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Indian pharma investing in technology to detect pharmaceutical residues at low thresholds
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Nandita Vijay, Bengaluru
June 15 , 2022
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Indian pharma is investing in technology to detect pharmaceutical residues at extremely low thresholds. This is because pollution may increase if essential checks and balances are not implemented.
According to Manjit Singh, associate director- corporate sustainability, Centrient Pharmaceuticals, and Chair, Pharmaceutical Supply Chain Initiative (PSCI), the regulatory landscape to address pharma pollution is complex and warrants multi-sectoral and multi-level deliberations. While the Government of India has been conscious of the increase in pharma pollution, there is greater scope for government, policymakers and industry to collectively push robust measures that set limits of active pharmaceutical ingredients (APIs) in effluents. Without such regulations, pharma pollution will continue exacerbating the public and environmental health crisis.
In early 2020, the Ministry of Environment, Forests and Climate Change (MoEFCC) released draft environmental standards for the bulk drug and pharmaceutical manufacturing industry. The proposed standards was to limit the concentration of antibiotics and other toxins in effluents from the bulk drug manufacturing sector. This was a promising move by the GoI that recognized the importance of environmental regulations in addressing rising pharma pollution. However, the following year, when the MoEFCC notified Environment (Protection) Second Amendment Rules, 2021, which did not account for the limits of APIs in pharmaceutical effluents, it exposed the sector to further challenges, he added.
Pharma companies including Centrient have made efforts to put in place systems to thwart pollution and protect environment control practices.
While some companies have self-regulated, many continue to pollute. At times to save costs, untreated wastewater is directly released into the soil and any adjoining water bodies. Also, the efficacy of Common Effluent Treatment Plants (CETPs) needs improvement as they may not be able to neutralize certain pharmaceutical compounds in the wastewater they receive from industries, Singh told Pharmabiz in an email.
India is rapidly emerging as a sought-after hub for pharma production but this comes at a cost. Several studies have exposed the environmental and health risks from rising pharma pollution caused by the release of untreated effluents from manufacturing hubs. These toxins not only lead to contamination of air, water, and soil around manufacturing facilities and, but also aggravate the spread of AMR, a looming public and environmental threat. Across Telangana, Andhra Pradesh, Himachal Pradesh, and Delhi, incidences of pharma pollution are reported, he noted.
A major challenge concerning pollution control is limiting the active compounds that escape into the wastewaters. When these compounds are absorbed in the soil and mixed with water bodies, they may promote antimicrobial resistance (AMR). Here adopting newer technologies is one of the solutions, and many companies, including Centrient Pharmaceuticals, have taken that approach. Moving to newer technologies allows detection of pharmaceutical residues at even extremely low thresholds. Also, regular audits and risk assessments of the manufacturing units ensure that there is no leakage and wastewater that is untreated, he said.
Our company pursues environmentally sustainable production and procurement very seriously. Continued investment in R&D has drastically reduced the environmental impact. We are also mindful of the adverse effects of antibiotic manufacturing on the environment and, therefore, self-regulate to comply with the Predicted No-Effect Concentration (PNEC) targets set by the AMR Industry Alliance and capability building through PSCI. We have been working with our suppliers to ensure that our procurement is in compliance with PNEC targets, thus enabling a green supply chain. As a result of our sustained efforts, our oral antibiotics range recently achieved PNEC compliance, said Singh.
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