Interphex in Review: On India, China, PAT and E-Pedigrees

Editor in Chief Agnes Shanley recaps the highlights of a "really big shoe."

By Agnes Shanley, Editor in Chief

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Editor's Note: The following report/review on Interphex 2006 was originally published on our weblog, pharmamanufacturing.wordpress.com



Last week's Interphex conference and exposition in New York City [Mar. 20-23] was far more upbeat than the previous year's event. Attendance seemed higher, the conference program was stronger and much better organized, and the subsidiary conference theme of "globalization" (focused on India and China) was right on target. Reed will take Interphex to India and China this year, and also to Mexico. Brazil is on a short list of possible new venues for the program. Here are just a few impressions/tidbits from this year's program.

Facility of the Year

Baxter Biopharma Solution's vial-filling plant in Bloomington, Ind., was named 2006 Facility of the Year, beating other extremely worthy competitors from Ireland, U.K., Japan and Belgium, in the competition organized by ISPE and Reed. I'd had the pleasure of visiting that facility, which we profiled in an article in Pharmaceutical Manufacturing back in 2004, and it is truly a marvel of modular, fast-track construction and cutting-edge syringe and vial filling (with an inspection system developed by engineers who'd designed the vision system for the Mars Rover).

The Rise of China and India

At Interphex, we heard about China's and India's pharmaceutical industries, both of which are growing at double-digit rates. (Stay tuned for articles on India in April's issue of Pharmaceutical Manufacturing, including an interview with Ranbaxy's quality chief, Ranjit Barshikar, whose team is embracing "quality by design" and PAT).China is growing by 15% per year with biotech growing faster, and demand for over-the-counter medications [and chain drug stores] is growing rapidly, in step with the growth of China's urban middle class. As demand for OTC drugs increases by 15% per year China will overtake Japan to become the world's second largest OTC market by 2010.

Local generics companies face an unsure future, and stiffer competition from higher-cost generics and global pharma brands, since insured urbanites can now afford more expensive drugs.

China is investing heavily in API manufacturing, and over the next 3 years its API capacity will be tripling. Within the next five years, contract research, now a $30-million business, will grow to $150 million.

India, likewise, is expanding rapidly. It's already the fourth largest pharma manufacturer (on a volume basis — the 14th based on product value), and leading manufacturers are now setting their sites on global markets and rapid expansion.

Some quick statistics: India has 74 FDA approved manufacturing sites, the largest number outside the U.S., and last year, Indian firms filed almost 20% of ANDAs to FDA. In 2004, India filed 197 DMFs with FDA, and Indian scientists applied for 37% more patents in 2003 than they did the previous year. (The number of technical papers published by Indian scientists has doubled between 1998 and 2003). A comment was made, only half jokingly, that FDA should establish a base in India to better handle the growing workload originating in that country.

As you may know, Roche recently filed the first patent under the nation's new patent program. Growth is bringing change, and, as in China, India's small-to- medium sized generic manufacturers will struggle to compete in the new environment.

Also bearing witness to the growth of Asian markets was filtration and separation specialist Pall Corp.'s announcement that it is investing heavily in India, China and Singapore. The company's CEO and leadership spoke at a press conference at Interphex. Two top executives, Holly Haughney and Vinay Jobanputra, have already relocated to India (for Mr. Jobanputra, this has meant "going home" again, for Ms. Haughney, it is also a homecoming of sorts, since she has family connections to India and has travelled there extensively.) Pall is establishing a Center of Excellence in Bangalore, already a center for interdisciplinary R&D, that will include proteomics and validation laboratories and provide "hands on" training.

Several comments were made about the excellence of India's workforce, and Subodh Priolkar, director of the Indian Pharmaceutical Association, mentioned India's R&D productivity advantages (70 hours per worker in India vs. 45 hours per worker in the U.S. or Europe — perhaps a slight exaggeration? It's not as if everyone in the U.S. or Europe skips out of the laboratory, plant or office blithely at 5 p.m. each evening. Presumably, their Indian peers also "have lives." But interesting nonetheless).

PAT and Risk Based Manufacturing

A number of presentations focused on process analytical technologies, including a nice case history presented by NNE's Connie Heinz that emphasized the importance, not of "technology," but process understanding and improvement using the tools of operational excellence (statistical process control, risk assessment, value stream mapping) that Japan's quality gurus brought to U.S. manufacturing.

Aegis Analytical's Justin Neway gave an excellent presentation on risk assessment and the impact that it is having, and will have in the future, on drug manufacturing. The company is an IBM partner and its flagship product, Discoverant, is now being demonstrated at a new "proof of concept" center in France.

Mr. Neway was cautiously optimistic about PAT, and said that the industry finally understands the importance of real-time data acquisition. (Read more in our next PAT Insider e-newsletter, which will blast Thursday, May 4).

The conference also highlighted RFID and product security technologies, containment technologies, and rapid microbiological measurement and monitoring technologies.

Pedigree Laws: Where's the Interest?

What a difference a few years make. Two years ago at New York's Interphex show, SupplyScape's chief strategy officer Robin Koh spoke before a standing-room-only audience about RFID's potential and what it could mean in terms of drug product authentication.

This year, Koh spoke before an audience of, well, three-two, not counting the press. Perhaps it was because his topic — the success of the Drug Security Network pilot, the first test run for a comprehensive electronic pedigree program — wasn't quite as sexy as RFID was two years ago. But it also has something to do with the fact that the e-pedigree topic just hasn't put fear into manufacturers the way that RFID and the Wal-Mart mandate did.

The funny thing is, Koh says, is that unlike RFID for authentication, e-pedigrees (whether done via RFID or not) are actually required by law-and stiffer laws are not far on the horizon. Florida's new law takes effect July 1, California's January 1, 2007.

The California legislation should really get manufacturers attention, Koh says, because it places the responsibility of initiating an end-to-end e-pedigree solution on the shoulders of the manufacturer. And anyone thinking that the states will exercise leniency will probably be mistaken, Koh says.

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