Generic Drugs Is the de­ci­sion poor cen­tric?

The gov­ern­ment’s move may be coun­ter­pro­duc­tive un­less we cre­ate a lo­cal frame­work free of cor­rupt prac­tices to pro­vide qual­ity in generic drug test­ing and also cre­ate strin­gent process of is­su­ing li­censes.

Rural & Marketing - - HEALTHCARE - Dr. Ashok Pana­gariya For­mer VC, Ra­jasthan Medical Univer­sity Writes Dr Ashok Pana­gariya

Two ar­gu­ments, which will con­vince even the most bril­liant and prag­matic politi­cian for pol­icy change in our coun­try, are when this is even done in Amer­ica than why not in In­dia and the ru­ral peo­ple shall be the great­est ben­e­fi­ciary of change. While any­thing for the poor and ru­ral peo­ple is al­ways a wel­come idea but not at the cost of hu­man health and sur­vival.

To com­pare Amer­i­can con­di­tions with ours could be a naive if not dis­as­trous idea some­times. Our bu­reau­cracy is so clever in us­ing both th­ese, ei­ther suo motto or through their tech­ni­cal sub­or­di­nates, whose es­teem they have suf­fi­ciently di­luted. It is an open se­cret that Amer­ica is more than 260 years old democ­racy and un­like In­dia at­tracts the best of the tal­ents from the world and the pub­lic is ruled by a set of gov­er­nance with a min­i­mal bureau­cratic con­trol. Con­trary to that we are a de­vel­op­ing na­tion with a short his­tory and merit has very of­ten than not has been a ca­su­alty. While the per­cep­tion of the de­ci­sion is poor-cen­tric but ul­ti­mately it is this class which bears the brunt of poor qual­ity in a sys­tem dom­i­nated by the rich and the pow­er­ful.

The story of gener­ics ver­sus branded medicine be­ing used to treat the pa­tients all over the world is not new. While there is no de­nial to the fact that good qual­ity gener­ics are al­ways com­pa­ra­ble to the branded medicine, the qual­ity of the prod­uct de­pends on the so­phis­ti­cated pro­cess­ing and man­u­fac­tur­ing of a re­search molecule. It is a world over ex­pe­ri­ence of the clin­i­cians that the orig­i­nal mol­e­cules are more ef­fi­ca­cious and have higher

bi­o­log­i­cal avail­abil­ity to act on the root of the dis­ease process vis-à-vis those man­u­fac­tured un­der dif­fer­ent con­di­tions and mar­keted after procur­ing li­censes through du­bi­ous means.

While in US, there is a strin­gent qual­ity con­trol and a se­ri­ous pe­ri­odic mon­i­tor­ing of the qual­ity, this is far from truth in In­dia, where to get a drug li­cense through po­lit­i­cal or bureau­cratic con­nec­tions by cor­rupt means is as easy as buy­ing veg­eta­bles in the mar­ket. The drug con­trol mech­a­nisms in In­dia have huge lim­i­ta­tions both in terms of avail­abil­ity of man­power and tech­nol­ogy and ram­pant cor­rup­tions in the sys­tem makes it worse. The other ma­jor lim­i­ta­tions in our coun­try is the non­avail­abil­ity of qual­i­fied phar­ma­cist and dis­pensers on the medical shops. The phar­ma­cies or the drug shops all across In­dia are largely manned by un­trained youths or fam­ily mem­bers. The phar­ma­cist by and large out­sources his li­cense and takes his com­mis­sion out of the con­tract. Left to them, it could have very se­ri­ous im­pli­ca­tions where the tech­ni­cal in­gre­di­ents of which the dis­penser is ig­no­rant could be wrongly dis­pensed un­der the huge risk of al­ler­gies and side ef­fects. Many for­mu­la­tions with com­bi­na­tions shall be dif­fi­cult for the un­qual­i­fied shop­keeper to de­liver.

With the mush­room­ing pharma com­pa­nies with in­cen­tives the owner of the drug stores shall be least con­cerned with the qual­ity of the drug. While it is true that some of the medical pro­fes­sion­als have been in hand in glove with the

The drug con­trol mech­a­nisms in In­dia have huge lim­i­ta­tions, both in terms of avail­abil­ity of man­power and tech­nol­ogy. The other ma­jor lim­i­ta­tions in our coun­try is the non-avail­abil­ity of qual­i­fied phar­ma­cist and dis­pensers on the medical shops

pharma com­pa­nies and could have harmed pa­tient in­ter­ests but by and large a doc­tor would al­ways like his pa­tient to be cured and would pre­fer a qual­ity medicine with good bioavail­abil­ity for pri­mary ill­ness. He may be us­ing cer­tain ad­juncts to ben­e­fit the com­pany which could al­ways be cur­tailed by a pre­scrip­tion au­dit­ing through the Medical Coun­cil. This would cer­tainly be more pre­ferred than leav­ing pa­tients to the mercy of un­qual­i­fied drug dis­pensers. Leav­ing it to the dis­cre­tion of the phar­ma­cist, could be even more coun­ter­pro­duc­tive. Chemists are un­reg­u­lated and have no obli­ga­tions, eth­i­cal or com­mer­cial for sell­ing prod­ucts.

Re­gard­ing the drug pric­ing, the Na­tional Phar­ma­ceu­ti­cal Pric­ing Au­thor­ity (NPPA) can al­ways re­duce the max­i­mum re­tail price and leave very lit­tle room for ma­nip­u­la­tion by the pharma com­pa­nies. Gov­ern­ment could also con­sider in­tro­duc­ing uni­form code of mar­ket­ing for bring­ing down the cost of medicines.

No medical pro­fes­sional would be against the low cost generic pro­vided it that is a qual­ity drug but it is be­lieved that not more than 1 per­cent of generic drugs sold in In­dia, un­dergo qual­ity tes. En­sur­ing avail­abil­ity of uni­form qual­ity of generic drugs would fa­cil­i­tate doc­tors to pre­scribe them.

If this is ig­nored, it is likely to cre­ate a dis­as­trous situation for the com­mon men where his suf­fer­ing would in­crease if he is dis­pensed “cheaper” poor qual­ity gener­ics. The brunt would fall on the have nots since, the af­flu­ent and the pow­er­ful would al­ways man­age the qual­ity drugs ei­ther generic or branded. This has hap­pened in the larger gov­ern­ment in­sti­tu­tions where the branded medicines were re­placed by gener­ics.

Re­mem­ber while com­par­ing gener­ics with the branded medicines, it is just not the con­tent of the in­gre­di­ent, it is the pu­rity and the con­cen­tra­tion pro­duc­ing ef­fec­tive bi­o­log­i­cal lev­els in the blood. An­other fall­out of the pro­posed change would neg­a­tively in­cen­tivise pharma com­pa­nies to in­vest in R&D. Not only it will cre­ate huge un­em­ploy­ment is­sues but will greatly ham­per cre­ation of newer mol­e­cules.

I strongly urge the con­cerned au­thor­i­ties to first set their house in or­der and cre­ate a lo­cal frame­work free of cor­rupt prac­tices to pro­vide qual­ity in generic drug test­ing and also cre­ate strin­gent process of is­su­ing li­censes.

Once this is avail­able, the Gener­ics would ob­vi­ously be as good as the so called branded. That would be a win-a-win situation for ev­ery­one.

(Dr. Ashok Pana­gariya is Pro­fes­sor Emer­i­tus and for­mer Vice Chan­cel­lor of Ra­jasthan Medical Univer­sity and a Padma Awardee. Views ex­pressed are per­sonal)

The NPPA can al­ways re­duce the max­i­mum re­tail price and leave very lit­tle room for ma­nip­u­la­tion by the pharma com­pa­nies. Gov­ern­ment could also con­sider in­tro­duc­ing uni­form code of mar­ket­ing for bring­ing down the cost of medicines

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