Tackling the rising sale of unapproved antibiotics in India

October 10, 2017, Newcastle University
Credit: Newcastle University

Indian government needs to do more to tackle rising sale of unapproved antibiotics, according to an analysis by researchers at Newcastle University and Queen Mary University of London.

In India, the sale of requiring the tightest control and regulation is rising the fastest, warn the researchers. The correspondence published in The Lancet Global Health highlights serious hurdles for controlling in the country.

In June 2017, the World Health Organization (WHO) adopted a new classification for antibiotics, to combat rising antimicrobial resistance and preserve the effectiveness of antibiotics that are a 'last resort'.

The new model comprised three categories: 'Key Access' antibiotics that should be widely available, 'Watch Group' that includes critically important antimicrobials which should only be used for certain infections, and 'Reserve Group' antibiotics for severe circumstances when all alternatives have failed.

Ensuring rational medicine prescribing and use

Professor Allyson Pollock, Director of the Institute of Health and Society at Newcastle University, said: "In India, rational use of antibiotics is imperative to limit antimicrobial resistance. It is of concern that of irrational and unsafe combinations are increasing and many have never been approved by the government. There are many calls from within the country for a new medicines Act and effective implementation of regulation to ensure rational medicine prescribing and use."

Dr Patricia McGettigan from Queen Mary University of London said: "In India, total sales of antibiotics are increasing, and for the antibiotics that require the most careful control and regulation, their sales are increasing at the fastest rate. The increases are driven by sales of fixed dose formulations, many of them indiscriminately combining two antibiotics together. Even worse, most of these formulations were never approved by India's national drugs regulator so their sale is illegal. The government has done nothing effective to stop the sales."

India is a major producer with some of the highest sales of antibiotics globally and the highest levels of antimicrobial resistance. Contributing factors include failures of India's drug regulatory system which have been identified in government reports, the sale of antibiotics without prescription, and the use of fixed-dose combination (FDC) antibiotics - formulations composed of two or more drugs in a single pill.

Scale of the problem

The team analysed antibiotic sales in India between 2007 and 2012, and found that total antibiotic sales increased by 26 per cent, with the increase mainly due to the growth in sales of FDCs, which rose by 38 per cent. By 2011–12, FDCs comprised a third of total sales in India.

When taking into account the new WHO categories, sales of FDCs with Key Access antibiotics had risen by 20 per cent in five years, but those with Watch Group or Reserve Group antibiotics had risen more steeply, by 73 per cent and 174 per cent, respectively.

Of 118 different formulations of FDCs being sold, only 43 were approved by India's national regulator, the Central Drugs Standard Control Organization (CDSCO), even though the sale of unapproved new medicines is illegal in India. Only five of the formulations were approved in the UK or US.

Looking at single drug formulations (SDFs) which are composed of a single drug on its own, the majority (58 per cent) of the 2011-12 sales were either Watch Group or Reserve Group antibiotics. Over five years, sales of Key Access antibiotics had risen by 13 per cent, Watch Group by 24 per cent, and Reserve Group by 69 per cent. Unlike FDCs, most of the 86 SDFs on the market in India were approved by the national regulator and were also approved in the UK and US.

Good use of antibiotics

The researchers say that the changes needed to achieve the WHO vision of good use of antibiotics include banning the sale of unapproved FDC antibiotics and enforcing existing regulations to prevent unapproved and illegal drugs reaching the market.

Improved access to health care to reduce non-prescription sales is also needed, alongside research to understand why doctors complicate problems by prescribing unapproved antibiotics.

Explore further: Many fixed-dose drug combinations in India lack central regulatory approval

Related Stories

Many fixed-dose drug combinations in India lack central regulatory approval

May 12, 2015
Fixed-dose drug combinations (FDCs) which have not received central regulatory approval are sold in substantial numbers in India—despite concerns over the safety and efficacy of these combinations—according to new research ...

A dose of 'wait-and-see' reduces unnecessary antibiotic use

September 21, 2017
Asking patients to take a 'wait-and-see' approach before having their antibiotic prescriptions filled significantly reduces unnecessary use, a University of Queensland study has shown.

A range of interventions could curb rising antibiotic resistance in India

March 2, 2016
Antibiotic resistance is a global public health threat and one of particular concern in India. A mix of poor public health systems, high rates of infectious disease, inexpensive antibiotics, and rising incomes are is coming ...

Slight increase in Norwegian drug consumption in 2015

April 20, 2016
Drug sales measured in defined daily doses (DDD) increased by 2 per cent from 2014 to 2015. Revenue growth was 8.6 per cent. This is shown in "Drug Consumption in Norway 2011-2015", a report issued by the Norwegian Institute ...

High levels of antibiotic-resistance in Indian poultry farming raises concerns

July 20, 2017
A new study from India raises questions about the dangers to human health of farming chicken with growth-promoting antibiotics—including some of the same drugs used in raising millions of chickens in the United States and ...

EU report: More evidence on link between antibiotic use and antibiotic resistance

July 27, 2017
The European Food Safety Authority, the European Medicines Agency and the European Centre for Disease Prevention and Control are concerned about the impact of use of antibiotics on the increase in antibiotic-resistant bacteria. ...

Recommended for you

Rapid response inpatient education boosts use of needed blood-thinning drugs

November 16, 2018
A new study designed to reach hospitalized patients at risk shows that a "real-time" educational conversation, video or leaflet can lower the missed dose rates of drugs that can prevent potentially lethal blood clots in their ...

Drug overdose epidemic goes far beyond opioids, requires new policies

November 7, 2018
Most government-funded initiatives to address the overdose epidemic in the United States have targeted opioids specifically and have neglected other drugs that are increasingly implicated in overdoses, such as cocaine and ...

Zebrafish larvae help in search for appetite suppressants

November 2, 2018
Researchers at the University of Zurich and Harvard University have developed a new strategy in the search for psychoactive drugs. By analyzing the behavior of larval zebrafish, they can filter out substances with unwanted ...

FDA OKs powerful opioid pill as alternative to IV painkiller

November 2, 2018
U.S. regulators on Friday approved a fast-acting, super-potent opioid tablet as an alternative to IV painkillers used in hospitals.

Amphetamine-related hospitalizations surged between 2003 and 2015

November 2, 2018
An analysis conducted by Hennepin Healthcare, University of Minnesota School of Public Health and University of Michigan researchers shows amphetamine-related hospitalizations increased more than 270 percent from 2008 to ...

Cocaine-fentanyl overdoses underscore need for more 'test strips' and rapid response

November 1, 2018
Penn Medicine emergency department physicians are calling for more readily available testing strips to identify the presence of fentanyl in patients experiencing a drug overdose, and a rapid, coordinated response among health ...


Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.