On the road to maturity

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Automation brings with it a number of benefits, most of which are already well documented. Especially from a drug company’s point of view, these include traceability, system validation, trend analysis, improved repeatability of batch production and reduced human intervention on the process lines.

As Indian pharma industry becomes more globalised, automation is becoming vital to deliver products and services to the marketplace. For, automation could unlock full value of the business chain by connecting the plant floor to business systems and business systems to R&D, through clinical trials to commercial manufacturing. It holds the potential to bring in efficiency and increase productivity in the entire drug development cycle.

Already, the Indian pharmaceutical industry stands fourth largest in terms of volume and 13th in terms of value. The country has one of the lowest costs of manufacturing and is attracting R&D services and clinical trials as well.

On one hand, there is a paradigm shift for pharma companies focussed on local markets and now aiming to be connected with global markets. They are pursuing aggressive strategies to foray into new and under-served markets such as Japan, South Africa, EU and CIS countries and Latin America. On the other hand, the industry is witnessing price erosion and drying up of product pipelines. Little wonder then, there is a strong case for automation, which could play a vital role to facilitate processes that enable measurement and control.

While automation started and progressed slowly in the pharmaceutical industry, it has come to play an increasingly important role in keeping the industry moving ahead. “To reach out to newer markets and alliances and business opportunities, companies are faced with the hard fact that unless they improve their return on investments, comply with tough regulatory norms and enhanced safety requirements, they will miss the mark,” says JP Singh, president, Automation Industry Association (AIA).

According to Singh, companies, which earlier were competing with stand-alone equipment and lower production costs, are now looking at a new era in manufacturing. Today, competition is in terms of value chains, with a lot more emphasis on time and delivery cost to market. Manufacturing firms have to look at a scenario where they have to sense the customer’s need and respond immediately. Therefore, integrated automation in this situation has become a must, rather than a mere requirement, he adds.

Globally, the acceptance of automated systems has increased considerably in the recent years, especially in pharmaceutical manufacturing. Analysts claim automation is worth $60 billion in the pharma industry alone. With a number of benefits like multiple recipes handling, human error elimination, better safety, increased productivity and the electronic documentation, many of the pharmaceutical manufacturing companies have adopted automation as a standard feature for the operation and control of their machines. While the manufacturing floor is equipped with advanced automation systems with networking capability and supervisory control and data acquisition system (SCADA), the quality control laboratories have also benefited from the advancement in automation technologies.

Unfortunately, Indian pharma industry has been a laggard in its adoption, especially the SME segment, which plays a key role in sourcing raw materials. So far, only big pharma companies like Ranbaxy, Cipla, Dr Reddy’s Laboratories, etc have made serious forays into automation.

Investments in automation include automating the facility by building management system, access control for security purpose, process control system, batch records and manufacturing executing systems, besides ERP and supply chain management.

“Pharma companies are likely to take different steps forward as they reshape their strategies and infrastructure to prepare for future developments. But the starting point has to be the vision where the company wants to be in a period of 10-15 years and how this will impact manufacturing methods and practices,’’ says Venkat Jasti, chairman, Suven Life Sciences Ltd.

According to Jasti, operational effectiveness and profit pressures require manufacturing to contribute and the industry has to work together to enable a compliant manufacturing environment that delivers products to plan with minimal cost and risk. The role of automation technologies is thus crucial in facilitating processes that enable measurement and control, ensure optimum efficiency and increase productivity. Automation is also the key in maintaining consistency and quality, and conforming to safety, environmental and a host of other stringent regulatory standards.

One of the main challenges in automation is the lack of awareness. Analysts say it is bound to enhance productivity and create a platform for safe and audited operations. In terms of cost, it is only 4-10% of the total project cost, which can yield 2-3 times improvement in production and quality consistency, says Singh. Interestingly, there is integration among pharma companies, wherein the control system and the enterprise system are getting converted.

In recent times, the industry is working towards a risk-based approach and uses more advanced control technologies. As Jasti puts it, a key trend is flexibility. “With businesses becoming more competitive, there is a need for improvising the supply chain efficiency, which calls for monitoring of labs and timely release of new products to improve the profitability of a company.”

Finally in packaging, a new trend that is observed is the ‘track and trace’ systems. There is an integration of systems in the packaging system using data matrix codes or bar codes. Usage of RFID tads, the in-house logistical processes and distribution gives all information about the final delivery of the product.