Im­plant im­plo­sion

The poorly reg­u­lated med­i­cal im­plant sec­tor is a scan­dal wait­ing to be­come tragedy. Pol­i­cy­mak­ers need to act

The Hindu Business Line - - THINK -

Are­cent in­ves­ti­ga­tion spear­headed by the In­ter­na­tional Con­sor­tium of In­ves­tiga­tive Jour­nal­ists — an um­brella body that in­cludes in­ter­na­tional news or­gan­i­sa­tions in 36 coun­tries, in­clud­ing The In­dian Ex­press in In­dia — has ex­posed the chill­ing lack of ac­count­abil­ity of the med­i­cal de­vices in­dus­try. In the In­dian con­text, the find­ings ex­pose the nexus be­tween im­plant mak­ers, health fi­nance play­ers and doc­tors, as they chase tar­gets at the ex­pense of vul­ner­a­ble, un­sus­pect­ing pa­tients. Qual­ity lapses are not read­ily ac­counted for (be it knee im­plants, hip im­plants, pace­mak­ers or in­tra-uter­ine de­vices) be­cause for pa­tients, there is no clear agency to deal with such sit­u­a­tions. With surg­eries be­ing per­formed, as the Ex­press re­ported, in “base­ment op­er­at­ing the­atres of DDA flats”, it is clear that the reg­u­la­tory sys­tem has failed. For an in­dus­try that is val­ued in In­dia at $5.2 bil­lion and is grow­ing at 16 per cent an­nu­ally, with im­ports ac­count­ing for 80 per cent of all sales, this is a grim state of af­fairs. The reg­u­la­tory fail­ure is ev­i­dent at var­i­ous lev­els: in the test­ing of the im­plants; in in­form­ing the pa­tient of the con­se­quences and mak­ing her aware of her rights; and in the com­pen­sa­tion mech­a­nism. In the case of J&J, In­dia’s drugs reg­u­la­tor was slow to re­act to the global re­call and es­tab­lish the ex­tent of dam­age. The wran­gling over com­pen­sa­tion con­tin­ues be­cause there are no clear norms laid down un­der the Drugs and Cos­met­ics Act, 1940 and the Med­i­cal De­vices Rules, 2017 for such even­tu­al­i­ties. Hence, while 8,000 US pa­tients have been awarded $2.5 bil­lion for hip im­plants gone awry, which works out to about ₹2 crore per pa­tient, in In­dia the com­pen­sa­tion lev­els are set to vary from ₹30 lakh to ₹1.2 crore. How­ever, it ap­pears that as a re­sponse to the pub­lic out­cry over faulty hip im­plants on 4,700 pa­tients in In­dia, some reg­u­la­tory changes are in the off­ing.

The Med­i­cal De­vices Rules, 2017 may be mod­i­fied to in­clude com­pen­sa­tion as­pects, with a com­mit­tee look­ing into the is­sue. So far, com­pen­sa­tion sums have been ar­rived at on the ba­sis of dam­ages laid down in clin­i­cal trial reg­u­la­tions. This is in­ap­pro­pri­ate, as a pa­tient or in­di­vid­ual who sub­mits her­self to clin­i­cal tri­als can­not be equated with one who ac­tu­ally needs an im­plant and opts for a trusted prod­uct. The rules rightly cat­e­gorise de­vices into var­i­ous cat­e­gories of risk and spell out reg­u­la­tory re­quire­ments for each. How­ever, over-reliance on cer­ti­fi­ca­tion from the US, EU or Ja­pan for im­ported prod­ucts may re­quire to be re­viewed.

There can be no get­ting away from dou­ble stan­dards in com­pen­sa­tion for In­dian lives lost in med­i­cal tragedies. From the Bhopal gas tragedy of 1984 to J&J im­plants 35 years later, it’s a tale of deja vu. This can­not carry on.

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