Quality, Leadership, and the Future of Indian Pharma: 38 Years of Wisdom from Dr Rajiv Desai

Pharma Now: Today's episode features a very special guest. He has spent almost four decades in pharmaceutical science, contributed to numerous innovations, and helped establish several standards for the pharmaceutical industry.

He served as Executive Vice President at Lupin, leading Corporate Quality, and today continues to support several major organisations and associations while helping prepare the Indian pharmaceutical sector for the future.

So, let's welcome Dr Rajiv Desai.

We will, of course, focus on your journey. We'd love to understand how you started your career, how you shaped it over the years, and what it was like handling a role such as Executive Vice President for Corporate Quality at a company like Lupin.

Can we begin with a quick introduction about yourself? My introduction was very brief, so it would be wonderful to hear it from you directly. After that, we can go back to your early days and understand how you chose pharma as your career.

Dr Rajiv Desai: My background is in pharmaceutical chemistry. I completed my PhD in Pharmaceutical Chemistry at ICT (then known as UDCT) in 1988.

As many would know, UDCT was well known for chemical technology and the chemical industry, so naturally, you always thought about entering either the pharmaceutical industry or the chemical industry.

After completing my PhD, I joined the pharmaceutical industry and initially worked with a couple of smaller companies. During those days, Mumbai was home to many large multinational companies, including Pfizer and Ciba-Geigy. Later, Ciba-Geigy and Sandoz merged to become Novartis.

Having completed my PhD in chemistry, I joined R&D at Ciba-Geigy. At that time, the company was heavily involved in basic research, and we had an excellent research centre in Goregaon, Mumbai.

Part of the research originated in Switzerland, and part was carried out in India. We were working on several innovative products during those years. I still remember working on products that have now become common OTC products but were prescription medicines at the time.

One example is Diclofenac Sodium, and another is Volini, which is now a household name. That product was actually developed during those days at the Mumbai research centre. Another example is Otrivin, which is now widely used for nasal decongestion but was previously available only by prescription. I consider myself fortunate to have worked on those products and to have gained that kind of R&D exposure early in my career.

After spending a few years in Mumbai, I was transferred to Switzerland as part of my assignment, where I was asked to continue my work there. It was an incredible experience, working in a multinational environment and understanding how the pharmaceutical industry operated at close quarters with some of the best technologies available at that time.

The assignment lasted two years, and I learned a great deal from my Swiss colleagues. I moved there with my wife, so it became a complete life experience rather than just a professional assignment. Naturally, I was nervous initially because it was my first time going abroad. But one thing I quickly realised was the level of respect people had for Indian professionals.

Whenever they knew someone was coming from India, they already recognised the technical capability and calibre of Indian scientists and professionals.

That was one of the best aspects of the experience. I learned immensely from them, and I always felt welcomed throughout my tenure there. After returning to India, I continued my work here before receiving an opportunity to join Piramal in Hyderabad. I was invited to work on a greenfield project and consciously decided to take it.

That was also my first exposure to the generics industry. Having worked exclusively with innovator companies, moving into generics was an entirely new experience for me. At Piramal, I headed Process Development and Quality Management. That was also the point at which I transitioned from R&D into Quality.

Of course, quality cannot exist in isolation. You cannot simply be compartmentalised within quality functions. You need to understand manufacturing, R&D, process development, and how all these pieces come together.

Working closely with your own teams and having the freedom to contribute across functions is always valuable. That experience turned out to be very unique and rewarding for me. My time in Switzerland also gave me opportunities to travel across Europe and learn extensively. Looking back, I believe returning to India was the right decision.

My wife and I met many Indians who had settled abroad after completing their education and starting their careers there. Whenever we spoke to them, many expressed a desire to return to India someday. However, by that stage, their families and children had become deeply accustomed to that environment and lifestyle, making it difficult to decide to return.

Life there can also feel quite lonely. Everything is quiet. There are no traffic jams, no honking, and everything is extremely organised and clean. You enjoy that environment for a while, but over time, you begin to miss the energy and vibrancy of cities like Mumbai and the life you are accustomed to here.

Spending a few years in that environment is an excellent experience, and I always encourage people to go and see how other countries function.

For me, however, returning to India always brought a sense of comfort and belonging. My parents were very happy when I came back, and I still remember the anxiety families experienced in those days when someone lived abroad.

I can never forget one particular moment. I was given an apartment in Switzerland, and a telephone was installed in the house. Back in India during those years, getting a landline connection could take almost ten years. So I picked up the receiver just to check whether it worked and heard the dial tone.

I dialled my home number in India and, to my surprise, the phone rang immediately. My father answered with a simple "Hello." I was amazed. In India, we were used to booking trunk calls and waiting endlessly, and suddenly, I was speaking to my family halfway across the world with a simple dial.

That was the level of infrastructure and systems operating in those countries at the time. Today, looking back at India's progress, I believe we have evolved tremendously. India has come a very long way, and the potential ahead is enormous. Those early years in the pharmaceutical industry laid the foundation for my career.

When I entered the generics industry, I honestly did not even fully understand what generics meant. In innovator companies, our focus was always on creating new products rather than replicating existing ones. The work was intensive, and we had to ensure that technologies developed in research would continue to work during scale-up and commercial manufacturing.

Generics, however, required a different mindset. You worked on products that were already commercialised and focused on developing robust processes and technologies to deliver high-quality products through cost-effective manufacturing.

My transition from R&D to Quality was a conscious decision. Even after moving into quality functions, I never disconnected myself from R&D. Even today, after so many years in the pharmaceutical industry, R&D remains the backbone of my knowledge and one of my greatest strengths. It continues to help me immensely in my current roles as well.

If I were to offer advice to young professionals and aspiring pharma leaders, I would strongly recommend spending time in manufacturing and R&D. Getting your hands dirty, understanding the processes firsthand, and then moving into quality gives you a much more holistic understanding of the business.

Rather than entering quality functions directly, I always recommend gaining exposure to these foundational departments first.

Only then can you truly support the requirements of Quality Control, Quality Assurance, and Regulatory Affairs, which have now become one of the most important and rapidly evolving functions in the industry.

Understanding the finer details of manufacturing and R&D ultimately makes you a stronger quality professional and a better pharmaceutical leader.

Pharma Now: Sir, during your career, you also pursued an MBA alongside your PhD in Pharmaceutical Chemistry. What motivated you to explore the management side as well and invest time in learning management?

Dr Rajiv Desai: Throughout my education and early career, my entire background revolved around chemistry and pharmaceutical sciences. It was always science, and I knew that science would remain my core area of expertise throughout my career.

However, over time, I observed the careers of many senior professionals and leaders we interacted with. I noticed that at a certain stage in their careers, they were not only technical experts but were also leading departments, managing teams, and supporting organisations at a much broader level.

That made me realise that managing activities, people, and businesses becomes equally important as you progress in your career. I thought, why not explore this aspect as well?

I was fortunate to have a very senior mentor who encouraged me to make that decision. During those days, management education offered limited options. You either pursued a two-year full-time MBA or enrolled in a three-year executive program, which was, in many ways, almost equivalent to a full-time commitment.

The program was affiliated with Bombay University, and admission involved written examinations, group discussions, and interviews. You can imagine the schedule, working an entire day in the company and then going directly to the institute for classes.

For three years and six semesters, that became my routine.

The experience, however, was absolutely worth it. There were around 60 students in the batch, all from very different backgrounds: banking, sales, marketing, commerce, engineering, and a few from science.

Those two hours we spent together every day became a fantastic learning experience about how the world works beyond science, which was the only thing many of us had known until then. That exposure helped me tremendously in my future growth and career progression.

Science was always going to remain with me; that foundation was already strong. But management education helped me understand how decisions are made involving people, businesses, and organisations.

As your career progresses, business decisions become increasingly important, and management education prepares you for those responsibilities.

I was genuinely surprised by the number of subjects we studied during those three years that had never once been covered during my graduation, post-graduation, or even my PhD. Not a single one of those topics had been part of my scientific education.

Today, I see that many educational programs include management components, which is a very positive development. It helps students become more holistic professionals and better understand the broader requirements of the industry.

Whether it is software, government policies, business strategy, or organisational behaviour, these subjects are equally important alongside technical knowledge.

We never had the opportunity to understand these finer aspects during our academic years.

Another advantage of the MBA program was the faculty itself. Most of our professors came directly from industry and brought practical experience into the classroom.

Listening to them share their experiences and perspectives was truly enriching. Interestingly, after retirement, I now find myself doing something very similar. Alongside my consulting work, which I continue because of my experience and expertise, I also spend significant time teaching.

Currently, I teach at NMIMS. One thing I appreciate about NMIMS is that even today, they continue the tradition of inviting industry experts to become part of the faculty as visiting professors. Last year, I taught an entire semester for the M.Pharm program at NMIMS.

They shared the syllabus prescribed by the Pharmacy Council of India and said, "This is what needs to be covered, but beyond that, you are free to teach whatever you believe students truly need to learn."

I ended up taking nearly sixty to seventy lectures during that semester.

The first thing I told the students was, "I am not here as a traditional professor. I want these sessions to be interactive discussions where you can ask questions freely and engage openly."

That approach led to many meaningful conversations throughout the semester.

More importantly, I focused heavily on topics that are highly relevant to today's pharmaceutical industry.

I spent considerable time discussing data integrity and compliance, which are critically important in the industry but are often inadequately covered in academic programs.

After completing the course, many students joined pharmaceutical companies and began reaching out to me.

They would call and say, "Sir, I joined this company, and everything you taught us about data integrity and compliance is exactly what we are dealing with every day."

I would tell them, "That is precisely the point." The fundamentals and scientific basics are essential, and I would never deny their importance. But students also need awareness of the realities of the industry they are about to enter.

That bridge between academics and industry expectations is becoming increasingly important, and fortunately, many institutes and universities have now started introducing such programs.

Pharma Now: Sir, you transitioned from R&D into Quality and went on to lead quality functions across organisations such as Alembic, Piramal, and later, Lupin. Everywhere you worked, quality remained at the centre of your career.

Why is quality so important in the pharmaceutical industry, and what is your assessment of the current state of Indian pharmaceuticals in terms of quality?

Dr Rajiv Desai: In the pharmaceutical industry, quality is essential because we are not dealing with ordinary commercial products. We are dealing with patients and their lives.

Patients depend on medicines, and they place immense trust in pharmaceutical companies, doctors, and hospitals when treatments are prescribed. Most people do not know what is inside the medicines they consume. They see tablets, capsules, syrups, injections, or ointments, and they trust that these products are safe and effective.

The patients receiving these medicines can range from a one-day-old baby to a seventy-year-old individual, and often someone else in the family is making decisions on their behalf.

That is why quality cannot be compromised.

Every person working in the pharmaceutical industry has a responsibility to ensure that whatever they do ultimately benefits the patient. That is the first lesson we always try to instil in people entering this industry.

I often tell professionals to ask themselves a simple question: if the medicines you manufacture were to be given to your own child, your parents, or your family members, would you hesitate?

If the answer is yes, then either you are in the wrong place, or you are not doing justice to your work. If you answer that you are fully confident in the medicine you have manufactured and would happily give it to your loved ones, then that is what quality truly means.

India is heavily focused on generics, and we play a crucial role in making medicines affordable worldwide. We work on products whose patents have expired and develop generic versions that can be manufactured at significantly lower costs.

However, reducing cost should never mean reducing quality. Affordable medicines and high-quality medicines are not mutually exclusive. Quality has to remain non-negotiable.

Quality is not limited to testing the finished product. We often say that quality must exist throughout the entire manufacturing value chain. Whether it is raw materials, equipment, manufacturing practices, environmental conditions, or process controls, every stage must operate at the highest standards.

If quality is built into every step of the process, the final product will naturally meet the required standards. Testing the finished product then becomes more of a confirmation rather than the primary safeguard.

When we look at the pharmaceutical industry globally, particularly in generics, India has established itself as one of the largest suppliers to markets such as the United States and Europe. It is a highly profitable business, and naturally, profitability attracts many players. Unfortunately, not everyone approaches the business with the same ethical standards.

There will always be a few players who view the industry purely as a business opportunity and may be tempted to take shortcuts. In the process, they damage not only their own reputation but also the country's.

However, in the larger picture, the overwhelming majority of Indian pharmaceutical companies supplying medicines globally have remained extremely mindful of quality standards. The companies that operate successfully in international markets understand that compromising quality ultimately damages their own business and market position.

High standards of compliance do not reduce business opportunities; they create them. Companies that consistently demonstrate quality and compliance continue to earn trust and grow globally.

Of course, there will always be organisations that attempt shortcuts or compromise standards, and those are the companies that eventually suffer the consequences while giving the industry an undeserved negative image. The Government of India, the Ministry of Pharmaceuticals, and export authorities are now providing strong support to ensure robust quality systems.

There is increasing focus on manufacturing standards, export controls, raw material testing, and finished product quality. At the same time, there is still work to be done within the domestic market.

Fortunately, we are now seeing a far more structured approach toward strengthening quality standards for medicines sold within India as well. Public awareness is also increasing rapidly. Patients today are better informed and rightly expect the highest-quality medicines to be available to them. At the end of the day, however, quality ultimately depends on people.

You may have the best technology and the best equipment, but people still operate those systems. That is why promoters and top management play an extremely important role in creating a quality-focused organisation.

The expectations around quality must reach every employee, from the most junior to the most senior. That is what we refer to as a quality culture.

If every employee feels personally responsible for quality, quality becomes sustainable rather than an occasional achievement.

Creating that culture is one of leadership's biggest responsibilities. Management must provide an environment where employees understand that quality can never be compromised. People should feel empowered to stop a process or raise concerns whenever they identify an issue.

They must know they have both the authority and the support to do so. Throughout my career, I was fortunate to work in organisations that maintained strong ethical values and a culture of quality. Thankfully, I was never placed under pressure to release a batch for commercial reasons if there were quality concerns.

That, in my opinion, is one of the organisation's biggest strengths. Today, when companies are regarded as benchmarks within the industry, it is because they earned that reputation by refusing to compromise on quality standards.

Many organisations, regardless of their size, aspire to emulate such companies because they know these organisations consistently prioritise quality over short-term business considerations.

When the outside world looks at these companies, they trust that inferior products will never knowingly enter the market from those organisations. One of the most important aspects of quality leadership is having the freedom to stop a product consignment from reaching the market whenever required.

I was fortunate to work with management teams that fully supported such decisions. Their expectation was very clear: Manufacturing must be right the first time. You cannot build a business around repeated reprocessing or salvaging batches simply for commercial reasons. If your processes are robust, your products will be right.

When a product does not meet specifications, you stop it. The next responsibility is to investigate why it happened. Stopping a batch is only the first step.

The real responsibility lies in identifying the root cause, correcting the process, and ensuring the issue never happens again. That is where quality leadership truly matters.

You cannot simply continue stopping batches without understanding and addressing the underlying reasons. As leaders, we also need to recognise that mistakes can happen. No leader can be physically present everywhere, especially when overseeing multiple sites and large organisations.

Delegation becomes essential. You trust your teams, empower them to make decisions, and support them in carrying out their responsibilities. Sometimes mistakes happen, and those mistakes can result in customer complaints or patient complaints.

The responsibility of leadership is not only to manage those risks but also to ensure people are trained to make compliant decisions. When I speak with many of my former colleagues and team members today, they are leading quality organisations across the industry.

They often tell me that one of the most valuable things I gave them was responsibility and trust. When people are trusted with responsibility, they usually rise to meet that responsibility. I have always believed in avoiding micromanagement. Instead, leaders should provide direction, support, and empowerment.

In my experience, that approach benefits both individuals and organisations in the long run.

Pharma Now: That's wonderful. I wanted to ask you something more personal. Looking back and connecting the dots across a career spanning almost 38 years, if there is one thing you would like to correct or do differently, what would that be?

Dr Rajiv Desai: If there is one thing I would change, it would probably be spending more time with my family.

My family has always been incredibly supportive of every assignment and responsibility I have taken on throughout my career. One thing I can say is that every role I accepted was driven by a pull factor rather than a push factor.

It was always the excitement of taking on newer responsibilities, bigger challenges, and larger roles that motivated me. However, you cannot make those decisions unless your family stands behind you.

Whether it involved moving from one city to another or taking on more demanding responsibilities, my family understood that there would be times when I would not always be available to them during important moments.

But I genuinely believe that work-life balance is important. Even today, when I look at some of my younger colleagues and leaders taking on significant responsibilities, I see the tremendous pressure they work under. Many struggle to find enough time for their families.

If there is one piece of advice I would give, it would be to consciously work towards achieving a better work-life balance throughout your career. That is probably the one thing I would like to correct if I had the opportunity to do it differently.

Pharma Now: My final question relates to the changing global landscape. Over the last two decades, the world has been moving towards becoming a global village. However, in recent years, countries have increasingly adopted a "country first" approach. Indian pharmaceuticals are facing tremendous pressure in this environment.

We have seen increasing attention on USFDA warning letters, and quality teams are often at the centre of these discussions. Countries such as the United States are encouraging domestic manufacturing, while regions such as the Gulf countries and several African nations are also building their own pharmaceutical manufacturing capabilities.

You are associated with the Indian Pharmaceutical Alliance (IPA), which represents an important voice for the Indian pharmaceutical industry.

How do you see Indian pharmaceuticals coping with this changing landscape? And what role will quality play, especially as quality professionals increasingly find themselves on the frontlines of these challenges?

Dr Rajiv Desai: Let me first correct one perception. There has not really been a significant increase in warning letters. The numbers have remained relatively similar over the years.

What has changed is visibility. Social media and digital platforms have amplified these events, making them far more visible than before. That said, warning letters should never be ignored.

Warning letters result from non-compliance, and if companies fail to meet expectations, regulatory agencies are absolutely right to take action. Regulatory authorities such as the US FDA carry enormous responsibility because they ultimately protect patients in their countries.

When they inspect facilities, they closely examine manufacturing practices, documentation systems, compliance procedures, and operational controls. Quite rightly, there can be no compromise in these areas.

At the same time, I would say that the quality of facilities, systems, and awareness within the Indian pharmaceutical industry is extremely high. In many ways, India's pharmaceutical manufacturing capabilities and compliance awareness are among the best in the world.

Coming to the larger geopolitical question, it is true that the industry has relied heavily on other countries for raw materials, APIs, and several key ingredients.

In the past, India manufactured many of these materials domestically, but over time, other countries achieved economies of scale that significantly reduced costs. Today, the Government of India is strongly encouraging and supporting greater backward integration.

If we can manufacture more of these inputs domestically, it will improve supply security and strengthen our long-term sustainability. At the same time, we must maintain a balance between what can be produced internally and what can continue to be sourced externally. International collaboration and partnerships will remain important.

After all, India became a global leader in generics by combining technical expertise with cost-effective manufacturing. The same principle applies to raw materials as well. The objective of backward integration is not isolation but resilience.

The COVID-19 pandemic was perhaps the biggest lesson in this regard. Supply chain disruptions and logistical challenges demonstrated how vulnerable global manufacturing systems could become.

That experience forced all of us to reconsider what could and should be manufactured locally. At the same time, many countries are now aspiring to become self-sufficient in pharmaceutical manufacturing.

Several nations with little or no domestic manufacturing capability have approached India for support in building their pharmaceutical ecosystems. They are asking India to help establish facilities, develop capabilities, and train their people. India is uniquely positioned to support such initiatives.

This presents an opportunity not only for business growth but also for long-term strategic collaborations between India and emerging pharmaceutical markets.

Geopolitical situations may not always be within our control, but building resilient manufacturing systems certainly is.

The key questions for the future will revolve around manufacturing sustainability, supply security, quality standards, and cost competitiveness.

Whatever can be manufactured domestically should be pursued aggressively. For areas where domestic manufacturing is not practical, strong international partnerships and reliable supply arrangements will remain essential.

Otherwise, long-term cost competitiveness will become difficult to maintain. India has already demonstrated its strength in generics by delivering affordable, high-quality medicines to the world. But the next aspiration should be even bigger.

The real milestone will come when the world begins recognising breakthrough medicines that are truly "Made in India."

The Government of India is already taking important steps in that direction, and hopefully, the ecosystem being built today will create the environment needed for Indian innovation to flourish globally. I am optimistic that we will see medicines discovered, developed, and proudly recognised as products invented in India.

Pharma Now: Sir, finally, if you had to leave our listeners with one message drawn from your 38 years of experience and wisdom, what would it be?

Dr Rajiv Desai: My message is for everyone working in the pharmaceutical industry, not just people in quality.

Whether you work in supply chain, manufacturing, R&D, quality, warehousing, regulatory affairs, or any other function, always remember who you are ultimately working for. The patient is the final destination of everything we do.

Every activity we perform eventually reaches a patient somewhere in the world. If you can approach your work with that perspective and ensure your efforts support patients, you will be doing something truly meaningful. 

Never lose sight of the fact that the patient sits at the centre of the entire pharmaceutical value chain.

Looking back on my career, one of the greatest sources of satisfaction is knowing that I worked in an industry that has positively impacted countless lives.

Yes, there is pressure in this industry. There are responsibilities, expectations, and challenges that come with it. But if you work in a structured, disciplined manner, the pharmaceutical industry offers an opportunity to make an extraordinary impact.

Few industries provide the level of professional satisfaction that comes from knowing your work has improved or saved someone's life.