Globally, the pharmaceutical industry is witnessing rapid advancements in processes and technological developments. Automation is emerging as an integral part of nearly all manufacturing processes and pharmaceutical big wigs are ready to invest in the future. Due to the implementation of regulatory norms and spiraling costs, pharmaceutical companies have been opting to outsource their manufacturing processes to contract manufacturing organizations in order to improve on efficiency and productivity. Countries such as Brazil, Ukraine, Mexico, Peru, China and India have taken full advantage of the need for lower manufacturing costs and have aided a boost in manufacturing growth, but this in itself has its own drawbacks.
Eighty percent of the drugs entering the U.S. and Western European markets in 2008 were tested overseas, but the FDA says they only inspect 0.7 percent of foreign clinical trial sites, according to a new report from the Health and Human Services Inspector General (for news see here). Critics say this makes it more difficult for regulators to verify clinical results. The report notes a growth in trials in places like India, China, Eastern Europe and South America. For example, the report cites particularly large trials in India.
Rep. Rosa DeLauro (D-Conn.) called the report "very frightening" and said, "The FDA also must improve its system for overseeing foreign clinical trial data because an inspection rate of 0.7 percent is dangerous and unacceptable." The report notes that early phase trials are increasingly practiced overseas with no FDA oversight, raising ethical concerns. "Early phase trials may pose more risk for subjects because the drugs or biologics have not been tested widely in humans and because they are being tested in an otherwise healthy population, the members of which have nothing to gain therapeutically."
It wasn’t too long ago that most drugs were manufactured in the same country from which they had been discovered; this meant more control and fewer mistakes. It is now predicted that up to 40% of drugs taken in the EU have been imported and up to 80% of the active ingredients in those drugs come from foreign sources. It has become harder and harder to keep track of the quality of ingredients and to inspect regularly those facilities from which the chemicals have been produced, increasing the need to rely on paperwork to control production. There has even been some concerning reports that some Indian manufacturers have been accused of forging documentation.
These latest revelations have lead to a need for dramatic change and European pharmaceutical leaders believe now is the time to bring manufacturing back to Europe. The NGP EU summit has been organized by some of the leading names in the pharmaceutical industry to discuss the need to re consolidate manufacturing within Europe.
Simon Orchard, VP Biotech Operating Unit Europe and Managing Director of the Strängnäs site (Sweden) and CEO for Pfizer Health AB is only too aware of the trials and tribulations in the world of pharmaceuticals and has become a valued member of the NGP EU Committee. He will be focusing on how to streamline the time-to-market for new products to respond more quickly to the growing demands of consumers, outsourcing the non-core functions to strategic partners and contractors within a better regulated environment and the regulatory compliance needed to ensure the continued quality of product. He will be joined by AstraZeneca - Eva Giertz, Director of Pharmaceuticals & Process Quality Assurance, Novartis - Thibaud Stoll, Head of Global Biopharmaceutical Operations, Sanofi Pasteur - Rene Labatut, VP Global Manufacturing Technology and Genzyme Europe - Raun Kupiec, Senior Director, Regulatory Affairs Europe.
This is set to be a year of revelations for the pharmaceutical industry and with the leading companies wishing to pull back on outsourced manufacturing it looks like now is once again the time to retreat from foreign soil and invest into reliable home grown manufacturing and more carefully selected ingredient partners.
Story provided by ng online news