11-September-2024-Special-Article

WASTEWATER AND SOLID WASTE MANAGEMENT FOR ANTIBIOTIC MANUFACTURING BY WHO

The World Health Organization (WHO) recently released “Guidance on wastewater and solid waste management for the manufacturing of antibiotics” to address the rising global threat of Antimicrobial Resistance (AMR).

AMR poses a significant challenge to public health, making many antibiotics ineffective, and this guidance provides a comprehensive framework to help tackle this issue, focusing on antibiotic production.

Highlights of the Guidance

This guidance provides a scientific basis for managing antibiotic waste and aims to support regulators, the pharmaceutical industry, and stakeholders in curbing AMR.

Objective

• The primary goal is to set measurable targets for waste management in antibiotic production, which can be integrated into regulatory policies to minimize AMR risks.

Non-binding Nature

• The document is not legally enforceable but is designed to promote uniformity in market regulations and policy, avoiding disjointed approaches to the issue.

Key Principles and Best Practices

• Risk Management Plans: The guidance emphasizes creating risk management plans similar to those in other sectors like food safety.
• Audit and Transparency: Internal and external audits are recommended, alongside public transparency about the waste management process.
• Progressive Implementation: It encourages gradual improvements, recognizing the need for both antibiotic supply protection and equitable access to high-quality antibiotics.

Target Audience

• Regulatory Authorities: National or regional bodies responsible for regulating pharmaceutical manufacturing and waste disposal.
• Audit and Inspection Bodies: Third-party organizations that oversee waste management processes.
• Generic Drug Authorities: Bodies responsible for generic drug approvals and reimbursements.
• Pharmaceutical Manufacturers: Industry players involved in producing antibiotics at various stages.
• Waste Management Companies: Entities handling solid and liquid waste from antibiotic production.

Scope of the Guidance

• Health-Based Targets: The primary focus is to reduce risks related to human health from antibiotic waste.
• Ecological Impact: Attention is also given to the effects of antibiotic waste on aquatic life and ecosystems.
• Manufacturing Stages Covered: The guidance applies to all phases of antibiotic production, including raw materials, active pharmaceutical ingredients (APIs), and packaging.
• Waste Types: Both liquid and solid waste are included, with a specific focus on liquid waste such as effluents and runoff that may carry antibiotic-resistant bacteria.

About Antimicrobial Resistance (AMR)

AMR occurs when microbes like bacteria, viruses, and fungi develop resistance to medicines, making treatments ineffective.

Global Threat

• AMR is recognized as a critical global health issue. In 2019, AMR was linked to nearly 1.27 million direct deaths and contributed to 4.95 million additional deaths.

Economic Impact

• AMR could lead to significant economic losses, with the World Bank estimating up to $1 trillion in healthcare costs by 2050, and a GDP loss of $1-3.4 trillion annually by 2030.

Causes of Increasing AMR

• Individual Misuse: Many individuals misuse antibiotics, such as taking them for viral infections like the flu, which doesn’t respond to these drugs.
• Over-prescription by Doctors: Doctors often prescribe broad-spectrum antibiotics without confirming the specific cause of infection, leading to unnecessary use.
• Lack of Diagnostics: Physicians may prescribe antibiotics based on symptoms rather than waiting for test results to confirm the infection type.
• Industrial Waste: Waste from antibiotic production plants often contributes to the development of drug-resistant bacteria, which can spread globally.

Common Resistant Pathogens in India

• Coli: Shows decreasing effectiveness of antibiotics, with a significant drop in response to carbapenems (81.4% in 2017 to 62.7% in 2023).
• Klebsiella Pneumoniae: A common cause of pneumonia and urinary tract infections, its resistance to carbapenems has increased.
• Acinetobacter Baumannii: Common in hospital settings, this pathogen has shown high resistance to many antibiotics, making treatment difficult.

How to Combat AMR

• Public Awareness Campaigns: Long-term campaigns can reduce unnecessary antibiotic prescriptions by informing the public about the dangers of overuse.
• Improved Sanitation: Better hygiene practices, clean environments, and efficient waste management can significantly reduce the spread of infections and resistant pathogens.
• Reducing Unnecessary Antibiotic Use: Doctors must ensure antibiotics are prescribed only when necessary, especially in hospitals, to avoid fostering resistance.
• Promoting Rapid Diagnostic Tests: Encouraging the development and use of rapid tests can help ensure antibiotics are prescribed only when truly needed.
• New Vaccines and Alternative Treatments: Investments in vaccines and alternative therapies like probiotics and phage therapy can reduce reliance on antibiotics.
• Incentivizing New Antibiotic Development: Governments and organizations should incentivize pharmaceutical companies to develop new antibiotics to tackle resistant infections.

Conclusion

The WHO’s guidance on managing waste from antibiotic manufacturing is a vital step toward tackling the global AMR crisis.

Implementing best practices in waste management, improving public awareness, and fostering the development of new antibiotics are essential strategies for reducing the threat of AMR.

While this guidance offers a voluntary framework, it plays a critical role in shaping consistent policies that can address the growing challenge of antibiotic resistance.

Mains question:

1. “Discuss the significance of the WHO’s ‘Guidance on wastewater and solid waste management for manufacturing of antibiotics’ in combating Antimicrobial Resistance (AMR) and suggest measures India can adopt to address the AMR challenge.” (150 WORDS)