Express Pharma

A different approach for different results

Subrata Chakraborty, Principal Advisor,  GxPFONT Consulting Group outlines some resolutions that India Pharma Inc should make in the New Year to sustain its growth momentum and put the lessons learnt from the COVID-19 pandemic to good use

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Although 2020 has been a year of a roller-coaster ride for the entire industry, it has joggled us to rethink and reimagine our business processes towards a better resilient future. The technological disruptions in pharma, which otherwise could have easily taken a decade, have gained significant momentum as a result of this pandemic. But the question to ask ourselves is; How impactful and long-lasting will this impetus be, especially after the pandemic is over?

The industry needs to come forward with the following five resolutions in the New Year!

We invite new innovative technologies with a different mindset: If we look at the trends of top regulatory citations, hardly anything has changed over last few decades, we are here with the same set of problems that we used to have 30 years ago. Although there has been a lot of technological breakthroughs along these years, they did not gain a meaningful foothold at the production shopfloors. We are apprehensive about regulatory questions, additional validation requirements and filing challenges, which is coupled with a lack of subject knowledge, and uncertainty about the return on investments.

We might need to bite a few hard bullets for a sustainable future for the industry. Challenging the traditional procedures and process controls would be essential to match new products, therapies and technologies.

We appreciate risk-based, scientifically-sound decision making: While science and technology are deeply rooted in the laboratories of both industry and the governments, we still value the tick-box approach to regulatory compliance more than risk-based, scientifically sound thinking when it comes to actual operations. Quality risk management has become a strong expectation of global health authorities. In recent years, FDA warning letters have increasingly cited absence or misuse of risk assessment tools in many organisations.

It is high time we look beyond traditional numeric risk assessment techniques, just to satisfy the regulators. Most of the time these tools become individual-biased, subjective and ineffective to meet their purpose. The focus should be on science-based risk assessment of processes than a regulatory compliance formality.

We invest in productivity for the larger interest of our patients: One of the most prominent reasons for drug shortages is declining profit margins of older generic products. Manufacturers of such products face intense price competition with uncertain revenue flows, and high investment requirements, all of these limit potential returns. When manufacturers are confronted with such a price pressure, the management usually has two choices- either meeting the challenge by lowering its price, even to an unsustainable level; or losing the market share of the product. As a result, many prescription drugs go out of market. 

The only way to counter this and keep patients’ interest secured, is to improve productivity at all layers of the value stream. It is also important to acknowledge that productivity and quality are not mutually exclusive or conflicting objectives. Embracing new innovative technologies can help improve productivity by reducing deviations, predicting failures and reducing human involvement in critical processes.

We strive for harmonised regulatory standards globally: With the increasing globalisation of pharma, more harmonised regulatory standards should be espoused around the globe. Why are there differences in various regulatory expectations, when there is no difference in science and patient risks based on the location of the patients? We need to bridge these differences in risk perception and application of scientific logic. Although in recent years there has been a lot of traction towards harmonisation of efforts between US FDA and EMA, there is a long way to travel before they reach a meaningful destination, with all other global health authorities joining hands.    

We retain our virtues that have revitalised during this pandemic: Apart from the determination and a changed outlook towards new technology adaptation, quality management philosophy, productivity in operations and a patient-centri