Traceability aids stage-one automation in Pharma and F&B

By Staff Report April 1, 2025 6:20 pm IST

The pharmaceutical and food & beverage (F&B) sectors are crucial because they are directly connected to human health. Therefore, ensuring end-to-end traceability and transparency is essential. Advanced traceability solutions will enhance the reliability of the Indian pharmaceutical and F&B sectors, ultimately boosting trade and exports. This article discusses the various solutions that manufacturers can implement.

Johnson & Johnson’s talcum powder was a household name in India until the controversy caused the Indian government to order Johnson & Johnson to recall specific pharmaceutical-grade talc batches in 2019. Concern was raised that some batches of baby talcum powder might contain cancer-causing asbestos. Advanced batch-level tracking helped authorities identify affected products quickly, preventing further sales. J&J used digital records and supplier traceability to verify raw material sources and prevent future contamination.

Also, our beloved Maggi Noodles faced a nationwide ban after the Food Safety and Standards Authority of India (FSSAI) found that certain batches contained lead levels above the permissible limit (2.5 ppm) in 2015. The controversy erupted when tests conducted by the Uttar Pradesh FDA found 17.2 ppm of lead in a sample, nearly seven times the legal limit. Additionally, the product was accused of containing MSG (monosodium glutamate) without proper labelling. Nestlé had to trace back affected batches using its internal tracking system. Nestlé used barcodes and batch numbers to identify the manufacturing plants involved quickly.

Last year, India’s Pharmaceutical Export Compliance and traceability Mandates were implemented. The Indian government made QR codes mandatory for the top 300 brands of pharmaceutical drugs to improve traceability. This was in response to increasing counterfeits and global export requirements. Sun Pharma, Cipla, Aurobindo, and Biocon integrated 2D barcodes on medicine strips and packaging. This allowed end-to-end tracking from manufacturing plants to end consumers, boosting India’s reputation as a reliable pharma exporter.

Challenge

A major challenge in today’s manufacturing sector is the lack of traceability at a large scale. Traceability refers to tracking and documenting a product’s journey through the supply chain. Fragmented supply chains, counterfeits, and inconsistent technology adoption further complicate this issue.

While some large companies have explored blockchain technology to enhance transparency, the results have varied. Many modern manufacturing plants have automated systems that record every production stage; however, it is still unclear how many advanced plants exist in India. The vision of a “Viksit Bharat” (Developed India) is closely linked to the growth of Micro, Small, and Medium Enterprises (MSMEs).

Small enterprises constitute more than half of India’s food supply chain but often lack effective tracking systems. To move forward, smaller organisations should embrace digital tools, standardise processes, and invest in training their workforce on the importance of proper documentation and tool adoption.

Solutions

Traceability is becoming increasingly essential in pharmaceutical drug manufacturing. Regarding large manufacturing sites, traceability and audit trail mapping are necessities, especially for companies involved in large assembly manufacturing. These companies need a comprehensive IT-OT setup that is well-mapped out and audited. At any given time, they should be able to trace any batch output to a specific scenario with an accurate timestamp. When we asked Kaushik Pal, Head of Systems Integration Services, Business Unit, Tata Elxsi, what they do for traceability, he shared, “To facilitate traceability, we utilise computer vision technologies, such as our IP or IRIS systems, to track various processes and assembly nomenclatures. This approach pinpoints the bad batch produced within a specific timeframe and assembly line rather than discarding the day’s work or batch output. By identifying and addressing the problematic batch, we can maintain return on investment (ROI)  and limit potential losses for manufacturers. We provide traceability solutions and also partner with ecosystem providers to enhance traceability. This aspect has become a critical part of our content manufacturing focus.”

Parminder Singh, Head of D&M Business at Autodesk India & SAARC, shares that a comprehensive suite of tools designed to support manufacturers in ensuring traceability can be incorporated within operations. Product Lifecycle Management (PLM) solutions can help manufacturers track and manage the entire lifecycle of a product, from inception through engineering design and manufacturing to service and disposal. This ensures that every stage of the product development process is well-documented and traceable. Digital Prototyping tools allow manufacturers to create and test digital prototypes of their products. This reduces the need for physical prototypes and ensures that all design changes and iterations are recorded and traceable. Data management securely stores and manages the engineering data. A version control factor ensures that all changes to design files are tracked and traceable. 

Manufacturing Execution Systems (MES) solutions help manufacturers track production processes in real-time. This includes monitoring the usage of materials, labour, and equipment and ensuring that all aspects of the manufacturing process are recorded and traceable. Quality Management ensures that any defects or issues are recorded and can be traced back to their source. Supply Chain Management tools can help manufacturers manage their supply chains by providing visibility into the sourcing and movement of materials. This ensures that all materials used in production can be traced back to their origin. 

Scanning Solutions

Technologies such as RFID, barcodes, and QR codes are evolving to enhance traceability in manufacturing.

Sameer Gandhi, MD, OMRON Automation, India, shares how RFID technology is integrated with the Internet of Things (IoT) and cloud computing, facilitating real-time data collection and analysis. Advances in the miniaturisation and cost reduction of RFID tags have made widespread use feasible, enabling detailed tracking of individual components and products. Improvements in RFID reader technology have enhanced read range and accuracy, ensuring better monitoring throughout the production process.

Barcodes are transitioning to 2D versions like Data Matrix and QR codes, which can store more information and are more resilient to damage. Modern barcode scanners have also advanced, offering faster and more accurate readings from various angles and distances, enhancing inventory management and quality control. These scanners integrate with digital systems for real-time tracking and data analysis, providing manufacturers valuable insights into production processes and supply chain management.

QR codes have significantly increased data capacity compared to traditional barcodes, making them ideal for detailed product tracking and traceability. Initially used for tracking automobile parts, they are widely adopted across various manufacturing sectors. They provide additional information to users, such as product details, usage instructions, and safety information, thereby enhancing transparency and traceability.

Advanced technologies will drive ROI for investors and bring transparency, resulting in greater trust in the brand’s reliability. Traceability and accountability can boost consumer confidence. Improved traceability and quality control can elevate export standards, expanding trade opportunities and strengthening the brand’s position in global markets.

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Kaushik Pal, Head of Systems Integration Services, Business Unit, Tata Elxsi

“Traceability is crucial for manufacturing efficiency. Advanced computer vision systems can help users pinpoint defects in real-time, ensuring precise batch tracking, reducing waste, and maximising ROI for manufacturers.”

Parminder Singh, Head, D&M Business, Autodesk India & SAARC 

“With Product Lifecycle Management, digital prototyping, and real-time production tracking, manufacturers can ensure complete traceability, enhancing accountability, compliance, and quality at every stage of the manufacturing process.”

Sameer Gandhi, MD, OMRON Automation, India

“Technologies like RFID, barcodes, and QR codes are major tools in traceability as they can enable real-time tracking, enhanced accuracy, and better insights. This improves efficiency, product quality, and customer satisfaction in manufacturing.”