Quality Is the Backbone of Growth: Mr. Digambar Nigade On Leadership, Compliance, And The Future Of Pharma

Pharma Now: Welcome to Pharma Now. Today, we are privileged to have Mr. Digambar Nigade, President, Quality at Amneal Pharmaceuticals. Could you tell us about your early years after education and how your journey in pharma began?

Mr. Digambar Nigade: To begin with, I completed my postgraduation from Goa College of Pharmacy, a government institution. Prior to that, I completed my B.Pharm. I also qualified in the GATE 1993, which was conducted by the IITs at the time. I was the first student from my college to qualify, and the only candidate that year. That helped me secure admission to Goa College of Pharmacy, which is one of the oldest pharmacy colleges in India.

I pursued my master’s in Quality Assurance. During that time, many of our faculty members were industry professionals, people heading production, operations, and laboratory functions. Some were founder members associated with institutions like Indian Institute of Packaging and CU Shah College of Pharmacy in Mumbai. They would come and teach us because the program was entirely industry-oriented.

That exposure gave us a strong practical understanding of how the industry functions. As students, we usually don’t know what the industry expects from us. But in Quality Assurance, especially for injectables, the science and regulatory guidance were very clearly defined. There were established EC guidelines and reference books we relied on. That foundation gave me clarity early in my career.

I started my professional journey in early 1995 after completing postgraduation. I joined a mid-sized company called Crosslands, which was later acquired by Ranbaxy Laboratories. However, I had moved on before the acquisition. I worked there for about a year and then joined Dr. Reddy’s Laboratories in 1996.

At that time, Dr. Reddy’s was primarily an API-based company and was gradually expanding into formulations. They were constructing new facilities in Hyderabad, while Bolaram was one of the foundational sites with both API and formulation setups. That phase gave me valuable exposure to a growing organization.

After that, I moved to Dabur Oncology in Delhi, which was known as the Dabur Research Foundation. I joined there in 1997 and stayed in Delhi until 2008. I worked with Dabur Oncology for six years.

During that period, I was deputed for regulated market expansion efforts, including South Africa and Europe. I was also deputed to the UK for six months to support the setup and commissioning of a manufacturing facility in England. That experience was transformative. It was a steep learning curve, understanding how Western teams operate and how structured their systems are. At that time, isolator technology was just emerging. There were no isolators in India then, but I had the opportunity to work with innovators in that space.

In parallel, between 1998 and 2002, I was deputed to Tata Memorial Hospital in Mumbai for clinical research. I conducted Phase II B, Phase III, and Phase IV clinical trials for oncology molecules. I was instrumental in introducing oncology molecules such as Paclitaxel for new indications, Topotecan, and Ifosfamide as adjunctive therapy into the Indian market.

I also conducted clinical research on Ayurvedic products, since it was a combined division within Dabur. So I was simultaneously handling oncology and Ayurvedic clinical research, two very different domains.

However, during my time in clinical research, I realized something important. The field was largely dominated by medical doctors. While we were responsible for writing case report forms, compiling data, interpreting results, and making recommendations on molecule behavior and patient response, we were not allowed to directly interact with patients. Only doctors could speak to patients and officially document findings.

You may do all the hard work, data compilation, interpretation, recommendations, but ultimately, it is presented under the doctor’s name. That made me reflect deeply on my long-term direction. I realized that my strength and interest lay in core Quality Assurance.

So I transitioned back to QA. After returning from the UK and gaining that international exposure, I felt ready for a bigger challenge. I moved to Corporate Quality at Ranbaxy Laboratories. At that time, Ranbaxy was the number one pharmaceutical company in India and a market leader. While Dabur was also strong, Ranbaxy had broader global visibility.

I worked at Ranbaxy for five years. During that period, I became extensively involved in global audits. I visited sites in Mohali, Goa, China, Malaysia, and Ireland. That global exposure built tremendous confidence in me. When I decided to leave, I was even offered the role of Head of Quality for Europe. Due to family priorities, I couldn’t accept the opportunity. I still regret that decision sometimes, but I believe things unfold as they are meant to.

My real regulated market exposure began at Ranbaxy, where everything we produced was destined for the US market. At that time, the company had crossed the $1 billion mark and had ambitious growth plans. There was strong leadership vision to take the company to $2 billion and beyond.

However, leadership changes and turbulence affected the organization. I then moved to a corporate quality role in Bangalore, where I worked for three years. That was my first opportunity to independently lead multiple verticals, microbiology, quality control, validation, cleaning validation, and quality assurance. It was a complete leadership setup for me, and it shaped my confidence as a quality leader.

Later, Ranbaxy called me back during the period when the company was signing the consent decree. By then, it was operating under the combined structure of Ranbaxy and Daiichi Sankyo. I joined in a regional quality role to support remediation efforts.

Those three years were intense. Significant efforts went into remediation and compliance strengthening. By the time I left, I was heading one of the largest sites as Quality Head. It was the biggest site in the organization, with more than 5,000 applications filed worldwide and exports to around 150 countries.

Handling such a large operation and leading a massive team was a significant challenge, but with strong team support and collective effort, we were able to stabilize and manage it successfully.

Pharma Now: I was about to ask you the same question. Usually, people get frightened when such instances happen in a facility, warning letters, observations, remediation work. What made you choose such a challenging environment?

Mr. Digambar Nigade: Every problem has a solution. You have to be optimistic and believe that you can solve it. If you have solution-oriented thinking, you will find a way forward. Your learning actually begins when a problem appears. Your thinking should not stop at the problem, it should start there. You ask yourself: What is the next solution?

Situations like warning letters can happen in any organization. I’m not referring to the consent decree, that was exceptional. Ranbaxy was the only Indian company to sign a consent decree in court with the US FDA. Coming out of a consent decree is a massive challenge.

But Ranbaxy was a huge organization. Despite not supplying to the US market for a period, its turnover did not decline. It performed extremely well in Europe, Africa, Canada, and other global markets. US supplies were about 23% of the total business, while 70–75% came from other international markets. Even with import alerts and the consent decree, the company continued to grow.

However, Daiichi Sankyo struggled to adapt to the generic business model. They came from an innovator background, with six or seven core molecules and highly structured, long development cycles, typically six to seven years per product. They were a $7 billion Japanese company with very defined processes.

When they evaluated Ranbaxy, they found a completely different model. In generics, Ranbaxy was filing 60–70 applications a year, with development cycles of 9 to 18 months. For Daiichi Sankyo, this speed and complexity were difficult to reconcile. They were new to the generic environment, and eventually, they could not align with that setup. Later, the company was sold to another pharma organization.

After Ranbaxy and before Sun Pharmaceutical Industries acquired it, I moved to Wockhardt due to family priorities and because I knew some people there. I joined to support their remediation efforts.

But at Wockhardt, the situation was extremely difficult. The US FDA was not convinced by the remediation progress. There seemed to be a perception that the company might not sustain compliance. When there is no visible regulatory confidence, management also hesitates to invest heavily in remediation. We were working exclusively on remediation, with no clear breakthrough. That is when I decided to move again.

I then joined Lupin Limited. At that time, Lupin had no warning letters, and I believed it was a green zone organization. However, between my interview and joining, an audit took place, and it did not go well. By the time I joined, responses had already been submitted. Subsequent audits followed.

Eventually, one API site received a warning letter, and it continued for almost three to four years. But this experience was different. Lupin’s management took it very seriously. They invested significant resources and ran a structured remediation program.

That phase was another major learning curve for me. I had the opportunity to work with world-class consultants and see remediation done with complete intent to resolve, not just to respond.

Lupin eventually came out of the warning letter, including the Goa site. After about five years, I wanted to focus more deeply on injectables. I briefly worked with Dr. Reddy’s Laboratories Biologics, but it was a smaller setup.

Soon after, I received an opportunity at Amneal Pharmaceuticals, and I transitioned because the scale here was significantly larger. There are more than 20–24 injectable lines supplying to the US market.

When I started my career, there were hardly two or three injectable lines in India supplying to the US. Today, there are more than 150 US FDA-approved injectable lines in India. The scale has transformed completely. Injectables are the future, especially with biologics gaining momentum. Finished biologics are also injectables, so understanding biologics is essential.

Biologics is an expensive business. Development costs are very high, often exceeding $50 million, primarily due to clinical requirements. In traditional generics, you can file 10–12 applications a year at relatively lower cost. But biologics demand deeper scientific capability, longer timelines, and significant financial commitment. That evolution is what makes the injectable and biologics space both challenging and exciting.

Pharma Now: Could you give us more clarity on this? When you say conventional generics versus biologics, what is the typical cycle duration? How does the timeline for generics compare to biosimilars?

Mr. Digambar Nigade: For biosimilars, the landscape has evolved. The US FDA has issued new guidance that, in some cases, allows waivers for certain clinical requirements. That has helped reduce timelines and cost to some extent.

However, the cost is still significant. I don’t see it dropping drastically. Even today, development can require $20–25 million per molecule, and often more.

The reason is the complexity. You start with cell culture development, establish cell banks, scale up through upstream and downstream processing, reach the API stage, and then move to fill-finish. Fill-finish can be managed in India, as many capable CMOs are available. But developing the active moiety—the biologic substance, is the real challenge.

You must ensure minimal impurities, high purity, and, most importantly, biological similarity to the innovator product. That similarity is critical. Biologics are inherently complex, which makes development demanding but also highly rewarding.

If you look at the global market, biologics command enormous value. For example, Merck & Co. markets Keytruda, and that single product generates around $30 billion globally. To put that in perspective, India’s total pharmaceutical exports are roughly $28 billion. One biologic product can exceed the annual export value of an entire country’s pharma industry. That shows the scale and potential of biologics.

But entering biologics requires appetite, for investment, patience, and scientific depth. In India, some companies have taken that step. Lupin Limited has invested in biologics. Zydus Lifesciences is active in the space. At Amneal Pharmaceuticals, we already have two to three biologic molecules commercialized.

At Amneal, our focus is on complex injectables, complex molecules, and new drug applications, high-value products. If you manufacture high-value products, you can sustain compliance costs. Otherwise, in a highly competitive generic market, margins are tight. You may produce millions of units, but without profitability, you cannot invest in new technologies or advanced platforms. Then the mindset becomes reactive instead of progressive.

What I appreciate about Amneal is its origin and philosophy. The company was founded in the US by two brothers with a very compliance-oriented mindset. They firmly believe that patients come first and that integrity and quality are the backbone of growth. According to them, without integrity and quality, sustainability is impossible. That makes it meaningful to work in such an environment.

Here, I lead the India injectable cluster for new products, including microsphere lines and complex injectables. We have received approvals for multiple NDAs and ophthalmic products, which are also aseptic lines. We are in the process of filing for aseptic bag lines, which are highly complex to qualify and manufacture. Many companies work with standard bag lines, but aseptic bag lines require a much higher level of control and validation.

Over the years, I’ve built professional relationships across the industry—even with regulators. Regulators are also human. In difficult situations, constructive engagement helps. They guide you, provided your intent is genuine and transparent.

Ultimately, handling warning letters or serious observations is not impossible. What matters is having a concrete plan and a highly focused approach. Regulators expect robust implementation of ALCOA principles—data integrity must be strong and unquestionable.

Automation also plays a key role. The more you move toward automated systems, the more confidence regulators have. Human errors are often questioned. Instrument or system-driven controls, when properly validated, build trust.

So whether it’s generics or biologics, or whether you’re facing a warning letter or scaling new technology, the fundamentals remain the same: scientific rigor, data integrity, automation, and a culture that truly values quality.

Pharma Now: With over 25 years in the industry, how do you compare your early days to the present? And how do you see the future of quality evolving?

Mr. Digambar Nigade: The future of quality is very bright. India is becoming a global manufacturing hub for pharmaceuticals. As Indians, we have a moral responsibility to serve patients worldwide. Irrespective of market value, we must ensure that only good products leave our custody. We should never release a wrong batch into the market. There must be zero harm to patients from the products we manufacture.

Earlier, quality did not receive the same level of focus. But over the last two decades, quality has become central to the business. Interestingly, from a regulatory standpoint, there is no formal designation called “Quality Assurance.” Agencies recognize quality units, like QC, manufacturing chemists, microbiologists, but not an “approved QA person.” The concept of Quality Assurance evolved more from industry practice, yet today it stands as a supreme and independent function above manufacturing and QC.

Going forward, quality must play an even more critical role. We should aim to match the standards of countries like Germany. Germany’s pharmaceutical exports are around $90–100 billion annually, while India’s total exports are about $28 billion. Germany also faces fewer recalls and regulatory issues compared to India. That tells us something important.

If we want to be known as the pharmacy of the world, our quality systems must be equally world-class and disciplined.

Indian scientists are highly capable. We receive numerous approvals, and most companies have strong pipelines for the next three to five years. But a single regulatory hurdle, like an OAI status or warning letter, can disrupt everything. New approvals get stuck, revenue generation is affected, and the entire organization becomes unstable. Ultimately, the blame falls on quality.

Instead of reacting to crises, quality must be proactive. It should provide confidence to management, manufacturing teams, and most importantly, patients.

We also need to be judicious in exercising our authority, especially during batch release. There is always a thin line between releasing and rejecting a batch. Documentation requirements and testing volumes have increased significantly. Batch manufacturing records are massive. Testing expectations are high.

Electronic systems have improved control, but they also bring challenges. If electronic data is lost, even when the batch is technically fine, you may not be able to release it. That is the flip side of digital intervention. So we must strike the right balance, leveraging automation and data integrity while safeguarding continuity.

The goal is clear: minimal rejections, negligible market complaints, no recalls, and no stability failures. Some complaints may be non-genuine, but systemic quality failures should not occur.

Quality must function proactively, passionately, and with integrity. When done sincerely, the sky is the limit for the quality function. That is how I see the future, stronger systems, greater accountability, and a deeper commitment to patient safety at every level.

Pharma Now: You’ve faced numerous challenges throughout your journey, some of them repeatedly. What message would you give to young pharmacists or biologists entering the pharmaceutical industry? What should they follow to bring the kind of change the industry needs?

Mr. Digambar Nigade: For young professionals entering the pharma industry, whether in microbiology or any other department, the first requirement is knowledge. You must be knowledgeable and open to hard work. Not just hard work, but smart work.

You need innovative thinking. And today, you must also be AI-savvy. Artificial intelligence is going to transform many roles. If you are not comfortable using AI tools and adapting to new technologies, you risk being left behind.

The combination of domain knowledge, technical skills, and AI capability will define who sustains and grows in this industry.

Young professionals must stay aligned with global industry developments, not just what is happening in India, but internationally. Take microbiology as an example. The fundamentals, gram staining, microorganism identification, remain the same across the world. Whether you are in India, Australia, Japan, or the US, the basics do not change.

But what evolves are the techniques. Rapid microbiology methods, real-time environmental monitoring, these are becoming more common. They may be expensive, but understanding their principles is important. Read about them. Watch demonstrations. Study the science behind them. When you get the opportunity, try to introduce such advancements in your organization.

That mindset of continuous learning is critical. Routine work is necessary, but whatever you do must be flawless. Your work should be 100% question-free. There should be no scope for objections in what you execute or document.

Young professionals must not rely on supervisors to catch and correct their mistakes. The responsibility begins with them. Documentation should be accurate. Records should be error-free. Attention to detail is non-negotiable in pharma. If they remain focused, disciplined, and curious, they will not only sustain in the industry, they will grow.

Pharma Now: Thank you, sir. Your journey is truly inspiring, and I’m sure it will resonate with many of our viewers. Thank you for sharing your insights and your message for the next generation. If they implement what you’ve said, it will certainly guide them in the right direction and contribute to the growth of the pharmaceutical industry.

Mr. Digambar Nigade: Thank you once again for giving me the opportunity to share my experiences. It refreshes my own memories and gives me a sense of fulfillment. People can grow in this industry. They can reach strong leadership positions, contribute to global health, and truly serve patients.

Pharma is a noble field. It is meaningful work. I would encourage young professionals to stay in this industry, commit to it, and contribute to it. Thank you very much.