Pharmaceutical manufacturing is at a crossroads. There is widespread realization among the regulators and the industry that the current state of high variability and “Quality by Inspection” is no longer adequate. While the industry still largely employs first generation quality management tools, the products that are being marketed are very complex to develop and manufacture. There is agreement between the regulators and the industry that “Quality by Design” or QbD is the way forward. The root cause of the current issues with pharmaceutical manufacturing is that the level of science and technology for pharmaceutical development and manufacturing lags far behind the state-of-the-art science and technology being deployed to discover new molecular entities. According to the U.S. FDA, one of the key reasons for the decline in the rate of entry of new drugs to the market is that the applied sciences needed for medical product development (translational research) have not kept pace with the tremendous advances in the basic sciences. While there is significant investment in discovery research by the pharma companies and the U.S. federal government, investment in basic research in the science of product development and manufacturing has been woefully small.
Pharmaceutical companies in the U.S. and Europe are outsourcing more and more to countries like India and China to take advantage of the lower costs. These countries are inheriting the highly inefficient manufacturing technology from the West. If nothing else changes, as labor costs are going to increase in India, pharmaceutical manufacturing will likely move to countries which may provide even cheaper labor.
There are similarities between the state of pharmaceutical manufacturing and the state of the auto industry about 50-60 years ago. U.S. automakers were content in spending large sums in marketing rather than in basic science and on improvement of quality. While the Japanese companies started out by assembling foreign cars in Japan in late thirties, by the mid-fifties they started heavily investing in automation, new manufacturing technology and in quality initiatives. In this regard, the efforts of W. Edwards Demming are well known to every one. India has two choices of moving forward. India can either chose to follow the Japanese auto industry model and investing in science and technology and quality and be a leader in pharmaceutical development and manufacturing in the future. Alternatively, India can continue to rely on ancient technologies with high manual labor, high rejection rate and wastage, overbearing documentation load and heavy reliance on manual inspection. The ultimate consequences of the latter will not be good for the Indian economy or its people.
Prior to joining Purdue University in February, 2004, Dr. Basu worked in the pharmaceutical industry (Searle, Pharmacia and Pfizer) for over 20 years in various capacities in research, development, manufacturing, and outsourcing.
Prabir Basu earned a Ph.D. in Chemical Engineering from the University of California, Berkeley and an MBA from Webster University in St. Louis, MO. Before joining Searle in 1984, Dr. Basu briefly taught Chemical Engineering at the Indian Institute of Technology, Kanpur in 1972 and worked for Hindustan Lever Limited, India from 1973 to 1983. He is a Fellow of the American Institute of Chemical Engineers and editor of the Journal of Validation Technology and Journal of GxP Compliance.
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Centre for Cellular and Molecular Biology, Hyderabad, India