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Antibiotics menace: Govt not doing enough to curb sale of unapproved drugs

India is known as the pharmacy of the world, due to its large pharmaceutical industry

Patricia McGettigan & Allyson Pollock| The Conversation 

Photo: Shutterstock
Photo: Shutterstock

Efforts to conquer antimicrobial resistance are being jeopardised in due to the of huge volumes of that combine two anti-microbial in one pill, a latest analysis reveals. Many of these fixed-dose combination (FDC) formulations, as they are known, have not been approved by India’s Their is illegal.

Antibiotic resistance is a global crisis, threatening to reverse the astonishing health benefits achieved with As adapt to survive, effective treatments, even for common infections, are diminishing.

Unfortunately, new in development are not yet offering realistic prospects for treating the infections caused by resistant These infections include common kidney and chest infections, as well as life-threatening conditions, such as sepsis and meningitis.

So, wherever we live and in whatever guise we encounter – as patients, prescribers, pharmacists, drug sellers, pharmaceutical companies, drug developers, animal owners or veterinarians – we have a shared responsibility to ensure our existing stash of these precious remains as effective as possible against disease-causing The World Health Organisation (WHO) is acutely aware of this, using its unique position to lead policy change for rational antibiotic use.

This year, the made a major revision to its list of essential medicines, classifying into three categories with recommendations on when each category should be used in common bacterial infections (such as chest or kidney infections, and excluding tuberculosis and viral infections, such as HIV).

The first category, so-called “key access group” antibiotics, are those that should be “widely available, affordable and quality assured”. These are suitable to treat most common bacterial infections. The second category, “watch group” antibiotics, are recommended for specific infections. tend to develop resistance easily to these drugs, so judicious use is needed.

The final category, “reserve group” antibiotics, should only be used as a last resort when all alternatives have failed. The specifies that these should be “protected and prioritised” to preserve their effectiveness.

Lack of regulatory scrutiny

is known as “the pharmacy of the world”, due to its large pharmaceutical industry. It has among the highest per capita sales of globally, as well as high levels of antimicrobial resistance.

In our study of antibiotic sales in between 2007 and 2012, we found that total sales were rising annually, and the increase was driven by While total antibiotic sales increased by 26% over five years, FDC sales rose by 38%. By 2011–12, comprised a third of all sold in (872m units).

Analysed according to the new categories, we found that sales of with key access had risen by 20% in five years. However, of watch group and reserve group rose much more steeply – by 73% and 174%, respectively.

We found 118 different antibiotic FDC formulations on the market, but only 43 were approved by India’s drug regulator, the Central Standard Control Organisation. The of unapproved new is illegal in India, yet 75 formulations had no approval record. So they had no regulatory scrutiny to decide if they were likely, on balance, to be of more public benefit than harm.

Antibiotics menace: Govt not doing enough to curb sale of unapproved drugs

Unapproved formulations figured hugely in sales – 270m units of the FDC sold in 2011-12 contained unapproved formulations. The Indian banned some unapproved FDCs, including antibiotic formulations from – most recently in 2016. But the bans have been challenged by the industry and it appears the remain on

The ConversationConsidering the vision of conserving watch and reserve group antibiotics, their increasing sales, not to mention the numbers of unapproved formulations, suggest there is a formidable task ahead in


Patricia McGettigan, Reader in Clinical Pharmacology and Medical Education, Queen Mary University of London and Allyson Pollock, Professor of Public Health, Newcastle University

This article was originally published on The Conversation. Read the original article.

The Conversation

First Published: Fri, October 13 2017. 09:33 IST
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