, the focus should be on talks with countries from which the majority of the medications originate at venues such as the upcoming G-20 summit, among others. Gröhe says that "wagging fingers at others" and threatening pharmaceutical producers with exclusion from the European market will not solve the problem. India and China, he says, "must recognize their own self-interest in not endangering the effectiveness of the medical care provided to their large populations."

Indian Producers Deny Responsibility

Most Indian producers declined to respond to several written requests for comment. Only very few companies replied, including MSN, an important supplier of German pharmaceutical corporations. In samples taken in the immediate vicinity of two of the company's factories, researchers found high concentrations of pharmaceuticals. MSN denies responsibility for these concentrations and has expressed skepticism regarding the test results. Other companies likewise stated that it was impossible that the substances discovered originated in their factories, claiming that they did not release wastewater into the environment.Hyderabad, meanwhile, celebrates itself as the "Pharma Capital of India" and plays host to over 200 producers. And it has found an apt slogan for one of its promotional videos: "Minimum Inspection, Maximum Facilitation."

The documentary "Der unsichtbare Feind - Tödliche Supererreger aus Pharmafabriken" ("The Invisible Enemy: Deadly Superbugs from Pharmaceutical Factories") will be aired at 10:45 p.m. CET on May 8, 2017 on ARD.

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