ANTIBIOTIC RESISTANCE BY ENVIRONMENTAL ANTIBIOTIC POLLUTION- A MATTER OF SERIOUS CONCERN IN INDIA

TIDES OF INDIAN PHARMA, BY LEVINTHOMAS

ANTIBIOTIC RESISTANCE BY ENVIRONMENTAL ANTIBIOTIC POLLUTION- A MATTER OF SERIOUS CONCERN IN INDIA

Antimicrobial resistance (AMR) is defined by the WHO as the resistance of a microorganism to an antimicrobial  drug which was originally effective for  treatment of infections caused by it. AMR  threatens the effective prevention and  treatment of an ever-increasing range of  infections caused by bacteria, parasites,  viruses and fungi. A report (August 2014) in the journal The Lancet Infectious Diseases, said that in 2010, India consumed 13 billion units of antibiotics, the highest in the world (10.7 units per person).  Between 2005 and 2009, consumption shot up by 40 per cent. And the impact of this unregulated usage is already showing. Between 2008 and 2013, E.coli bacteria resistant to third-generation cephalosporins increased from 70 to 83 per cent; it went up from 8 to 13 per cent in the case of carbapenems and 78 to 85 per cent in the case of fluoroquinolone, notes a paper published on March 3, 2016 in PLOS Medicine. Environmental antibiotic pollution is a major driver for this antibiotic resistance.

Environmental antibiotic pollution encourages the transfer of resistance genes to human commensal and pathogenic bacteria. In particular, waste water treatment plants serving antibiotic manufacturing facilities have been implicated in the transfer of resistance genes into human microbiota and pose a serious threat to antibiotic effectiveness given the size of India’s pharmaceutical sector. In 2007, the first in a series of papers by a Swedish researcher Joakim Larsson was published, showing very high emissions of pharmaceuticals from drug manufacturers in Patancheru, near Hyderabad, India. Tests on effluent from a treatment plant receiving waste water from about 90 manufacturing plants showed that concentrations for some pharmaceuticals were greater than those found in the blood of patients  undergoing treatment. The researchers found that concentrations of antibiotics in the river sediment further downstream were so high that if “ciprofloxacin had been more expensive, we could mine it from the ground.”!! Since India is one of the leading pharmaceutical producers, there needs to be stringent mechanisms for disposing waste into local public water streams such as lakes, rivers and water bodies. There are several hundred manufacturers of APIs in India (active pharma ingredients), out of which only a small percentage are compliant. Compliance here refers to effective waste management, following good manufacturing practices, following the guidelines issued by central and state pollution boards. Manufacturers don’t either have waste treatment plants or don’t use them due to the costs involved. Some pharma companies make use of common facility centres for waste treatment, others don’t have, or have not constructed any. They simply dump the waste into nearby rivers and water streams. Weak enforcement and current gaps in law further aggravate the problem. Environmental criteria that enforce responsible production of antibiotics and regulate the discharge of antibiotics in the environment are missing from regulations and policies related to the procurement, prescription and reimbursement of antibiotics.  Today, environmental regulation and its enforcement are left up to national regulators. Compliance with ‘Good Manufacturing Practices’ (GMP), a mandatory requirement for accessing the EU and US markets, do not include environmental criteria.

Another cause of antibiotic resistance is the routine feeding of antibiotics to animals in industrial livestock production to help them endure crowded, dirty, and stressful conditions and grow faster. According to the WHO reports, more antibiotics are given to healthy animals than are used to treat diseases among human patients. The extensive use of antibiotics in animal breeding stems from the 1940s and 1950s when the industry discovered that antibiotics could serve as growth stimulants and for disease control, which made it possible to rear large flocks of chickens or herds of cows in confinement. The prophylactic use of antibiotics in animal breeding is problematic because the regular administration of low doses of drugs wipes out weaker bacteria and leaves the field open for stronger strains. When the manure is sold on as fertiliser or washed downstream into rivers and groundwater, the resistant genes are spread to the wider bacterial community. In 2012, Chinese researchers studying the manure from pig farms in China found 149 unique resistance genes. In the U.S. in 2013, the Food and Drug Administration (FDA) found that 65 percent of chicken breasts and 44 percent of ground beef carried bacteria resistant to tetracycline, and 11 percent of pork chops carried bacteria resistant to five classes of drugs. The rising global demand for cheap meat is expected to further increase the already extensive use of antibiotics in livestock rearing. In light of the huge threat to human health and animal welfare posed by antibiotic resistance, numerous organisations have launched major campaigns aimed at putting a stop to the non-therapeutic use of antibiotics in animals and calling for the restriction of some types of antibiotics exclusively for human use. The European Union is considering banning the prophylactic use of antibiotics and some countries such as Denmark and Sweden have already begun to drastically reduce their consumption. Currently, India does not have regulatory provisions for the use of antimicrobials in cattle, chickens, and pigs raised for domestic consumption. Recent studies in various regions of India have discovered antimicrobial residues in food animal products (such as chicken meat and milk), indicating that antibiotic use in food animal production is widespread. There are no standards for tolerance of antibiotic residues in poultry, although such standards do exist for seafood—including shrimps, prawns, or any other variety of fish and fishery products—under the Food Safety and Standards (Contaminants, Toxins, and Residues) Regulations of 2011.

 

A few urgent priorities for immediate implementation stand out. Improved capacity of drug regulatory bodies is essential to safeguard against powerful antibiotics being sold over the counter and to phase out the use of antimicrobial growth promoters in livestock. These capabilities are also needed to ensure the safety and reliability of India’s pharmaceutical manufacturing sector, which now supplies a significant proportion of the world’s pharmaceutical needs. India should phase out antimicrobial growth promoters from livestock when these drugs are medically important and when these are premixed with feed. Such a move would have regional consequences and would send a strong signal of the country’s commitment to tackle this issue. The government should also urgently regulate drug companies discharging antimicrobial waste into the environment and regulate the use of antibiotics in animal feed to combat antibiotic resistance and obtain healthier animal products. Better sanitation and effective infection control measures in health-care settings will also drastically cut the spread of drug-resistant strains.