India Pharma Inc, hailed for its prowess in the production of high-quality generic medicines, now needs to shift from a conventional, volume-based business strategy to a value-based approach to keep it up its growth momentum. In this context, finding the right opportunities and understanding the challenges has become crucial.
Hence, Express Pharma is organising a series of “Pharma Summits” across the country’s pharma hubs to strategically leverage opportunities as well as find and apply new operating business models that support a value-driven approach to foster business growth. The overarching theme for this year’s Pharma Summits is “Volume to Value Leadership: Opportunities and Challenges for India Pharma Inc.”
The first one of this series in FY2023-24 was the Ahmedabad Pharma Summit. Held on April 21, 2023, at the DoubleTree by Hilton, Ahmedabad, the maiden edition of this event emerged as a platform for experts, thought leaders and veterans from the industry and regulatory bodies to assess the potential growth areas in the life sciences industry and explore opportunities for businesses in this sphere to create value and long-term sustainability.
Here is a summary of the lessons learnt from the views and insights shared by the distinguished speakers at Ahmedabad Pharma Summit 2023:
Technology can aid regulators to enable good governance, compliance
Dr Hemant Koshia, Commissioner, FDCA-Gujarat gave a very insightful key note address on the topic, Ahmedabad: A go-to destination for pharma manufacturing capabilities. In this session, he not only established the relevance and importance of Ahmedabad as a major pharma manufacturing hub, but also showcased how Gujarat is very relevant and key to India Pharma Inc’s growth trajectory. Highlighting Gujarat’s contributions in the life sciences sector, he informed that the state accounts for >32 per cent of national pharma production ($6.9 billion) and >28% of national pharma exports ($6.6 billion). It has over 110 USFDA approved sites, 50 EUGMP approved sites, 1081 WHO GMP approved units. Speaking on FDCA’s efforts, as a regulatory agency, to help build and sustain and healthy and thriving pharma sector in the state, Dr Koshia detailed how technology was leveraged to implement e-governance, and various advanced tools of enforcement were utilised to enable quality enforcement in the state by the regulatory officials.
A key learning from his session was that as the life sciences sector evolves and market demands change, traditional approaches to enable compliance must make way for newer and more effective models. Adoption of digital technologies can help regulatory agencies to drive and maintain compliance by improving their capabilities to analyse data, detect compliance issues, identify risks, promote good regulatory practices, enforce drug quality, facilitate consistent and accurate data documentation, etc.
Value leadership requires innovation and differentiation
After emerging as a key supplier of generics medicines globally and being the “Pharmacy of the World”, India now has to prove its mettle as a value-driven leader in pharma to continue its growth momentum. Union Health Minister Mansukh Mandaviya too gave the call for a shift from ‘Volume’ to ‘Value’ leadership to capture global pharma markets in the recent past as part of Vision 2047, a road map that envisages India as a developed nation by the year 2047.
So, a special address from Dr Viranchi Shah, National President, IDMA and Director, Saga Laboratories on ‘Indian pharma – Towards value leadership’ at the Ahmedabad Pharma Summit was very timely and pertinent. He informs that the goal for the Indian pharma sector by 2047 is to become a $500 billion industry and this is possible only through value leadership. To meet this ambitious target, he emphasised on the importance of adopting global best practices in pharma R&D and manufacturing. He also stressed that innovation and differentiation will be of utmost importance to accelerate production, increase global footprint, improve clinical outcomes and drive patient-centricity.
One of the most important takeaways from his session was that all pharma stakeholders should contribute and strive collectively towards building a robust ecosystem through scientific advancements, advanced skills, progressive regulatory changes, and use of data and emerging technologies.
Right processes and practices enable and empower strategies
An insightful session on ’Enabling and optimising operational excellence,” by Dr Sanjay Kumar Jain, President – India Operations, Amneal Pharmaceuticals accentuated how rising operational costs can lead to diminishing returns on products and affect the growth of life sciences organisations. He emphasised that operational excellence is essential in the pharma industry to balance cost and product excellence through optimised processes and best practices.
Dr Jain outlined a five-step strategy for operational excellence which involves assembling a cross-functional team to create a multi-dimensional plan, clearly defining the benchmark, strategy and performance goals for the endeavour at hand, aligning the organisation’s growth with a digital transformation journey, prioritising the implementation of this strategy by balancing risk, cost and performance, and reviewing the lessons learnt to continuously optimise the plan. He explained about the role of performance management, leadership, people, culture, risk and quality management etc. in enabling operational excellence
Dr Jain also outlined and detailed the methods or approaches that can help achieve operational excellence such as Kaizen, Lean Manufacturing, Siz Sigma, Process Mapping, 5S implementation, X Matrix, Automation/Digitisation, Poka Yoke etc.
A vital lesson from his session was that operational excellence is pivotal to maximise productivity, add value and offer more differentiation in products, eliminate risks, and identify growth opportunities, and safeguard quality.
Driving a culture change is imperative to achieve value leadership
Another important session at Ahmedabad Pharma Summit was on ‘Manufacturing Science and Technology: A road map for value-driven, hybrid business model’. The speaker for this session, Gouri Prasad Nanda, GM – MS&T, Zydus Group, enlightened the audience about some common lapses and errors in the pharma sector with a few hard-hitting questions and observations. His session highlighted that as the industry undergoes a shift from a volume-based to a value-based business model, it should learn to effectively balance product quality, cost-effectiveness and patient-centricity to achieve long-term success.
He also explained how manufacturing science and technology (MS&T), a relatively new function can help and support key activities such as risk management and troubleshooting, monitoring and analysis of process data, lead technical transfer activities, process change control management, technology strategy and innovation etc to ensure that products are in a constant state of control. It can also aid the implementation of a people and capability development strategy to guarantee the right talent and skill-set across the organisation to achieve its goals.
One of the major learnings from this session was that since quality equates to value, each pharma organisation must tackle behavioral issues that threaten meaningful change. Building and nurturing a culture of quality and compliance is a must to make products and processes more robust, efficient and effective.
Healthcare’s transforming landscape necessitates future-ready pharma facilities
The last session at Ahmedabad Pharma Summit was on ‘Building future ready pharma facilities,’ a relevant topic since infrastructure is of the essence to sustain progress in the pharma industry. Sanjeev Mahajan, VP-Quality, Cadila Pharmaceuticals, explained that automation and digitalisation, modular design, flexble manufacturing platforms, sustainability, regulatory compliance, robust quality management and effective talent management are some of the facets of future-ready pharma facilities.
Future-ready facilities will enable cost effectiveness and manufacturing efficiencies, reduce probability of errors, enhance manufacturer confidence on product and processes and generate more confidence and credibility among regulatory agencies.
Thus, a major take away from this session was that pharma facilities have to adapt to a rapidly evolving healthcare landscape and meet the need for innovative therapies. Focussing on implementation of future-ready facilities is the need of the hour to deliver safe and cost effective pharma products and meeting the challenges of an evolving pharma industry.
Facilitating progress
Thus, the Ahmedabad Pharma Summit very clearly brought out that India Pharma Inc needs to continuously evolve and transform with the help of new-age technologies, novel approaches, innovative techniques, skilled and trained resources, and a growth-oriented mindset to prepare for an illustrious future. Express Pharma will continue to cover and chronicle learnings to experts and leaders from various pharma hubs for our readers with similar endeavours across the country. Stay tuned for updates and coverage about our upcoming Pharma Summits. The next one, Vizag Pharma Summit 2023, will be held in Visakhaptanam on May 19, 2023.
lakshmipriya.nair@expressindia.com