Panel Discussion Reveals How Fear-Based Workplace Cultures Undermine Risk Management despite Advanced Systems and Procedures
A candid panel discussion at analytica India Lab 2025 stripped away industry platitudes to expose fundamental cultural barriers that prevent effective risk management implementation across pharmaceutical organizations. Led by Harish Jain, National President of the Federation of Pharma Entrepreneurs, the conversation revealed how entrenched workplace cultures of fear and pressure create systemic compliance failures that sophisticated procedures and digital systems cannot resolve.
The Digital Transformation Paradox
Mukul Lakhani from Dr. Reddy’s Laboratories opened the discussion by highlighting critical vulnerabilities emerging from pharmaceutical industry digitalization. While clinical trials increasingly rely on decentralized models, cloud-based systems, and patient-reported outcomes, these technological advances create unprecedented risks in data integrity, cybersecurity, and regulatory compliance.
“The biggest challenge is the digital transformation. With the advent of AI and more interest towards the decentralized trial, it’s very difficult to control the audit trail,” Lakhani explained, describing how patients participating in home-based clinical trials create verification challenges that traditional oversight models cannot address.
The discussion revealed how regulatory agencies expect pharmaceutical companies to demonstrate complete data control and patient confidentiality protection while utilizing cloud-based platforms and remote monitoring systems whose security architectures may not meet pharmaceutical compliance requirements. This creates a fundamental tension between operational efficiency demands and regulatory compliance expectations.
AI: Promise and Peril
Rakesh Kumar Sinha from Biological E. Limited provided nuanced perspective on artificial intelligence implementation that challenged simplistic technology adoption narratives. While acknowledging AI’s potential for generating standard operating procedures and analyzing process data, he warned against over-reliance on advanced AI systems for critical decision-making.
“The biggest challenge comes when you start analyzing the brain of AI, which is agentic AI. There we need to be a little cautious. It can give you a decision. Last couple of days, I was trying to put the AI, same question, and it is coming out with a different answer all the time,” Sinha observed, illustrating how AI inconsistency creates regulatory compliance risks.
This insight revealed a critical gap in pharmaceutical AI implementation strategies, where organizations invest in sophisticated systems without establishing appropriate validation frameworks or decision-making protocols. The pharmaceutical industry’s tradition of reproducible, validated processes conflicts with AI systems that may generate different outputs for identical inputs.
Regulatory Submission Minefield
Dr. Rajendra Singh from Mankind Pharma detailed the complex architecture of regulatory submissions that create multiple failure points across Chemistry, Manufacturing, and Controls (CMC) components, clinical data, pharmacovigilance systems, and post-approval compliance obligations. His systematic breakdown revealed how regulatory submissions represent integrated systems where single component failures can undermine entire applications.
“If we put all these components together, the information is put in a structured way. That is the major objective of giving the information to the agency in a structured way, so that they can review, they can come out with a conclusion and quality of submission is a big component there,” Singh explained, emphasizing how document quality and consistency determine submission success.
The discussion highlighted how regulatory agencies increasingly expect pharmaceutical companies to demonstrate comprehensive risk assessment capabilities across all submission components while maintaining compliance with periodically updated requirements and evolving safety information. This creates ongoing compliance obligations that extend far beyond initial approval processes.
Root Cause Reality
Dr. Souvik Nandy from Themis Medicare identified fundamental submission failures that persist despite sophisticated quality systems: inadequate documentation levels, insufficient subject matter expertise, delayed responses to regulatory queries, and superficial risk assessments. These failures reflect systemic organizational problems rather than technical deficiencies.
“The proactive way of responding to the queries. It is another because most of the thing which I have observed is the time when they give and the response time they give to the regulators is very delayed. So, the regulators in kind of I can say a loss of hope on the submitted to the part of data competition,” Nandy observed, describing how organizational dysfunction manifests in regulatory compliance failures.
This analysis revealed how regulatory submission quality reflects broader organizational capabilities including project management, technical expertise, and cultural commitment to excellence rather than simply technical knowledge or procedural compliance.
Bias Problem in Risk Assessment
Dr. Sanjit Singh Lamba delivered perhaps the discussion’s most critical insight by exposing systematic bias in pharmaceutical risk assessment practices. His observation that risk rating assignments often reflect desired outcomes rather than objective analysis challenged fundamental assumptions about risk management effectiveness.
“There is a lot of bias today in the risk assessment. You can give a rating of 8 somewhere. You can give a rating of 6 somewhere. It is all subjective. How do you make sure that you reduce this subjectiveness or a bias in the risk assessment? Otherwise it becomes just a paper exercise,” Lamba explained, describing how subjective risk assessment undermines regulatory credibility.
The discussion revealed how pharmaceutical companies often manipulate risk assessment methodologies to achieve predetermined compliance conclusions rather than conducting objective risk analysis. This fundamental dishonesty in risk assessment processes creates regulatory vulnerabilities that sophisticated procedures cannot address.
The Three-to-Five-Year Reality
Lamba’s most sobering revelation concerned cultural transformation timelines that challenge industry expectations for rapid compliance improvements. His assertion that meaningful cultural change requires three to five years minimum directly contradicts organizational assumptions about implementing compliance improvements through training programs or procedural modifications.
“Culture of quality and culture of compliance. You know, we all know with our experience today that that is one area which is most difficult, that is one area which is very very slow and since it involves transformation, though on one side digital transformation can be done early, human transformation takes lot of time,” Lamba stated, emphasizing how human behavior change represents the most challenging aspect of pharmaceutical compliance improvement.
The discussion revealed how pharmaceutical companies consistently underestimate cultural transformation requirements while overestimating the impact of procedural changes, technology implementations, and training programs on compliance behavior.
Workplace Culture as Compliance Barrier
Multiple panelists identified fear-based workplace cultures as fundamental barriers to effective risk management implementation. The discussion revealed how employees avoid reporting compliance issues due to concerns about professional consequences, creating hidden risks that undermine systematic risk management approaches.
“The real issue is that if something goes wrong, whether people are really reporting it or they are putting under the carpet. Most of the time when we look at the more and more work under the carpet, the more and more difficult it is for organizations to come out of it,” Lamba observed, describing how fear-driven behavior creates systematic compliance failures.
Dr. Souvik Nandy reinforced this concern by emphasizing how management pressure creates compliance failures: “Due to making of the peer pressure of the, on the working people from the top management, these things, the quality culture or quality maturity is getting hampered.”
The Tone at the Top Problem
The discussion included a particularly revealing exchange about leadership behavior that undermines compliance culture despite formal quality commitments. Lamba described situations where senior leaders publicly support quality requirements while privately pressuring staff to compromise compliance standards for business objectives.
“The leader is saying something in a meeting and says, I have asked, you know, not to, this person says, not to release the batch, but I think maybe in a week or so you’ll release a batch. This is a practical, this is what has happened,” Lamba explained, illustrating how leadership inconsistency creates cultural dysfunction that procedural controls cannot address.
This insight revealed how pharmaceutical compliance failures often originate from senior leadership behavior rather than technical deficiencies or inadequate procedures, suggesting that cultural transformation must begin with executive accountability and behavioral change.
Technology Implementation without Cultural Foundation
The panel discussion revealed how pharmaceutical companies frequently implement sophisticated technology systems without addressing underlying cultural barriers that prevent effective utilization. Automation, digitalization, and AI systems require cultural foundations of honesty, transparency, and systematic thinking that many organizations lack.
Sinha’s emphasis on automation benefits including error reduction, data visibility, and process control highlighted technology’s potential while acknowledging that human oversight remains essential for critical decision-making. However, the discussion revealed how cultural dysfunction can undermine even sophisticated technological implementations.
The Consultation Fallacy
A particularly pointed exchange addressed pharmaceutical industry reliance on external consultants for cultural transformation initiatives. Dr. Rajiv Desai’s question about overseas consultants’ effectiveness prompted Lamba’s emphatic response that external cultural transformation efforts typically fail without genuine organizational commitment to change.
“Bringing a person outside from a country and bringing in India to say that you have a cultural transformation never works like that,” Lamba stated, describing successful cultural transformation as requiring internal leadership commitment and sustained organizational effort rather than external expertise.
This insight challenged common pharmaceutical industry practices of hiring consulting firms to implement compliance improvements while avoiding the difficult work of examining and changing fundamental organizational behaviors and leadership practices.
Proactive Versus Reactive Compliance
Throughout the discussion, panelists consistently emphasized the need for proactive rather than reactive compliance approaches. However, their detailed examples revealed how organizational cultures, resource constraints, and leadership priorities often prevent proactive risk management implementation despite clear benefits.
The conversation highlighted fundamental tensions between pharmaceutical industry business pressures and systematic risk management requirements. While participants advocated for proactive approaches, their examples consistently revealed reactive organizational behaviors driven by immediate business pressures rather than long-term compliance strategies.
The Incentive Misalignment Problem
The discussion revealed systematic misalignment between pharmaceutical industry incentive structures and effective risk management implementation. Organizations reward business results while treating compliance as cost center, creating cultural incentives that discourage proactive risk identification and reporting.
Lamba’s emphasis on developing incentive systems that reward honesty and risk reporting challenged fundamental assumptions about pharmaceutical industry performance management while acknowledging the difficulty of implementing such systems within existing organizational structures.
Real-World Implementation Barriers
The panel’s collective experience revealed multiple practical barriers to effective risk management implementation including resource constraints, competing organizational priorities, inadequate technical expertise, and resistance to systematic change. These barriers persist despite clear regulatory requirements and obvious business benefits of effective risk management.
The discussion suggested that pharmaceutical industry risk management failures reflect broader organizational dysfunction rather than technical deficiencies, requiring comprehensive organizational development rather than procedural improvements or technology implementations.
The Cultural Imperative
The panel discussion concluded with acknowledgment that effective pharmaceutical risk management requires cultural transformation that begins with leadership accountability and extends throughout organizational structures. This transformation cannot be achieved through training programs, procedural improvements, or technology implementations alone.
The conversation revealed that pharmaceutical industry compliance challenges reflect fundamental cultural and organizational problems that require sustained commitment to systematic change. Organizations that fail to address these cultural foundations will continue experiencing compliance failures despite sophisticated systems and procedures.
The panel’s collective expertise demonstrated that pharmaceutical risk management effectiveness depends more on organizational culture, leadership behavior, and systematic commitment to excellence than on technical procedures or regulatory knowledge. This insight challenges industry assumptions about compliance improvement while providing clear direction for organizations committed to systematic risk management enhancement.
- Naresh Nunna
