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India should take lead in setting standards for antibiotic content in pharma waste

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India should create awareness across all stakeholders and improve its knowledge base to strengthen its leadership role on anti microbial resistant (AMR), informs Frans Vlaar, Business Unit Director, EA (Europe and America) and AMEA (Asia-Pacific, Middle East and Africa), DSM Sinochem Pharmaceuticals (DSP)

Is there a need for local research and ongoing studies to map increase in health hazards related to AMR and its implications?

Frans Vlaar

The National Action Plan (NAP) on AMR – issued in April this year – has identified promotion of AMR research as one of the strategic priorities, and has called for consolidation of existing knowledge resources and bridging knowledge gaps. There is a strong need to increase investment in AMR research, innovations and interventions. For any nation today, including India, it is important to assess the impact of AMR and what it is costs to the exchequer. It is necessary to develop new antibiotics, diagnostics, and vaccines as well as identify current gaps in knowledge and data on AMR by improved surveillance, which should focus on human health, agriculture and environment.

Next steps on the NAP-AMR involve finalising a national research agenda and operational research plan on AMR. Governments across the globe are beginning to recognise the importance of funding and piloting research projects and developing new models to curb AMR in humans, animals, food and environment. Evidence-based AMR research will have a huge impact on the way the issue is viewed by policymakers and public alike. To strengthen India’s leadership on AMR, it has to build awareness across all stakeholders and improve its knowledge base.

Do companies in India need to work on technological improvements and requirements to measure Active Pharmaceutical ingredients (API) and antibiotic content in effluents?

While at present there are no minimum standards and guidelines for antibiotic content and guidelines in effluents, the NAP-AMR has expressly listed devising such standards as a target. However, even in the absence of such standards, it is important for pharma manufacturers to proactively monitor and treat their effluents to remove traces of antibiotics, in order to ensure the longevity of antibiotics and secure modern healthcare, which is key for our business continuity.

As pointed out by several reports from NGOs and academia, many manufacturers, especially around pharma hubs in Andhra Pradesh and Telangana do not have proper discharge controls in place, leading to the release of untreated waste into the environment or to common treatment plants, which are not adequately equipped to treat for antibiotic residues.

With some Indian players having signed the United Nations General Assembly UNGA Industry Roadmap for AMR, the situation will hopefully change. Already, the signatories have started to review their supply chains on environmental management and discharge performance, while improving their manufacturing and waste treatment processes. By doing so, we hope to set a benchmark for the rest of the industry.

The technology to treat antibiotic content in waste is not expensive and for sure much more economical than the costs caused by AMR. This needs to be highlighted among all concerned. With standards for antibiotic levels in pharma waste expected soon, the industry will need to up the ante and comply with the regulations.

Is there a global standard for the containment of antibiotic content in effluents? Any examples like Sweden?

Over the years, Sweden has established itself as the world leader in sustainable antibiotic use and production. Recently, it became the first country to notify standards on maximum antibiotic residue levels that can be discharged by pharma industry. Also, they have introduced mechanisms that include environmental criteria in sourcing decisions of buyers. These standards have now been taken up for consideration by the European Union.

While no other country currently has residue limit standards for antibiotics in pharma effluents, India’s NAP-AMR recognised this gap and has targeted setting up of such standards. It needs to be kept in mind that India along with China contribute to nearly 80-90 per cent of the world’s antibiotic manufacturing, and accordingly bear the burden of pharma effluent-led AMR. It is therefore of prime importance for India to take the lead in setting standards for maximum limits of antibiotic content in pharma waste, so as to allow our citizens to lead healthy lives, without compromising our flourishing pharma manufacturing industry.

The AMR phenomenon is assuming the form of a serious public health issue in many developing and developed countries today. What is the current scenario globally and where does India stand?

AMR is considered as one of the biggest threats to public health and global health security. This has been reiterated by the the World Health Organisation (WHO) and several UN agencies. The situation is such that Government of India has identified AMR as one of the top ten priorities for the Health Ministry’s collaborative work with the WHO. AMR has far reaching consequences and knows no geographical boundaries. The case of New Delhi metallo-beta lactamase-1 reaching practically all countries including the UK, the US and Sweden is a testimony of antimicrobial resistance travelling across the globe.

The only difference between developed and developing countries is that stricter rules and regulations along with national action plans have been initiated in most of the developed economies, barring few. Meanwhile, developing countries have delayed producing and formulating national action plans on AMR due to lack of resources and focus on other health and societal concerns. Except India, Vietnam and a few others, South Asian countries lag in giving attention to the issue it warrants. With the signing of the Delhi Declaration and the National Action Plan, a new phase of combating AMR has started. This has been a timely development since AMR contributes to over 7,00,000 annual deaths globally, and in India alone, more than 58,000 children die due to resistant infections every year. It must also be kept in mind that India and China contribute to almost 80-90 per cent of antibiotic production, so the burden of disease in these countries is higher due to impact of pharma effluents. Government reports state that the NAP-AMR too have stated that an estimated 4,10,000 children, aged five years or less, die from pneumonia in India annually. It is startling to observe that pneumonia accounts for almost 25 per cent of all child deaths in India. The crude mortality from infectious disease is 417 per 100,000 persons in India, which is huge and the impact of AMR is higher in the Indian setting. The Red Line Campaign by the Government of India, which  mandated having a red vertical line on the packages of all antibiotics is one such step to mitigate the risk of AMR and ensure availability of quality antibiotics.

Do you think a national consultation with various stakeholders and industry representatives like pharma companies is necessary?

The NAP-AMR calls for a multi-sectoral or a one-health approach. This is much like the approach that is being taken in countries such as the Netherlands and Sweden that are leading in tackling AMR. Combating AMR through a multi-sectoral approach has been well taken in the National Action Plan, 2017. AMR occurs due to many reasons and it is imperative to look at it the various causes that lead to AMR. Some leading causes include inappropriate use of antibiotics among humans and animals, pharma pollution and hospital waste. The NAP document, through its six strategic points, recognises the need for involving industry bodies, both for developing and implementing a strategy and operational plan and defining standards for effluent plants to reduce environmental impact of AMR. The onus on the pharma industry and healthcare organisations to take this initiative forward, therefore, is very high as they are one of the most important stakeholders in tackling AMR. Impact of pharma pollution to AMR has been documented and studies have proven that pharma waste is a key breeding ground for resistant bacteria.

How important is it to regulate the pharma/ medical sector, with regards to the prescription of medicines. How dangerous is it to irrationally use antibiotics. Give some examples?

India is the largest manufacturer and consumer of antibiotics globally. The OTC sales of drugs and medicines is very high in India due to several factors such as easy access to drugs, high disease burden of TB, pneumonia and weak regulations. Also, it has a strong cultural element. What India needs at this point of time is to have stronger education fuelling awareness levels and stricter regulations where sale of antibiotics will be only through proper prescription from physicians. Presently, many of the last line of antibiotics such as carbapenems can be easily purchased from pharmacies in India without prescriptions. Thus, it is imperative for the government and the regulatory bodies to enforce stricter rules to prevent long-term negatives. The recent report on ‘The Selection and Use of Essential Medicines,’ specifically touched upon reviewing antibacterials. The report has added 10 anti-bacterials into essential medicines and 12 to the essential medicines for children and a new categorisation of antibacterials into three groups.

The classification is as follows: ACCESS – first and second choice antibiotics for the empiric treatment of most common infectious syndromes; WATCH – antibiotics with higher resistance potential whose use as first and second choice treatment should be limited to a small number of syndromes or patient groups; and RESERVE – antibiotics to be used mainly as ‘last resort’ treatment options.

What is the impact on AMR if pharma effluents or waste released during production process are not treated properly? Do you think Indian pharma companies don’t have proper waste treatment plants?

Various studies done by both Indian and global research organisations have stated that non- treatment of effluents or low or negligible use of treatment plants contribute to the rise of AMR. Recent studies by the scientific journal Infection have found “excessively high” levels of antibiotic and antifungal drug residues in water sources in and around a major drug production hub in the Indian city of Hyderabad, as well as high levels of bacteria and fungi resistant to those drugs. A study by IIT Bombay too substantiates the fact that pharma production discharges released into the environment are endangering aquatic life. A recent German report revealed that the Musi River in Hyderabad is emerging as a hotspot for ‘superbugs’ because of pharma waste dumping in the Bollaram-Patancheru area. Some of the reasons for non-treatment of effluents at the source by most of the companies are to save costs, though it is mandated to have treatment plants. The added technologies to remove active pharma ingredients are relatively economical, and several corporations who are co-signatories to the UNGA Industry roadmap have already started reviewing their supply chain and started revising their discharge policy and treatment processes.

How is pharma waste responsible for increasing AMR in the country? What contribution can pharma manufacturers make to reduce it?

Almost all the samples taken from Bollaram-Patancheru area in the vicinity of Hyderabad city contained bacteria and fungi resistant to multiple drugs. The pharma industry needs to be a key stakeholder in an effort to develop a state action plan and its implementation of NAP-AMR in mitigating the risk of AMR by following a zero discharge policy, acting as per guidelines, adopting global best practises in sustainable sourcing, manufacturing and supply so as to reduce environmental and health impact of antibiotics. Leading pharma players can come together to agree on maximum tolerance levels for antibiotic discharge and advocate within the industry for support. This in one way to reduce the cost and resources involved and at the same time help in containment of AMR, while securing modern health care.

What are DSP’s initiatives to prevent and control antibiotic resistance?

DSP has long maintained its practice to follow clean and sustainable manufacturing practices throughout its operations. It is one among the pharma companies that are signatories to the ‘Industry Declaration on AMR’ held in Davos in the month of January, 2016. DSP uses clean technology with dedicated state-of-the-art affluent treatment plants in all its plants across the globe. The waste water treatment plants used across its operations reduce the antibiotic content and through the application of regular antibiotic water tests, clean water is disposed. As DSP is the leading supplier of antibiotics in the world, it is in the best interest of DSP to adhere to clean and sustainable manufacturing practices. The basic approach that DSP follows across its operations in China, India and elsewhere is to ensure that its manufacturing process is sustainable. DSP’s manufacturing process makes use of green, enzymatic technology. As one the signatories to the UNGA industry roadmap and also as a member of AMR Industry Alliance, DSP supports the WHO call to action: Combat Antimicrobial Resistance and Preserve Antimicrobials for Future Generations. WHO call to action is supported by “The Ecumenical Pharmaceutical Network (EPN, a faith-based organisation, which includes over 100 members from over 30 countries across five continents). DSP also advocates the issue with governments for more stringent regulation for pharma manufacturing.

The Davos Declaration* signed by >100 companies and trade associations in January 2016, called for collective action to create a sustainable and predictable market for antibiotics, vaccines and diagnostics, that enhances conservation for new and existing treatments.

What role should a state government and the pollution control boards in the centre play when it comes to AMR?

The six NAP strategic priorities capture the importance of collaboration among national and sub-national agencies for containment of AMR. Now that the NAP has been formulated, state action plans in all the states need to be activated. The Central Pollution Board and State Pollution Boards are the monitoring and implementing agencies to ensure environmental rules/maximum standards/ discharge guidelines are set and met as formulated by the government. State pollution control boards should have regulatory powers to not allow pharma plants located at different settings to flout environmental norms. In some instances, state pollution boards have waved the red flag against pharma companies flouting norms but the broader picture is lack of surveillance mechanisms and skilled human resources acting as an impediment for not taking action.

What are the main myths about antibiotics and resistance that you would like to dispel?

Myths around AMR are huge given the lack of awareness and any sustained campaign around the issue. A report published by World Health Organisation (WHO) shows that 64 per cent of people surveyed say that AMR is a problem, but they are clueless about how it affects them and what they can do about it. Some of the myths circling around AMR are as follows:

You don’t have to take all the antibiotics you’re prescribed: Many people are of the view that when one feels or gets better, they should stop taking antibiotics. But the fact of the matter is that the full dose over the prescribed time frame should be taken.

AMR means the body no longer responds to drugs: It is not the human body that has become resistant to antibiotics, it is the bacteria that live outside and inside us and that become resistant and spread illness.

AMR risk happens to people who use antibiotics regularly: The World Health Organisation (WHO) has categorically stated that anyone can get an infection that’s resistant to antimicrobials.

For the treatment of cold and flu, antibiotics are necessary: Cold and flu are caused by viruses and antibiotics are meant to be used for treating bacteria. Using antibiotics inappropriately, like for viral infections, can lead to resistance problems.

There’s nothing you can do to lower your risk: Everyone from the common public, medical professionals, hospitals and organisations can reduce or lower the risk of spreading AMR. The US Centre for Disease Control and Prevention (CDC) says people should take their antibiotics exactly as the doctor prescribes them, should not share or use leftover or dated antibiotics, should not ask for antibiotics if the doctor doesn’t think they’re necessary and should prevent infections by practising good hygiene and getting necessary vaccines.

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