Industrial pollution from Indian pharmaceutical companies making medicines for nearly all the world’s major drug companies is fuelling the creation of deadly superbugs, suggests new research. Global health authorities have no regulations in place to stop this happening.
A major study published this week in the prestigious scientific journal Infection found “excessively high” levels of antibiotic and antifungal drug residue in water sources in and around a major drug production hub in Hyderabad, as well as high levels of bacteria and fungi resistant to those drugs. Scientists told the Bureau the quantities found meant they believe the drug residues must have originated from pharmaceutical factories.
The presence of drug residues in the natural environment allows the microbes living there to build up resistance to the ingredients in the medicines that are supposed to kill them, turning them into what we call superbugs. The resistant microbes travel easily and have multiplied in huge numbers all over the world, creating a grave public health emergency that is already thought to kill hundreds of thousands of people a year.
When antimicrobial drugs stop working common infections can become fatal, and scientists and public health leaders say the worsening problem of antibiotic resistance (also known as AMR) could reverse half a century of medical progress if the world does not act fast. Yet while policies are being put into place to counter the overuse and misuse of drugs which has propelled the crisis, international regulators are allowing dirty drug production methods to continue unchecked.
Global authorities like the Food and Drug Administration and the European Medicines Agency strictly regulate drug supply chains in terms of drug safety – but environmental standards do not feature in their rulebook. Drug producers must adhere to Good Manufacturing Practices guidelines - but those guidelines do not cover pollution.
Even the World Health Organisation – a global public health body which has repeatedly called for concerted international action to tackle the dangerous threat of antibiotic resistance – buys antibiotics from companies whose drug ingredients are made in Hyderabad without carrying out environmental checks.
The international bodies say the governments of the countries where the drugs are made are the ones responsible for stopping pollution – but domestic legislation is having little impact on the ground, say the study’s authors. The lack of international regulation must be addressed, they argue, highlighting the grave public health threat faced by antibiotic resistance as well as the rampant global spread of superbugs from India, which has become an epicentre of the crisis.
‘Unprecedented antimicrobial drug contamination’
A group of scientists based at the University of Leipzig worked with German journalists to take an in-depth look at pharmaceutical pollution in Hyderabad, where 50% of India’s drug exports are produced. A fifth of the world’s generic drugs are produced in India, with factories based in Hyderabad supplying Big Pharma and public health authorities like World Health Organisation with millions of tons of antibiotics and antifungals each year.
The researchers tested 28 water samples in and around the Patancheru-Bollaram Industrial zone on the outskirts of the city, where more than than 30 drug manufacturing companies supplying nearly all the world’s major drug companies are based. Thousands of tons of pharmaceutical waste are produced by the factories each day, the paper says.
Almost all the samples contained bacteria and fungi resistant to multiple drugs (known as MDR pathogens, the technical name for superbugs). Researchers then tested 16 of the samples for drug residues and found 13 of them were contaminated with antibiotics and antifungals. Previous studies have shown how exposure to antibiotics and antifungals in the environment causes bacteria and fungi to develop immunity to those drugs.
Environmental pollution and poor management of wastewater in Hyderabad is causing “unprecedented antimicrobial drug contamination” of surrounding water sources, conclude the researchers - contamination which appears to be driving the creation and spread of dangerous superbugs which have spread across the world. Combined with the mass misuse of antibiotics and poor sanitation, superbugs are already having severe consequences in India - an estimated 56,000 newborn babies die from resistant infections there each year.
German broadcaster NDR, which contributed to the study, identified 19 companies operating inside the area tested as suppliers of antibiotics to the European market. Of those 19, the Bureau has identified at least four companies which supply the UK and five which supply the US.
The companies in question strongly deny that their factories pollute the environment, and the sheer number of factories operating in Hyderabad means it is impossible to identify exactly which companies are responsible for the contamination found in the samples tested.
What is clear is one of the world’s biggest drug production hubs is producing dangerous levels of pharmaceutical pollution, and the international bodies tasked with ensuring drug safety are doing little to address it.
Health regulators have to take action, said Professor Ramanan Laxminarayan, director of the Center for Disease Dynamics, Economics & Policy and a leading voice on antibiotic resistance. “We need to take environmental contamination from bulk manufacturing facilities seriously and put an immediate end to the practice,” he said. “This should be a part of GMP without question and pharmaceutical companies throughout the world should be subject to an audit to ensure that they are compliant with what the industry has promised to do.”
The densely populated and increasingly prosperous city of Hyderabad in southern India was once an international trading centre for diamonds and pearls. Today, it is a major international hub for the pharmaceutical and biotech industries, producing millions of tons of medicines, chemicals and pesticides each year.
Around 170 companies making bulk drugs like antibiotics operate in and around Hyderabad, the majority clustered in sprawling industrial estates along the banks of the Musi river. Companies in Europe and the US, as well as health authorities like WHO and the UK’s NHS are reliant on drugs being produced in these factories.
The area has long been criticised for its pollution, which has continued unabated despite decades of campaigning by Indian NGOs, say the report authors. In 2009 the Patancheru-Bollaram zone was classified as “critically polluted” in India’s national pollution index and construction in the area was banned. But the government relaxed the rules in 2014 and building was allowed to begin again.
Last year India’s Supreme Court ordered the country’s pharmaceutical companies to operate a zero liquid waste policy, but “massive violations” have reportedly occurred, says the Infection report.
As India’s drug production industry has grown, so has the prevalence of superbugs – a national crisis intensified by the widespread overuse and misuse of antibiotics, which are easily bought over the counter, and poor sanitation Alongside the creation of individual superbugs, genes and enzymes have developed which can pass between multiple types of bacteria, making them resistant to drugs.
India has become the epicentre of the global drug resistance crisis, with 56,000 newborn Indian babies estimated to die each year from drug-resistant blood infections, and 70% to 90% of people who travel to India returning home with multi-drug-resistant bacteria in their gut, according to the study.
The bacteria can remain in the gut without causing problems, but if they travel from there into a patient’s bloodstream or urinary tract they can cause serious infections. They can also pass on resistance to other bacteria in the gut - so if a patient gets food poisoning the bacteria that caused it could acquire the resistance and become hard to treat.
Many previous studies have highlighted pharmaceutical pollution in India and China - which together produce most of the world’s antibiotics – and shown how such pollution fuels the proliferation of superbugs worldwide. The authors of the new Infection study set out to provide a detailed picture of the levels and types of pollution in Hyderabad and its links to drug resistance.
Researchers took water samples from rivers, lakes, groundwater, drinking water and surface water from rural and urban areas in and around the industrial estate, as well as pools near factories and water sources contaminated by sewage treatment plants. Four were taken from taps, one from a borehole, and the remaining 23 were classed as environmental samples.
The samples were tested for bacteria resistant to multiple drugs (known as MDR pathogens, the technical name for superbugs). The researchers then tested 16 of the samples for the antibiotics and antifungals used to treat infections.
All samples apart from one taken from tap water at a four star hotel were found to contain drug-resistant bacteria. All 23 environmental samples contained carbapenemase-producing bacteria - a group of bugs dubbed the “nightmare bacteria” because they are virtually untreatable and kill 40-50% of people whose blood gets infected with them.
Of the 16 samples then tested for drug residue, 13 were found to be contaminated with antibiotics and antifungals, some in disturbingly high levels. The researchers compared the levels of residue to limits recommended by leading microbiologists; once levels exceed those limits it is likely that superbugs will develop.
A sample taken from one sewer contained concentrations of the antifungal drug fluconazole – a drug used in ointments for fungal infections such as thrush and athlete’s foot or given intravenously for more serious infections – at levels 950,000 times higher than the recommended safe limit. The researchers repeatedly analysed this finding to make sure it was correct. “To our knowledge, this is the highest concentration of any drug ever measured in the environment,” wrote the authors.
Samples from sewers in the industrial area were also found to contain “extremely high concentrations” of nine different antibiotics. Levels of moxifloxacin – used to treat lung, skin and sinus infections as well as tuberculosis – were up to 5,500 times higher than the recommended limit, while another common antibiotic ciprofloxacin was found at levels up to 700 times above that recommended. Concentrations of the antibiotics clarithromycin and ampicillin were found at levels more than 100 times higher than the safe limit.
The amounts of antimicrobials found in the new tests were “eye-wateringly high”, said Dr Mark Holmes, a microbiologist at the University of Cambridge. “The quantities involved mean the amount in the water is almost the same as a therapeutic dose,” he said, calling on the Indian authorities to investigate immediately by testing each factory’s effluent. “That’s not just getting rid of a few tablets down the toilet.”
Pharmaceutical pollution is not the only way in which antibiotics get into the Indian environment – excrement from people and animals and waste from hospitals and farms also contain residues of the drugs. But some of the levels detected in the recent testing mean the residues can only have come from bulk manufacturing, according to scientists.
Professor Joakim Larsson, of the University of Gothenburg believes the levels of antimicrobials found could not be explained by anything else other than industrial discharges. “So it tells us that the problem is still there, it needs to be solved,” he told German journalists who worked on the report.
The pharmaceutical industry in Hyderabad produces “enormous amounts” of waste each day, says the Infection report. Effluent is transported in trucks to one waste treatment plant, it says, where it is treated before being sent to a mega sewage plant. There, it is mixed with sewage and further treated then discharged into the nearby Musi river.
Adhering to the zero liquid waste policy ordered by the Supreme Court requires expensive technology, and some waste is still clandestinely sent to the waste treatment plant or dumped straight into the surrounding environment, according to the report.
Virtually all of the world’s major drug companies are supplied by production plants in Hyderabad. Various companies whose factories are located next to or near sites where the water samples were taken supply the US and UK markets, though with such huge amounts of antibiotics present throughout the Indian environment it is impossible to concretely link specific factories to specific test results.
Using the Bulk Drug Manufacturing Industry’s 2015 manual, which lists all Indian drug manufacturers, their locations and their products, journalists at NDR were able to identify 19 companies operating in the Patancheru-Bollaram area which produce the antimicrobial drugs found in the water samples. (There may be other unnamed manufacturers operating in the area or companies which do not advertise which antimicrobials they produce.)
The Bureau has linked a number of these companies to the US and UK markets. MSN Pharmachem is one of the fastest growing drug manufacturers in India. It makes the raw ingredient of the antibiotic moxifloxacin on behalf of international drug companies Macleods and Sun Pharmaceuticals, which then turn it into a finished product supplied to the World Health Organisation.
Other major companies operating in the zone which supply the US and UK markets include Aurobindo, a leading Indian producer which exports to more than 150 countries around the globe, and Mylan, a company which claims its products fill one out of every 13 prescriptions dispensed in America. Mylan also supplies the European Union market, and says it is the fourth biggest supplier of generic (non-branded) drugs in the UK.
The companies strongly refute suggestions that their factories are responsible for pollution.
MSN Pharmachem said it conformed to the highest industry standards, applicable laws and regulations, and operated a zero discharge policy at its factories.
“Our sites are regularly monitored internally and inspected externally,” said a spokesperson. “We are committed to a clean environment, health of all our employees, neighbors, partners and customers.”
Aurobindo said it was impossible any pollution could have originated from its factories as it also operated a zero liquid waste policy – all waste is treated and recycled within the plants. It also said the topography and water flows of the relevant locations meant not even rainwater or drain water would be able to flow from its factories to the sample collection sites.
Mylan also said its factory could not have contributed to the residues identified by the researchers, as all its plants operated a zero liquid waste policy whereby all effluent is recycled and reused on site. It has its own wastewater treatment systems at all its Hyderabad plants, said a spokesperson, which use advanced technology to eliminate harmful waste. “These plants are operated 24 hours a day, seven days a week by qualified individuals,” said the statement.
Macleods and Sun Pharmaceuticals did not respond to requests for comment.
A WHO spokesperson said the organisation did not buy the drug ingredients, just the final medicine, and had no contact with ingredient manufacturers. “Manufacturing sites are typically inspected for Good Manufacturing Practice which focuses on ensuring consistent quality for the product in question from the perspective of human health risk,” said a statement. “GMP does not address waste management and environmental management measures vis-à- vis emissions and pollution control – as here relevant domestic environmental and industrial regulations would apply.”
No mention of pollution
There are reams of regulations and stipulations that manufacturers have to adhere to in order to export their products to the US and Europe – known as the Good Manufacturing Practices framework. These focus on making sure drugs are safe, pure, and effective.
Stringent inspections by the FDA, WHO and European authorities check that these rules are being followed.
However these regulations do not address environmental concerns. Inspectors have no mandate to sanction a factory for polluting, failing to treat its waste or other environmental problems – this falls within the remit of local governments.
Within India, there are environmental regulations covering what ingredients factories are allowed to produce, how they use water and how they dispose of their waste. In Hyderabad, the Telangana State Pollution Board inspects factories based on these.
However these inspection have been labelled toothless by local and international campaign groups. In November 2015, an analysis of TSPCB inspection reports by the Centre for Science and Environment in Delhi found that 15 bulk drug manufacturers within the Patancheru Bollaram industrial area were producing ingredients for which they did not have permission, using more water than the permitted limit, and dumping more effluents and hazardous waste than allowed.
Lots of promises have been made. More than 100 drug companies (including Mylan) signed a declaration at the World Economic Forum in Davos at the beginning of last year pledging to clean up production; commitments which were repeated in an industry roadmap released by 13 major manufacturers in the run-up to the first ever high-level United Nations meeting on antimicrobial resistance last September.
Last week the European Commission also published a roadmap acknowledging the release of antimicrobial ingredients into the environment during manufacture “may pose a risk.” It promised it would explore how to address the challenge in 2018, but fell short of committing to actual policy.
The UK government promised to take action on pollution in NHS supply chains following a previous Bureau report last October, but could not comment on whether this had been followed up due to purdah rules prohibiting any policy announcements in the run-up to an election.
And WHO, along with sister UN agencies, signed a “Statement of Intent” last December aimed at “advancing environmental and socially responsible procurement” of their health products. Just this week, WHO director-general Margaret Chan warned the world was moving towards a “post-antibiotic era” and called once again for concerted global action. She listed actions which were urgently needed, including cutting antibiotic prescriptions, developing new drugs, and coordinated government policies around the world. She did not mention pharmaceutical pollution.
The European Public Health Alliance, an umbrella group for more than 90 non-profit organisations, lambasted the failure of international regulators to do anything about the “rife” pollution which was a “clear cause” of AMR.
“This glaring omission must be rectified by including legally binding environmental standards in GMP protocols, particularly with regard to contamination with antimicrobial substances – as a condition for authorisation and import of drugs,” said a spokesperson. “Voluntary agreements are not enough to stop a race to the bottom, where pharmaceutical companies exploit weak links in global supply chains, in places where there is little or no enforcement of vital environmental standards.”
Tighter regulations on pollution must be introduced, said Dr Yohei Doi, Associate Professor of Medicine at the University of Pittsburgh School of Medicine, and it was up to international buyers of drugs such as the FDA to make this happen. “It’s the buyers in the US that pay for these things,” he said. “As long as people buy these drugs, the companies will keep making them in this way.”
This article was first published on The Bureau of Investigative Journalism.
Uchafuzi wa viwanda unaotokana na makampuni ya dawa ya India yanayotengeneza dawa kwa ajili ya makampuni makubwa ya dawa duniani unachochea kuanzishwa kwa bakteria hatari, utafiti mpya unaonyesha. Mamlaka za afya duniani hazina sheria za kuzuia jambo hili lisitokee. Utafiti uliochapishwa wiki hii katika jarida la kisayansi la Infection uligundua viwango vya juu sana vya mabaki ya dawa za antibiotic na anti-fungal katika vyanzo vya maji ndani na karibu na kituo kikuu cha uzalishaji wa dawa huko Hyderabad, pamoja na viwango vya juu vya bakteria na kuvu sugu kwa dawa hizo. Wanasayansi wameliambia shirika la habari la Marekani la FBI kwamba idadi ya dawa hizo zilizopatikana zinaonyesha kwamba zinatoka katika viwanda vya kutengeneza dawa. "Uwepo wa mabaki ya dawa katika mazingira ya asili huwawezesha vimelea vinavyoishi huko kujenga upinzani kwa viungo katika dawa ambazo zinapaswa kuwaua, na kugeuza kuwa kile tunachokiita ""superbugs.""" Vimelea hivyo vinaweza kusafiri kwa urahisi na vimeongezeka sana duniani kote, na hivyo kutokeza hali ya dharura ya afya ya umma ambayo inadhaniwa kuwa inaua mamia ya maelfu ya watu kila mwaka. "Wanasayansi na viongozi wa afya ya umma wanasema tatizo linalozidi kuongezeka la upinzani wa viuavijasumu (AMR) linaweza kubadilisha nusu karne ya maendeleo ya matibabu ikiwa ulimwengu hauitwi haraka.""" Hata hivyo, wakati sera zinatekelezwa kupambana na matumizi ya kupita kiasi na matumizi mabaya ya dawa za kulevya ambayo yamechochea mgogoro, wasimamizi wa kimataifa wanaruhusu mbinu chafu za uzalishaji wa dawa za kulevya kuendelea bila kudhibitiwa. Mamlaka za kimataifa kama vile Utawala wa Chakula na Dawa na Shirika la Dawa la Ulaya zinadhibiti kwa ukali minyororo ya usambazaji wa dawa katika suala la usalama wa dawa <unk> lakini viwango vya mazingira havionekani katika kitabu cha sheria zao. Watengenezaji wa dawa lazima washikamane na miongozo ya Mazoea Mazuri ya Utengenezaji - lakini miongozo hiyo haifai uchafuzi. Hata Shirika la Afya Duniani (WHO) - shirika la afya ya umma duniani ambalo limetoa wito mara kwa mara kwa hatua za kimataifa za kukabiliana na tishio la hatari la upinzani wa viuavijasumu - linanunua viuavijasumu kutoka kwa makampuni ambayo viungo vya dawa hutengenezwa Hyderabad bila kufanya ukaguzi wa mazingira. "Mashirika ya kimataifa yanasema serikali za nchi ambazo dawa hizo zinatengenezwa ndizo zinazohusika na kuzuia uchafuzi, lakini sheria za ndani zina athari ndogo sana, wanasema waandishi wa utafiti huo.""" "Wanasema kwamba ukosefu wa kanuni za kimataifa lazima utatuliwe, wakikazia tishio kubwa la afya ya umma linalokabiliwa na upinzani wa antibiotic na pia kuenea kwa ulimwengu wa ""superbugs"" kutoka India, ambayo imekuwa kitovu cha mgogoro huo." "Kundi la wanasayansi wa Chuo Kikuu cha Leipzig, Ujerumani, walifanya kazi na waandishi wa habari wa Ujerumani kuchunguza kwa kina uchafuzi wa dawa huko Hyderabad, ambapo 50% ya bidhaa za nje za dawa za India zinatengenezwa. """ India inazalisha asilimia tano ya dawa za kawaida duniani, na viwanda vilivyo Hyderabad vinatoa mamilioni ya tani za dawa za kuua wadudu na dawa za kuua kuua vimelea kwa kila mwaka. Watafiti walichunguza sampuli 28 za maji katika eneo la viwanda la Patancheru-Bololam, ambapo kampuni zaidi ya 30 za kutengeneza dawa zinazotoa dawa kwa karibu makampuni yote makubwa ya dawa duniani. Maelfu ya tani za taka za dawa hutokezwa na viwanda kila siku, gazeti hilo lasema. "Kama ilivyoelezwa hapo juu, ""virusi vya kuambukiza"" ni bakteria na kuvu ambazo zina uwezo wa kuambukiza virusi vya kuambukiza, na kwa hivyo zinajulikana kama ""MDR"" (jina la kiufundi la virusi vya kuambukiza)." Watafiti walichunguza sampuli 16 za dawa na kugundua 13 zilikuwa na dawa za kuua wadudu. Uchunguzi wa awali umeonyesha jinsi kuambukizwa kwa viuavijasumu na viuavijasumu katika mazingira husababisha bakteria na kuvu kuendeleza kinga dhidi ya dawa hizo. Uchafuzi wa mazingira na usimamizi mbaya wa maji machafu huko Hyderabad unasababisha "uchafuzi usio na kifani wa dawa za antimicrobial" za vyanzo vya maji vinavyozunguka, watafiti wanahitimisha - uchafuzi ambao unaonekana kuendesha uundaji na kuenea kwa superbugs hatari ambazo zimeenea ulimwenguni. Pamoja na matumizi mabaya ya dawa za kuua viini na usafi duni, bakteria kubwa tayari zina matokeo mabaya nchini India - takriban watoto wachanga 56,000 hufa kutokana na maambukizo ya kuua viini kila mwaka. Kituo cha habari cha Ujerumani cha NDR, ambacho kilisaidia katika utafiti huo, kilitambua makampuni 19 yanayofanya kazi katika eneo hilo kama wauzaji wa dawa za kuua viini kwa soko la Ulaya. Kati ya kampuni hizo 19, angalau nne zinatumia vifaa vya Uingereza na tano zinatumia vifaa vya Marekani. Kampuni hizo zinakataa kabisa kuwa viwanda vyao vinaharibu mazingira, na idadi kubwa ya viwanda vinavyofanya kazi huko Hyderabad inamaanisha haiwezekani kutambua ni kampuni zipi zinazohusika na uchafuzi uliopatikana katika sampuli zilizochunguzwa. "Kile kilicho wazi ni kwamba moja ya vituo vikubwa vya uzalishaji wa dawa duniani ni kuzalisha viwango hatari vya uchafuzi wa dawa, na mashirika ya kimataifa ya kuhakikisha usalama wa dawa ni kufanya kidogo kushughulikia hilo. """ "Hata hivyo, kuna uwezekano wa kuathiri athari za dawa za kulevya, ""alisema Profesa Raman Laxminarayan, mkurugenzi wa Kituo cha Dhinamiki ya Magonjwa, Uchumi na Sera na sauti inayoongoza juu ya upinzani wa antibiotics." "Tunahitaji kuchukua uchafuzi wa mazingira kutoka kwa vifaa vya utengenezaji wa wingi kwa uzito na kumaliza mara moja mazoezi hayo", alisema. "Hii inapaswa kuwa sehemu ya GMP bila shaka na makampuni ya dawa duniani kote yanapaswa kuwa chini ya ukaguzi ili kuhakikisha kwamba wanakubaliana na kile sekta imeahidi kufanya. ""Jiji la Hyderabad lenye watu wengi na lenye ufanisi zaidi kusini mwa India wakati mmoja lilikuwa kituo cha biashara ya kimataifa kwa almasi na lulu." Leo, ni kitovu kikuu cha kimataifa cha viwanda vya dawa na biotech, vikizalisha mamilioni ya tani za dawa, kemikali na dawa za kuua wadudu kila mwaka. Kampuni 170 zinazozalisha dawa za kulevya zinafanya kazi katika Hyderabad na maeneo ya karibu, na nyingi ziko katika maeneo makubwa ya viwanda kando ya Mto Musi. Kampuni za Ulaya na Marekani, pamoja na mamlaka za afya kama vile WHO na NHS ya Uingereza zinategemea dawa zinazozalishwa katika viwanda hivi. Kwa muda mrefu eneo hilo limekuwa likikosolewa kwa uchafuzi wake, ambao umeendelea bila kupunguzwa licha ya kampeni za miongo kadhaa za mashirika yasiyo ya kiserikali ya India, wanasema waandishi wa ripoti hiyo. Mwaka 2009 eneo la Patancheru-Bollaram lilionwa kuwa na uchafuzi mkubwa katika orodha ya uchafuzi wa hewa nchini India na ujenzi katika eneo hilo ulipigwa marufuku. Serikali iliruhusu sheria hizo ziondolewe mwaka 2014 na ujenzi wa nyumba hizo ukaanza tena. Mwaka jana Mahakama Kuu ya India iliamuru makampuni ya dawa ya nchi hiyo kutekeleza sera ya kutokuwa na taka ya kioevu, lakini "kukiuka kwa wingi" kumeripotiwa kutokea, inasema ripoti ya Maambukizo. "Kama sekta ya uzalishaji wa dawa nchini India imeongezeka, hivyo pia ina kuenea kwa superbugs - mgogoro wa kitaifa uliozidiwa na matumizi ya kupita kiasi na matumizi mabaya ya viuavijasumu, ambayo yanunuliwa kwa urahisi juu ya counter, na usafi duni, pamoja na uundaji wa superbugs binafsi, jeni na enzymes zimebadilika ambayo inaweza kupita kati ya aina nyingi za bakteria, na kuwafanya kuwa sugu kwa dawa. """ India imekuwa kitovu cha mgogoro wa kimataifa wa upinzani wa dawa, na watoto wapya wa India 56,000 wanakadiriwa kufa kila mwaka kutokana na maambukizi ya damu ya dawa, na asilimia 70 hadi 90 ya watu wanaosafiri kwenda India wanarudi nyumbani na bakteria nyingi za dawa katika matumbo yao. Bakteria inaweza kubaki katika matumbo bila kusababisha matatizo, lakini kama wao kusafiri kutoka huko katika mtiririko wa damu ya mgonjwa au njia ya mkojo wanaweza kusababisha maambukizi makubwa. Pia wanaweza kupitisha upinzani kwa bakteria nyingine katika matumbo - kwa hivyo ikiwa mgonjwa anapata sumu ya chakula bakteria iliyosababisha inaweza kupata upinzani na kuwa ngumu kutibu. Uchunguzi wa awali umeonyesha uchafuzi wa dawa nchini India na China - ambazo pamoja hutengeneza antibiotics nyingi ulimwenguni - na kuonyesha jinsi uchafuzi huo unavyoongeza kuenea kwa bakteria kubwa ulimwenguni. Watafiti wa utafiti huo wamejaribu kutoa picha ya kina ya viwango na aina za uchafuzi wa mazingira huko Hyderabad na uhusiano wake na upinzani wa dawa. Watafiti walichukua sampuli za maji kutoka mito, maziwa, maji ya chini ya ardhi, maji ya kunywa na maji ya uso kutoka maeneo ya vijijini na mijini ndani na karibu na eneo la viwanda, pamoja na vidimbwi karibu na viwanda na vyanzo vya maji vilivyotumiwa na viwanda vya kusafisha maji taka. Nane zilitolewa kwenye mabomba, moja kutoka kwenye shimo la kuchimba, na 23 zilizobaki zilitolewa kama sampuli za mazingira. Kwa mfano, kuna bakteria ambazo ni sugu kwa dawa nyingi (MDR), ambayo ni jina la kiufundi la bakteria. Watafiti walichunguza sampuli 16 za dawa za kuua viini na dawa za kuua kuua kuua kuua kuua kuua kuua kuua kuua kuua kuua kuua kuua kuua kuua kuua kuua kuua kuua kuua kuua kuua kuua kuua kuua kuua kuua kuua kuua kuua. Sampuli zote isipokuwa moja iliyochukuliwa kutoka kwa maji ya bomba katika hoteli ya nyota nne ziligunduliwa kuwa na bakteria sugu kwa dawa. "Wanafunzi hao walipata kwamba sampuli zote 23 za mazingira zilikuwa na bakteria zinazozalisha carbapenemase, kundi la wadudu wanaojulikana kama ""bacteria ya ndoto mbaya"" kwa sababu hawawezi kutibiwa na huua 40-50% ya watu ambao damu yao imeambukizwa." Katika sampuli 16 zilizochunguzwa, 13 zilipatikana kuwa na kemikali za kuua wadudu na dawa za kuua wadudu, na baadhi ya sampuli hizo zilikuwa na viwango vya juu vya kemikali hizo. Watafiti walilinganisha viwango vya mabaki na mipaka iliyopendekezwa na wataalamu wa microbiolojia; mara tu viwango vinapozidi mipaka hiyo, inawezekana kwamba bakteria kubwa zitaendelea. Kwa mfano, katika sampuli iliyopigwa kutoka kwa mfereji mmoja, kulikuwa na kiasi cha dawa ya kuzuia kuvu (fluconazole) - dawa inayotumiwa katika matoleo ya dawa za kutibu maambukizo ya kuvu kama vile thrush na athlete's foot au inayotolewa kwa njia ya mshipa kwa maambukizo mazito zaidi - ambayo ilikuwa mara 950,000 zaidi ya kiwango cha usalama kilichopendekezwa. Watafiti walichanganua mara kwa mara matokeo hayo ili kuhakikisha kwamba yalikuwa sahihi. "Kwa habari yetu, hii ndiyo kiwango cha juu zaidi cha dawa yoyote iliyowahi kupimwa katika mazingira", waliandika waandishi. Sampuli kutoka mifereji ya maji machafu katika eneo la viwanda pia ziligunduliwa kuwa na <unk>mkusanyiko wa juu sana<unk> wa viuavijasumu tisa tofauti. Kiwango cha moxifloxacin, ambayo hutumiwa kutibu maambukizi ya mapafu, ngozi na sinus, pamoja na kifua kikuu, kilikuwa mara 5,500 juu ya kiwango kilichopendekezwa, wakati kipimo cha ciprofloxacin, dawa nyingine ya kawaida, kilikuwa mara 700 juu ya kiwango kilichopendekezwa. Kwa mfano, viwango vya clarithromycin na ampicillin vilipatikana katika viwango vya juu zaidi ya mara 100 ya kiwango cha usalama. Kiasi cha antimicrobials kupatikana katika vipimo vipya walikuwa "macho-wateringly juu", alisema Dk Mark Holmes, microbiologist katika Chuo Kikuu cha Cambridge. "Wingi unaohusika unamaanisha kiasi katika maji ni karibu sawa na kipimo cha matibabu, "alisema, akitoa wito kwa mamlaka za India kuchunguza mara moja kwa kupima maji machafu ya kila kiwanda. "Hiyo si kuondoa tu vidonge vichache kwenye choo. Uchafuzi wa dawa sio njia pekee ambayo viuavijasumu vinaingia katika mazingira ya India. Mchuzi kutoka kwa watu na wanyama na taka kutoka hospitali na mashamba pia zina mabaki ya dawa. """ Lakini viwango fulani vilivyogunduliwa katika majaribio ya hivi karibuni vinamaanisha mabaki yanaweza tu kuja kutoka kwa utengenezaji wa wingi, kulingana na wanasayansi. Profesa Joakim Larsson wa Chuo Kikuu cha Gothenburg anasema kuwa kiwango cha kemikali za kuua viini vilivyopatikana katika majaribio hayo hakingeweza kuelezwa na kitu kingine chochote isipokuwa kutolewa kwa kemikali kutoka viwanda. "Kwa hiyo inatuambia kwamba tatizo bado lipo, linahitaji kutatuliwa", aliwaambia waandishi wa habari wa Ujerumani waliofanya kazi kwenye ripoti hiyo. Ripoti ya Infection inasema kwamba viwanda vya dawa huko Hyderabad hutokeza "kiasi kikubwa" cha taka kila siku. Maji ya taka husafirishwa kwa lori hadi kwenye kiwanda kimoja cha kusafisha taka, ambapo hutengenezwa kabla ya kupelekwa kwenye kiwanda kikubwa cha maji machafu. Huko, huchanganywa na maji machafu na kusafishwa zaidi kisha kutolewa katika mto wa Musi ulio karibu. Kufuata sera ya kutokuwa na taka za kioevu iliyoamriwa na Mahakama Kuu inahitaji teknolojia ghali, na baadhi ya taka bado hutumwa kwa siri kwenye kiwanda cha matibabu ya taka au kutupwa moja kwa moja katika mazingira ya karibu. Karibu makampuni yote makubwa ya dawa ulimwenguni hutolewa na viwanda vya uzalishaji huko Hyderabad. Kampuni mbalimbali ambazo viwanda vyake viko karibu na maeneo ambapo sampuli za maji zilichukuliwa, hutoa bidhaa kwa masoko ya Marekani na Uingereza, ingawa kwa kiasi kikubwa cha viuavijasumu katika mazingira yote ya India, haiwezekani kuunganisha viwanda maalum na matokeo maalum ya majaribio. Kwa kutumia mwongozo wa 2015 wa Bidhaa za Bidhaa za Bulk, ambao unaorodhesha wazalishaji wote wa dawa za India, maeneo yao na bidhaa zao, waandishi wa habari wa NDR waliweza kutambua makampuni 19 yanayofanya kazi katika eneo la Patancheru-Bolapuram ambayo hutengeneza dawa za antimicrobial zilizopatikana katika sampuli za maji. (Kunaweza kuwa na wazalishaji wengine wasiojulikana wanaofanya kazi katika eneo hilo au makampuni ambayo hayatangazi ni dawa gani za kuua vimelea wanazozalisha.) Ofisi hiyo imehusianisha idadi ya makampuni haya na masoko ya Marekani na Uingereza. MSN Pharmachem ni moja ya wazalishaji wa dawa wanaokua kwa kasi zaidi nchini India. "Kampuni hiyo ya dawa ya ""Moxifloxacin"" inazalisha dawa za kulevya kwa ajili ya makampuni ya kimataifa ya dawa ya ""Macleod's"" na ""Sun Pharmaceuticals"" ambayo kisha kugeuka katika bidhaa ya kumaliza zinazotolewa kwa Shirika la Afya Ulimwenguni." Kampuni nyingine kubwa zinazofanya kazi katika eneo hilo ambazo zinatoa bidhaa kwa masoko ya Marekani na Uingereza ni pamoja na Aurobindo, mtengenezaji wa India anayeongoza ambaye husafirisha bidhaa zake kwa nchi zaidi ya 150 duniani kote, na Mylan, kampuni ambayo inadai bidhaa zake zinatumia dawa moja kati ya 13 zinazotumiwa nchini Marekani. Mylan pia inatoa soko la Umoja wa Ulaya, na inasema ni muuzaji wa nne kwa ukubwa wa dawa za kawaida (zisizo za chapa) nchini Uingereza. Kampuni hizo zinakataa kabisa madai kwamba viwanda vyao vinawafanya watu wachafue mazingira. MSN Pharmachem imesema inafanya kazi kulingana na viwango vya juu vya tasnia, sheria na kanuni zinazotumika, na inafanya kazi sera ya kutolewa kwa sifuri katika viwanda vyake. "Maeneo yetu yanatazamiwa mara kwa mara ndani na kuchunguzwa nje", alisema msemaji. "Tumejitolea kwa mazingira safi, afya ya wafanyakazi wetu wote, majirani, washirika na wateja. ""Aurobindo alisema ni haiwezekani uchafuzi wowote unaweza kutokea kutoka kwa viwanda vyake kwani pia inafanya kazi sera ya taka ya kioevu "" taka zote hutibiwa na kuchukuliwa upya ndani ya viwanda." "Kama ilivyoelezwa hapo juu, ""kiwango cha maji katika maeneo hayo ni kiasi kwamba hata maji ya mvua au maji ya mifereji hayawezi kutoka kwenye viwanda vyao hadi kwenye maeneo ya ukusanyaji sampuli.""" "Milan pia alisema kiwanda chake hakingeweza kuchangia mabaki yaliyotambuliwa na watafiti, kwani viwanda vyake vyote vilitumia sera ya ""takwimu taka za kioevu,"" ambapo maji yote ya taka yanarudishwa na kutumiwa tena mahali hapo." Kampuni hiyo ina mifumo yake ya kusafisha maji machafu katika viwanda vyake vyote vya Hyderabad, alisema msemaji, ambayo hutumia teknolojia ya kisasa ili kuondoa taka zenye madhara. "Vituo hivi vinaendeshwa masaa 24 kwa siku, siku saba kwa wiki na watu waliohitimu", ilisema taarifa hiyo. Macleods na Sun Pharmaceuticals hawakujibu maombi ya maoni. "Msimamizi wa WHO alisema shirika hilo halikununua viungo vya dawa, tu dawa ya mwisho, na halikuwa na mawasiliano na wazalishaji wa viungo. """ "Maeneo ya utengenezaji kwa kawaida huchunguzwa kwa Mazoea Mazuri ya Utengenezaji ambayo huzingatia kuhakikisha ubora thabiti kwa bidhaa inayohusika kutoka kwa mtazamo wa hatari ya afya ya binadamu", ilisema taarifa. "GMP haijalishi hatua za usimamizi wa taka na usimamizi wa mazingira dhidi ya uzalishaji na udhibiti wa uchafuzi wa mazingira, kwani hapa kanuni husika za mazingira na viwanda zinatumika. ""Hakuna kutaja uchafuzi kuna sheria na masharti ambayo watengenezaji wanapaswa kufuata ili kusafirisha bidhaa zao kwenda Marekani na Ulaya, inayojulikana kama ""Mazoea mazuri ya utengenezaji.""" Hizi hukazia kuhakikisha kwamba dawa ni salama, safi, na zenye matokeo. Uchunguzi wa FDA, WHO na mamlaka za Ulaya huangalia kwamba sheria hizi zinafuatwa. Hata hivyo, kanuni hizo hazizungumzii masuala ya mazingira. Wakaguzi hawana mamlaka ya kuadhibu kiwanda kwa uchafuzi, kushindwa kutibu taka zake au matatizo mengine ya mazingira - hii ni ndani ya mamlaka ya serikali za mitaa. India ina sheria za mazingira zinazohusu viungo ambavyo viwanda vinaweza kutengeneza, jinsi vinavyotumia maji na jinsi wanavyotupa taka zao. Katika Hyderabad, Telangana State Pollution Board inachunguza viwanda kulingana na hizi. Hata hivyo ukaguzi huu umetajwa kuwa hauna meno na vikundi vya kampeni vya ndani na vya kimataifa. Uchunguzi wa ripoti za ukaguzi wa TSPCB uliofanywa na Kituo cha Sayansi na Mazingira huko Delhi uligundua kuwa wazalishaji wa dawa 15 ndani ya eneo la viwanda la Patancheru-Bolgaram walikuwa wakizalisha viungo ambavyo hawakuwa na ruhusa, wakitumia maji zaidi ya kiwango kilichoruhusiwa, na kutupa maji mengi na taka hatari kuliko kuruhusiwa. Ahadi nyingi zimefanywa. Kampuni zaidi ya 100 za dawa (ikiwa ni pamoja na Mylan) zilitia saini tamko katika Mkutano wa Uchumi wa Dunia huko Davos mwanzoni mwa mwaka jana, zikijitolea kusafisha uzalishaji; ahadi ambazo zilirudia katika ramani ya sekta iliyotolewa na wazalishaji wakuu 13 kabla ya mkutano wa kwanza wa kiwango cha juu wa Umoja wa Mataifa juu ya upinzani wa antimicrobial Septemba iliyopita. Tume ya Ulaya pia ilitoa ramani ya barabara ya kugundua kutolewa kwa viungo vya antimicrobial katika mazingira wakati wa utengenezaji - inaweza kuwa na hatari - na kuahidi kuchunguza jinsi ya kukabiliana na changamoto hiyo mnamo 2018, lakini haikufikia ahadi ya sera halisi. Serikali ya Uingereza ilitoa ahadi ya kuchukua hatua dhidi ya uchafuzi wa mazingira katika minyororo ya usambazaji wa NHS kufuatia ripoti ya awali ya Ofisi ya Uchumi Oktoba iliyopita, lakini haikuweza kutoa maoni juu ya ikiwa hii ilifuatwa kwa sababu ya sheria za purdah zinazokataza matangazo yoyote ya sera kabla ya uchaguzi. WHO na mashirika mengine ya Umoja wa Mataifa yamesajili mkataba wa dhamira mwezi Desemba mwaka jana, ambao unakusudia kuendeleza ununuzi wa bidhaa za afya kwa njia ya mazingira na kijamii. "Mkurugenzi mkuu wa WHO, Margaret Chan, amesema kuwa ""utamaduni wa dawa za kulevya unaendelea kuenea katika ulimwengu,"" na pia ameomba hatua za pamoja za kimataifa." "Alichanganya hatua zinazohitajika haraka, ikiwa ni pamoja na kupunguza dawa za antibiotiki, kuendeleza dawa mpya, na sera za serikali zilizounganishwa ulimwenguni kote. """ Yeye hakutaja uchafuzi wa dawa. Umoja wa Ulaya wa Afya ya Umma (EPAH), ambao unajumuisha mashirika zaidi ya 90 yasiyo ya faida, umekosoa kwa ukosefu wa uaminifu wa watawala wa kimataifa wa kufanya chochote juu ya uchafuzi wa mazingira, ambao ni sababu ya wazi ya AMR. "Ukosefu huu mkubwa lazima urekebishwe kwa kuingiza viwango vya mazingira vinavyofunga kisheria katika itifaki za GMP, haswa kwa habari ya uchafuzi na vitu vya antimicrobial - kama sharti la idhini na uagizaji wa dawa", alisema msemaji. "Makubaliano ya hiari hayatoshi kuzuia mbio ya chini, ambapo makampuni ya dawa hutumia viungo dhaifu katika minyororo ya usambazaji wa kimataifa, katika maeneo ambapo kuna utekelezaji mdogo au hakuna wa viwango muhimu vya mazingira. ""Masharti kali zaidi juu ya uchafuzi lazima yatokezwe, ""alisema Dk Yohei Doi, Profesa Mshirika wa Tiba katika Chuo Kikuu cha Pittsburgh School of Medicine." "Ni wanunuzi nchini Marekani ambao hulipa vitu hivi", alisema. """Wakati watu wanaponunua dawa hizi, makampuni yataendelea kuzitengeneza kwa njia hii,"" alisema katika makala yake ya kwanza kwenye jarida la The Bureau of Investigative Journalism."