The Karnataka government is keen to have systems in place for sustainable antibiotic manufacturing. The intent is to reduce levels of antibiotic emissions by pharma companies into the environment and establish a common framework for managing antibiotic discharge.
This is even as the UK-based ShawView Consulting which initiated RATSAM (Reducing AMR Through Sustainable Antibiotic Manufacturing) a programme where it intends to rope in the Karnataka Drugs and Pharmaceutical Association to implement a pilot project in the state to adopt AMR Industry Alliance’s Common Manufacturing Framework and Discharge Limits.
From a national perspective, the Central Pollution Control Board has issued a draft recommendation on this and DBT and UKRI are eager to provide grants on the research and development of sustainable manufacturing of antibiotics. Moreover, the government has launched a major study to check antibiotic resistance in the river Ganga among other similar water bodies in the country.
The need of the hour is to build capacity of local companies to meet new global procurement standards and adhere to the domestic environmental regulations to monitor antibiotic manufacturing, said Brendan Shaw, Principal, Shaw View Consulting, UK
According to Gunjan Krishna, Karnataka Commissioner for Industrial Development, we need to discuss the issue of how antibiotics are polluting the water bodies. In this regard, there is a need to keep a close watch on the CTPs (combined waste water treatment plants) and the ETPs (effluent treatments plants). While the government is offering subsidies for ETPs and CETPs, we need to devise a workable model on the same. Comprehending the gravity of the issue, the government can facilitate the ETPs but the pharma industry needs to adopt the best practices as going forward regulations are going to be stringent and every export order of antibiotics to global markets will insist on data of responsible anti microbial procurement from manufacturers with high standards of environmental systems for supply chains.
A panel of experts at a workshop hosted by Government of Karnataka, Karnataka Drugs and Pharmaceutical Association and RATSAM Partners which focused on adoption and implementation of global standards in reducing AMR through sustainable antibiotic manufacturing, deliberated the need to review manufacturing and supply chains to assess good practice in controlling releases of antibiotics into the environment. While the UK and the Nordic countries have already included sustainable antibiotic manufacturing in their drug procurement rules, there was every need for India which is the pharmacy of the world to take this into account. Already the European Union procurement criteria focuses on sustainable manufacturing and environmental standards and for India the region is an important market.
In order to implement RATSAM in Karnataka, the state government sees the need to develop a practical mechanism for pharma supply chains to meet the standards of the AMR Industry Alliance’s Common Manufacturing Framework. The pharma industry will need to work with independent technical experts to establish a science-driven, risk-based methodology for discharge concentrations of antibiotics and adhere to good practice methods to reduce environmental impact of manufacturing discharges.