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Indian pharma grapples with quality culture, needs changes in industry mindset: Dr Tom Thomas
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Peethaambaran Kunnathoor, Chennai
July 14 , 2025
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As global regulatory scrutiny intensifies, pharmaceutical companies are facing increasing pressure to not only meet compliance standards but to embed a robust quality culture into their very core operations.
Fostering such a culture is no longer a mere option but a critical imperative for sustainable growth, according to Dr. Tom Thomas Puthiyaparampil, country head, Syner–G Biopharma Group.
Asserting that ‘without a strong quality culture, no industry can sustain today’, he said this heightened-focus necessitates that pharmaceutical industries should proactively adopt multifaceted strategies to build and maintain the foundational quality culture essential for thriving in today's complex regulatory landscape. He made these remarks while delivering a keynote speech on ‘Development of Sustainable Quality Culture in Pharma Industry’ at an industry conference held last week in Chennai as part of the pharmaceutical exhibition, Pharmac South.
Dr. Tom stated that, among the several strategies crucial for developing a strong quality culture, leadership and governance emerge as foundational. Ethical decision-making, often referred to as "tone from the top," is paramount, as it directly encourages a deep commitment to compliance, fosters accountability across all levels, and provides visible support for quality initiatives from senior management. Beyond leadership, employee engagement is critical. This encompasses comprehensive training to ensure competence, genuine recognition for quality contributions, and meaningful involvement in decision-making processes, empowering every team member to be a steward of quality.
Along with good people-practices, good operational systems are also needed to work together to achieve a truly strong and sustainable quality culture. This operational system should include implementation of integrated quality systems with harmonised Standard Operating Procedures (SOPs) to ensure consistency and efficiency across operations. The adoption of a digital Quality Management System (QMS) facilitates real-time monitoring of processes, enabling proactive identification and mitigation of issues through effective quality risk management. Finally, consistent communication and feedback loops are vital, ensuring that quality expectations are clear, concerns are addressed, and a culture of continuous improvement is embedded throughout the organization.
According to him, the principle of the 'Right First Time' (RFT) approach will help industries to complete every task, process, and product correctly on the initial attempt, eliminating the need for costly rework and ensuring inherent quality from the outset.
Later, speaking to Pharmabiz, Dr. Tom Thomas stated that maintaining a high-quality culture would significantly reduce non-compliance, which he identified as the biggest hurdle for the growth of Indian pharmaceutical companies. "The Indian pharma industry needs a cultural change in its mindset with regard to documentation and practices to ensure compliance. Today, there are challenging regulations worldwide, and while the demand for Indian pharmaceuticals is increasing, scepticism is also there about the quality of Indian-made products,” he said.
When asked about the exact number of fully compliant companies in India, Dr. Tom Thomas acknowledged that it was difficult to provide a precise figure. However, he estimated that very few companies achieve full compliance. He further elaborated that approximately 30 per cent of Indian pharmaceutical companies are fairly compliant, another 30 per cent are moderately compliant, while the remaining 40 per cent periodically face serious compliance issues.
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