The opening remarks by Mr. Nilesh Gupta, Chair – Quality Committee, IPA and Managing Director, Lupin, began with the fantastic journey that the Indian pharmaceutical industry has had over the years. “Currently 55 billion in revenues, supplying 20% of the world’s vaccines, 40% of the generic medicines in the United States, 50% of Africa’s demand for generics, pharma exports making up 6% of the total merchandise exports from India, over 10,000 manufacturing facilities, 3,000 pharmaceutical companies, and 650 USFDA approved plants – the highest number outside the United States, we are rightfully the pharmacy of the world.”

Although, every time we come up with nothing less than the best compliance story, we have had challenges in the form of spurious medicine. We have had some bad players painting the industry in a bad light, he added. “Now more than ever, we need to not just meet, but exceed the expectations of regulators around the world. And if you look back at 2024, it has actually been a good year. We had several positive developments.”

In 2024, the US Food and Drug Administration (FDA) conducted 206 inspections in India, a decrease from the 225 inspections in 2023, with fewer cases of Official Action Indicated (OAI) and Voluntary Action Indicated (VAI). “So, there is definitely improvement. I think the revised Schedule M is wonderful. It is a very positive step towards ensuring the quality and safety of medicines being manufactured in India,” said Mr. Gupta.

The quality forum of IPA was born 10 years ago with the vision to help the Indian pharmaceutical industry become the global benchmark of quality and compliance. “We have obviously been doing a lot of work. The quality forum has remained committed to a journey of improving pharma industry standards, overcoming key challenges, and fostering a culture of excellence and compliance for the industry at large.”

“Today, the Indian pharma industry stands on the threshold of significant transformation. At this juncture, there can be no compromise on manufacturing and quality standards. Global quality standards are becoming stricter with stricter penalties. India has made significant strides in meeting international quality standards. This forum recognizes the need for continuous improvement. Like Mr. Sudarshan Jain put it, ‘Quality is a journey, not a destination.’ I would love to arrive, but I think it is still a journey.”

“This forum recognizes the need for this continuous improvement in compliance and quality standards to maintain that global leadership. This Summit is not just a celebration of our past achievements, it is a launch pad for the next decade of global pharmaceutical excellence.”

“Looking back at the journey of the past ten years, we have had a decade of progress with this quality forum. Our efforts have focused on several critical areas such as data reliability – ensuring accuracy and integrity in all aspects of manufacturing and regulatory reporting – best practices and metrics, sharing them across companies and across the industry. And also, culture and capability building, knowledge sharing and skill development, and lastly, investigation.”

“Last year, we took a major step in competency building by conceptualizing the establishment of a training institute for the industry. I am very happy to share that we have shortlisted Ahmedabad and Hyderabad as the first two locations for the institute, which will focus on real-world manufacturing and quality control equipment, ensuring hands-on training for new and existing professionals.”

“We hope to have the centre up and running in the first half of next year. As you all know, at the same time, AI made a big appearance in the last year, and I believe that it has the potential now to positively disrupt how we train, how we manufacture, how we test, and how we release products.”

“These are very, very exciting times. Over the next two days, this Summit will explore several key areas: regulatory harmonization, cross-sector insights – hearing from very different industries on how they build quality excellence – the future of manufacturing, new technologies, biopharma transformations, supply chain innovation – how do we strengthen resiliency and agility – building a workforce that champions excellence, and lastly, sustainability in manufacturing, creating responsible and humane operations. I have said this before – ensuring quality is not only a regulatory obligation but a moral responsibility to the patients that we serve and to those who rely on the products that we make.”

“As we embark on the next decade of building quality, let us continue to push the boundaries of quality, innovation, and excellence. The future of the pharmaceutical industry lies in our ability to collaborate, adapt, and lead with integrity. In closing, I read a great quote today, and I think it was very opportune for today: ‘India isn’t just the pharmacy of the world, it’s also the backbone of a stable, resilient, and equitable global healthcare system’,” concluded Mr. Gupta.

During the keynote address, Dr. Arvind Virmani, Hon’ble Member of NITI Aayog, emphasised that India’s demographic advantage will be instrumental in realising the country’s potential for Viksit Bharat. He highlighted that the pharmaceutical sector will remain a key driver in shaping public health, which is crucial for the nation’s economic growth.

Dr. Rajeev Raghuvanshi, Drug Controller General of India, Government of India, remarked, “True growth in the pharmaceutical industry is driven by quality, not profitability. India plays a critical role in global healthcare, contributing significantly to human genetics, vaccines, and medicines. We serve a large portion of the global population, and our commitment extends beyond business – it is a service to the world.

“While much of India’s pharmaceutical exports are directed to regions with stringent regulations such as the US and the EU, a substantial

proportion is also exported to countries with less strict regulations, relying on the integrity of India’s systems. Indian companies are vital in supporting these global frameworks, and it is imperative that we work together to enhance our regulatory environment. Ultimately, our mission is to serve a significant portion of the world’s population with high-quality products and care.”