Viewpoint: Regulators Hinder Process Innovation

Regulators are creating bottlenecks in pharmaceutical manufacturing practices by dictating approaches to innovation, says Girish Malhotra, president of EPCOT International; however, shorter approval times and financial incentives can encourage innovation.

In an article he authored in the first part of the sixth CPhI Annual Report, Malhotra warned regulators will induce innovation inertia without a change of philosophy. “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. 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,” writes Malhotra.

The cGMP practice guidelines essentially force a “cultural dogma”’ in pharma companies that aims to meet regulations rather than encourage to innovate, he writes. Valuable process advances may be lost if regulators continue to dictate approaches.

Contract manufacturers have strong economic incentives to innovate process and manufacturing improvements, he argues, and these organizations can play a role in promoting manufacturing innovation.

The CPhI Annual Report, which will include more than 10 expert contributions and the CPhI manufacturing and bio leagues tables, will be released at CPhI Worldwide, Oct. 9–11, 2018, in Madrid, Spain. CPhI Worldwide announced the first part of the report in an Aug. 23, 2018 press statement.

CPhI and Pharmaceutical Technology are UBM (part of Informa plc) brands.

Source: CPhI 2018 Annual Report (free registration required)