New certification scheme launched to ensure responsible antibiotic manufacturing in India

Subject: Science and technology

Section: Health

Concept :

A new certification scheme to promote responsible antibiotics manufacturing was launched in India on June 26, 2023, by British Standards Institute (BSI) and AMR Industry Alliance.

Details

AMR Industry Alliance, one of the largest private sector coalitions that provide long-term solutions to antimicrobial resistance, engaged BSI, a business improvement and standards company, to provide expert services for the development of this standard.
The certification is the first of its kind, with a third-party validation process, to monitor environmental concerns in the antibiotic manufacturing process. The certification helps in determining whether environmental and waste control procedures are in place throughout the manufacturing process.
This intends to ensure that the concentration of antibiotics in waste streams is below a threshold that does not result in the emergence of AMR in the environment. During the development of this certification, several manufacturers have expressed their willingness to self-regulate the processes.
In 2022, The AMR Industry Alliance and BSI came up with a set of Antibiotic Manufacturing Standards and launched the certification to ensure their implementation.

Antibiotic Manufacturing Standards

The Standard, facilitated by BSI Standards Limited (BSI), provides clear guidance to manufacturers in the global antibiotic supply chain to ensure that their antibiotics are made responsibly, helping to minimize the risk of AMR in the environment.
The Standard marks the formalization of the Alliance’s 2018 Common Antibiotic Manufacturing Framework, which described a risk-based approach to assessing and controlling antibiotic manufacturing waste streams.
The AMR Industry Alliance engaged BSI, the business improvement and standards company, to provide expert services in relation to the development of this antibiotic manufacturing standard.
BSI facilitated the development of the Standard by working with the Alliance and a number of industry stakeholders.

Antibiotic Resistance

Antimicrobial Resistance is the resistance acquired by any microorganism (bacteria, viruses, fungi, parasite, etc.) against antimicrobial drugs that are used to treat infections.
It occurs when a microorganism changes over time and no longer responds to medicines making infections harder to treat and increasing the risk of disease spread, severe illness and death.
The World Health Organisation (WHO) has identified AMR as one of the top ten threats to global health.
Microorganisms that develop antimicrobial resistance are sometimes referred to as “superbugs”.
In India, over 56,000 newborn deaths each year due to sepsis caused by organisms that are resistant to first line antibiotics.

Reasons for Spread of AMR:

Antibiotic residues enter waterways from various sources, including hospital wastewater, farms, sewage systems and others.
While antibiotic overuse in humans and animals is considered the primary cause of AMR, the environmental aspect of AMR is gaining global attention.
The misuse of antimicrobials in medicine and inappropriate use in agriculture.
Contamination around pharmaceutical manufacturing sites where untreated waste releases large amounts of active antimicrobials into the environment.