India Pharmaceutical Adopting Automation Technologies

Overview

India pharmaceutical adopting automation technologies despite its pharmaceutical sector having been traditionally based largely on manual operations. It is now adopting new automated operational technology (OT) and information technology (IT) to remain competitive in a connected world.  Only through continuous innovation and judicious adoption of new technologies will companies in this sector, domestic and global, succeed in surmounting today’s challenges.  These include:

• Global regulatory compliance
• Quality issues
• Inconsistent manual manufacturing workflows
• Human errors
• Cost pressures

• Increasing global competition

Considering India’s continuing strength in the IT services space, pharmaceutical companies should leverage this local expertise to modernize operations and implement new Industrial Internet of Things (IIoT)-related technologies and approaches such as smart sensors, Big Data, predictive analytics, and cloud computing. In addition to helping improve the patient experience through connected healthcare, these could enhance R&D, manufacturing, and regulatory compliance.  Significantly, the successful implementation of these technologies requires the convergence of multiple skillsets, industries, and domains. To leapfrog to the next level, the pharmaceutical industry must aim for end-to-end systems from the plant floor to the boardroom, across the supply chain, and – ultimately – out to the end consumers.

ARC Advisory Group believes that pharmaceutical enterprises will need to rapidly embrace mobility, cloud, and other automation and IT technologies and standards because the risk of not deploying them could be greater than the risk typically associated with deploying new technology…even if this should require costly and time-consuming revalidation of equipment and processes.  

This Insight highlights some technology trends that are shaping the new business environment with specific reference to India’s pharmaceutical sector.   Clearly, technology implemented at the micro level will impact the macro level.  When deploying new technology brings quantifiable benefits for one domestic company, other domestic companies will also adopt it; then companies in other countries adopt it and the global reach expands.

Deploying Technology in the India Pharmaceutical Sector

The pharma sector in India needs to take a closer look at both new operational technologies (such as wireless sensors and automation) and new information technology (ERP, EAM, MES, SCM, IoT, etc.)

Increased automation can help the pharmaceutical industry make more efficient usage of energy and raw materials; improve safety in working conditions; enhance regulatory compliance, and improve both product quality and consistency.  Information technology brings in the much–needed interconnectivity between equipment, operations, and people.

India’s IT and pharmaceutical sectors are closely linked. While lower cost competitors are emerging in this space, India remains a favored destination for IT outsourcing; while India’s pharmaceutical industry is the world’s third largest in terms of volume. Today, India’s pharmaceutical industry is implementing technology for process management, data analytics, content management, identifying cost-effective therapies, and to engage with the healthcare providers and customers.

Connected devices in pharmaceutical manufacturing facilities help improve business and manufacturing efficiency and reduce risk by enabling: 

• Remote access to equipment
• Proactive maintenance
• Real-time plant floor visibility
• Ability to quickly recognize and respond to compliance issues
• Alleviate and prevent human errors

• Monitoring, control, and safety

IT and operational technologies (OT) in the pharmaceutical industry decreases the manual work, enables e-documentation, improves competitiveness, and reduces time-to-market. Automated IT systems or IT-supported automated processes for this sector include: enterprise resource planning (ERP); electronic batch record systems (EBRS); manufacturing execution systems (MES); quality management systems (QMS); and mobile technology, to name a few.

• ERP is an integration between human resources, BOM (bill of materials), and demand that is sent to the production system.
• EBRS supports automatic data capture and storage, exchange of batch information, batch records management, and report generation to increase operator productivity and accuracy.
• MES deployment streamlines process operations by applying production management functions such as production execution, material tracking, resource management, batch production management, and electronic work instructions. These applications have enabled facilities to transition from paper-based systems to digitized, paperless operations; improving efficiency and reducing inaccuracies in manufacturing.
• QMS, the crux of any quality and compliance process, can be part of the MES technology.  Documented evidence of quality production is essential.  An automated QMS reduces audit times and risk of recalls by the FDA/ISO and other regulatory bodies.
• Mobile technology is being implemented for manufacturing applications for notifications and alerts and increased visibility.

• IIoT-enabled technologies and approaches can be used to support smart serialization, raw material and finished product tracking, predictive maintenance for processing equipment and other manufacturing assets, as well as R&D and patient experience.

In a digital world, pharmaceutical companies must deploy these types of next-generation technologies to streamline and improve their manufacturing and business processes. They need to strive for real-time transparency of their R&D; smooth sales and operations planning in the supply chain; as well as meet new standards and expectations in efficiency and agility.  The IT-OT (operations technology) convergence is now becoming a reality.

Case Study Showcases Effective Technology Implementation

At the exclusive session for end user presentations at the 2015 ARC India Forum, one presentation focused on IT deployment in the pharmaceutical industry.  The objective at Strides Arcolab was to have an end-to-end paperless system with first-time-right and real-time documentation to eliminate inefficient "doer-checker" policies. All systems were to include barcoding for better traceability with systems in place to track all equipment maintenance and usage activities.

Strides Arcolab took an integrated approach using a “galaxy of systems” with the core focus on manufacturing surrounded by a layer of manufacturing execution systems (MES).  These include laboratory information management systems (LIMS), quality management systems (QMS), building automation and control systems (BMS), and warehouse management systems (WMS). According to the presenter, this IT-OT convergence approach resulted in world class manufacturing and a total business transformation. 

Recommendations

Technology can play a pivotal role in driving success in India’s pharmaceutical industry and some companies are already on the right path.   However, as technology advances, there are associated risks and challenges when it comes to security and data privacy in the pharmaceutical industry. The security angle must be addressed by all pharmaceutical companies via investment in IT and developing a culture of prevention.  And, of course, the potential benefits of implementing new technology must be balanced against the cost, time, and effort required to validate new equipment, systems, and/or processes to meet US FDA and other governmental requirements.

The lines between IT and OT are blurring as the “3Cs” - connectivity, communication, and collaboration are now recognized as business enablers.  

Based on ARC research and analysis, we recommend the following actions for owner-operators and technology providers:

For Owner-Operators:

• New technologies and ways of doing business are reshaping the business landscape. Adopt or lose the race
• The initial investment in new technologies may seem high; but the long-term benefits typically justify the investment
• Learn from the strategies and best practices of your competitors. If it has worked for them, it could for you too

• Automation and information technologies can work together to help reduce costs, reduce errors, and improve manufacturing and business processes

For Technology Providers:

• Create awareness about the new technology and how it will help streamline processes
• On-site pilot demonstrations of the product/process will be more effective in convincing the prospective user
• Develop and document case studies of successful implementation
• Update existing customers
• Provide prompt after-sales service to nurture customer relationships

• Offer built-in cybersecurity, where possible, and do everything possible to simplify the validation process for your customers

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Keywords: India, Pharmaceutical Industry, Automation, Technologies, IIoT, IT, Regulatory Compliance, Case Study, ARC Advisory Group.