Regulators are holding back the pharmaceutical industry’s ability to innovate, according to Girish Malhotra, president of EPCOT International, a Pepper Pike, OH-based consulting firm focusing on manufacturing and technology for pharmaceuticals, chemicals, coatings and allied industries.
Malhotra makes the claim in the first part of CPhI‘s new annual report to be released at the start of CPhI Worldwide in Madrid, October 9-11, 2018.
Event organizers point out that pharma manufacturers, suppliers, and contract development and manufacturing organizations (CDMOs) have claimed for some time that efforts to innovate in process development and formulation are often hampered by long regulatory pathways.
“The problem we have presently is that for manufacturing technology innovations to be successful, pharma companies (brand and generics) need to have an economic and commercial incentive,” Malhotra states. “It is this incentive that drives forward innovation and advancement. But the regulators—in particular the FDA—are still dictating approaches to industry without asking what the commercial justifications are to support them.”
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. He 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 approach, not only would drug affordability improve, but drug shortages could also decrease, aligning with the manufacturing philosophy of maximizing profits, while retaining product quality and safety.
“I am hopeful the regulators will pass the buck to pharma and manufacturing companies and let market forces drive process innovation,” Malhotra says. “But my fear is that we are still at least three years away from this.”
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, according to the event organizers.
CPhI Worldwide co-locates with other groups, including the International Contract Services Expo (ICSE), a pharmaceutical exhibition and networking event focusing on outsourcing and contract services; InnoPack, an international trade fair for packaging and packaging solutions for the pharmaceutical, biopharmaceutical, veterinary, and medical industry; and P-MEC, targeting pharmaceutical machinery and equipment.
(Source: CPhI Worldwide)
