Even though Chinese suppliers have probably gotten the worst rap in the media in recent years for pharma quality issues, companies -- and consumers -- should be equally concerned about supplier practices in India as well. Consider this telling tale from down under which notes that a New Zealand company is "considering banning the sole supplier of an antibiotic prescribed to nearly half a million Kiwi children." The company in question, ironically named MedSafe, "is poised to ban imports of 12 drugs from Indian company Ranbaxy following American concerns over the drugs' production process and possible cross-contamination." The Indian supplier in question failed an FDA audit because it had ignored GMP practices at two of its facilities. This latest pharma supply risk scare is further testament to the fact that companies need to invest in their own supplier development and monitoring programs rather than simply waiting for regulatory bodies to do it for them. From a global sourcing perspective, the added cost should not be an issue -- low-cost API (active pharmaceutical ingredient) sourcing can yield cost savings that exceed 50%. Yet given the tremendous pressure to cut costs as more drugs come off patent and as new drug discovery and approval pipelines slow, most pharmaceutical companies just aren't doing enough.
- Jason Busch