By Prathiba Raju and Abhijeet Singh
Hyderabad: Constructing a formidable presence in the global pharmaceutical landscape has required India to overcome numerous challenges, including cash deficits, skill gaps, regulatory hurdles, and supply chain issues. Establishing robust R&D laboratories has been a top priority for the industry, enabling significant advancements and collaborations that have propelled India’s pharma story to success, voiced experts at the second edition of the ET Pharma Next-Gen Lab conference, which served as a crucial platform for industry leaders to share insights and discuss the evolution and future of pharmaceutical laboratories.
The Next-Gen LabCon event, themed ‘Future-Ready Labs: Analog to Digital,’ provided a comprehensive overview of the evolution of laboratories, featuring insights from top industry leaders, regulatory personnel, and researchers. The conference was supported by Revvity Signals and Apna Employers as exhibit partners, RXpropolleant as infrastructure partner, and LABGUARD and Aizen as supporting partners.
Hitting the bull’s eye the pharma industry stakeholders created such a network which increased their access to innovations, advancements, adaptations, collaborations and realignments. Pharma labs delivered a standout supporting performance, which greatly ensured India’s pharma story to be a box-office hit.
Advancing its efforts to uncover the long history and evolution of laboratories along with their possible future outlook ET Pharma hosted the second edition of Next-Gen LabCon event themed ‘Future-Ready Labs: Analog to Digital.’.
The conference was supported by Revvity signals and Apna employers as exhibit partners; RXpropolleant as infrastructure partner; and LABGUARD and Aizen as supporting partners.
The conference served as a platform to provide a credible and valuable synopsis of the evolution of laboratories, right from their initial beginning with analog to the contemporary digital world. It aimed to bring together key Industry leaders, regulatory personnels and researchers who had been at the centre of this change and even contributed to it as well.
The conference initiated with a welcome address by Vikas Dandekar, Editor, ETPharma, which was followed by the Chief Guest’s address by Raja Bhanu, Director General, Pharmexcil on ‘Navigating the future of Pharmaceutical Exports: Quality Imperatives and Global Compliance.’
In his address Bhanu emphasised that in the pharma sector, time has come when the MSMEs need to invest in technology for early detection and mitigation of errors to maintain their quality which is acceptable and compatible in the global market. For achieving this advancements like automation, data analytics and AI needs to be placed.
“One of the pertinent issue in our labs when the product fail to meet their specification there are scientific reasons for that rejection but we always bracket them as a human error which is not the correct way indeed you (manufacturer) needs to be in a position to analyse it along with a procedure to control and a system to mitigate them, ” he highlighted.
Following the guest address there was an inaugural panel discussion on ‘Indian Laboratories – what does it take, to take it to a global scale?.’ The panelists for the session were Annaswamy Vaidheesh, Executive Chairperson, Suven Pharma; Dr KVS Ram Rao, CEO & Joint Managing Director, Granules India; Akhil Ravi, Chief Executive Officer, Aurigene Pharmaceutical Services; and Dr Sauri Gudlavalleti, Chief Operating Officer, Sai Lifesciences and the session was moderated by Vikas Dandekar, Editor, ETPharma.
Initiating the discussion Dr Gudlavalleti stressed that, India has already got a good position in this field, although China and Europe are ahead in some spheres but India is the only other country which can achieve the required scale needed for this Industry.
“Going further we need to get used to a much higher degree of speed, the rate at we work in India needs to double-triple, secondly there is a huge opportunity in India for the next-generation talent to enter this Industry and along with these two we need to advance over the use of technology both physical and digital,” he added.
Highlighting the role of small players, another panelist Akhil Ravi said, “Even though there are many big players globally there is always some customer who is underserved, it is important for us to identify our skill set… and can you serve them (customer). Innovation is not taking place only in Pfizer, Novartis etc it is happening in countless unknown biotech’s…. so there is an opportunity which one needs to identify. Additionally the supply-chain leaders are also looking for alternatives to reduce the risk in supply-chain and India is a credible option.”
Focusing on the potential role and challenges for Indian players, Annaswamy Vaidheesh echoed, “The job of companies like J&J, Merck etc. is to look how fast they can bring a drug into the market and for that they are looking for support organisations to speed up and deliver that particular requirement where traditionally China developed a comprehensive strategy as a country by investing in PhD graduates to study in US and all those students took the market by storm with a sheer speed, scientific knowledge, project management capabilities”
“Whereas the Indian industry is not looking at the service Industry as much as the formulation and we are doing what are doing in the 1.0 phase but now with the biosecurity act, ongoing tensions between US and China and Europe not being in a position to control inflation the context has changed and the tide is turning. The inhibitors are looking to solve this for a long term by having number two instead of China … but this Industry doesn’t have the required talent to deal with the explosion we are going to witness in the next 10-15 years,” Vaidheesh extended.
Advancing his views, another panelist, Dr Rao underscored, “The reason behind India being one of the focused nations for CDMO, complex generics etc. is because there is some geo-political tensions among others so it is not a natural choice that everybody is coming to you. So first of all we need to answer: are we the most preferred partners for outsourcing business? Do we have the ecosystem as it is in China? Are there opportunities where we can differentiate ourselves? and fourthly the challenge of carbon footprint which was not spoken for a very long time and China was the most preferred partner.”
Responding to a query from one of the attendees over possible strategies to transfer and share knowledge with other generations Dr Gudlavalleti suggested Apprenticeship, electronic lab notebooks along with encouragement to students to join basic sciences and chemistry.
The inaugural discussion was followed by another panel discussion on ‘Role of Sensors, AI, ML, RPA in Enhancing R&D Experimentation’. The panel comprised Dr Mandar Ghatnekar, Global Head of IT & Digital Transformation, Biocon Biologics; Chitti Babu, Chief Information Officer (CIO), Aurobindo Pharma; Tushar Zade, CDO & CIO of Aurigene Pharmaceuticals Services Ltd; Dr Sujay Rajhans, President, Head R&D, JB Pharma and the session was moderated by Chakravarthi AVPS, Chairman, Federation of Pharma Entrepreneurs – Telangana & Andhra Pradesh, FOPE South.
Giving his opening remarks over topic Dr Rajhans said, “ Many drugs are failing in pockets although we have so many QA (Quality assurance) guys but it is not possible to human to ensure the quality of every tablet and that’s where the digital evolution with sensors will help us which will give an opportunity to monitor the process at a molecular model right from raw material then production to packaging and distribution.”
Elaborating on the usage of AI technologies, Dr Ghatnekar stated, “It’s currently applied in three main ways: for improving productivity of employees through small-scale ‘snackable’ AI, creating new content through ‘generative’ AI, and performing complex tasks like protein structure prediction with ‘expert’ AI.”
“Being one of the later adopters of technology one of the key challenges for the Indian pharmaceutical industry is the lack of data so before we start to make massive investments on the frontend of AI we need to ensure that enough data is available in the pipeline which can be consumed by these algorithms,” the expert cautioned.
Commenting over the challenges over the adoption of AI and other cutting-edge technologies Tushar Zade said, “AI is a double-edged sword how do you use it is the whole context primarily there are four things firstly Data, secondly how you are going to churn it out along with its cost, thirdly looking after right talent along with their retention and lastly the validation of results as AI is something which hallucinates.”
Provisioning some insights of the evolution of technology in the value chain another panelist Chitti Babu voiced, there was no cross-functional experience and each department used to work independently so Industry has evolved from there.
Over the future of AI another expert Chitti Babu said, “AI is nothing but a statistical formula which works purely on data. There is a misconception in the Industry that AI will replace humans but it will never replace Human Intelligence.”
“We are bringing digitalisation to the Indian Pharmaceutical Industry but all data is either hand written or scanned PDF document so moving towards Pharma 4.0 is a big challenge where we have to find how we are going to digitise historical data, bring them to specific format, store them and apply some specific algorithms.” he underlined.
The panel discussion was followed by a presentation on Gen AI in Pharmaceutical & Drug Discovery by Tushar Zade, CDO & CIO, Aurigene Pharmaceuticals Services Ltd.
Following the presentation there was a panel discussion on ‘Ask the Experts- Upscaling to Electronic Batch Records: Lessons from a Pharmaceutical Manufacturer’ where Industry stalwarts like Dr Pavan Bhat, Executive Director, Natco Pharma and Sandeep Raktate, President- India & Ireland Operations, Amneal Pharmaceuticals featured at the panel and the session was moderated by Vikas Dandekar, Editor, ETPharma.
Dr Bhat initiated the discussion by acknowledging a clear digital divide in the Pharmaceutical Industry, he stressed that, “the pharma industry is lagging behind in terms of all Industries and our excuse has always been that we are a highly regulated Industry. To catch the irony where we are stuck somewhere and It also reflects the existing digital divide in the Industry there are leaders who have taken a leap and are cashing on the early adoption but a large part of Industry is lagging behind.”
Adding to it other panelist Sandeep Raktate emphasised that, “Digital transformation is must for everyone whether it is small, medium or large organisation and considering the priorities and skill sets it could be teller made according to the business. Electronic batch records is a need of the hour over which regulators are looking for and the basic challenge is how we move from paper to electronic one can start with e-logs than MES (Manufacturing Execution System) where most important is data-integrity and who is based in it are in the forefront to face FDA”
Over the penetration of digitisation of records in CDMO (Contract Development and Manufacturing Organisations) in comparison to generics Dr Bhat responded, CDMO is much quicker in adoption given their business is driven by customer requirements. On the generic part there is a divide between early adopters and those who are pondering this but if you want to be a global competitor you have no choice but to keep up and if you do it as a reaction not pre-action the time for implementation is going to be very long.
Sharing insights over the time and benefits of shifting to EBRs (Electronic Batch Records) Raktate said, “The most important thing is SKEDA compliance once you achieve it on every equipment that’s the right time to move on to EBR and you have an it (EBR) you have everything in place e-log is an bye product of MES and it is more convenient any exception in your processing or operation gets pop-up .”
“Going forward the next 5-10 years the regulators are going to sit in one row and will go through the system whether batch record or QMS, they will do the compliance on the screen itself,” Raktate added.
Following the discussion there was another panel discussion on ‘Implementing Green Chemistry Principles in CDMO Operations: A Sustainable Digital Transformation Journey’. The panelists for the dialogue include Dr Vijayavitthal T Mathad, Chief Operating Officer, CRAMSN Research Park; Dr Damodharan Muniyandi, Chief Quality Officer, Global Quality & Regulatory Affairs, Sai Life Sciences Ltd; and Dr Rakeshwar Bandichhor, Vice President and Head of Chemistry, API Process R&D, Dr Reddy’s Laboratories. Ivy Louis, Board Member, Parenteral Drug Association (PDA Inc.); Director-Vienni Training & Consulting LLP was the moderator of the session.
Dr Mathad initiated by stating the importance and significance of green chemistry in present time. He said, “Decades before the Pharmaceutical Industry focused on saving the patients and as a result the patients started getting saved but the planet started dying so we need to focus on both of them. Currently 43 per cent of rivers across the globe are contaminated with API (Active Pharmaceutical Ingredient) which are extremely hazardous to human health, 60,000 newborn babies are dying in India alone due to drug resistance developed through water, everything is contaminated because of Industrialisation and Pharma Industry has the most dangerous ramifications on life .”
Speaking over the role of green chemistry in laboratory another panelist Dr Bandichhor voiced, “If any process is giving 90 per cent yield is not a good news but doing what you are getting 90 per cent yield matters more, in this regard there is a idea that the input should be minimal to get maximum output through which the concept of atom economy emergers i.e. ensuring that whatever the atoms are in the reaction should be accorded in the product and secondly what ingredients you add to get the product, using minimal ingredients will help to reduce the process mass intensity. To make all these things happen in the industry, there are several considerations based on physico-chemical parameters, amount of solvent, dielectric constant of solvent etc.”
“All these things are newer avenues, in western world people are capitalising by making medicines at lower prices without contributing maximally to the carbon footprint in the environment,” he added.
Dr Muniyandi underscored, “Green chemistry is not a new subject this principle was stated applying in Industry (at GSK) in 2000 and now the digital transformation of Industry will definitely help in the green chemistry journey especially in India thousands of experiments have been done and if you analyse those data to reduce the solvent quantity through AI and ML we can increase the operational efficiency along with reducing the carbon footprint and a lot of AI and ML tools are available particularly for R&D for doing retrosynthesis and predictive synthesis.”
Concluding the session Dr Bandichhor suggested that, “If the tools get integrated into a single interface, for example, if flow chemistry is augmented with photochemistry, electrochemistry, mechanochemistry, and further advancements in flow, we will achieve significant advantages in manufacturing. The time exposure of products will be minimal, and the product formation in the pipeline will be least, thereby decreasing the need for extensive energy and solvent in purification while retaining the quality of the product.”
The conference concluded with the closing remarks by Prabhat Prakash, Senior Digital Content Producer, ETPharma.
