Jonas Salk, the inventor of the polio vaccine, asked the question “Are we being good ancestors?” This long-term measure of success recognizes that anything valuable takes time to create, and current difficulties while painful are less important for the long-term than we think. The Indian pharmaceutical industry is already known for being the pharmacy for the world. To now rise from our current challenges, to be known as the benchmark of global quality will not just be valuable in creating a sustainable competitive advantage, it will pave the way for us decades later to be known as good ancestors.
The last 5 years of inspections by the US FDA in India show that approximately 10% of inspections were classified as unacceptable. There is some improvement over time but it cannot be considered meaningful. Past scores of US FDA inspections indicate that average scores amongst Indian sites were 6.8, materially lower than the global average of 7.4. While India takes pride in being the Pharmacy for the world, if we want to build sustainable value, we have to be known for being the global benchmark of quality also.
Medicine use is at an all-time high, in a good way
A report on Global Medicine Use in 2020 estimated that 4.5 trillion doses of medicine are used worldwide. That translates into at least one dose per day for each person in this world. Other estimates from the UK suggest that people in the UK take about 14,000 pills a year. Across the world, the continuum of diagnosis and treatment is on the rise. We would all want medication to be an occasional presence in our lives, but far from being occasional, medicines or pharmaceuticals are an everyday one. Efficacy, purity and safety literally has to be baked in to something we consume every day.
The COVID-19 pandemic has shown pharmaceutical companies in the best possible light. Pharma companies and especially us Indian counterparts have shown resilience by showing that we can be agile, relevant and responsible. Being agile meant responding to rapidly changing treatment paradigms and customer demands, and bringing the latest Covid medicines to market weeks or months after they were available in the most developed markets; Being relevant meant adopting new ways of working, rapidly scaling up and jumping through any hoop that came our way; Being responsible meant taking charge of the country and the world’s pharmaceutical (and vaccine) needs.
The COVID-19 pandemic has also changed the way healthcare is perceived. Healthcare is no longer different segments of clinical practice, hospitals, pharmaceuticals or healthcare services. It is instead a continuum that includes them all. The quality of what we produce has direct relevance on health and clinical outcomes. We have also seen that medicines (and vaccines) don’t just heal people when sick, they can change the way people live their lives.
5 Mindset Changes will help shape the Indian Pharma Quality Agenda
For the Indian pharma industry to continue to be resilient, to continue to be relevant and to continue to be responsible, we now have to set sights on being the global benchmark of Quality. There are 5 mindset changes that are needed to help shape the Quality agenda for the Indian Pharmaceutical Industry.
One, Culture. Quality management guru Phil Crosby, who is called the zero defects thinker, made this point emphatically, “Quality is the result of a carefully constructed cultural environment. It has to be the fabric of the organization, not part of the fabric.” For us to be the benchmark of Quality we need to acknowledge the cultural change that we have to drive, putting patients at the center of all we serve, even above doctors, customers or shareholders.
Two, companies have to go beyond current approaches to quality and safety which have typically been guided by regulation; the authorities set standards and companies comply. Officially mandated standards, no matter how high they may seem, are still only a minimum for a manufacturer to achieve.
Three, we need to aim higher and carry the value chain with us. Our scope and our purview should extend all the way from laboratory research and development, material procurement, manufacturing, testing and packaging, storage and distribution. This then encompasses a comprehensive value chain that we need to carry in our Quality agenda, encompassing vendors, suppliers and even customers.
Four, we need to maximize to our benefit the fact that the pharmaceutical industry is no longer process-driven, but is data-driven. From decoding the human genome to using AI to make sense of enormous amounts of data that a human mind cannot, technology is increasingly one of the most effective tools in drug discovery and development. We need to harness the power of data in the way we do research, manufacture and even test and release product.
Five, we need to adopt technology in all we do, embracing the many applications that are being developed for different stages of manufacturing and testing product. We cannot continue to manufacture, test and release product the way it was done decades ago – a whole-hearted adoption of new technology will lead to much more efficient manufacture, reducing equipment downtimes, tracking material consumption and supply chain cycles, for example.
Future generations will decide if we are good ancestors. But if we are known for holding the highest quality standards in the world, not just for being the pharmacy for the world, that is a scorecard worth working towards.