Anurag Roy, Business Unit Director, Asia Pacific, Middle East and Africa, DSM Sinochem Pharmaceuticals Pvt Ltd shares his perspective on how pharma companies use insufficient waste management and treatment systems and dump untreated waste water and antibiotics into the environment while producing thousands of tons of antibiotics. In an interview with Shardul Nautiyal, he further says that there is an urgent need for greater advocacy to strengthen compliance, address gaps in legislation and guidelines, make pollution control boards accountable, tighten regulations and spread greater public and policy level awareness in the interest of patient, public and environmental safety.

Excerpts:
There has been an issue of compliance around safe disposal of waste water. What is the main concern and which Act or guideline does it fall under?
At the outset I would like to say, DSM Sinochem has been following a stringent quality control and waste management process by taking into account global standards, zero discharge policy, superior technology, proper waste treatment and how the waste water post-treatment can be used for horticulture.

Modern medicine is incomplete without Antibiotics which are being used across the globe in the treatment of deep-rooted infections, complex surgeries and even common ailments. As per Centre for Disease Control (CDC), Antibiotics and related drugs, together called antimicrobial agents, have been used for the last 70 years to treat patients. However in recent decades, widespread and rampant use of antibiotics, especially in low and middle income countries have led to the phenomenon of antibiotic resistance or anti-microbial resistance (AMR).

A study done in China found that nearly all companies were flouting water pollution norms and not following good manufacturing practices. It is therefore essential to ensure that waste from the antibiotic industry is treated in dedicated Waste water Treatment Plants before leaving the production sites.

A 12- member study conducted by WHO in 2014-15 among 97, 772 respondents across 12 countries, came up with some key findings that  antibiotic use is widespread, especially among low income countries, there are low levels of awareness on their use and 72% of respondents across the 12 countries included in the survey correctly believe that many infections are becoming increasingly resistant to treatment by antibiotics. In India, annually, 60,000 newborns die from sepsis caused by bacteria resistant to antibiotics. In 2012, there were about 4,50,000 new cases of multidrug resistant tuberculosis (MDR-TB) worldwide – just one disease that had been long considered easily treatable with modern medicine.

In addition, there is another important aspect here that is missing from the debate about AMR but must be addressed. The manufacturing of antibiotics and as well as the management of waste and waste water which is an inevitable part throughout the entire supply chain is an issue which is not given due importance.

In 2009, Joakim Larsson of the University of Goteborg and his team found rivers near Hyderabad, one of India’s pharmaceutical nodal centres - to have concentrations of certain antibiotics higher than that in the blood of a patient undergoing treatment.  

How grave is the problem of non-compliance around safe disposal of waste water?
In December 2014, an investigative report by CCTV, China’s state television, featured a segment on antibiotics found in the municipal water supply of Chinese cities. The report uncovered that antibiotics producers have been illegally discharging waste water containing high concentrations of antibiotics, making it unsafe to drink.

In the summer of 2015, the Scandinavian investment group Nordea, which manages assets worth $240 bn and has holdings in Novartis, AbbVie and Roche, communicated in the Financial Times that drug makers risk losing financial backing if they don't ensure their suppliers have adequate waste management in place. They made these comments after a visit to India during which it uncovered deficiencies at a number of bulk drug suppliers. Treatment of waste water from pharma industry in the places we visited is beyond any acceptable level. There is lack of treatment plants as well as a lack of supervision from authorities regarding pollution, Nordea said.

Such reports raise several concerns and indicate that the pharma industry is adding to the growing problem of AMR, while instead it should be a part of the solution and participate in the public debate.

What is the scenario in India as far as compliance is concerned?
Since India and China are leading producers, they need to enforce stringent mechanisms. The number of compliant manufacturers are few, most are non-compliant, thriving under weak enforcement and disposing waste into local public water streams such as lakes, rivers and water bodies.

There are several hundred manufacturers of APIs (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, etc. Manufacturers don’t either have waste treatment plants or don’t use them due to the costs involved. Companies sourcing API from manufacturers also look for low cost products, instead of focusing on quality and pure ingredients. Government departments are also based on tender systems placing priority on costs rather than long terms implications.

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.

What needs to be done to tackle the non-compliance?
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. In order to tackle AMR effectively, the EU and US should amend the rules under the GMP framework for the production of pharmaceutical products by including environmental criteria.

Manufacturers of medicinal products should be required to comply with specific requirements limiting discharges and emissions of active pharmaceutical ingredients into the water environment. This would force all companies importing active pharmaceutical ingredients in the EU and the US to apply the same level of emission control.

These should define pollution prevention policies, in particular, and the best available techniques and best environmental practices, to ensure the enforcement of good waste management. Large purchasers of medicines, such as pharmacies and hospitals are important stakeholders and as such they could assume greater responsibility; as an example, Swedish county councils have started to require some degree of control over environmental emissions from production when they procure pharmaceuticals for hospitals.

Action in this area is critical because most governments are focusing on cost as the primary driver of policy decisions, whereas it should be quality. Accordingly, the Swedish government has proposed a change in the system for generic substitution and reimbursement of pharmaceutical costs, where not only price but also control over environmental emissions from production will be taken into account.

In short, without urgent, coordinated action, we are heading towards a post-antibiotic era, in which common infections and minor injuries can once again kill. A world in which essential medical procedures, such as surgeries, cancer treatments and organ transplants can no longer be carried out safely. The current estimate is that – if not addressed – by 2050, Antibiotic Resistance will be the leading cause of health-related deaths, even surpassing cancer, with more than 10 million lives lost every year.

What is the pharma industry’s role in tackling AMR?
While we will also need to develop new antibiotics in the future, we cannot solely focus on this approach as a solution. New drugs take time for development, testing and approval before they are available to patients and bacteria keep on evolving. If we do not instil behaviour change, we will continue to stimulate bacteria to develop resistance against the new antibiotics of the future. Without seriously considering environmental dimensions, global antibiotic resistance dissemination is expected to be fueled even further.
 
The industry should first and foremost address and improve its product stewardship including its environmental performance throughout the entire production and supply chain. We cannot allow the illegal discharge of waste containing active antibiotics and other non-compliant practices, which contribute to AMR.

Today, most raw materials and intermediates for antibiotics are manufactured in China and India (80- 90%). Therefore these countries carry a huge responsibility to contribute to the solution. In recent years, we have seen a rising number of product recalls and even import bans initiated often by the US Food and Drug Administration (FDA) or the European Directorate for the Quality of Medicines and Health Care (EDQM).

The Chinese Ministry of Environmental Protection and China’s provincial Environmental Protection Bureaus (EPB) oversee compliance and operate a website where warning letters and violations are posted online and publicly. Similar websites are also operated by the FDA and the EDQM. These authorities can shut down factories, quarantine shipments and ban products.

In a worst case scenario, this can endanger security of supply of these lifesaving drugs. Compliance with ‘Good Manufacturing Practices’ (GMP) is a mandatory requirement across the globe and should be in India as well. Manufacturers of medicinal products should be required to comply with specific requirements limiting discharges and emissions of active pharmaceutical ingredients into the water environment. Large purchasers such as pharmacies, bulk purchasers and hospitals are important stakeholders and should be called to assume greater responsibility.