Pharmaceutical company packaging OEE's (Overall Equipment Effectiveness) are reported to be among the lowest in the industry. Experience teaches that those feeling the greatest amount of pain are the ones most likely to successfully drive change. Perhaps that is why three giant pharmaceutical companies reported on their efforts in this area at ARC's Forum on Winning Strategies and Best Practices for Global Manufacturers.
A two-year-old boy is rushed to a Kwale hospital in Kenya’s Coast Province. The clinical officer at the health facility diagnoses febrile convulsions and quickly rushes to the hospital’s pharmacy for a dose of medicine that will ease the boy’s suffering. But nothing happens, so the boy is given additional doses but still the boy does not respond. Finally, he dies. Only later, upon investigation, is it discovered that the drug had no active ingredients. The drug was a fake. Read how health officials and drug manufacturers are developing ways to battle counterfeiting in an effort to keep this African nation from becoming what some would call “a healthcare catastrophe.”
Jan Gates, principal sterile barrier (packaging) engineer, Abbott Vascular, offered the following recommendations when considering hiring a consultant, or working with consultants. Her comments come from the January 28 MD&M (Medical Design & Manufacturing) West Conference in Anaheim, CA:
• Hire a consultant when temporary assistance is required – new business deadlines, short term business problems, independent advise needed, searching for cost savings, etc.
The recent rash of news about quality and identity issues involving a broad range of products imported from China has companies and consumers wondering. Counterfeit drugs and other products have recently been the subjects of one or another problem.
The recent rash of news about quality and identity issues involving a broad range of products imported from China has companies and consumers wondering. Counterfeit drugs and other products have recently been the subjects of one or another problem. China has been recognized by companies, the Food & Drug Administration, and other governments as a problematic source of counterfeit drugs for years. So what's the answer, are Chinese products and ingredients immediately suspect?
Developed countries in Western Europe, the United States, and Japan will account for nearly three-fourths of the demand for worldwide pharmaceutical packaging. The Freedonia Group projected this demand to increase 5.9% per year to more than $34 billion in 2011. In its new study, World Pharmaceutical Packaging, Freedonia notes that China will provide the strongest growth opportunities, while India and Brazil “will evolve into fast-growing pharmaceutical packaging markets as drug-producing sectors are upgraded and diversified,” especially generic drugs.
Healthcare Packaging Contributing Editor Chang-Hong Whitney (shown) reports that rapid economic gain, a weak legal system and lack of enforcement have helped counterfeiting flourish in China, but the global healthcare community can help the country battle counterfeiting. “Fake products are everywhere. We can’t trust anything on the market.” Such comments are common in China by people from all walks of life. Everything from household items to foods to industrial and commercial products, and to drugs are being copied, manufactured illegally, and sold on the open market via various channels and vendors. Living in China requires vigilance even for a trip to the grocery store.
• Biopharmaceutical and biomedical technologies and treatments will be advanced in large part by developing countries. Although only 5% to 7% of biological products now in clinical development will actually make it to the market, they will play an important role as the life sciences industry begins to develop custom solutions for individual patients rather than focusing exclusively on the larger market. But such treatments will require a change in packaging and processing methods, as well as regulatory procedures.
Half the 1,200 clinical trials conducted by a dozen of the largest U.S. pharmaceutical companies were conducted offshore in 2005. So says a report from management consultancy A.T. Kearney (www.atkearney.com), "Make Your Move: Taking Clinical Trials to the Best Location." The report cites China as the best bet for outsourcing clinical trials. According to an article posted on DrugResearcher.com http://www.drugresearcher.com/news/ng.asp?id=72702, China was chosen both for cheap labor and facilities, as well as a huge urban patient pool.
Growth in the medical device business in China is a mixed blessing, according to Chang-Hong Whitney, president of Whitney Consulting Ltd. (www.whitney consulting.net). "There is a belief that the country is growing too fast for its infrastructure," she said in a presentation entitled "China: Opportunities in an emerging giant," March 9 at HealthPACK 2007 in New Orleans. "But China has $1 trillion in foreign currency reserves, so it has the money to take care of this."
Growth in the medical device business in China is a mixed blessing, according to Chang-Hong Whitney, president of Whitney Consulting Ltd. “There is a belief that the country is growing too fast for its infrastructure,” she said in a presentation entitled “China: Opportunities in an emerging giant,” March 9 at HealthPACK 2007 in New Orleans. “But China has $1 trillion in foreign currency reserves, so it has the money to take care of this.”
China's cold chain infrastructure is still fragmented, under-funded, and scrambling to keep up with soaring demand, reports the China Supply Chain Council.
Analysts predict 8% to 9% growth in China’s healthcare market through 2010. Contributing one-fifth of the global population, China has become more open and affluent.
At last month’s International Society for Pharmaceutical Engineers (ISPE) 25th Annual Meeting in Phoenix, AZ, keynote speaker David Pulman, president of global manufacturing and supply at GlaxoSmithKline, stated that our society “has to better educate people, train them, then continue that education in the workplace.”
Genetech Inc.’s vice president of global quality, Ronald Branning, raised more than a few eyebrows at the event by saying, “last year, China graduated 600,000 engineers. In the United States, that number was 70,000. We need to stimulate engineering.”
International attendance at U.S. expositions and conferences has taken a hit the last few years due to Homeland Security stemming from 9-11-01. Typically, international visitors decide to attend a show three to four months preceding the event. Visa applications to travel to the U.S. from countries such as China or India can take as long as nine months.
So, a packaging machinery or materials company in the U.S. that markets to global prospects has to find new ways to reach these international customers. That heightens the importance of your Web site, and the use of new technology such as Webcasts (see next article).
At the recently concluded interpack, the exhibitors were pleased, show sponsor Messe Düsseldorf was happy, and even the weather—for the first four days at least—cooperated. Our take-aways:
The evidence seems to indicate that, for most medical device and pharmaceutical manufacturers, China represents far more of an opportunity than a threat. But the opportunity is more about manufacturing in China to sell locally—not exporting back to the United States or Europe.
With all the concerns here in the U.S. for a secure supply chain, moving your own facility thousands of miles away is not conducive to secure operations. In fact, some manufacturers have reported moving back to Mexico where a “putting out the fires” trip is far less time consuming and less expensive.
