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Are Regulators Hindering Innovation?

Published on 24th August

CPhI Worldwide the world’s largest pharma event, this year scheduled to taking place in Madrid, Spain, October 9-11, 2018 and organized by UBM, which in June 2018 combined with Informa PLC to become a leading B2B information services group and the largest B2B Events organizer in the world, has released the first part of its 6th Annual Report with a stark warning from Girish Malhotra, President of EPCOT International, that regulators are holding back the industry’s ability to innovate.

The report’s findings foresee regulators inducing ‘innovation inertia’ without a change of philosophy, but encouragingly – for contract service providers at ICSE – predict CDMOs can potentially form a key part of the solution, as they have strong economic incentives to innovate process and manufacturing improvements.

Economic and commercial incentive
“The problem we have presently is that for manufacturing technology innovations to be successful brand and generic pharma companies need to have an economic and commercial incentive. It is this incentive that drives forward innovation and advancement. But the regulators, in particular the United States Food and drug Administration (FDA), are still dictating approaches to industry without asking what the commercial justifications are to support them,” Malhotra added

Photo 1.0: Girish Malhotra, President of EPCOT International.

Analyzing the negative impact, Malhotra argues that if regulators do not stop dictating approaches, valuable process advances could potentially be lost.

In his view, the cGMP practice guidelines essentially force a ‘cultural dogma’ in pharma companies, where their main aim is to meet regulations rather than to encourage to innovate.

Malhotra also questions whether these recommendations are being introduced by people that have ‘hands on’ experience in process development, design, commercialization and/or operation of pharmaceutical plants.

The report highlights that for pharmaceutical companies with patented products there is little incentive to innovate due to the short patent life after new drug discovery, ability to secure their demanded selling price and long approval times.

However, Malhotra has suggested that by shortening approval times, companies will be incentivized to innovate, compete on a cost and quality basis, and allow them to capture a bigger market. Under his guidelines, not only would drug affordability improve, but drug shortages could also decrease, aligning with the manufacturing philosophy of maximizing profits, whilst retaining product quality and safety.




Most promisingly, Malhotra suggests that with contract services increasing globally, and a little adjustment to the approval process, we could potentially create an entire sector innovating for its pharma customers and driving efficient manufacturing process. A new golden era of innovation and drug affordability.

“Overall my prediction is that whilst the regulators are trying to improve the situation, we will again lose any major manufacturing improvements over the next one or two years. In the longer term however, I am hopeful the regulators will pass the buck to pharma and manufacturing companies and let market forces drive process innovation. But my fear is that we are still at least three years away from this,” concluded Malhotra.

“This report highlights a number of important long-term issues for the industry and pharma manufacturers, suppliers and CDMOs – whose efforts to innovate in process development and formulation are often reported to be hampered by long regulatory pathways,”  Tara Dougal, Head of content – Pharma at UBM observed.

“It’s also why we have a number of experts presenting at CPhI this year to discuss how the regulators and industry should tackle process timelines, whilst safeguarding patients. The agenda will also explore new manufacturing approaches, such as, continuous processing and QbD,” Dougal concluded.

The full findings of the CPhI Annual Report will include more than 10 in-depth expert contributions as well as the CPhI manufacturing and bio leagues tables, which will be released on the first day of the event.


Last Editorial Review: August 24, 2018

Featured Image: IFEMA_Feria_de_Madrid_Spain Courtesy: © 2017 – 2018. Sunvalley Communication – Evan Wendt. Used with permission. Photo 1.0. Girish Malhotra, President of EPCOT International. Courtesy: © 2018. EPCOT International. Used with permission.

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