Shahid Akhter, editor, ETHealthworld spoke to Dilip Sawhney, Managing Director- India, Rockwell Automation India Pvt. Ltd, Noida to know more about the role of automation in drug manufacturing to enhance quality control and regulatory compliances.
How is automation, AI and machine learning impacting pharma and life sciences.
Pharmaceutical manufacturing is a very complex game. You have to not only balance the needs which are applicable to all manufacturers in any industry, but you also have to keep yourself in very close compliance to the manufacturing norms and the good manufacturing practices that have been laid out, which regulators hold you accountable for. When you talk about the possibilities which automation and information and the contemporary technologies such as machine learning and AI can bring to pharmaceutical manufacturers, the possibilities are limitless. Pharmaceutical manufacturers are trying to balance being compliant yet producing at rates which is globally competitive because eventually you are making in India and supplying to the world. To put it in perspective, there are two dimensions to manufacturing, one – critical to process, two- being critical to quality; and there’s lot of impact that automation and information can have on both aspects of manufacturing in pharmaceuticals. Going further, imagining Pharmaceutical manufacturing without the participation of automation and information would not be feasible.
How has Rockwell Automation benefited the Indian pharma sector ?
This is Rockwell Automation’s 35th year in India – and we have been working very closely particularly in the last decade or so, as the Indian pharmaceutical industry has really come of age, spreading its wings. We all know that Indian pharmaceutical companies are now in every bit very global in their mindset, we are delighted to be partners with many of them – in some cases the partnership is lot wider while in some cases it’s focused on automation – but our partnership basically is focused on unlocking business value for pharmaceutical manufacturers by working on their manufacturing processes. With some we are working on very wide solutions, such as serialization, which ultimately have a lot of role to play in patient safety and also the brand protection for pharma manufacturers. There are a lot of things that are going on which are very diverse across the pharma landscape and we are finding ourselves participating in number of those areas.some which are limited to the four walls of the plants or factories and some which transcend the entire pharma manufacturing enterprise.
How can automation – spur medical innovations and augment drug research ?
Automation is basically all about allowing you to innovate faster, equips you with deeper insights into whatever your production happenings are; that’s what we stand for. Having analytics which can allow you to run AI on vast streams of unstructured data that’s coming in from your production processes, some from business systems, some from the external world, and being able to blend them and bring out insights which can then allow you to draw the right business conclusions to create the right business impact. In this case, the case of accelerating, say contract research scenarios, I think why not, I think the possibilities are quite limitless. Although, the used cases which spur up to my mind right now are more around how do you make manufacturing a lot more effective.
Pharma sector is highly regulated and monitored. How is automation helping drug makers with compliance and quality control?
This is very critical to what we do for our pharma customers, because it’s the question of what keeps the CEO awake at night – ‘Am I being compliant to the stipulations that have been laid down by the regulator? In many cases these are the regulators such as the USFDAs and all, who are extremely active as such. So what we do for them is basically allow them to ensure that data hygiene, data integrity, and managing the manufacturing workflows in a manner which is untouched by human hand – meaning the data is not tampered by humans at all. All of this is very closely observed and scrutinized by the regulator. So when it comes to assuring the quality of the production processes and the quality of the drug itself – which you and I may be ingesting – rest assured our systems have a lot of role to play in that.
How is Rockwell Automation helping make Indian manufacturing globally competitive under ‘Make in India’ ?
There are two parts to this question: one is the piece on Make of India which we will come to later. How do we allow Indian companies to conquer the world so to say, I think we are already witnessing a lot of success with the customers we are partnering with. Let me give you a couple of examples: it is first of all very important for them to ensure that they are in very tight compliance to the regulator’s expectations. Secondly, what is also critical when you go out to the global markets is to assure that your brand is protected, meaning there isn’t another supplier at any time from any global source that is selling spurious drugs under your name. There are technologies and techniques, strategies that manufacturers are utilizing, serialization being one of them. We are working with our customer partners to help them implement serialization solutions which allow them to protect the customers and their own brand as well.
Let’s just talk a little bit about making manufacturing itself much more effective – at the end of the day a pharma manufacturer is a manufacturer and they worry about the first pass yields and the supports and batch rejections and so forth. Putting strong automation practices and having tightly coupled DCS and information systems which allows them to do that – those are the kind of things that we are working along with our Indian Generics companies and these are the things which are helping them become much more globally competitive. You spoke about Make in India, I believe life sciences industry has always been making in India. They’ve in many ways been a poster child of this concept.
How agressively is the pharma and healthcare industry investing in automation and how do you see this stimulate growth ?
I’ve been a witness to this industry and the application of automation to this industry now for over a quarter of a century, and there are distinct phases. At one point of time there was no automation at all – the manufacturing scales were different, awareness was low and there wasn’t much of a regulatory expectation. Over the last 10-15 years, as the Indian Generics companies started to be very successful in the Western markets as suppliers, they became very aware of the regulators’ requirements – so regulation became the key overarching requirement for them to embrace automation. Now over the last 3-5 years, I’m beginning to find that the manufacturers are not only wanting to be adopting automation and information for the sake of compliance but also for the sake of making their manufacturing processes much more leaner, having lower rejection rates, having tighter line regulations, etc. And those are all very good things – things which help the industry mature a lot faster.
Your Future Plans
India is a very key global market for Rockwell Automation. We were one of the earliest multinational companies to set a base in India, as soon as we could have setup wholly on subsidiary we did that, regardless of what the economic cycle is ongoing. I just completed 10 years with the company, and pretty much throughout the 10 years we have kept on increasing our investment in India. We today have over 1000 Rockwell employees across the country and we’ve created a number of new capabilities in India which allows us to serve our customers a lot better. So we talk about things like Smart Manufacturing, Industry 4.0 investing into our capabilities to help our customers embrace these concepts, having domain experts who understand how these things work and can be implemented – those are one kind of things and then we have also been investing in India to create global platforms which allow us to have both product development as well as global engineering supported from India. We absolutely want to participate in the growth of the economy that is going on, maybe contribute to it. Also we look at India as a very strategic part of our global talent pool, a number of people from here are supporting a lot of global programmes. Rockwell has been here for 35 years, and we definitely look at being there when we plan for the decade ahead.