Transforming API & Pharma Manufacturing with Next-Gen EHS Technologies

Dr. Kuber Jagdale, a seasoned business transformation leader, brings 35+ years of experience driving organizational performance, with expertise in API and Pharma manufacturing, operational excellence, EHS, cGMP, supply chain management, strategic planning, and business development.

In an interview with Thiruamuthan, Assistant Editor at India Pharma Outlook, Dr Kuber Jagdale, President - API Business Unit, Emcure Pharmaceuticals Limited, discusses how Indian API and pharma are shifting to data-driven, proactive EHS strategies using AI, IoT, and automation to improve compliance, safety, and operational efficiency. He also highlights key challenges and innovations shaping future-ready and sustainable EHS practices.

As India’s pharma industry faces evolving regulations, how are manufacturers using next-gen EHS technologies to improve compliance, reduce risks, and enhance operational efficiency in production?

The Indian pharma industry today is heading in a direction from a reactive to a proactive mode and trying to implement the data-driven approach, address the EHS-related compliance requirements. Besides this, this journey has been already started by many top companies. The Ministry of Corporate Affairs requires that some of this information should be published in their annual reports.

As this journey has started, most of the top companies have already progressed well in automating these requirements through SAP-EHS module, which captures all the data and provides a dashboard and gives timely alerts for monitoring, etc. There are some other compliance tools available to meet EHS compliance requirements, which are also being used by some companies.

How next-gen EHS technologies are helping Indian pharmaceutical manufacturers reduce their environmental impact while maintaining high production quality and ensuring compliance with sustainability and safety standards?

The next-gen technologies are helping very well, and the reason is because now companies have started adopting and monitoring them. Unless measurements and monitoring are in place, improvements cannot be effectively pursued further. When companies adopt these systems, all the data required for environment related EHS compliance gets monitored. This in turn encourages stakeholders to focus on reducing impacts in areas such as carbon neutrality, waste management, energy and water conservation, waste generation etc. Once monitoring is in place, organizations start identifying ways to reduce these metrics further. Many companies have started setting annual targets, typically around 2 to 5 percent reduction.

Also Read: How Digital Maturity is Powering Pharma's GMP Evolution

How are AI and IoT technologies transforming risk assessment processes in Indian pharmaceutical plants, particularly in predictive analytics and real-time monitoring of health and safety protocols?

For companies to use AI- or IoT-based tools, what is important is having data in data lake for whatever they are doing; otherwise, AI is not going to help if there is no basic data in place.

So, what companies are trying to do first is create a data management system to capture live data from production, quality control, engineering, etc. There are various systems being installed to capture this data. Once that is done as a basic requirement, AI- or IoT-based tools can be installed so that they can further analyze the data, provide analytics, and create dashboards for management to take decisions. The use of AI or IoT has started, but it is still at an early stage of implementation, as companies first must address data management systems and establish data lakes before adopting AI- or IoT-based solutions.

In what ways is integrating real-time data and AI-driven analytics into EHS systems helping Indian pharma manufacturers reduce risks while improving compliance, efficiency, and operational workflows?

Currently, in most companies, especially the top companies have already installed automation systems for production, quality control, and engineering. For production, there is an MES system for quality control, there is a LIMS system; and for warehouse and material management, there is an SAP/ bar code system. All these systems are already being used by many pharma companies and are at a fairly mature stage.

Now, the focus is on how to make use of these systems when all the data is available at common place. Companies have started building analytics to create dashboards. Once all the systems are integrated into a single platform, AI tools can be introduced to generate predictive insights, which can help organizations improve their overall EHS compliance.

What challenges are Indian pharmaceutical manufacturers facing in adopting next-gen EHS technologies, such as cost, infrastructure, and skills gaps, and how are they overcoming these obstacles?

There are certain challenges companies face in integrating these technologies. To clearly further, one is adaptability.  Implementing such systems in existing operational plants takes time because it requires several modifications to the plant and systems. It can be implemented immediately on day one if a new plant is being designed or constructed.

The second challenge is timelines. Due to the above complexities, the timelines tend to be longer. Timelines also depend on the ability of companies to invest, as implementing this technology in existing plants requires additional capex. Another challenge is the need for skilled personnel. Implementing automation, analytics, or AI-based systems requires people who understand these technologies and have the necessary education and skills.

These are the key challenges most organizations are facing, and it is a matter of time as most companies are moving in this direction for future EHS compliance.

Also Read: Why Global Pharma Expects CDMOs to Be Ready for Joint Inspections

Looking ahead, how do you see AI and machine learning shaping future EHS compliance strategies and safety standards in India’s pharmaceutical manufacturing sector, especially with regulatory changes?

When companies move from a reactive to a proactive mode, it is going to improve overall EHS standards as well as compliance and regulatory requirements. To achieve this, they need to first create a data management system and a data lake, and then implement AI and data analytics, which will provide dashboards at various levels as required.

Some next-generation technologies are also being adopted; smart EHS wearables are now available that can capture live data on the shop floor, send it to a data lake, and provide predictive insights. Additionally, remote drones are being used for large or high-rise buildings to capture data. Such technologies are becoming more common, and new innovations continue to evolve as this journey progresses.