San­jeev Gupta, Manag­ing Di­rec­tor, Kusum Group of Com­pa­nies, In­dia

BioSpectrum (India) - - BIO CONTENT - San­jeev Gupta, Manag­ing Di­rec­tor, Kusum Group of Com­pa­nies, In­dia

In­dian pharma should fo­cus on qual­ity

In­dian pop­u­la­tion has been suf­fer­ing from long with lower stan­dard cheap drugs with re­duced or no ef­fi­cacy. It is only right that the best qual­ity prod­ucts is made avail­able first to the na­tion and then be ex­ported else­where. This will also help off­shore com­pa­nies to in­vest heav­ily in In­dia, not­ing the vol­ume that In­dia drives.

If not that ram­pantly in the de­vel­oped coun­tries, but def­i­nitely in the de­vel­op­ing coun­tries, and es­pe­cially in In­dia, ac­cess to medicines comes first, even ear­lier than the ac­cess to health­care fa­cil­i­ties or doc­tors. This essen­tially means that come ill­ness, most likely one would swal­low a pill first and then visit a doc­tor, if at all felt nec­es­sary.

In a state where con­sump­tion of medicines takes such prece­dence, the qual­ity stan­dard of drugs need to be the pri­mary fo­cus area for the phar­ma­ceu­ti­cal in­dus­try. Not that the in­dus­try en­cour­ages the un­reg­u­lated con­sumer habits of pur­chas­ing over the counter drugs, but the onus of man­u­fac­tur­ing high qual­ity medicines with fewer ad­verse ef­fects has to be the borne by the phar­ma­ceu­ti­cal in­dus­try.

When com­pos­ing a medic­i­nal drug, the most im­por­tant con­sid­er­a­tions in­vari­ably are iden­tity and pu­rity. The slight­est de­vi­a­tions from the set norms com­plied by the orig­i­na­tor can be dam­ag­ing to masses, if the same goes unchecked dur­ing the re­search and de­vel­op­ment process.

The creation and ac­ces­si­bil­ity of com­pre­hen­sive phar­ma­copoeias them­selves is a mat­ter of much care and com­plex­ity. It is of the wider pub­lic knowl­edge and un­der­stand­ing that ex­port qual­ity of prod­ucts nonex­clu­sive to phar­ma­ceu­ti­cal drugs is dif­fer­ent to what is ei­ther im­ported or sold in­ter­nally. In prod­ucts as es­sen­tial as medicines, it be­comes all the more im­por­tant to eval­u­ate the qual­ity stan­dards of the drugs ex­ported to those be­ing sold to one’s own cit­i­zens.

Qual­ity Stan­dard of Drugs: Brief Con­text

It is es­ti­mated that 70 per cent of phar­ma­ceu­ti­cal drugs in In­dia is generic, with 9 per cent be­ing ori­ented and 21 per cent be­ing over the counter drugs. The en­tire generic drug in­dus­try is es­ti­mated to be of around $ 30 bil­lion. The phar­ma­ceu­ti­cal in­dus­try is much ex­port ori­ented; how­ever in re­cent years, var­i­ous fac­tors con­trib­uted to an ex­port slump, with ex­port fig­ures drop­ping from $ 6488 mil­lion in 2015 to $ 2082 mil­lion in 2016.

The drop­ping of ex­port fig­ures is re­flec­tive of the var­i­ous chal­lenges faced by the in­dus­try in reestab­lish­ing the In­dian pharma brand and cul­ture as one which is qual­ity ori­ented. In the oth­er­wise flour­ish­ing and grow­ing in­dus­try, qual­ity stan­dard of drugs re­mains the ma­jor burn­ing area.

In­dia has re­mained the largest sup­plier of phar­ma­ceu­ti­cal drugs to United States. Till last year, US Food and Drug Ad­min­is­tra­tion (FDA) had sent 42 warn­ing let­ters to its global man­u­fac­tur­ers of drugs. Nine of those let­ters were di­rected to­wards In­dian fa­cil­i­ties. In light of re­peated con­cerns, US FDA in­spec­tion in In­dia has in­creased by over 20 per cent.

While the other de­vel­op­ing coun­tries in­clud­ing CIS (Rus­sian Com­mon­wealth) na­tions, Latin Amer­i­can na­tions, African Coun­tries have fa­vored In­dia for im­port­ing pharma prod­ucts, keep­ing the im­me­di­ate com­peti­tor, China, fairly be­hind; it is only fair that the rep­u­ta­tion gained of be­ing a qual­ity af­ford­able drugs

provider be sus­tained with con­sis­tent qual­ity de­liv­ery, even though the qual­ity assess­ment pro­ce­dures in these coun­tries may not be as rigid as US FDA.

Chal­lenges and So­lu­tions

It will only be ben­e­fi­cial to the cred­i­bil­ity of the in­dus­try in the longer run if the chal­lenges are iden­ti­fied and a roadmap be worked upon to ad­dress these is­sues in a time bound man­ner. Some of the com­mon chal­lenges that have been ail­ing the in­dus­try in­clude

Low Gov­ern­ment in­vest­ment in health­care.

The gov­ern­ment in­vest­ment in health­care is still shy­ing away to touch the 2 per cent GDP mark, which is not only af­fect­ing the hos­pi­tal in­dus­try but the pharma in­dus­try as well. A 1 to

2 per cent in­crease of in­vest­ment in health­care, and per­haps a min­i­mum ded­i­cated in­vest­ment for phar­ma­ceu­ti­cal in­dus­try, will give the in­dus­try the re­quired boost to strengthen its man­u­fac­tur­ing out­put and up­grade the qual­ity stan­dards across the board.

En­sur­ing bet­ter level play­ing field.

The ex­ist­ing fo­cus has been on pro­mot­ing low-scale in­dige­nous man­u­fac­tur­ing en­ter­prises to push un­branded generic medicines at a much cheaper rate. While the same may seem ben­e­fi­cial for the poorer masses, the same should be al­lowed only when the do­mes­tic en­ti­ties match the qual­ity and uni­form stan­dards those that ex­port to a global con­sumers. Lower qual­ity stan­dard is not only detri­men­tal to the cred­i­bil­ity of the in­dus­try at large but also to the health of the na­tion. A ro­bust qual­ity frame­work for do­mes­tic mar­kets also helps in cre­at­ing larger and bet­ter global im­pres­sion of In­dian phar­ma­ceu­ti­cal in­dus­try as a re­li­able player, as ex­porters nec­es­sar­ily face higher qual­ity com­pli­ance re­quire­ments to main­tain ex­port com­pet­i­tive­ness and in­ter­na­tional cred­i­bil­ity. Reg­u­la­tory author­i­ties such as the Cen­tral Drugs Stan­dards Con­trol Or­ga­ni­za­tion (CDSCO) should be em­pow­ered more to en­sure the com­pli­ance of es­tab­lished law.

An­other im­por­tant ben­e­fit of en­sur­ing level play­ing field is that In­dian pop­u­la­tion has been suf­fer­ing from long with lower stan­dard cheap drugs with re­duced or no ef­fi­cacy. It is only right that the best qual­ity prod­ucts is made avail­able first to the na­tion and then be ex­ported else­where. This will also help off­shore com­pa­nies to in­vest heav­ily in In­dia, not­ing the vol­ume that In­dia drives.

Limit the range of medicines that are sub­ject to price con­trol. Re­search and de­vel­op­ment, cou­pled with the com­plete man­u­fac­tur­ing process, and added qual­ity check­ing mech­a­nisms such as pharma covig­i­lance is a high man­u­fac­tur­ing cost of the fi­nal prod­uct. Ex­tend­ing the num­ber of medicines, which is now 20 per cent of drugs by sales vol­ume, that are sub­jected to price con­trol will ad­versely af­fect the pro­duc­tion of qual­ity prod­ucts in or­der to main­tain sus­tain­abil­ity. High mar­gin com­bi­na­tion drugs will also suf­fer from this.

En­sur­ing ef­fi­cacy of In­dian man­u­fac­tured drugs, data in­tegrity, and hy­giene fac­tors.

These three form one of the strong pil­lars for en­sur­ing qual­ity stan­dards in In­dian drugs. Stronger guide­lines for man­u­fac­tur­ing drugs, due dili­gence in main­tain­ing data in­tegrity, and im­ple­men­ta­tion of strong hy­giene pol­icy from the time of im­port­ing of raw ma­te­ri­als to the time of pack­ag­ing and fi­nal­iz­ing batch for sales, are es­sen­tial el­e­ments to en­sure qual­ity stan­dard.

The Good News

The gov­ern­ment has re­cently pro­vided much hope and pos­i­tiv­ity to the en­tire in­dus­try and the world by ini­ti­at­ing the draft­ing of Phar­ma­ceu­ti­cal Pol­icy 2017, which gives sig­nif­i­cant fo­cus on the qual­ity con­cerns chal­leng­ing the in­dus­try to­day. The draft is yet to ma­ture, but the same will hap­pen when the in­dus­try lead­ers across the board, pol­icy mak­ers, health­care ex­perts, gov­ern­ment, do­mes­tic and pri­vate play­ers, all come on board to en­gage and de­bate se­verely in or­der to re­solve the qual­ity chal­lenges of the in­dus­try. Re­cently, the an­nounce­ment by Drug Con­troller Gen­eral of In­dia (DCGI) to start the sin­gle win­dow fa­cil­ity for pro­vid­ing con­sent, ap­provals, and other in­for­ma­tion will fur­ther ease the process for In­dian man­u­fac­tur­ers, al­low­ing them to fo­cus their en­ergy on other mat­ters. Dig­i­tal in­te­gra­tion of phar­ma­cies will not only ease the flow of drugs with a proper track from one point to an­other but also help reg­u­late phar­ma­cies.

More ini­tia­tives are re­quired at a quicker pace for In­dia to dom­i­nate pharma in­dus­tries of the world, as coun­tries like China are clos­ing on our heels with

many ag­gres­sive mea­sures.

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