Drug watch­dog to in­crease ac­tiv­i­ties in China

China Daily (Canada) - - CHINA - By WANG HONGYI in Shang­hai wanghongyi@chi­nadaily.com.cn

The US-based RX-360, a global phar­ma­ceu­ti­cal in­dus­try con­sor­tium of vol­un­teers pro­tect­ing pa­tient safety and en­hanc­ing sup­ply- chain se­cu­rity, plans to in­crease its ac­tiv­i­ties in China, which has be­come a ma­jor sup­plier for the global drug in­dus­try.

The Wash­ing­ton- based non­profit or­ga­ni­za­tion was es­tab­lished in 2009 to pro­tect pa­tient safety by shar­ing in­for­ma­tion and de­vel­op­ing pro­cesses re­lated to the in­tegrity of the health­care sup­ply chain and the qual­ity of ma­te­ri­als within the sup­ply chain.

“With glob­al­iza­tion of dis­tri­bu­tion for both drug com­po­nents and fin­ished prod­ucts, China has un­doubt­edly played an im­por­tant role in the global phar­ma­ceu­ti­cal in­dus­try. The coun­try has a large num­ber of man­u­fac­tures, sup­ply­ing raw ma­te­ri­als to the world,” said Brian John­son, chair­man of RX-360, who is also the se­nior di­rec­tor of sup­ply chain se­cu­rity at the drug com­pany Pfizer. “How to en­sure the se­cu­rity of sourc­ing and sup­ply chain and in­crease the aware­ness in the coun­try be­comes very crit­i­cal as with many prob­lems that to date have yet to be re­solved.”

The group’s work in China will par­al­lel what it has been do­ing in the US and Europe for sev­eral years, such as rais­ing aware­ness of is­sues that have an im­pact on the se­cu­rity and in­tegrity of phar­ma­ceu­ti­cal prod­ucts and shar­ing best prac­tices through ed­u­ca­tion It will also pro­mote the ef­fi­cient use of joint and shared au­dit pro­grams to con­tinue to im­prove the trans­parency of sup­ply chan­nels.

The group has also de­vel­oped a se­ries of tools and pub­lished white pa­pers to help the in­dus­try and reg­u­la­tors ad­dress key ar­eas of sup­ply­chain se­cu­rity such as cargo theft, il­le­gal prod­uct di­ver­sion, eco­nom­i­cally mo­ti­vated adul­ter­ation, mon­i­tor­ing of drug short­ages.

“Our goal is to work with lo­cal in­dus­tries and reg­u­la­tors to fur­ther our mis­sion in China,” said John­son, adding that this is also a step for RX-360 to in­vite more par­tic­i­pa­tion by lo­cal sup­pli­ers through­out Asian coun­tries.

“Leading in­dus­try groups such as RX-360 will be very happy to share their ex­per­tise with lo­cal in­dus­tries in com­bat­ing se­cu­rity threats in our com­mon sup­ply chain. And I think these ed­u­ca­tional and best-prac­tice shar­ing ac­tiv­i­ties will ben­e­fit Chi­nese com­pa­nies, es­pe­cially those smaller ones,” said Wil­liam Pay, Greater China head of the global strate­gic sourc­ing of­fice at Bayer Health­care, which was a co­found­ing mem­ber of RX-360 con­sor­tium along with Pfizer, Takeda, Am­gen , Eli Lily, Roche and oth­ers.

The group also stressed the need for cracking down on on­line sales of coun­ter­feited drugs, which has be­come in­creas­ingly ram­pant in China.

In De­cem­ber last year, the Chi­nese govern­ment ar­rested more than 1,300 people in­volved in var­i­ous coun­ter­feit drugs sold on on­line.

Ear­lier this month, China’s Food and Drug Ad­min­is­tra­tion warned about au­then­tic­ity and qual­ity of over­seas drugs sold on­line, and said 75 per­cent of over­seas generic anti-cancer drugs sup­plied by on­line agents are fake and in­ef­fec­tive.

Also this year, po­lice from Cen­tral China’s He­nan prov­ince ar­rested 19 sus­pects for al­legedly bo­gus med­i­cal de­vices, bust­ing 13 mar­ket­ing dens and seiz­ing 48 med­i­cal de­vices orig­i­nat­ing from over­seas waste.

“The on­line sales of coun­ter­feit drugs now are a big is­sue for the whole phar­ma­ceu­ti­cal in­dus­try in se­cur­ing sup­ply chain safety. More ef­forts should be given to this sec­tion, and mean­while, how to carry out ef­fec­tive su­per­vi­sion work is also im­por­tant,” said Rory Budi­han­dojo, di­rec­tor of the Asia-Pa­cific au­dit cen­ter of ex­cel­lence at Boehringer In­gel­heim China, also a mem­ber of the group.

RX-360 was founded in the aftermath of the hep­arin scan­dal in 2008, when tainted raw hep­arin was found in fin­ished prod­ucts sold around the world, which led to the deaths of more than 100 Amer­i­cans.

Since then, RX-360 mem­ber com­pa­nies in the phar­ma­ceu­ti­cal in­dus­try be­gan to share their in­for­ma­tion of sup­ply-chain se­cu­rity and also es­tab­lished white pa­pers and guid­ance on pre­vent­ing coun­ter­feits and ex­pos­ing other forms of phar­ma­ceu­ti­cal crimes.

So far, the group has more than 80 mem­bers, in­clud­ing man­u­fac­tur­ers, sup­pli­ers and in­dus­try as­so­ci­a­tions. The group has set up an Asia Work­ing Group run by Dr Zhi­jian Xiao, head of qual­ity op­er­a­tions Asia Pa­cific of As­traZeneca.


Brian John­son, chair­man of RX-360.

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