India is the first country that has defined effluent standards for antibiotics production. Yet, the ground realities present a different picture. Over-use of antibiotics by people, its use and misuse in agriculture as well as its presence in extremely high concentrations in effluents of pharmaceutical factories continue to be a cause for concern.

Growing instances of antimicrobial resistance (AMR) are a major public health problem globally and antibacterial resistance (ABR) is seen as posing a serious health threat.

In April 2017, India released its National Action Plan for Containment of Antimicrobial Resistance (AMR) and an inter-ministerial group pledged to adopt a holistic and collaborative approach, which resulted in the Delhi Declaration on AMR. The strategic objectives of India’s Action Plan are aligned with the WHO’s Global Action Plan on AMR. The target is to have the standards ready by 31 August.

India is part of the Global AMR Industry Alliance, which is laying out a roadmap to combat antimicrobial resistance (AMR) by 2020. While lauding India’s efforts, Tim Rutten, Business Director, Asia, Middle East and Africa, of DSM Sinochem Pharmaceuticals, which is a member of the AMR Industry Alliance and a global leader in sustainable production of antibiotics, spoke of the need to implement a regulatory framework to contain antibiotic misuse.

Rutten, who is also a member of the Global Shapers Community, World Economic Forum, has been actively advocating clean manufacturing practices and multi-stakeholder action to control industrial pollution and reduce antibiotic resistance.

He was in India this month to address a workshop, organised by his Netherlands-based company in collaboration with the Indian Institute of Technology (IIT), New Delhi, on Sustainability Through Excellence in Manufacturing (STEM) on advanced, clean, sustainable manufacturing and quality techniques.

In an interview to ASHA RAMACHANDRAN, he spoke on the present global AMR situation and how India needs to take a leadership role. Excerpts:

Q: How serious is the threat of drug resistance or resistance to antibiotics globally today?

A: Spread of drug resistance is, unfortunately, a very, very serious issue. Looking at the situation today, and I refer to the AMR (antimicrobial resistance) review, 700,000 people die as a consequence of drug resistant bacteria.

The AMR review has looked at future projections. If we don’t do anything today, there would be an estimated 10 million deaths by 2050. This is more than the number of deaths caused by cancer.

In India today, 58,000 people die because of bacterial infection that cannot be cured because they are drug-resistant bacteria. These numbers today are staggering.

Those numbers and the AMR review show how significant the spread is for global health-care. What we need to keep in mind is that antibiotics don’t just treat bacterial infections, which we can catch anywhere, but they also anchor modern health care.

Other medical procedures would not be possible without antibiotics ~ cancer treatment, organ transplants, other surgical procedures, all depend on antibiotics to prevent infection. So, this also places a big threat to the overall health-care system. It needs immediate action.

Q: What is the situation in India, which houses several big pharmaceutical companies?

A: Looking at the situation in India, unfortunately, the numbers are not less severe. Resistant levels in India are among the highest in the world. So, clearly, action in India is also required, just like on the global scale.

Talking about clean manufacturing, 80-90 per cent of all antibiotics are produced in India and China. The drivers at the global level are: overuse by humans, use and misuse in agriculture and also pharmaceutical production.

Very good action is, incidentally, being taken in India. The Red-line campaign, where a red line on the pack indicates it’s a prescription drug, creates awareness about this.

Q: Who are the key stakeholders who need to take steps to control rising AMR?

A: There is no one company, one country, one NGO or international body that can take action. This calls for an inter-sectoral approach. There are different drivers of AMR and all need to be addressed.

At the UN level the inter-agency initiative has been signed, commissioned to address and make sure the agencies will work together. Of course, a global action plan for AMR that has now been drawn up. The one in India was commissioned in April 2017 with very clear actions.

Also, all different angles and different stakeholders ~ civil society, business, industry, government ~ are listed. (However), industry must step up themselves and make sure that their production is clean.

But it’s also clear that a regulatory framework and evidence-based standards of effluents and the amount of antibiotics that can be present need to be established.

Q: After the Davos Declaration and the UNGA Roadmap, the new AMR Benchmark Report 2018 mentions pharma companies following good manufacturing practices. How far have the pharma companies implemented this?

A: In 2016, 13 companies had signed the UNGA roadmap, with a clear commitment to drive clean production within our own companies. And that roadmap says, first of all, to assess our supply chains, work towards evidence-based standards, set up a framework to manage antibiotic discharge and design a way to transparently communicate about this.

There’s also the Davos Declaration, 2016. These two units have come together and the AMR Industry Alliance was created in May 2017. It brings together over 100 companies that are now jointly working to fight against AMR through the same four pillars as the roadmap.

The Industry Alliance has now set up working groups to work on these different parts. It’s important that the momentum is kept but the regulatory framework is still required.

Q: Several Asian countries, including India, have National Action Plans to contain AMR. How far have they been implemented?

A: India is a frontrunner as far as setting up of a regulatory framework is concerned. India is the first country that is defining the effluent standards as part of the National Action Plan and is under the review of Ministry of Environment.

The Central Pollution Control Board (CPCB) has called for an expert group consisting of academics, corporations, research experts and some NGOs. India has taken the step and we are fully supporting that.

We are looking forward to see how it pans out, because India is the first country to take this step. We hope this goes out to a lot of other countries. India is a leading part of the Alliance and we are working closely together.

Q: Is sustainable manufacturing of antibiotics economically viable?

A: It is estimated that around 50 cents is the additional cost for a kg of API (active pharmaceutical ingredients) waste treatment, which is less than a cent per capsule.

The initial cost is there but next to the projected 10 million deaths (due to AMR), this is an essential investment. We need to align cost to society with cost of business.

We are trying to expand our group and set up regulatory framework to manage the discharge. In this, India has taken the initiative. We must also see that we do not reward bad action by continuing to give big contracts to providers who do not follow norms.

Q: What can be done to help smaller pharma companies adopt green technologies and processes for antibiotics production?

A: It is important that we have an inclusive approach. That means regulation will be there but also the industry approach. That means also, from an Industry Alliance perspective, we jointly create awareness … how to engage these smaller companies.

From our side we will share the best practices technologies. But I don’t think we can have one size fits all approach. We need to work together to solve a major problem like AMR.