Deep impact

  • Asha Ramachandran

    December 15, 2016 | 07:25 AM

Representational image (PHOTO: Getty Images)

Any medicine, including what we think as harmless vitamins, has an adverse or side effect, asserted a senior oncologist in a major corporate hospital. After all, he explained, any medicine, whether taken orally or injected, is adding a potent chemical to the system. While they are essential to treat diseases, often indiscriminate use due to over-prescription or self medication can lead to more harm than good.
A more alarming phenomenon, which has been around for decades but gaining recognition more recently, is Antimicrobial Resistance (AMR). In simple words, this is the resistance of various disease-causing bacteria to antibiotics, making it difficult to treat various diseases. While AMR is a phenomenon that has emerged recently, it is the result of decades of domination of the allopathic system of medication, right from the time when Penicillin was first introduced in the early 20th century.
Today, antibiotics are part of our daily life and are critical in medical procedures such as surgeries and long-term treatment of chronic diseases, including diabetes and cancer. Ironically, this increasing use and dependence on antibiotics is proving to be its unmaking.According to the World Health Organisation (WHO), AMR is a resistance of microorganisms to an antimicrobial drug that was originally effective for the treatment of infections caused by it.However, later the human body develops a resistance to it as many common drugs are so widely used and for so long that the infectious organisms the antibiotics were designed to kill have adapted to them, making the drugs less effective.
"One of the key causes of antibiotic resistance is inappropriate use of antibiotics in humans and overuse in intensive animal farming," asserted Lucas Wiarda, Head of Sustainable Antibiotics Program, DSM Sinochem Pharmaceuticals. Natural excretion that adds antibiotics to environment is another factor. But a major cause, often overlooked is the pharmaceutical manufacturing process, which releases antibiotics into natural resources  --  water and soil. "All three angles are important when one considers AMR," pointed out LucasWiarda.
The AMR phenomenon is assuming the form of a serious public health issue in many developing and developed countries today. The main reason is the excessive usage of antibiotics in unnecessary and unscrupulous manners. Antibiotics are cheap and easy to get today as Over the Counter (OTC) drugs without any prescription from the physicians leading to their prolific use. Simple bacterial illnesses such as cough, fever or cold are treated with antibiotics today as people want early cure.
A global health threat
The WHO's 2014 report on global surveillance of AMR revealed that "antibiotic resistance is no longer a prediction for the future, it is happening right now, across the world, and is putting at risk the ability to treat common infections in the community and hospitals." The WHO and other eminent global health experts warn that we are at the dawn of a "post-antibiotic era", which will result in millions of fatalities every year.
The UK's Independent Review on AMR projects a death toll of 10 million people per annum by 2050 if resistance is left unchecked, with a whopping cost of up to 100 trillion dollars. This, said Lucas Wiarda, is a conservative estimate, which only takes into account part of the impact of AMR.
Rising resistance to antibiotics is taking a devastating toll on the Indian population, particularly the most vulnerable members of society. The first State of World's Antibiotics report published by the Washington-based Center for Disease Dynamics, Economics and Policy (CDDEP) in 2015 noted that 58,000 newborn babies in India died in 2013 as a result of drug-resistant infections, while Indian drug resistance rates for several major pathogens is on the rise.
Manufacturing right
In addition to medicine overuse, another critical factor, which is not being addressed strongly enough, is AMR due to industrial pollution of our waters. Pharmaceutical companies don't have proper waste treatment plants. Pharma effluents or waste released during production process are not treated properly. 
In India, many pharma companies are dumping industrial waste directly into our waters.Hyderabad, which is known as the bulk drug capital of India, today has the most polluted areas in the country due to this reason as per research reports.
The pharmaceutical industry is one of the fastest growing segments of the Indian economy and has experienced rapid and sustained expansion since the second half of the 20th century. The market is expected to grow to 100 billion dollars by 2025. The sector is geographically fragmented, located in various clusters around India, including Andhra Pradesh, Telengana, Tamil Nadu, Karnataka, Himachal Pradesh, Punjab, Maharashtra, Gujarat, Madhya Pradesh and West Bengal.
According to a report by Sweden-based Nordea Asset Management, overwhelmed by the manufacturing might of China, which is flooding the Indian market with pharmaceutical APIs (active pharmaceutical ingredients), a new drive to boost India's bulk drug industry was announced in 2015 with a high-level committee recommending the establishment of large manufacturing zones or "mega-zones" across the country.
India is one of the world's leading suppliers of generic drugs, with generic drug revenues of 15 billion dollars in 2014. Over half of India's pharmaceutical exports are to highly regulated markets such as the US and the EU. Following opening up of the economy to overseas players in the mid-2000s, multinational drug companies have flocked to manufacturing hubs acrossIndia. Incidentally, some of the larger Indian firms are also competing at the global level.
Way forward
Calling for proactive steps to address the critical issue of AMR and industrial pollution in India, an Antibiotic Awareness Week was observed from 14-20 November. On this occasion, a call was given for decisive action from all industry stakeholders to gather together on a unified platform. This call for action followed the United Nations General Assembly (UNGA) Industry Roadmap on AMR published on 20 September, just ahead of a UNGA High Level Meeting. This Roadmap is signed by 13 leading bio-pharmaceutical companies and has placed the environmental impact of antibiotics manufacturing as No. 1 priority.
Signatory companies who signed the roadmap committed to reviewing theirown manufacturing and supply chains to assess good practices in controlling releases of antibiotics into the environment; establishing a common framework for managing antibiotic discharge and starting to apply it across their own manufacturing and supply chain by 2018; working with stakeholders to develop a practical mechanism to transparently demonstrate that the supply chains meet the standards in the framework and working with independent technical experts to establish science-driven, risk-based targets for discharge concentrations for antibiotics and good practice methods to reduce environmental impact of manufacturing discharges, by 2020. These are all steps to move towards safer antibiotic manufacturing processes where sustainable manufacturing is an essential prerequisite.
In India, Prime Minister Narendra Modi in his monthly radio programme "Mann Ki Baat" also spoke about AMR, where he recognised it as a serious public health issue and called for responsible use of antibiotics. Recognising the magnitude of threat posed by AMR, the Ministry of Health and Family Welfare, India, is working towards a comprehensive policy framework to combat the threat posed by AMR. It has taken measures such as formulating a National Policy for Containment of Antimicrobial Resistance, leading the way towards "Red Line Campaign" that aims to put a red line on antibiotic packages to curb their over-the-counter sale, among others. 
"While countries are in the process of making their National Action Plans, it is critical that environmental policymakers in developing countries are actively involved in this exercise, along with policymakers from the agriculture and health sectors. The global guidance also needs to adequately address environmental spread of antibiotic resistance," said Sunita Narain, director general of the Centre for Science and Environment (CSE), addressing a two-day international conference held in the capital here, on National Action Plans of Developing Countries on Antimicrobial Resistance, organized as part of the Antibiotic Awareness Week in November.
"Other than food, environmental spread of resistance is a big issue," said Chandra Bhushan, deputy director general, CSE. "It has been neglected so far, particularly in developing countries such as India. Countries need to reduce environmental entry of antibiotic residues and resistant bacteria by managing waste from livestock and aquaculture farms, slaughter houses and animal food processing units. Discharge effluents from the pharmaceutical industry, particularly in India, also need urgent attention to minimise antibiotic contamination of the environment."   
Besides focusing on biosecurity measures, countries must work towards developing necessary laws and standards on waste from farms and factories as well as institutionalise systems for environmental surveillance of resistance. "This has to be an integral part of country-level action plans," added Bhushan.
Lucas Wiarda noted that it was only recently that more and more stakeholders were coming on board. But there is need, he said, not just for manufacturing standards but also discharge standards. "Nowhere in the world are there environmental legislations (for pharmaceutical discharge). The only focus is on chemicals but not microbial activity." Moreover, he added, there is no incentive for environmental responsibility.
But above all, there is need for a massive global public awareness campaign to reduce unnecessary use of antimicrobials in agriculture and their dissemination into the environment. As part of this, experts also advocate new, rapid diagnostic methods to confirm a physician's initial diagnosis. This would cut unnecessary prescription of antibiotics.
The battle may appear a long way off, but with all stakeholders pitching in, it is not impossible. After all, it's our life that's at stake.