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ENSURE AUTHENTICITY OF MEDICINES1
3 Apr 2018kas­miah@nst.com.my
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THE next time you buy a medic­i­nal prod­uct, check if it has a reg­is­tra­tion num­ber and a holo­gram se­cu­rity im­age on its pack­ag­ing. If none, or only one of the fea­tures is vis­i­ble, it is an un­reg­is­tered or fake prod­uct. Un­reg­is­tered prod­ucts are not reg­is­tered with the Drug Con­trol Author­ity of Malaysia. All phar­ma­ceu­ti­cal and medic­i­nal prod­ucts must be reg­is­tered prior to be­ing mar­keted in Malaysia.


Fake prod­ucts are im­i­ta­tion or il­le­gal copies of reg­is­tered prod­ucts. A fake prod­uct may look very sim­i­lar to the orig­i­nal but its con­tent is un­known as it has not been of­fi­cially tested. In Malaysia, fake prod­ucts are clas­si­fied and treated as un­reg­is­tered prod­ucts un­der the Sale of Drugs Act 1952.


Health Min­istry Foren­sic Phar­macy (phar­ma­ceu­tial en­force­ment di­vi­sion) deputy di­rec­tor Ma­zlan Is­mail says reg­is­tered phar­ma­ceu­ti­cal and medic­i­nal prod­ucts have gone through strin­gent qual­ity con­trol tests with the Health Min­istry to make sure they are safe. They are eval­u­ated in terms of safety, qual­ity and ef­fi­cacy.


Tra­di­tional medicines are also eval­u­ated and tested for safety and qual­ity. “Once they have been eval­u­ated, they are deemed to be a reg­is­tered prod­uct. The ob­jec­tive of the eval­u­a­tion is to en­sure they do not con­tain pro­hib­ited in­gre­di­ents, in­clud­ing sched­uled poi­sons. “Reg­is­tered prod­ucts have re­ceived the gov­ern­ment’s guar­an­tee on qual­ity and safety so the pub­lic do not have to worry about side ef­fects.”


Ma­zlan says with thou­sands of medic­i­nal and phar­ma­ceu­ti­cal prod­ucts in the mar­ket, it is up to con­sumers to make sure they are not buy­ing un­reg­is­tered items. This is be­cause de­spite var­i­ous raids by the Health Min­istry, these prod­ucts are still be­ing sold due to de­mand. He says the main dif­fi­culty faced by the phar­ma­ceu­tial en­force­ment di­vi­sion is track­ing un­reg­is­tered prod­ucts, es­pe­cially those im­ported from In­done­sia, China, Myan­mar and In­dia.


As of Novem­ber last year, 43,207 un­reg­is­tered prod­ucts were seized, val­ued at RM75.4 mil­lion. From 2012 to Oc­to­ber last year, 1,575 un­reg­is­tered medic­i­nal prod­ucts that were sold on­line val­ued at RM4 mil­lion were seized. These prod­ucts were seized for be­ing un­reg­is­tered or coun­ter­feit; adul­ter­ated or laced with con­trolled sub­stances or con­tain­ing harm­ful or dan­ger­ous sub­stances; con­tain­ing sched­uled poi­sons sold by un­law­ful per­sons or at un­li­cenced premises; or hav­ing prod­uct reg­is­tra­tions which had ex­pired or been can­celled.


IN HIGH DE­MAND


Ma­zlan says the high­est num­ber of prod­ucts seized are tra­di­tional medicines, es­pe­cially those for weight loss or those that act as sex­ual stim­u­lants. These usu­ally con­tain poi­sons and can have dan­ger­ous side ef­fects when taken in large quan­ti­ties. For ex­am­ple, some weight-loss prod­ucts con­tain sibu­tramine, an ap­petite sup­pres­sant that can in­crease the risk of heart at­tacks and strokes, he says.


Many tra­di­tional medicines are ei­ther man­u­fac­tured at home or in a fac­tory that is not li­cenced. Reg­is­tered prod­ucts must be man­u­fac­tured in a fac­tory with good man­u­fac­tur­ing prac­tices, says Ma­zlan. “They don’t want to set up a man­u­fac­tur­ing plant be­cause it costs mil­lions. They also have to re­veal the in­gre­di­ents in the prod­ucts. So they make and sell the prod­ucts with­out get­ting reg­is­tered. “The prod­ucts may not con­tain pro­hib­ited in­gre­di­ents but they must still be reg­is­tered. Maybe the amount of the in­gre­di­ent is too small to have an im­me­di­ate ef­fect but the long-term im­pact will be there.”


All reg­is­tered phar­ma­ceu­ti­cal and medicine prod­ucts will have reg­is­tra­tion num­bers that start with the word “MAL”, fol­lowed by eight num­bers, and end­ing with ei­ther the let­ter A for con­trolled medicines, X (over-the-counter medicines), T (tra­di­tional medicines) or N (sup­ple­ments). In ad­di­tion, the prod­ucts are also la­belled with the Med­itag se­cu­rity holo­gram, which was im­ple­mented in 2005. The lat­est ver­sion is Med­itag 4, in­tro­duced in Oc­to­ber last year to re­place Med­itag 3.


In ad­di­tion, the prod­ucts are also la­belled with the Med­itag se­cu­rity holo­gram, which was im­ple­mented in 2005. The lat­est ver­sion is Med­itag 4, in­tro­duced in Oc­to­ber last year to re­place Med­itag 3. Med­itag 4 is equipped with the lat­est se­cu­rity fea­tures in­cor­po­rat­ing sec­ond and third level con­trols to make it dif­fi­cult to be fully copied or im­i­tated. Un­like the pre­vi­ous se­cu­rity holo­gram, a unique fea­ture is im­ple­mented on the Med­itag 4 that al­lows con­sumers to ver­ify the se­cu­rity holo­gram’s orig­i­nal­ity us­ing the checker app. The app can be down­loaded from Ap­ple App Store or Google Play Store.


Ma­zlan says with the checker app, con­sumers can find out whether the prod­ucts are reg­is­tered with a sim­ple step. “All one needs to do is run the app across the holo­gram. If it is gen­uine, the app will show green. If the holo­gram is fake, it will be red. “The ad­di­tional func­tions in the checker app also al­low con­sumers to di­rectly re­port un­reg­is­tered prod­ucts to the Min­istry,” he says.


As for prod­ucts that are still us­ing Med­itag 3, con­sumers can check the au­then­tic­ity of the holo­gram us­ing the Med­itag decoder. The decoder is cur­rently avail­able at all li­cenced phar­ma­cies or gov­ern­ment hospi­tals and clin­ics through­out Malaysia. Con­sumers can also check the prod­uct’s reg­is­tra­tion sta­tus at the Na­tional Phar­ma­ceu­ti­cal Reg­u­la­tory Agency web­site at www.npra.moh.gov. my. If the reg­is­tra­tion num­ber or prod­uct de­tails are dif­fer­ent from the one listed on the web­site, it could be a fake prod­uct. Reg­is­tered prod­ucts have re­ceived the gov­ern­ment’s guar­an­tee on qual­ity and safety.

Reference:
1. Ensure authenticity of medicines. New Straits Times (April 2018). Available at: https://www.pressreader.com/malaysia/new-straits-times/20180403/282488594289563. Accessed on: 20 March 2020.

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