Inside Shilpa Medicare’s growth strategy: Quality, digital and global ambitions

You have recently stepped into a new role as COO of Shilpa Medicare – Formulations. What excites you the most, and what are you most careful about?  Joining Shilpa Medicare at this stage of its evolution is both an exciting opportunity and a significant responsibility. What excites me most is the opportunity to contribute to an organisation that has already established strong scientific capabilities and a differentiated position in oncology and specialty pharma. The global pharma landscape is evolving rapidly, and companies that can consistently combine scientific innovation, manufacturing excellence, and regulatory credibility will emerge as long-term leaders.  I believe there is tremendous opportunity to further strengthen operational excellence, accelerate commercialisation, improve execution speed, and build an integrated quality culture across the organisation. My focus will be on creating sustainable systems rather than short-term achievements.  At the same time, I am very conscious that growth should never compromise quality or patient safety. The pharma industry operates on trust. Every product we manufacture ultimately reaches patients whose lives depend on our commitment to quality. Therefore, maintaining regulatory compliance, strengthening our pharma quality system, developing our people, and ensuring robust governance will remain non-negotiable priorities.  For me, sustainable growth is achieved when scientific excellence, operational excellence, and quality excellence progress together.  You’ve spent much of your career building scale, strengthening operations, and navigating global regulatory environments. How will that experience shape your leadership approach at Shilpa Medicare – Formulations?  Throughout my career, I have learned that successful pharma organisations are built on systems rather than individuals. My leadership philosophy has always centered around creating processes that are scalable, predictable, compliant, and continuously improving.  Global regulatory inspections have taught me that compliance cannot be prepared for just before an inspection—it must be embedded into daily operations. This requires cross-functional collaboration where quality, manufacturing, engineering, supply chain, R&D, regulatory affairs, and commercial teams work towards common objectives.  My approach will emphasise three pillars:  Operational excellence:  Building highly efficient, data driven manufacturing systems that improve productivity while maintaining the highest quality standards.  Quality culture: Moving beyond documentation-driven compliance toward a culture where every employee understands their responsibility toward patient safety and product quality. People development:   Investing in leadership development, technical competency, and empowering teams to make scientific, evidence-based decisions. Ultimately, my objective is to create an organisation where operational discipline and innovation complement each other rather than compete.  Biosimilars are getting more competitive. Where do you see real room to differentiate today?  The biosimilar industry has evolved significantly. Price alone is no longer a sustainable differentiator. True differentiation now lies in delivering consistent quality, regulatory confidence, supply reliability, and patient-centric solutions.  Manufacturing excellence has become a strategic advantage. Companies that demonstrate robust process controls, strong analytical capabilities, and reliable commercial supply will gain greater confidence from regulators and healthcare providers.  Another important differentiator is lifecycle management. Developing improved formulations, convenient delivery systems, patient support services, and digital health integration can significantly enhance value beyond the molecule itself.  Global partnerships will also play an increasingly important role. Collaborations that combine scientific expertise, manufacturing capability, and commercial reach can accelerate market access while reducing development risks.  Finally, digital manufacturing, artificial intelligence, advanced analytics, and continuous manufacturing technologies will become increasingly important in improving efficiency, reducing costs, and ensuring product consistency. When you look at Shilpa Medicare – Formulations three years from now, what do you want it to be known for? What is the one big bet you think will define whether you get there or not?  Three years from now, I would like Shilpa Medicare Formulations to be recognised globally for three attributes: uncompromising quality, execution excellence, and scientific innovation.  I envision an organisation known for consistently delivering high-quality oncology and specialty medicines across global markets while maintaining strong regulatory credibility. The one strategic bet that will define this journey is building an integrated culture of operational excellence supported by digital transformation. Digital technologies— including electronic quality systems, advanced manufacturing analytics, predictive maintenance, automation, and real-time process monitoring—can transform both compliance and operational performance. However, technology alone is insufficient. Success depends on developing people who understand how to leverage these tools effectively.  Organisations that successfully combine digital capabilities with strong quality culture will be best positioned for sustainable growth.  There’s a lot happening in science, be it new therapies or new technologies. How do you decide what is worth investing in and what is just noise?  Every innovation should ultimately answer one question: Does it create meaningful value for patients, healthcare systems, and the organisation?  I generally evaluate investments across five dimensions: Scientific differentiation, Unmet medical need, Regulatory feasibility, Commercial sustainability and Operational scalability.  Not every emerging technology requires immediate adoption. Some technologies generate excitement but lack commercial maturity or practical application.  Conversely, technologies that improve product quality, manufacturing robustness, regulatory compliance, data integrity, supply reliability, or patient outcomes deserve serious consideration.  I also believe innovation should not be confined to drug discovery. Process innovation, manufacturing innovation, quality innovation, and digital innovation often generate equally significant competitive advantages. Balanced investment decisions require scientific rigor, business discipline, and long-term strategic thinking.  As regulatory expectations for oncology and other niche formulations like TDS and ODG rise globally, credibility is becoming a business moat. How do you plan to build that at Shilpa Medicare – Formulations?  Credibility cannot be built during inspections—it is built every day through disciplined execution. My approach focuses on strengthening the entire Pharmaceutical Quality System rather than isolated compliance initiatives.  This includes:  Robust quality risk management  Strong contamination control strategies  Advanced data integrity practices  Effective deviation and CAPA systems  Scientific process validation  Comprehensive training and competency development  Continuous process verification  Transparent quality governance  For specialised formulations such as oncology products, transdermal systems (TDS), and orally disintegrating dosage forms (ODG), manufacturing complexity demands even greater process understanding and contamination control.  Equally important is leadership behavior. Quality should never be viewed as the responsibility of the QA department alone. Every function—from R&D to Engineering to Manufacturing—must own quality.  When this culture becomes embedded throughout the organisation, regulatory confidence naturally follows.  Which markets are you most focused on right now, and why?  Our focus should remain balanced between highly regulated markets and highgrowth emerging markets. Highly regulated markets such as the US, Europe, Canada, Australia, Japan, and the UK continue to represent significant opportunities because they reward companies with strong quality systems and regulatory excellence.  At the same time, emerging markets across Asia, Latin America, Africa, and the Middle East continue to experience increasing demand for high-quality, affordable specialty medicines. A diversified global presence reduces business risk while creating sustainable long-term growth. Success in these markets will depend not only on obtaining approvals but also on ensuring reliable supply, maintaining regulatory compliance, understanding local healthcare needs, and building long-term partnerships.  At a strategic level, what do you believe companies like yours should focus on: innovation, partnerships or scale? Why?  I do not view innovation, partnerships and scale as competing priorities—they are mutually reinforcing. Innovation creates differentiated products and technologies. Partnerships accelerate development, expand market access, and bring complementary capabilities. Scale enables affordability, operational efficiency, and global competitiveness. The companies that will lead the next decade are those capable of integrating all three.  However, if I had to identify the foundational element, I would say quality-driven innovation. Innovation without quality cannot reach patients. Scale without quality is unsustainable. Partnerships succeed only when built on trust and credibility.  Ultimately, pharma success is built on a simple principle: delivering safe, effective, high-quality medicines to patients consistently. Everything else—innovation, partnerships, and scale— should strengthen that mission.    lakshmipriya.nair@expressindia.com  laxmipriyanair@gmail.com The post Inside Shilpa Medicare’s growth strategy: Quality, digital and global ambitions appeared first on Express Pharma.