"If you are a pharma CEO, what keeps you up at night, is the regulator," says Rockwell India Managing Director Dilip Sawhney
In not too distant future, Indian drug factories will run on data analytics, augmented reality, machine learning and artificial intelligence, as they begin to invest in automation to beat regulatory compliance woes.
Automation is also expected to help Indian pharma companies raise quality, reduce costs by replacing increasingly expensive labour with cheap machines, improve safety and make manufacturing leaner.
These efforts are already underway at Sun Pharma, Dr Reddy’s, Cipla and Mylan, who have all been pushing for automation at their plants, and aiding them in that journey are companies like Rockwell Automation.
The NYSE-listed industrial automation equipment maker highlighted the main trigger for the transition was the rising expectation from regulatory agencies such as the USFDA and European Medicines Agency (EMA), apart from the sector's aim to catch up with tech-intensive industries like auto.
India has emerged as a drug factory of the world cornering one-fifth of the global share of generic medicines taking advantage of the abundant cheap talent and low cost of production. The country exported $17.3 billion in 2017-18, of which highly regulated markets like the US and Europe accounted half.
However, pharmaceutical export growth largely remained stagnant in the last three fiscal years due to increasing regulatory concerns, pricing pressures in the global markets and currency fluctuations.
As the US market generated little over 30 percent of the export proceeds, Indian drug makers felt the heat with adverse observations, warning letters and import bans handed out by the USFDA.
According to Dilip Sawhney, Managing Director of Rockwell Automation, India, there is some co-relation between regulatory scrutiny and adoption of automation.
"If you are a pharma CEO, what keeps you up at night, is the regulator. What regulator wants you to ensure is data integrity, data hygiene, when it comes to your manufacturing process. And you know the technology has the answer," Sawhney noted.
Rockwell helps Indian drug makers to deploy Internet of Things (IoT) using a network of tools like software, sensors, camera and actuators to capture every action and data on the shop floor seamlessly, eliminating the possibility of human errors.
For instance, one of the major problems for pharma companies is out-of-specification (OOS) batches which means the end product deviates from acceptable criteria set in terms of parameters such as dose uniformity, dissolution, impurities, among others. The US FDA has asked companies to do a root cause investigation to find out the reason behind the OOS batches if they are recurring, and come up with corrective and preventive action.
In many OOS cases, companies had a challenging time getting to the bottom of the problem, as the production processes weren't documented well, and worse they didn't know how to prevent them from recurring.
Rockwell said it uses the power of data analytics and artificial intelligence that can interpret data to help in troubleshooting and process improvement.
"So we can tell you what's going to happen to a particular device like whether it’s going to fail or not before it actually fails, alerting the operator and avoiding the downtime," said Sawhney.
He said automation is much more than just finding out loopholes in production.
“The idea is to have an end to end integration right from R&D down to production and supply chain that allows for greater productivity at the lowest possible cost,” Sawhney added.
Bet on India
Rockwell Automation which had global sales of $6.3 billion in the year ended September 2017 generates about $866 million or only 14 percent of sales from Asia-Pacific of which India is a part.
But the Milwaukee, Wisconsin based company said it’s betting big on the Asia Pacific focusing on India and China. In India, it sees life-sciences as a sector that’s ripe for automation, but it is also helping several other companies from different sectors.
Rockwell employs about 1,000 people in India, across sales, engineering centre in Pune and product development centre in Bengaluru.Sawhney said India is one of the fastest growing geographies for them in terms of business and people employed.