The resistance level to a large number of antibiotics is extremely high in India compared to other parts of the world. Resistance to normal penicillin and also to theophylline and even to the last line antibiotics such as carbapenems and colistin have high resistance level.
This has been further substantiated by data collated from “State of the World Antibiotics” report of the Centre for Disease Dynamics, Economics and Policy (CDDEP) 2015 which has noted that 58000 babies in India died in the year 2013 because of drug resistance infections.
The major reason in general is seen as misuse and overuse of antibiotics by human beings, misuse and overuse of antibiotics in agriculture and thirdly, the environmental impact of antibiotics manufacturing and antibiotics pollution associated with manufacturing. The environmental angle is driven by natural excretion, by humans and by animals and also through pharmaceutical antibiotic discharge by industries.
Corporate initiatives
Pharmaceutical company DSM Sinochem has started having an effluent treatment plant at its source of their Active Pharmaceuticals Ingredients (API) plant so as to ensure sustainable and environment friendly products.
This is so important to India especially because India has become the biggest manufacturer of antibiotics in the world. Says Lucas Wiarda, Global Marketing Director and Head of Sustainable Antibiotics Program, DSM Sinochem Pharmaceuticals. “Manufacturing of antibiotics comes with pollution and since India is the numero uno antibiotics maker of the world, we also have to manage the pollution that comes with manufacturing,” he adds.
“But in India, the manufacturing is done largely by small companies and the unorganised sector. The large pharmaceuticals should take leadership in solving the issue of cleaning up the supply chain. At this moment, there is no fair level playing field in a highly commercialised industry. There are no incentives, there are no penalties for making antibiotics responsibly. Such mechanisms should either be introduced by the government or an enforcement body. The pollution control boards both at national and the state-levels play an important role. At this moment, there are no standards defined for antibiotics discharges. So, this needs to be introduced either through standards or through formal legislation. However it is preferable to have incentives rather than legislation,” he explains.
“DSM is present in China, India, in Europe and Latin America and we run all these plants in a similar fashion. The company operates in cleanest technology available and has its own waste water treatment plants running 24 x 7, 365 days annually.
DSM also runs its antimicrobial activity tests to make sure that its effluent is free of activities to find the tolerance level”, he pointed out.
“Since we are not amongst the biggest manufacturers, we are showing the world that it is economically feasible to do it and that we don’t use any revolutionary technology. It is technology that is available on the mark. All the manufacturers of antibiotics should know how to manage waste in the treatment plants and how to operate it. They should take the responsibility of the waste and responsibility for cleaning the water they have received from the nature. Now antimicrobial resistance has even entered the food chain in India. Chicken are fed with the antibiotics. So, resistance are formed. Normally, the issue is about misuse and overuse of antibiotics by humans, misuse and overuse of antibiotics by agriculture systems including, chicken, cow and pig,” he further adds.
It is important that antibiotics should remain effective today, tomorrow and for the coming generations. If antibiotics become ineffective, then there would be no pharma product to sell. For the industries, it means if antibiotics become ineffective then treatments in cancer, surgeries etc will not work. Therefore, we have to take measures to contain the increase of AMR through proper systems, mechanisms and controls.
“All this will require a multi-stakeholder approach. We are meeting several ministries including the Ministry of Health, Ministry of Environment, Ministry of Bio-technology and Ministry of Chemical and Fertilizers. We have also managed to mobilize 13 leading pharmaceuticals companies that made several commitments amongst others to reduce the environment impact,” Lucas informs.
These companies include CIPLA, Wockhardt, including DSM, Pfizer, GSK and Merck. Industry initiatives such as Pharmaceuticals Supply Change Initiative (PSEI) is defining the criteria to work together with the signatories companies on new legislation and new standards.
Integrated Disease Surveillance Project
The Ministry of Health and Family Welfare has initiated the Integrated Disease Surveillance Project (IDSP) in the year 1998 funded by the World Bank.
IDSP is a decentralized form, district based form of surveillance for high priority based diseases that can be found in district hospitals settings.
Drugs prices in India are the lowest all over the world. The reason can be of the very fact that India Patent Act allows ‘Reverse engineering’ where Indian companies can manufacture the same substance. It automatically results to cheap prices and availability of drugs
Chennai Declaration has strategized to make sure that there is complete ban of over the Counter (OTC) sale of antibiotics without prescription in metros and cities all over India. To avoid unscrupulous and inappropriate usage of medicines, the Tamil Nadu government has formed a Tamil Nadu Medical Services Corporation in the year 1994 for better procurement of medicines by government run hospitals in a more efficient, cheap and consistent way. The corporation has strict control mechanism for procurement process where quality control is maintained.
Though many of the research papers and studies have spoken about the inappropriate and unscrupulous usage of antibiotics by humans, little was mentioned about the effects and harm contributed by the non treatment of effluents coming out of API plants in India.
According to a study and reports of Nordea Investments, half of bacterial infections and diseases in and around the periphery of API plants in the area of Patancheru and Bollaram are becoming untreatable. Not to mention the loss of agricultural activities and livelihood in and around the area because of non treatment of effluents coming out of the plants. Lakes and rivers have gone dry and have become unusable for both domestic usage and for drinking purposes. The need of the hour is to have an overall approach in tackling this problem of combating AMR .
Effective measures needed
In order to tackle the resistance of antimicrobials in India and around the world, it is imperative that various stakeholders come together to discuss, mediate and explore the best solutions to mitigate the problem. The government is by far the key stakeholder in the issue and it alone has the mandate to develop the required policies and regulations.
Secondly, the Government can set up a task force or an expert group to engage with multilateral organizations, NGOs, civil society partners, pharmacists associations, pharma industry boards, public health organizations and legal activists/groups by way of having a dialogue and by mobilizing them on a common platform.
It is laudable that the Government of India in consultation with the governments of various countries has foreseen a common platform at the 68th World Health Assembly to be held in India for a resolution for Global Action Plan on AMR. The member states envisage a National Action Plan on AMR by 2017.
Another significant initiative is the notification by the Ministry of Health and Family Welfare, Government of India about the mandatory requirement of red labelling on the packets of antibiotics and compulsory prescriptions required from physicians while buying antibiotics from the pharmacy.
It is a good step and moving us all closer to a more efficient way of being aware of and using medicinal drugs. But keeping aside the government initiative and the good work they have done, the effluents produced by pharma plants and their disposal is a major defining factor for the resistance of many antibiotics that we see around. This part of the problem needs to be addressed with utmost urgency through consultations, recommendations, decision making, policy making and general debate.
A project such as “Reducing Antimicrobial Resistance in Indian Hospitals” by the United Kingdom Government in association with Foreign and Commonwealth Office Prosperity Fund is a step forward in reducing resistance of antimicrobials.