How to Avoid a Bad Trip

The Economic Times - - The Edit Page - Di­nesh S Thakur

When Prime Min­is­ter Naren­dra Modi had an­nounced the am­bi­tious ‘Make in In­dia’ agenda on Au­gust 15, 2015, he was care­ful to in­clude a sec­ond mis­sion state­ment: ‘Zero De­fect, Zero Ef­fect’. “We should man­u­fac­ture goods in such a way that they carry zero de­fect and that our ex­ported goods are never re­turned to us. We should man­u­fac­ture goods with zero ef­fect that they should not have a neg­a­tive im­pact on the en­vi­ron­ment,” he had clearly stated.

The truth of the mat­ter, as re­ported in ET (, is that the US Food and Drug Ad­min­is­tra­tion (USFDA) re­jected 13,334 In­dian-made food and drug prod­ucts over the last five years, just slightly less than the 15,087 re­jected Chi­nese-made prod­ucts, de­spite the fact that China is the US’ third-largest trad­ing part­ner, while In­dia is the 11th. In ad­di­tion to the re­jec­tions, the USFDA has slapped im­port bans on ap­prox­i­mately 44 phar­ma­ceu­ti­cal man­u­fac­tur­ing plants lo­cated in In­dia be­cause of poor com­pli­ance with good man­u­fac­tur­ing prac­tices.

The story re­gard­ing In­dian food and drug ex­ports to Europe is no bet­ter. Ac­cord­ing to data avail­able on the Euro­pean Com­mis­sion’s web­site, the coun­tries con­sti­tut­ing the Euro­pean Union (EU) re­jected con­sign­ments, is­sued alerts or sought more in­for­ma­tion in a to­tal of 1,431 cases of im­port of food or agri­cul­tural prod­ucts from In­dia dur­ing 2011-16 due to con­tam­i­na­tions or in­fes­ta­tions or use of pro­hib­ited sub­stances such as an­tibi­otics.

In 2014, the Euro­pean Com­mis­sion’s Stand­ing Com­mit­tee on Pub­lic Health im­posed an im­port ban on a range of farm prod­ucts like Alphonso man­goes, egg­plant, taro plant, bit­ter gourd and snake gourd, be­cause of con­tam­i­na­tions and in­fes­ta­tions. In 2015, the EU can­celled 700 drug ap­provals be­cause the sup­port­ing safety data gen­er­ated at GVK Bio was sus­pected of be­ing ei­ther ma­nip­u­lated or fab­ri­cated.

What is the govern­ment do­ing to rec­tify the sit­u­a­tion? Min­is­ters un­der pres­sure to show growth of in­dus­tries are ei­ther in de­nial or choose to ig­nore the qual­ity is­sue. For ex­am­ple, last year, Union food pro­cess­ing min­is­ter Har­sim­rat Kaur Badal com­plained that the Food Safety and Stan­dards Au­thor­ity of In­dia was a new ‘in­spec­tor raj’ threat­en­ing the govern­ment’s ‘Make in In­dia’ ini­tia­tive, stalling over­seas in­vest­ment and killing in­no­va­tion. Her col­league Nir­mala Sithara­man, the min­is­ter of com­merce, re­sponded to the GVK Bio is­sue by first can­celling long-pend­ing trade talks with the EU be­fore re­vers­ing that de­ci­sion and agree­ing to speak to the EU.

The main ve­hi­cle for Modi’s ‘Zero De­fect, Zero Ef­fect’ cam­paign is the Qual­ity Coun­cil of In­dia (QCI), an au­ton­o­mous in­sti­tu­tion set up by the de­part­ment of in­dus­trial pol­icy and pro­mo­tion (Dipp) in 1996 with the stated mis­sion of im­prov­ing “qual­ity stan­dards in all im­por­tant spheres of ac­tiv­i­ties in­clud­ing ed­u­ca­tion, health­care, en­vi­ron­ment pro­tec­tion, gov­er­nance, so­cial sec­tors, in­fras­truc­ture sec­tor and such other ar­eas of or­gan­ised ac­tiv­i­ties”. In the last few years, the QCI has main­tained a blessed si­lence on the se­vere qual­ity is­sues be­ing faced by the phar­ma­ceu­ti­cal in­dus­try de­spite the fact that the in­dus­try’s rep­u­ta­tion is tak­ing a beat­ing on the in­ter­na­tional scene be­cause of a se­ries of scan­dals.

More wor­ry­ingly, since its in­cep­tion, the QCI’s em­pha­sis has been on cre­at­ing vol­un­tary ac­cred­i­ta­tion schemes such as the Na­tional Ac­cred­i­ta­tion Board for Hos­pi­tals and Health­care Providers and the Na­tional Ac­cred­i­ta­tion Board for Ed­u­ca­tion and Train­ing. Modi’s call for ‘zero de­fects’ led the QCI to merely cre­ate a new cer­ti­fi­ca­tion scheme, called ‘ZED Cer­ti­fi­ca­tion’ for the mi­cro, small and medium en­ter­prises (MSME) in­dus­try.

The ZED cer­ti­fi­ca­tion is de­scribed as “an in­te­grated and holis­tic cer­ti­fi­ca­tion sys­tem that will ac­count for qual­ity, pro­duc­tiv­ity, en­ergy ef­fi­ciency, pol­lu­tion mit­i­ga­tion, fi­nan­cial sta­tus, hu­man re­source and tech­no­log­i­cal depth in­clud­ing de­sign and IPR [in­tel­lec­tual prop­erty rights] in both prod­ucts and pro­cesses”. Given the dif­fi­culty the govern­ment faces in en­forc­ing manda­tory laws, it is doubt­ful whether vol­un­tary ac­cred­i­ta­tion schemes are the best way to in­crease qual­ity stan­dards.

More prob­lem­at­i­cally, in the con­text of food and drugs, there is lit­tle dis­cus­sion ei­ther at the QCI or within the govern­ment on how best to tackle the cur­rent night­mar­ish sce­nario posed to pub­lic health in In­dia and what we ex­port. As high­lighted by the food min­is­ter’s and com­merce min­is­ter’s words and ac­tions, it is un­re­al­is­tic to be­lieve that min­istries re­spon­si­ble for the growth of in­dus­try are go­ing to ini­ti­ate a con­ver­sa­tion on qual­ity con­trol.

The country needs the con­ver­sa­tion to be­gin from out­side the govern­ment. The QCI is in a unique po­si­tion to re­de­fine its mis­sion and lead the charge. It is high time it does so.

The writer is ex­ec­u­tive chair­man, Medas­sure Global Com­pli­ance Cor­po­ra­tion

Uh-oh, I just popped a pill made in In­dia

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