Restricting antibiotics

India is the largest consumer of antibiotics in the world, concluded a recent study titled Global antibiotic consumption 2000 to 2010: an analysis of national pharmaceutical sales data. In the course of those 10 years, overall retail antibiotic consumption in the South Asian nation increased by about 68 percent to nearly 13 billion antibiotic pills in 2010, according to the researchers.

On average, an Indian citizen consumed about 7.4 antibiotic pills in 2000, which increased to about 11.7 antibiotic pills in 2010. The report also found that the use of antibiotics rose an alarming 36 percent worldwide, with five countries - Brazil, Russia, India, China and South Africa (BRICS) - responsible for more than three-quarters of that increase. In terms of per capita intake, however, the US still outperforms all other countries, with Americans consuming twice as many antibiotics as Indians.

Although the consumption patterns point out that an increasing number of people are now able to access and afford these drugs, such widespread use of antibiotics is also a source of concern, with scientists linking it to the emergence of new "superbugs," or bacteria that are resistant to most antibiotics currently in use.

Furthermore, it is projected that millions of people worldwide will die of drug resistant infections by 2050. An analysis, titled Review on Antimicrobial Resistance, presented by economist Jim O'Neill on December 11, estimates that figure to be more than 10 million. The world economy would also suffer to the tune of up to 100 trillion USD unless action is taken, said O'Neill.

In a DW interview, Ramanan Laxminarayan, director of the Center for Disease Dynamics, Economics & Policy, in New Delhi, explains the reasons behind the rampant use of antibiotics in India and its potential consequences on public health not only in the South Asian nation, but also across the world.

DW: Why is an increasing number of Indians using antibiotics?

Ramanan Laxminarayan: More Indians are now able to afford antibiotics and that is a good thing since antibiotics are now reducing deaths and illnesses. Antibiotic consumption in India increased by about 68 percent between 2000 and 2010, from about 7.7 billion antibiotic pills in 2000 to about 12.9 billion pills in 2010. On average, an Indian citizen consumed about 7.4 antibiotic pills in 2000, which increased to about 11.7 antibiotic pills in 2010.

Antibiotics are most commonly used in India for treating common cold, acute diarrheal infections and fever. However, a majority of this use is inappropriate as many of these illnesses are viral in origin against which antibiotics are ineffective.

What are the main consequences of this development?

Antibiotics are used for treating bacterial infections. But after repeated exposures, some bacteria will develop mechanisms to overcome the effect of the antibiotic and will no longer respond to the drug.

This is what we call antibiotic resistance. Resistance is also a natural process, which occurs due to the adaptive capability of bacteria, but high levels of antibiotic consumption - both appropriate and inappropriate - aid the resistance process in bacteria and lead to the emergence of antibiotic resistant bacteria. Once bacteria acquire resistance genes, they are very good at sharing these genes to other bacteria.

Widespread inappropriate use of even last-line antibiotics, such as carbapenems, has led to the emergence of superbugs, like carbapenem-resistant Enterobacteriaceae (CRE), which are resistant to almost all available antibiotics.

How does this development potentially affect other countries?

Antibiotic resistant bacteria are not limited by geographical boundaries and can quickly spread to regions far distant from their origin. Indiscriminate use of antibiotics in a country leads to the emergence of antibiotic resistant bacteria there.

Rapid dissemination of these resistant bacteria occurs locally due to poor sanitation in the community and poor infection control practices in hospitals: both of which are common scenarios in low- and middle-income countries like India.

Widespread resistant bacteria spread across countries more easily now than ever before due to increased globalization. There have been several incidences where superbugs like carbapenem-resistant Enterobacteriaceae, which have very limited treatment options, are imported by humans traveling from South-east Asian countries and India to Europe, North America and Australia.

Has the over-the-counter sale of at least strong antibiotics been banned?

To prevent over-the-counter (OTC) sales of important antibiotics, the Central Drugs Standard Control Organization (CDSCO) implemented Schedule H1 in India starting March 1, 2014.

To designate drugs as prescription-based in India, they have to be identified in schedules to the Drugs & Cosmetic Rules, 1945. Schedule H1 covers 46 drugs and includes 24 antibiotics, such as third and fourth generation cephalosporins, carbapenems, anti-tuberculosis drugs and newer fluoroquinolones.

These drugs carry a prominent Rx symbol in red and contain a box with red borders with printed warning on their packaging. The retail pharmacies are also subjected to surprise inspections by government officials to check for violations.

Although Schedule H1 restricts OTC sales of newer, stronger and last-line antibiotics, several other antibiotics, which are commonly misused for common cold, acute diarrhea and fever, are available over the counter.

There is also a possibility of an increase in misuse of these OTC antibiotics by pharmacists to compensate for the restricted sales of stronger prescription antibiotics.

Why is slashing the use of antibiotics in India so difficult?

India's bacterial infection burden is among the highest in the world, and antibiotics play a major role in preventing deaths. For instance, pneumonia is the number one disease in terms of killing children in India, with an estimated 388,000 deaths of children aged under five each year. A significant number of these deaths occur because many patients do not have access to life-saving antibiotics when they are urgently needed.

Although eliminating OTC availability of antibiotics could decrease the inappropriate use of antibiotics, it could also cut off antibiotic access of the rural, poor population. Many of India's poor also prefer to visit a pharmacy and get drugs from the pharmacist or retailers based on their recommendations, as opposed to visiting the doctor for a proper diagnosis.

Other factors include: unwillingness of patients to undergo diagnostic tests, patients' expectations of being given antibiotics, incentives for pharmacists on drug sales, and lack of knowledge about appropriate use among general public.

What must Indian authorities do to curb consumption without a prescription?

Restricting OTC availability of stronger antibiotics is the right step; however, there is an absolute need for full enforcement of this provision in pharmacies to curb consumption. In addition, widespread public campaigns aimed at the general public and pharmacists are necessary to increase the awareness of antibiotic resistance and encourage appropriate use of antibiotics.

Ramanan Laxminarayan directs the Center for Disease Dynamics, Economics & Policy. He is also a Senior Research Scholar and Lecturer at Princeton University. His research deals with the integration of epidemiological models of infectious diseases and drug resistance into the economic analysis of public health problems.