Asia-Pacific GMP Update Part 1
With 60% of the world’s population living in the Asia-Pacific region, it is the fastest growing region in the world. In addition, this region is a major supplier of pharmaceuticals. Bob Tribe, AP Regulatory Affairs Advisor, gave an update and outlook for the Asia-Pacific region at the ISPE 2015 Annual Meeting. Below are some of the key take-aways from the presentation.
Kicking-off the session, Tribe reviewed recent facts from the FDA in relation to the pharmaceutical industry:
- Nearly 40% of the drug products consumed in the USA are made outside of the USA
- Approximately 80% of the manufacturers of active pharmaceutical ingredients used in the USA are located outside our borders
- China and India are each expected to see a more than 400% increase in product exports between now and 2020, with China accounting for nearly 20% of all global product exports by that time
In addition to these staggering facts, Tribe discussed problems currently trending in some of the Asia-Pacific countries related to the production of pharmaceuticals:
- Guanxi in China and “old boy network” in India where business connections and relationship create reciprocal favors
- Operating “shadow factories” – A “showcase” factory is created for the public to see and on the other side, there is another factory operating at a lower standard
- Absence of deviations and complaints on record
- Data integrity – recent increase in the detection of data integrity breaches
- Site rules not observed
- Manufacture of counterfeit/falsified medicines:
- 31% of counterfeited medicines originate from India
- 20% originate from China
- Almost, 15% of medicines in the global supply chain are counterfeit
Tribe shared some eye opening images in relation to the counterfeit medicines being created in the Asia-Pacific region.
Here is an example of counterfeited Viagra:
Here is what the Manufacturer’s facility looked like that was creating the counterfeit Viagra tablets:
As the Asia-Pacific region continues to grow and more medicines are manufactured in this region, we are responsible for doing our due diligence to ensure we are working with quality partners to produce quality medicines.
Check-out Part 2, which provides an update on specific agencies influencing the Asia-Pacific region, as well as an update as to what is currently going on in China and India.
- Counterfeit image source: http://www.pbs.org/wgbh/nova/next/body/uncovering-counterfeit-medicines