Pharma Focus Asia

Unveiling the Evolution

A thought leader's insights into the pharmacovigilance industry

Vivek Ahuja, Pioneer in Pharmacovigilance

As the sea of data continues to surge, demanding more resources and investments, the industry must navigate treacherous waters, contending with outsourcing challenges while striving for consolidation and standardisation. In the next five years, an exhilarating journey awaits as the industry gears up for monumental growth, laser-focused strategies, and the embrace of ground-breaking technologies. Brace yourselves, for these exciting times that herald the dawn of automation, artificial intelligence, machine learning, and the birth of co-development partnerships that will redefine the landscape forever. Service providers armed with comprehensive solutions will shape the future of pharmacovigilance.

You have been in the pharmacovigilance industry for nearly 23 years, and were an early pioneer of this area in India. As a globally recognised thought leader, how have you seen this evolve in the past two decades?

Getting exposure very early on, in the science and business of pharmacovigilance was a very fortunate thing for me. In the early 2000s this area was all about the fascination of doing something new and different for some of us because clinical trials were the usual area of interest and a natural career inclination given the growth trajectory it was on then. We started it as a small nest in the year 2005 in Ranbaxy then and then never looked back. By the year 2010, Indian pharma companies and International clinical research organisations (CROs) had all begun to set up a base in India and India was beginning to get recognized as the outsourcing destination for worldwide pharma given the significant cost arbitrage of doing work in India. By 2015, not only was the majority of work in this area begun to be offshored and outsourced to India but also the nature of the work being done also began to change character and besides the manual data entry and management related work, India also became the preferred destination for work requiring higher intellectual expertise like benefit risk assessment and medical review also. The next five years until 2025 saw further expansion and evolution of this space, with technological advances like adoption of cloud computing, experimentation with automation and so on.

Was India a ‘rightshoring–outsourcing’ destination for this ?

I see India as a strong established destination, with significant future investments being made by not only the Indian tech companies who evangelised the concept of running this work as business process outsourcing shops processing terabytes of data but also by large pharma who have set up captive bases in India and are increasing their investments. Not many may know this fact, but the top 2 companies who hold majority of the market share of the pharmacovigilance software were started by Indian entrepreneurs based in the US in the 1990s. Their back end offices were based in India then. The tech software and service industry around pharmacovigilance has now mushroomed and there are several successful start up ventures who have made a significant mark in this area.

What in your opinion are the top issues faced globally by major pharma to fulfil their pharmacovigilance compliance needs today?

In my opinion, the locus of problems has moved further down the value chain now, however the character of the problems has not changed. In fact, they have got compounded now with additional problems. Let’s take a step back to understand the subject. Ten years ago the problem was to find good talent, the problem is still the same, we are always looking for better talent. Five years ago we were looking for better technology, we are still looking for better technology. We have always been looking to achieve higher quality, it is no different even now. Regulations have been evolving very significantly every now and then since the past ten years, right after the introduction of the EU GVP modules and then the introduction of the R3 standards. That is the only area that appears fairly silent and maturing to the level that there are no upcoming major changes visible on the horizon.

What in your opinion is the reason for all of this?

Data has been burgeoning since ever, and there is no respite from it —there is never going to be. And the science of pharmacovigilance feeds on the data by looking at the cumulative data rather than the incremental delta data. More the data, more the probability of finding a statistically stronger correlation between an adverse event and a drug. To manage the data better, regulators evolved the data standards.

Do you see this as a concern?

So, fundamentally more data is good for us and helps us take better decisions. But more data also means more resource requirements, greater expense, need for higher quality, better talent, and greater investments into technology. Besides this, the locus of the focus has increasingly shifted from reactive to proactive pharmacovigilance. In anticipation of the risks, greater focus is now on prevention of these risks via the introduction of the risk management programs and introduction of risk minimization measures, targeted follow ups. This requires additional investments in both technology and resources.

What are the other areas that the industry is grappling with?

Another area that the industry is grappling with but not yet consciously acknowledging is that every company is outsourcing work in bits and pieces to multiple vendors and then further investing in multiple manpower resources to manage this multiplicity. Simple principles like drawing on economies of scale, consolidation and standardization of approaches, being technology agnostic will go a long way in tackling these challenges.

How do you see this panning out over the next five years?

Like in every industry there will be the usual lifecycle of the stages of scaling up, focus and consolidate and then balance and alliance. There is an element of unpredictability with respect to how much the technology will turn out to be the panacea for all these problems and in turn create a fresh wave of problems like job losses, requirement for newer kinds of skills. In such situations, speculations rule the roost and exercising prudence is the most prudent thing to do. Open mindedness to experiment and take risks for adoption of newer technologies will determine who gets to this goal post first.

Besides this, service providers who can offer everything under one roof, all the services ranging from the infrastructure and talent to handle the first complaint call that comes from the consumer right up to the last product label update or the additional risk minimization measure implemented. Incidentally, that is just only a hundred and eighty degrees of support that a marketing authorisation holder needs to fulfil its compliance obligations. Just that one side. The remaining hundred eighty degrees of the spectrum or the other side is formed by the technology behind the scenes i.e. the hosting and upkeep of the safety database and the automation that galvanizes this engine. Add to that the services like literature monitoring, translations capability, QPPV services, local country pharmacovigilance associates, regulatory intelligence services that must also come from the same stable. If you think the list got over, provision of all these services in Japan adds a completely new additional dimension to the requirement list.

Any closing remarks from you ?

These are very exciting times to be in the world of pharmacovigilance. It’s going to be a watershed moment in the history of pharmacovigilance when the  industry will undergo a tectonic shift and roll over into a new era revved up by robotic process automation, artificial intelligence, machine learning on one hand and vendor consolidation to complement it. Over the years,the relationship with these vendors will transform into co-development partnerships.

--Issue 53--

Author Bio

Vivek Ahuja

Vivek Ahuja is a pioneer in pharmacovigilance in India. With over 22 years of experience, he established the country's first global pharmacovigilance unit. He is a renowned thought leader, who has worked in drugs, biologics, device and vaccine safety. He is passionate about AI, ML, and NLP, and is actively involved in policymaking. Notably, he was the co-author of the Pharmacovigilance Program of India. Currently, as a Senior Vice President at EVERSANA, he drives Delivery Excellence, Strategy & Growth in the organization’s growing Pharmacovigilance, Regulatory and Quality teams.

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