Batch Destruction Over Risk: Why Quality Always Wins Biological E's Vice President

Pharma Now: Mr. Sinha, welcome to the show. I came to know about the depth of wisdom you carry, and I’m genuinely excited for this discussion.

So, let’s get started. You have over 30 years of experience in manufacturing various types of products, and today, you’re responsible for managing a huge plant, handling nearly 1,300 people and overseeing the production of millions of vaccine doses. How does that feel for you?

Mr Sinha: It feels like a long journey, and yet, it also feels like we just started yesterday. The journey continues, and there are still miles to go. But it gives me immense satisfaction to make vaccines available for the masses. Vaccines are a form of preventive medicine; they protect even the youngest children from serious diseases, and that’s the truly rewarding part. 

At the same time, it demands a high level of excellence and care, because when you're producing something that will go into a newborn baby, every step must be handled with the utmost precision and responsibility. We’re committed to that journey, serving millions of people through our work.

Pharma Now: Sir, so do you get a peaceful sleep every day?

Mr Sinha: Yes, this happens because the organizations I’ve worked with are truly quality-conscious. The effort is such that even if we have to destroy a million doses, not a single dose that doesn’t meet the standard or conform to quality specifications ever reaches the market. That level of commitment is what keeps the pharmaceutical and vaccine segments growing. At the core, it’s about ensuring customer safety and satisfaction, and that’s what drives us.

Pharma Now: Do you remember any such incident where you actually had to roll back or destroy a large quantity of production?

Mr. Sinha: Yes, during my journey, there have been instances where we had to destroy large quantities, sometimes even entire batches. One particular situation stands out as very tense.

We were in the middle of evaluating batches when, due to an error in testing, we received data that didn’t meet the required specifications. This triggered a major investigation, production was halted, and everyone was trying to figure out what went wrong. We followed the proper process, and after a thorough root cause analysis, we found that one of the reagents used in testing wasn’t performing correctly. Eventually, we resolved the issue, but the journey took about three months. Production was on hold for a longer period, and all the ready-to-dispatch batches were quarantined.

Only after retesting and proving that everything met the quality standards were those batches released to the market. This happened early in my career, when I had about ten years of experience, and the one thought that gave me peace during that time was that none of the product had been released to the market. So, there was no risk to anyone’s health. Of course, any productive organization is mindful of costs, but in pharma, quality is always the topmost priority.

I really appreciate the management for taking that kind of call, putting product quality above everything else. During batch processing, all the data is captured and tracked. In this particular case, all the data were giving positive signals, indicating that everything had been followed as per the process. Naturally, there was a lot of discussion and concern. People were asking, “We followed the same system, the same process, everything conformed to the specifications, so why is this batch being questioned?”

That created a perception that the product was fine. But the fact remained, one test result wasn’t meeting the specification. And despite everything looking right, there was doubt. So, the decision was made to pause and evaluate, to find the real root cause. And eventually, we discovered that one of the reagents used in testing was not delivering accurate results. That level of thoroughness is what defines a quality-first mindset.

I was tense during this period, not for myself, but for my team. Every day, they would come to me asking, “What should we do? How do we investigate? Where did it go wrong?”

My mind was working 24/7, constantly thinking, “What if we don’t find anything? What if the issue remains unresolved?” Each and every piece of data was reviewed again and again, multiple times. We even brought in external consultants. They also reviewed everything and confirmed that all processes were followed exactly as per the design. So we went into even deeper levels of investigation. That’s the way we have to deal with any kind of non-conformance, whether it’s confirmed or still under evaluation. Unless it is thoroughly confirmed and understood, no decision can be made on releasing a batch.

Pharma Now: So, let’s go back 30 years, back to when you started your career. I’d really like to understand: how did you begin, and how did you come into the field of manufacturing?

Mr. Sinha:  Actually, the journey started a little earlier, during my intermediate studies. Back then, the aspiration was to become an engineer. Like most students, I had big dreams. I felt like the sky was the limit, and everything seemed possible.

I appeared for competitive entrance exams, including the IIT-JEE. That was my first real taste of competition, where you start realizing not just your own capabilities, but also how you compare with the rest of the world. Fortunately, I got through. My rank wasn’t very high, but it was good enough to secure admission to an IIT.

There was a bit of confusion over branch selection, as I didn’t know much about the various engineering streams. Based on some advice I received, I chose Pharmaceutical Engineering, which is how I entered the world of pharma. Honestly, I didn’t know much about the field at the time. The only thing I knew was “engineering.” I didn’t even know much about the different branches.

It was only after joining IIT that my perspective began to open up. You’d meet students studying electronics, mechanical, or computer science, and start to understand how career paths are shaped. Back then, computer science was the big craze, much like how AI or ChatGPT is today. In 1989, computer engineering was the most coveted stream, and those with the highest ranks typically chose it. 

Even so, studying side by side with students from other disciplines, sharing the same hostel, and experiencing that culture, it was truly eye-opening and enriching. That’s how I entered pharmaceutical manufacturing.

When I started working, I thought: “Okay, studies are finally over, now it’s time for a job, money, independence, and nothing will be as tough anymore.” But I soon realized that real learning never stops.

I consider myself fortunate that I began my career from the basics. My first job was with Nicholas Piramal at one of their fantastic facilities. They were using some of the most advanced technologies at the time, and I had access to activities and systems that were quite rare back then.

I still remember my first day clearly, July 1993. It happened to be the annual day of the plant, and the promoter himself was present. He was such a great entrepreneur and visionary. That experience was truly fascinating and memorable, and it marked the beginning of my professional journey.

Pharma Now: How today it feel like when you remember that day in 1993?

Mr. Sinha: It feels like a stepping stone in the right direction when I look back. I learned a lot during my time as a trainee. Back then, money was tight and I used to ask my father to send me some. He’d say, “What kind of job are you doing that you still need money?” At that time, pharma wasn’t really known for high salaries.

Things began to change post-2002, especially vaccine manufacturing, when India became a secretary of the WTO, under the General Agreement on Tariffs and Trade (GATT). After that, the pharma industry had opportunities to sell products in the US, Europe, and other global markets. 

One thing that stood out, and made us feel quite comfortable, was the environment at the facility. Everything was controlled with central air conditioning, HVAC systems. At home, we didn’t have air conditioners. But at work, we were operating in a fully climate-controlled space. We used to call it air conditioning, but it’s actually HVAC (Heating, Ventilation, and Air Conditioning), covering both heating and cooling. It was quite impressive at the time.

Pharma Now: But even today, when someone graduates from IIT, their doors to the US or Europe usually open up. Did you never think of going to the US?

Mr. Sinha: It really depends on how you plan your future. I come from a small village, and moving to Varanasi, where 20,000 people lived in a single campus, was my first big exposure. I was constantly measuring myself, "This guy is better than me, I have to catch up," or "That idea is good, let me adopt it." That mindset shaped my journey.

Many of my classmates from that time are still in the U.S.; they went there and settled. But I also had seniors who were working in the industry here in India, and they became my role models. So I’d say it was 50-50. I did think about going to the U.S., but I wasn’t very aware of how to go about it. By the time I learned about the GRE and other requirements, there wasn’t enough time to prepare and qualify.

Later, I did get opportunities to go abroad. But over time, responsibilities built up, and I started feeling more connected to the country. You start to feel that the country has given you so much, and now it's time to give back. That sense of purpose starts growing.

I worked for five years with Dabur after completing my training at Nicholas Piramal. I had a chance to work in Egypt, Dubai, and across different parts of India. In fact, I set up a plant in the Sahara Desert, in a place called the 10th of Ramadan Industrial Area, about 58 kilometers from Cairo. It was extremely challenging, temperatures would hit 54–55°C, but under the shade, it could drop to just 5°C.

I commissioned that plant for Dabur, but after I got married and my wife joined me in Egypt, we realized that life there wasn’t what we had anticipated for the long term. After a year, we decided to return to India. Around that time, our first son was born, who was a special-needs child. We needed family support, and it was important to raise him in an environment where he’d be cared for and understood. That decision shaped our lives. He’s now 24 years old and a self-driven, wonderful child. I believe he taught me so much; he made me more patient, more empathetic, and more human. Because of him, my interactions with my colleagues and teams have become much more understanding and grounded.

Pharma Now: That was actually my next question, you handle 1,300 employees! How do you keep your cool and stay calm?

Mr. Sinha: It’s basically not that all 1,300 people meet me every day. A few of them do, and a few don’t. You engage with people as needed, at the right time. The key challenge in manufacturing is delivery, quality, and consistently following the process day in and day out.

If your processes are well-established, robust with minimal variation, you can start predicting your outcomes. And once you can predict your daily outcomes, like knowing what production will look like, everything becomes more manageable.

You can look at it two ways: every job is difficult until you learn and practice it. The more you practice, the better you become. Take Tendulkar, for example, he’s not the god of cricket just because he made thousands of runs, but because he practiced to the level where he could perform at that level consistently. That’s the kind of learning we need to apply.

I was fortunate to have some really good superiors who guided me. They taught me a lot, but they never scolded me. A few of them truly held me through the process. They helped me build focus and understand that every process has a start and an end, like any journey from one city to another. But while driving, what matters is the road you're on at that moment. Being present is critical.

Initially, I used to seek shelter behind a simple “sorry” when something went wrong. Until one day, a colleague told me, “I don’t have a lorry to carry your sorry.” That hit me hard. I realized I was reacting, apologizing, and moving on, but not necessarily correcting my mistakes. That’s when I started making conscious efforts to change, to correct, not just acknowledge.

Sometimes, people would ask, “You didn’t say anything about this problem for two days, and you’re talking about everything else?” And I’d say, “Let’s first acknowledge what’s going well. That issue, we’ll address it later, but properly.” I may be a bit slow to react, but I believe in converting reactions into thoughtful responses.

Take, for example, an issue in vaccine filling, where a batch has full volume. Sure, the patient is still safe, but the company loses money. Now, instead of reacting harshly and saying, “This should never happen again,” we need to look into why it happened.

There’s a TQM (Total Quality Management) term called DIOL—Doing It On Location. Go to the site. Watch what the operator did, how they set up the machine, and how the volume was configured. You’ll start to uncover the real reasons. Maybe training wasn’t sufficient, maybe the correction method isn’t effective. If it keeps recurring, the process itself needs a revamp.

Pharma Now: But do you really have any margin for error there? Because you're really dealing with a critical subject.

Mr. Sinha: That’s exactly why, before starting any production line, a huge number of activities take place. In summary, we call it installation, commissioning, and qualification. But if you go into the details, it's an extensive process. Every injection, every vaccine we produce eventually goes through clinical trials. The efficacy is tested, and the quality is already assessed in our labs. Various parameters and indicators are verified even before the clinical trials begin.

Once it's tested and proven to be effective and safe, that means all the systems we've developed are in a validated and sustainable state. Only then does commercial manufacturing begin, where batches come into the picture. Before this stage, some drugs go through animal testing, while others undergo different types of assessments. There are countless activities that must be completed to ensure robustness before entering commercial production. A lot happens beforehand to eliminate the scope for error.

Pharma Now: When you were talking about human control or emotional control, I was mentally relating it to my own organization. I’m not running a pharma manufacturing company, but more of a software marketing setup. Still, the problem statements seem to remain the same. I think there’s a lot for me to learn from this conversation as well. Converting reaction into response is a truly valuable lesson.

Mr. Sinha: It’s been a 10-year journey, and yes, these things do happen. But over time, the frequency started reducing. Complete elimination came much later. I recall that in the last 26 months, I may have lost my temper only twice. I began keeping track of that because that’s how you monitor yourself. Unless you're tracking it, you can't improve. That’s exactly what Total Quality Management (TQM) teaches us: one-time or spontaneous results don’t mean much unless there's a visible trend.

So I started measuring myself. For example, if I used to say “sorry” four times a day, I’d ask myself. Did it come down to three today? Was there a day when he didn’t say it at all? Those days made me genuinely happy. My colleagues often noticed and asked why I seemed so cheerful, and I’d just say it was because I hadn’t needed to apologize to anyone. They’d laugh and joke that it wasn’t a big deal, that you first mess up and then say sorry, and now you are celebrating just because you didn’t have to say it today.

But to me, it meant I had responded well and didn’t make an error that required an apology. That’s the perspective shift. Everyone must devise their own method to improve. Continuous improvement isn’t just for manufacturing; it applies to human behavior and mindset, too. Once you start practicing being happy today because you didn’t react, again tomorrow, you’ll realize that happiness becomes a regulating factor. I can honestly say that this shift from reaction to response has been the toughest part of my journey.

The best part? My last two learning experiences were responses, not reactions. One time, my superior called, not to blame me, but to discuss how to handle such situations better. He didn’t say, “Rakesh, you did this wrong.” Instead, he said, “If this kind of thing happens, how do you think we should respond?” That’s what makes someone a true mentor, guiding you without judgment. Because ultimately, life is the most important thing. I produce vaccines to save lives, to prevent diseases, and that’s human life. But our own life is just as precious.

If you're happy, your family will be happy. If you're upset, they will be too. I began realizing that a bit late, because in our culture, response is often the last step, and reaction is the first. Imagine two people in a car accident. Rather than asking, “Are you okay? Can we fix this?” they jump to fighting. But think about it, the car still needs to be repaired. So why not do that calmly? Shake hands, accept responsibility, maybe say, “Let me use your insurance. I’ll cover the repair. You won’t lose your bonus.” But that rarely happens. We're culturally tuned to react more than respond. I realized this late, but I’m glad I did. And now, some level of control is definitely there.

Pharma Now: That’s really wonderful. I think let’s now shift back to your operational experience. It’s been great to understand your leadership mantras and how you’ve led teams so far. Now, on the operations side, when you’re managing such large-scale manufacturing, cost is becoming a significant challenge.

A few years ago, India had a clear advantage due to lower manpower and resource costs, especially when it came to manufacturing vaccines or other drugs. But today, that edge is slowly fading. I’ve heard you’re considered an expert in this domain, so I’d love to understand your philosophy. How do you manage cost control effectively in today's environment?

Mr. Sinha: I wouldn’t exactly call myself an expert—I'm still learning every day. But I can say this: being born and brought up in India, “jugaad” (creative problem-solving) comes naturally to us. In the early days, there was often a tussle between jugaad and structured approaches like TPM (Total Productive Maintenance). Eventually, TQM (Total Quality Management) started to take the lead.

However, you can’t implement TQM in isolation—it requires full organizational commitment. There are companies like Toyota or Tata Motors that have implemented it quite successfully. In pharma, we’ve been more driven by regulatory compliance, especially with the FDA and other global regulators. But over the last 10 years, many pharma companies have also started adopting operational excellence practices.

Different organizations label it differently; some call it Six Sigma, others Operational Excellence, but the core principle is the same. Previously, many cost-saving actions were labeled as jugaad or even “crisis management.” Now, there’s a growing maturity in our approach. We're moving toward systematic process improvement.

There are two main philosophies at play:

1. Cause and Effect: Eliminate the root cause, and the effect will go away.
2. Waste Elimination: Waste is a cost from the past. Eliminate waste, and you automatically reduce cost.

Now, cost-cutting may sound harsh, and I agree, it sometimes carries a negative connotation. But what we really aim for is cost efficiency in manufacturing.

Let me give you a practical example: Imagine a filling line that’s designed to run at 400 units per minute. Once purchased, you have access to it 24 hours a day. If I set up my processes to only utilize 16 hours of productive time and spend 8 hours on preparation or cleaning, I’ve immediately lost one-third of my potential. But if I design a system where the preparation time still stays at 8 hours, but I can now run for the full 24 hours, my productivity goes up and my per-unit cost goes down.

The goal is not layoffs; we all want job security, whether it's for me, my team, or my superiors. But we still need to be cost-competitive in the market. That's where efficient processes come in. TQM offers many tools and modules. Implementing the full system may take 7 to 8 years to yield results. But even partial implementation, focusing on specific modules, can begin to deliver measurable gains within a shorter time.

To summarize: If I have a machine capable of 500 units per minute but I’m only running it at 400, I’m inherently designing for inefficiency. If I find ways to run it closer to its true capacity, I’ve just gained 100 units per minute, without any new investment. That’s cost efficiency.

Pharma Now: This makes me recollect a book called Goal by Goldratt, which talks about a term called blocker, which is similar to the way you are describing cost and identifying and fixing the gap rather than laying off people.

Mr. Sinha: One of the most crucial concepts in vaccine manufacturing is CAPA (Corrective and Preventive Action). It’s a buzzword in the industry. Whenever anything deviates from the designed process, it needs to be documented as a deviation. From there, we initiate corrective and preventive actions.

To simplify, corrective action is immediate. Imagine you’re driving a car and it starts turning left, your instinct is to correct it by turning right. That’s correction. But if you don’t fix the root cause, the car will continue to turn left again and again. Preventive action is like getting the wheel alignment done; that’s what keeps the car stable long term.

This same concept applies to pharma manufacturing. We’re generally good at corrective actions, fixing what went wrong in the moment, but we often fall short on the preventive side. That’s because preventive actions take time, technology, experience, and most importantly, team collaboration. Everyone needs to contribute a little to build a robust, sustainable system.

Pharma Now: That’s insightful. In all of this, how important is technology upgradation?

Mr. Sinha: It’s extremely important. Technology multiplies efficiency. Let me give you a simple example: When you're maintaining records on paper, and you want to locate or correct something, you have to manually search through stacks of documents, write, rewrite, and physically correct errors. But in an electronic system, all it takes is a quick search, Ctrl+F, and you can edit, correct, and finalize in minutes.

The same logic applies across manufacturing operations. Digitalization makes data accessible, and accessibility leads to knowledge. I remember once, we couldn’t read a doctor’s handwriting about whether a drug was to be taken before or after a meal. We Googled it, and that digital access gave us the right information instantly. That’s the power of a knowledge platform.

In manufacturing, especially batch-based processes like ours, every batch must be consistent and repeatable. Let’s say one batch performs exceptionally well, faster, higher yield, better quality. If the data is recorded manually, that efficiency might go unnoticed or undocumented. But with digital systems, you can log every input and output, analyze variations, and replicate success. Even though we may not call it Industry 4.0 explicitly, many of its components, data logging, process control, and predictive analysis, are already being used.

Let me give you another real-world example:

At one of the companies I worked with, we had a recurring issue with bearing failures. The downtime affected production. Initially, we had a fixed maintenance schedule, check the bearing every 6 months. But sometimes, they would fail in the 7th month. Through Total Quality Management (TQM) and Total Productive Maintenance (TPM) principles, we conducted a deep analysis of the bearing’s materials and usage patterns.

We approached the bearing manufacturer and discovered that another model with a slightly different material composition could last a full year. By switching, we eliminated unexpected failures and gained predictability in our production planning. That’s what TPM teaches: understand the lifecycle of each component, identify those that cause breakdowns or process variations, and eliminate the root cause. It’s a vast domain. Full TPM implementation may not always be feasible, but even adopting parts of it can yield massive benefits.

Pharma Now: Wonderful! I think we could talk for hours, there’s so much depth in your insights. But as we approach the conclusion of this conversation, I’d like to ask you one final question: What upcoming trends do you foresee in the pharmaceutical manufacturing domain?

Mr. Sinha: Great question. One major trend I see is the pursuit of excellence, and that’s being driven by a combination of AI, data analytics, and human adaptability. AI is no longer just a buzzword. It’s a tool for achieving operational excellence. For instance, if one of your batches gives exceptional results while staying within all specifications, AI and data analytics can help you pinpoint why that happened. It gives you insight, clarity, and repeatability.

In the past, people would wonder, “Who will guide us on this?” Now the answer is: AI will. Another key aspect is being open to new technology. Technology is evolving faster than ever, and so must our ability to learn and adapt. I always say: we need to befriend technology, not resist it. Today’s younger professionals entering the industry have incredible tech knowledge. Senior professionals, including myself, need to acknowledge that and be open. Too often, there’s a hesitation, almost a guilt, about not knowing the latest tech. But that should never hold us back. Instead, we should say: “In my time, this didn’t exist, but I’m open to learning from you.”

That attitude fosters true teamwork, regardless of age or designation. Alignment toward a shared goal, leveraging each other’s strengths, that’s the future of pharma manufacturing. And finally, I believe TQM (Total Quality Management) remains a timeless principle. Many of us apply it in parts, but if we implement it holistically, it can solve many operational challenges and uplift the entire manufacturing ecosystem.

Pharma Now: That’s a perfect note to end on. Your thoughts reminded me of that timeless quote by Steve Jobs: “Stay hungry, stay foolish.” We must always stay hungry for knowledge, and not be afraid to feel a little foolish when learning something new.

Rakeshji, thank you so much for your time. This conversation has been rich with insights, not just for manufacturing professionals but for pharmacists and industry newcomers as well. Personally, I loved your philosophy of responding versus reacting, it truly reflects leadership wisdom. Thank you again for generously sharing your experience and time with us.

Mr. Sinha: It was a pleasure speaking with you. Thank you so much, it’s been a wonderful conversation.