In­dian Govt bans more than 300 com­bi­na­tion drugs sold il­le­gally

The Pak Banker - - 6BUSINESS -

In­dia has banned the man­u­fac­ture and sale of more than 300 com­bi­na­tion medicines, in­clud­ing two widely used cough syrups, be­ing sold with­out govern­ment ap­proval, a se­nior health min­istry of­fi­cial said on Satur­day.

The move is aimed at curb­ing the mis­use of such medicines in In­dia, where nearly half the drugs sold in 2014 were so-called "fixed dose com­bi­na­tions."

Com­bi­na­tion drugs are used world­wide to im­prove pa­tients' com­pli­ance, as it is eas­ier to get pa­tients to take one drug rather than sev­eral. But in­con­sis- tent en­force­ment of drug laws in In­dia has led to the pro­lif­er­a­tion of hun­dreds of such medicines en­ter­ing the mar­ket based on ap­proval from reg­u­la­tors of in­di­vid­ual states, rather than the cen­tral govern­ment.

In 2014, In­dia set up a com­mit­tee to re­view more than 6,000 com­bi­na­tions that had en­tered the mar­ket based only on state reg­u­la­tors' ap­proval. Pol­i­cy­mak­ers gave phar­ma­ceu­ti­cal com­pa­nies a chance to retroac­tively prove the safety and ef­fi­cacy of th­ese drugs by sub­mit­ting data on their drugs. The com­mit­tee was tasked with clas­si­fy­ing the drugs into ra­tio­nal, ir­ra­tional, and those that need fur­ther stud- ies, said K.L. Sharma, a joint sec­re­tary at the health min­istry.

"Now based on re­sponses (and) as­sess­ment of prod­ucts, more than 300 drugs have been pro­hib­ited," he told Reuters. He did not name the medicines, but said an of­fi­cial no­tice an­nounc­ing the ban would be is­sued "in a few days." The Drug Con­troller Gen­eral of In­dia was not im­me­di­ately avail­able to com­ment.

The banned medicines in­clude the codeine-based cough syrups Phensedyl and Corex, the Times of In­dia said in a re­port ear­lier on Satur­day, cit­ing un­named sources. Phensedyl, made by US drug­maker Ab­bott Lab­o­ra­to­ries, ac­counts for about a third of the In­dian cough syrup mar­ket, and its sales are es­ti­mated to make up more than 3% of Ab­bott's $1 bil­lion In­dia rev­enue. Corex is sold by Pfizer Inc.

Reuters re­ported last Oc­to­ber that In­dian reg­u­la­tors were pri­vately pres­sur­ing drug firms to bet­ter po­lice the sell­ing of pop­u­lar codeine-based cough syrups to tackle smug­gling and ad­dic­tion. Nei­ther com­pany re­sponded to re­quests for com­ment on Satur­day.

Doc­tors and pub­lic health ex­perts in In­dia and abroad have warned that in­creas­ing use of an­tibi­otic com­bi­na­tions in In­dia may be con­tribut­ing to an­tibi­otic re­sis­tance. -

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