India urgently needs a national policy paradigm to stop superbugs
Recently, a woman in the US died from an incurable infection. Initially she was diagnosed with an inflammatory response syndrome resulting from an infected right hip operation in India. However the infection soon proved to be difficult to fight, as it resisted 26 different antibiotics, including the last resort aminoglycosides and polymyxins.
The WHO defines anti-microbial resistance (AMR) as a condition wherein microbes survive when exposed to the drug which would have normally caused them to die. In simple terms, drugs become dysfunctional or ineffective in fighting microbes.
The resistance of superbugs is not confined to the place of production, but can be transmitted to different regions. The Central Pollution Control Board and various other State Pollution Control Boards have policies and regulatory jurisdiction over industrial effluents released in the air, water, through municipal waste and various other sources, but there are no clear-cut policies or norms for effluents released by pharmaceutical industries, which are a key factor behind the development of superbugs.
AMR has received a lot of attention on a worldwide scale with public opinions and a global action plan coming to the forefront. The WHO’s “Global Action Plan on Antimicrobial Resistance” calls upon member states to have their own national plan on AMR by 2017.
In September 2016, the FAO, Food and Agriculture Organisation, released the “Action Plan on Antimicrobial resistance 2016-2020”. One of the guiding lights in battling the resistance of superbugs comes from the AMR review, “Tackling drug-resistant infections globally” by the UK government and chaired by Jim O Neill.
At the 71st session of the United Nations General Assembly, a high-level meeting on AMR was organised in September 2016, where 13 pharmaceutical companies agreed to establish the “roadmap for progress on combating AMR”, which lays out some key commitments which these companies promise to deliver by 2020.
There are several contours of policy with regards to the pharmaceutical industry in India consisting of different ministries that have a stake in it, i.e. ministry of environment and forests, ministry of health and family welfare, department of pharmaceuticals and department of chemicals, fertilisers and petrochemicals.
The industry has seen varying laws, legislations and policies coming into play with regard to the manufacture and sale of drugs. The Drugs and Cosmetics Amendment Bill, Pharmaceutical Policy, 2002, The Pharmacy Act, 1948, The Drugs and Magic Remedies Act, 1954, The Medicinal and Toilet Preparations Act, 1954, The Narcotic Drugs and Psychotropic Substances Act, 1985 - are all laws that pertain to manufacture and sale of drugs in India.
But many of the policies regarding pharmaceutical companies are sector specific in nature. For instance, the Central Drug Standards and Control Organization (CDSCO) comes under the aegis of the ministry of health. This looks after the larger perspective of public health with respect to quality control issues of drugs and compliance of environment norms.
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| Anti-microbial resistance has received a lot of attention on a worldwide scale. (Photo: Reuters) |
The rise of superbug resistance and increase in pollution in the pharmaceutical industry can therefore also be attributed to the lack of a cohesive mechanism and information symmetry between the ministries.
Even though good manufacturing practices (GMP) and Schedule M compliance has been initiated in India, the overall essence of safe and sustainable manufacturing of drugs is not taken into consideration.
Most pharmaceutical companies based in India comply with GMP and Schedule M in order to foray into developed nations such as US, EU, UK, and Japan. GMP constitutes an international set of guidelines for the manufacture of drugs and medical devices in order to ensure the production of quality products. But it doesn’t account for a safe manufacturing environment which includes having effluent treatment plants at source, and segregating waste based on the enormity of the chemicals.
A new national policy paradigm is needed which takes into consideration the various viewpoints of different stakeholders; say from the industry standpoint, civil society, medical professionals, policy makers, and various other important stakeholders.
Some steps are underway - in the wake of increasing antibiotic resistance across the globe, the National Centre for Disease Control (NCDC) is set to formulate a national action plan to curb antimicrobial resistance and submit it to the ministry of health for incorporating into the national policy.
The ministry recognises that there is a need for increased education and awareness about antimicrobial resistance among the public and healthcare professionals. It is looking at developing and improving the surveillance system, particularly through improved linkage of data.
The government can incentivise pharmaceuticals companies to follow and practise sustainable manufacturing practices rather than act through coercive regulations which will be an impediment for the growth of the industry.
More pharmaceutical companies can then be expected to comply with the norm and help in mitigating the resistance. The other implementable policy can be of widespread media advocacy and building of public opinion and awareness, where dos and don’ts are communicated to larger stakeholders.
Behavioural change plays an important role in having a successful public policy, and in matters concerning resistance of antimicrobials, stricter rules, effective enforcement and not mere penalty is the solution.
In addition, AMR needs to be part of public discourse, widely spoken about and remaining in the minds of people.