The Indian pharma industry is now keen on adopting automation and digitalisation to ensure total transparency in operations. It is Pharma 4.0, a replicate of Industry 4.0 is the enabler of continuous manufacturing. The intent of the industry is to stall much of its manufacturing problems, increase quality and productivity and decrease risk and waste, stated Dr. Amit Biswas, executive vice president, Dr Reddy’s Labs.
 
Automation and digitalisation are imperative for drug research and manufacturing companies. In a phase where Quality by Design, focus on drug substance and product development take the centre-stage, we will see a paradigm shift in manufacturing operations with installations of robots and use of artificial intelligence, he added.
 
Dr. Biswas was deliberating at the recently concluded national symposium on Automation and Digital Transformation of Pharma & Life Sciences industry here in Bengaluru organised by ISA-Bangalore Section. He said this sector is both knowledge-intensive and dynamic. The investment in research and development is the highest. Much of the action is coming in from the US, China and Japan. India too is among the top 10 markets. The total value of the pharma industry globally is projected to breach the $1.5 trillion mark by 2021.
 
Five of the top 10 global generic companies are from India. Our country supplies 40 percent of the generic drugs to the US. This is because the country is also home to the highest number of the USFDA plants. Therefore we see Indian pharma to be generic driven. Here Pharma 4.0 will make a difference as it make medicine manufacture free from human contact, he said.
 
There is a need for integrated product development to enable significant competitive advantage. This is because automation and digital transformation will be spur cost-effectiveness and speed of development. Besides, there will be accountability of workforce and reliability on quality. These in-turn will build capability, cross functional collaboration and regulatory compliance, stated Dr. Biwas.
 
The concept is the ‘Internet of Things’, will establish intelligent machine-to-machine connectivity I for the active pharmaceutical ingredients (APIs) manufacture. This is because current API plants have high utility requirements for batch controls and processes. Most facilities are not in tune with the current times. The global regulatory authorities are demanding Quality by Design and product by performance. With this, the product development will become systematic with multivariate experiments. The focus will be on control strategy and robustness. This is will enable real-time risk management and monitoring, he said.

Taking the examples of an API’s like Tacrolimus prescribed to prevent rejection during an organ transplant and immuno suppressant drugs, Dr. Biswas said that there is need for technology and automation to enable stability, purity and manufacturability. There is also need for high skills and high investment in research and development. This is where Pharma 4.0 will enable continuous manufacture, small runs and 24/7 operations with no presence of operators.

For Indian pharma to adopt automation to transform operations going the digital way, it will need to scout for global collaborations and increase focus on the emerging science and technology applications to embrace Industry 4.0, stated Dr. Biswas.