Safety concerns about adulterated drug ingredients

Government regulators and pharmaceutical companies are moving to address a major new risk for the global supply of medicines: The possibility that unsafe ingredients are entering the supply chain as pharmaceutical companies increasingly outsource the production of drug ingredients to third parties. That's the topic of the cover story in the current edition of Chemical & Engineering News (C&EN), ACS' weekly newsmagazine.

C&EN Senior Editor Rick Mullin explains that the jolt for action came from several incidents. One incident —a major 2008 recall of contaminated heparin that likely caused 81 deaths in the U.S. In another incident, more than 300 people died in Panama after taking cough medicine manufactured with diethylene glycol that was shipped by a supplier as glycerin.

The story describes awareness within the U.S. Food and Drug Administration (FDA) that rampant globalization in drug manufacturing has outstripped the agency's resources for inspecting foreign facilities. FDA has responded by establishing an information sharing network with European, Japanese, and Australian regulators and has opened regional offices in Asia and elsewhere.

More information: pubs.acs.org/cen/coverstory/89/8920cover.html

add to favorites email to friend print save as pdf

Related Stories

Reducing gene-damaging impurities in medicines

Sep 29, 2010

Drug manufacturers have been adjusting to strict new government standards that limit the amount of potentially harmful impurities in medicine, according to the cover story of the current issue of Chemical & Engineering News ...

Heparin recall spreads in Europe

Mar 27, 2008

France, Italy and Denmark are recalling heparin after an Italian firm purchased contaminated ingredients from China, EU drug regulators said.

Recommended for you

Medical charity warns India over patent rules

Jan 21, 2015

Doctors without Borders on Wednesday warned the Indian government not to bow to US pressure to amend patent regulations that allow millions access to affordable medicines, ahead of a visit by President Barack Obama.

Why are some generic drugs getting so expensive?

Jan 21, 2015

More than eight out of every 10 prescriptions dispensed in the US is generic. This growth is due to a large number of top-selling drugs going off patent over the past decade, as well as innovations in t ...

Supreme Court sides with Teva in drug dispute

Jan 20, 2015

The Supreme Court on Tuesday sided with Teva Pharmaceutical Industries Ltd. in the company's high-profile patent dispute with rival firms over the top-selling multiple sclerosis drug.

User comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.