Health

AMR Awareness Week: Pharma must rise to the challenge as stewards of public health

Being in the pharmaceutical field, the mantle of responsibility falls upon us to forge ahead in the relentless pursuit of solutions to the daunting challenge of AMR

 
By Manjit Singh
Published: Wednesday 29 November 2023
Representational Photo from iStock

In the relentless battle against antimicrobial resistance (AMR), antibiotic producers find themselves at the forefront, facing an arduous task that demands unwavering commitment and innovative solutions.

With a decade of experience in the field, it is evident to me that the threat of AMR has escalated exponentially, necessitating a comprehensive and collaborative response from the pharmaceutical industry.

The escalating crisis: Sleeping pandemic

As we navigate the intricate landscape of AMR, statistical data paints a stark reality. According to recent research by The Lancet journal, AMR caused an estimated 700,000 deaths annually worldwide in 2019. India, with 297,000 deaths attributable to AMR in 2019, topped this list.

In India, most research on the Musi river and industries surrounding it in Hyderabad, Telangana indicated a deep linkage between AMR and antibiotic emissions from manufacturing.

Work on the Sirsa rivulet in the Baddi-Barotiwala-Nalagarh pharma cluster in Himachal Pradesh also flagged a similar linkage of AMR with industry.

Reports about antibiotic pollution in the media have shaken industry, governments and other stakeholders to contemplate and act.

Challenges, barriers and progress

The antibiotics industry faces the formidable challenge of preserving antibiotics efficacy and ensuring their supply chain. AMR poses a huge business and reputational risk.

A major chunk of industry is in a state of confusion given the magnitude of the challenge which comprises paucity of understanding, scientific knowledge, clear policy, methodologies for risk assessment, wastewater treatment technologies, infrastructure investments, wastewater treatment cost impact and eventually, sufficient margins to survive and compete.

However, the sector has diligently engaged with stakeholders to build approaches and continue optimistic messaging inside the antibiotics supply chain.

For instance, key players signed the United Nations General Assembly Declaration To Combat AMR and helped in the formation of Antimicrobial Resistance Industry Alliance (AMR IA). Pharmaceutical Supply Chain Initiatives (PSCI) have embraced AMR as a priority in their agenda.

Innovative approaches: A beacon of hope

Amid the challenges, there is a glimmer of hope as the pharmaceutical industry embarks on pioneering initiatives to tackle AMR. Collaborative industry efforts are exploring innovative avenues to reduce antibiotics emissions, such as high isolation yields, recovery of antibiotics from mother liquor, innovative decontamination methods and efficient wastewater treatment technologies to eliminate residual antibiotics.

The pioneering work of AMR IA and British Standards Institute (BSI) resulted in the release of the first Industry AMR standard in 2022 and AMR certification in 2023 for sustainable manufacture of antibiotics.

AMR standard provides solid guidance and direction by setting safe discharge limits known as Predicted No Effect Concentration (PNEC) for wastewater, Risk Quotient threshold limit, methodologies for risk assessment by deploying mass balance and / measurement through testing, measures to mitigate to avert AMR risk. The adaptation of AMR standard and certification by antibiotic manufacturers has tremendous potential to ameliorate the prevailing situation.

Global initiatives: Acting as pressure point to industry

Collaborations and initiatives are emerging in the direction of the One Health Approach programme launched by the World Health Organization, bringing together all stakeholders from manufacturing, healthcare, agriculture and authorities.

Some of the pathbreaking developments will discourage unsustainable manufacturing of antibiotics both, Active Pharmaceutical Ingredients (API) and Finish Dosage Forms. Unprepared manufacturers will be caught by surprise, with a sizeable impact on their operations in wake of the following developments.

  • Introduction of AMR criteria by insurers for medicine procurement tenders
  • WHO guidance to evaluate AMR during inspections
  • Five Nordic countries and UK proposed incorporation of AMR criteria for antibiotics procurement
  • EU pharma legislation revision (under approval) included environmental criteria including AMR for supply of medicines
  • Inclusion of residual antibiotics limits in the proposed Environment standard amendment 2020 by Indian Ministry of Environment, Forest and Climate Change. Although these limits are withheld in the approved amendment in 2021, ministry is contemplating to include in future
  • AMR IA member companies’ commitment to implement AMR standard and AMR certification
  • PSCI sustainability principles, many other platforms and NGO focus at antibiotics mfg. and their linkage with antimicrobial resistance

Bold steps ahead: Call to action to build an impactful momentum

As we stand at the precipice of a critical juncture in the fight against AMR, it is evident that bold and decisive action is paramount. The pharmaceutical industry must collectively rise to the occasion, not merely as purveyors of drugs but as stewards of public health. The present scale of efforts and industry preparedness at ground level is insufficient to tackle the AMR menace.

In conclusion, the industry associations, promoters, professionals, and authorities must act in tandem, include AMR into their business strategy, build actions plans, allocate budget for initiatives and targets.

It is paramount to have a carrot-and-stick policy in place to incentivise sustainable antibiotics suppliers. India, being a major player in the global pharmaceutical supply chain, must act proactively and with conviction to maintain leadership and reputation.

Being in the pharmaceutical field, the mantle of responsibility falls upon us to forge ahead in the relentless pursuit of solutions to the daunting challenge of AMR.

Manjit Singh is founder & AMR expert at Sustainability Edge Consulting. He is former global director- Corporate Sustainability Centrient Pharmaceuticals, former chair – PSCI and member of AMR IA

Views expressed are the author’s own and don’t necessarily reflect those of Down To Earth

Subscribe to Daily Newsletter :

Comments are moderated and will be published only after the site moderator’s approval. Please use a genuine email ID and provide your name. Selected comments may also be used in the ‘Letters’ section of the Down To Earth print edition.