Context:
The World Health Organization (WHO) has recently released guidelines on managing wastewater and solid waste in antibiotic production to combat the growing threat of Antimicrobial Resistance (AMR). This initiative underscores the critical need for responsible environmental practices in pharmaceutical manufacturing to prevent the escalation of AMR globally.
Relevance:
GS II: Health
Dimensions of the Article:
- Overview of the Guidance
- What is Antimicrobial Resistance (AMR)?
- Concerns regarding Antimicrobial resistance (AMR)
Overview of the Guidance:
- Provides a systematic approach for regulators and industry stakeholders to manage antibiotic resistance effectively.
- Serves as a scientific basis for incorporating specific targets into regulatory and policy frameworks to combat antibiotic resistance.
- Non-binding Guidance: Though not legally mandatory, it promotes consistency, transparency, and helps avoid piecemeal policy approaches.
Principles and Best Practices:
- Recommends best practices derived from other sectors such as food and water safety to develop risk management strategies.
- Stresses the need for regular internal and external audits and maintaining transparency in practices.
- Advocates for gradual improvements, acknowledging the need for global supply chain security and fair access to essential antibiotics.
Intended Audience:
- Regulatory Authorities: Targets national and regional officials overseeing pharmaceutical manufacturing and waste management.
- Audit Organizations: Addresses third-party bodies involved in the oversight of antibiotic production and waste management processes.
- Pharmaceutical Sector: Directs companies engaged in all phases of antibiotic production and related organizational bodies.
- Waste Management Entities: Focuses on those handling the disposal of antibiotic wastes and wastewater.
Scope and Focus of the Guidance:
- Concentrates on reducing antibiotic resistance risks.
- Highlights the ecotoxicological impacts on aquatic ecosystems from antibiotic residues.
- Encompasses the entire spectrum of antibiotic production, from active pharmaceutical ingredients (APIs) production to the final packaging.
- Focuses extensively on the management of both liquid and solid wastes, particularly emphasizing effluents and runoff management.
Risk Assessment Protocols:
- Mandates detailed risk assessments at manufacturing facilities producing multiple APIs, considering the environmental impact both before and after waste treatment processes.
What is Antimicrobial Resistance (AMR)?
- Antimicrobial resistance (AMR) is the ability of microorganisms such as bacteria, fungi, viruses, and parasites to remain unaffected or survive antimicrobial drugs such as antibiotics, antivirals and antimalarials.
- AMR occurs when microorganisms exposed to antimicrobial drugs develop antimicrobial resistance resulting in standard treatments becoming ineffective leading to persistence of infections and spreading of infections.
- Microorganisms that develop antimicrobial resistance are sometimes referred to as “superbugs”.
- The misuse of antimicrobials in medicine and inappropriate use in agriculture is one of the major causes of spread of Antimicrobial Resistance.
- Contamination around pharmaceutical manufacturing sites where untreated waste releases large amounts of active antimicrobials into the environment also leads to spread of AMR.
Basis of Antimicrobial Resistance
- Some bacteria due to the presence of resistance genes are intrinsically resistant and therefore survive on being exposed to antibiotics.
- Bacteria can also acquire resistance by sharing and transferring resistance genes present in the rest of the population, or by genetic mutations that help the bacteria survive antibiotic exposure.
Multi drug resistance
- Multiple drug resistance (MDR), multidrug resistance or multi-resistance is antimicrobial resistance shown by a species of microorganism to multiple antimicrobial drugs.
- The types most threatening to public health are MDR bacteria that resist multiple antibiotics; other types include MDR viruses, parasites (resistant to multiple antifungals, antiviral, and antiparasitic drugs of a wide chemical variety).
- Recognizing different degrees of MDR, the terms extensively drug resistant (XDR) and pandrug-resistant (PDR) have been introduced.
Concerns regarding Antimicrobial resistance (AMR)
- Medical procedures such as organ transplantation, cancer chemotherapy, diabetes management and major surgery (for example, caesarean sections or hip replacements) become very risky due to AMR.
- AMR increases the cost of healthcare with lengthier stays in hospitals, additional tests and use of more expensive drugs.
- No new classes of antibiotics have made it to the market in the last three decades, largely on account of inadequate incentives for their development and production.
- Without urgent action, we are heading towards a future without antibiotics and with bacteria becoming completely resistant to treatment and when common infections and minor injuries could once again kill (referred to as antibiotic apocalypse).
- It is putting the gains of the Millennium Development Goals at risk and endangers achievement of the Sustainable Development Goals.
Concerns regarding AMR in India
- India, with its combination of large population, rising incomes that facilitate purchase of antibiotics, high burden of infectious diseases and easy over-the-counter access to antibiotics, is an important locus for the generation of resistance genes.
- The multi-drug resistance determinant, New Delhi Metallo-beta-lactamase-1 (NDM-1), emerged from this region to spread globally – Africa, Europe and other parts of Asia have also been affected by multi-drug resistant typhoid originating from South Asia.
- In India, over 56,000 newborn deaths each year due to sepsis are caused by organisms that are resistant to first line antibiotics.
Way forward
- The use of antibiotics unrelated to treating human disease, such as in food and animal production, must be “optimised”.
- Greater action need to be taken to monitor and control infections, globally, nationally and within individual hospitals.
- Access to vaccines, clean water and sanitation ought to be expanded.
- And finally should be “more thoughtful” about our use of antimicrobial treatments —expanding access to lifesaving antibiotics where needed, minimising use where they are not necessary to improve human health and acting according to WHO’s recommendations on the same.
- Increasing funding for developing new antimicrobials and targeting priority pathogens such as K. pneumoniae and E. Coli and ensuring that they are affordable and accessible to most of the world.
-Source: The Hindu
