FDA finds il­le­gal meds at 90 of 92 in­spected Man­dalay phar­ma­cies

The Myanmar Times - - News - SI THU LWIN sithul­win@mm­times.com

THE Man­dalay Food and Drug Ad­min­is­tra­tion (FDA) an­nounced this week that 90 of 92 in­spected phar­ma­cies carry un­reg­is­tered or ex­pired med­i­ca­tions. The ad­min­is­tra­tion launched a crack­down in May, warn­ing drug­store own­ers that they could face prison time if they failed to fol­low reg­u­la­tions and con­tin­ued to stock black-mar­ket drugs, or those past their sell-by date.

In con­duct­ing checks, the FDA found 408 types of un­reg­is­tered med­i­ca­tion and 131 types of ex­pired med­i­ca­tion, said U Zin Zin Nwe, di­rec­tor of the Man­dalay branch of the FDA, at a meet­ing with Man­dalay phar­ma­cists held on July 22 at the Man­dalay City Devel­op­ment Com­mit­tee’s hall.

Those vi­o­la­tors re­ceived warn­ings this time, but ac­tion will be taken next time, U Zin Zin Nwe said at the meet­ing, which was at­tended by more than 400 peo­ple in­clud­ing rep­re­sen­ta­tives from re­tail and whole­sale phar­ma­cies, phar­ma­ceu­ti­cal com­pa­nies, hos­pi­tal heads, and of­fi­cials from seven town­ship Public Health De­part­ments.

In ad­di­tion to ex­pired or un­reg­is­tered med­i­ca­tion, di­rec­tor gen­eral Daw Theingi Zin of the Nay Pyi Taw branch of the FDA warned about pos­sess­ing or sell­ing con­trolled or il­le­gally im­ported drugs. Phar­ma­cists found to be sell­ing con­trolled medicines with­out a spe­cial li­cence can face pun­ish­ment un­der the nar­cotics laws, and could be ar­rested.

Pro­fes­sors, doctors and own­ers of phar­ma­cies who at­tended the meet­ing ap­pealed to the ad­min­is­tra­tion to loosen strict reg­u­la­tions around im­port­ing med­i­ca­tion, ask­ing for a sim­pli­fi­ca­tion of the reg­is­tra­tion process, and for a list of il­le­gal and unof­fi­cial drugs.

Ac­cess to med­i­ca­tion can be chal­leng­ing. New drugs need ap­proval from the FDA – a process that could take 18 months to two years and costs nearly US$800, The Myan­mar Times re­ported in June. While the drug sits in limbo with the FDA, pa­tients look for other ways of ob­tain­ing drugs they need. As a re­sult, un­reg­is­tered drugs that have been il­le­gally im­ported – of­ten from In­dia, Bangladesh or Thai­land – or pro­duced lo­cally pro­lif­er­ate the mar­ket, but can­not be reg­u­lated for safety.

In June, the FDA an­nounced a price cap on reg­is­tered drugs, hop­ing to bring prices in line with un­reg­is­tered drugs, which were be­ing cho­sen over the reg­u­lated op­tions for their af­ford­abil­ity.

Phar­ma­cists have sug­gested that shut­ting down the black-mar­ket medicines in­dus­try will leave many pa­tients with­out re­course, ei­ther be­cause they can­not af­ford­ing the reg­is­tered ver­sion of the drug or be­cause they are forced to wait for ap­proval for a newer med­i­ca­tion.

“Peo­ple are un­e­d­u­cated about medicine,” Man­dalay lo­cal Daw Myint Myint Maw told The Myan­mar Times. “The peo­ple who can af­ford it take med­i­ca­tion pre­scribed by a doc­tor but the peo­ple who can­not af­ford it go to the phar­macy and take non-pre­scribed medicines. It is best for the na­tion’s fi­nances and health if the gov­ern­ment pro­duces the med­i­ca­tions.”

– Trans­la­tion by San Layy

Photo: Zarni Phyo

Phar­ma­cists have been warned they may face prison time for stock­ing fake or ex­pired med­i­ca­tion.

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