Med­i­cal de­vices sec­tor still waits for reg­u­la­tion

13 years have gone but a com­pre­hen­sive reg­u­la­tory frame­work is elu­sive

The Hindu Business Line - - PULSE - PT JYOTHI DATTA

Thir­teen years. That’s how long it has been since a di­rec­tion was given to the In­dian health au­thor­i­ties to have a com­pre­hen­sive frame­work for med­i­cal de­vices.

In a case in­volv­ing drug-elut­ing stents be­ing heard at the Bom­bay High Court in Septem­ber 2005, then Chief Jus­tice did not just ex­press shock that med­i­cal de­vices like a heart valve or pace­maker, for in­stance, were not cov­ered by do­mes­tic, safety-re­lated reg­u­la­tions. He also di­rected the Cen­tral and State reg­u­la­tory ma­chin­ery to reg­u­late these prod­ucts.

The is­sue has been sim­mer­ing since, flar­ing up oc­ca­sion­ally. In 2010, Johnson and Johnson’s (J&J) DePuy Or­thopaedics vol­un­tar­ily re­called its faulty ASR Hip Sys­tem, glob­ally. And act­ing on a lo­cal pa­tient com­plaint, the Ma­ha­rash­tra Food and Drug Ad­min­is­tra­tion looked into the re­call and the sub­se­quent J&J pay­ment to set­tle pa­tient lit­i­ga­tion in the US (2013).

Eight years since the re­call, as of this week, In­dian pa­tients are still seek­ing re­dress and com­pen­sa­tion for their faulty hip im­plants, as they live with de­bil­i­tat­ing pain and dis­abil­ity.

Such con­cerns re­cently got am­pli­fied on a global scale fol­low­ing an in­ves­ti­ga­tion into med­i­cal de­vices by me­dia en­ti­ties. The re­portage re­vealed the opaque­ness around this in­dus­try.

Back in In­dia, failed prom­ises and in­dus­try data nar­rate the med­i­cal de­vice evo­lu­tion story. Just 23 of 5,000 prod­uct cat­e­gories are presently cov­ered by any reg­u­la­tion. And in­dus­try es­ti­mates peg the en­tire mar­ket at $10 bil­lion or an es­ti­mated ₹70,000 crore. On its part, the Cen­tre did im­ple­ment the Med­i­cal De­vice Rules, from Jan­uary 1, 2018. But this falls short of a 2015 prom­ise to have a sep­a­rate min­istry for phar­ma­ceu­ti­cals and med­i­cal de­vices — an as­sur­ance given by late Ananth Ku­mar, then Minister of Chem­i­cals and Fer­tilis­ers, the min­istry over­see­ing medicines and de­vices.

In­dus­try representatives also point to the shift from ini­tial dis­cus­sions, where pol­i­cy­mak­ers had agreed on treat­ing med­i­cal de­vices as dif­fer­ent from drugs. Med­i­cal de­vices con­tinue to be un­der the Drugs and Cos­met­ics Act 1940 and in­dus­try representatives are push­ing for a com­pre­hen­sive reg­u­la­tion that views med­i­cal de­vices sep­a­rately, through the en­tire life-cy­cle of the prod­uct, from de­sign to tests on pa­tients, in­cor­po­rat­ing doc­tor feed­back, and sur­veil­lance of pa­tients in whom the im­plants are used, etc.

This be­comes crit­i­cal in a prod­uct re­call, for ex­am­ple. Sev­eral global prod­uct re­calls see lit­tle or no fol­low-throughs in In­dia. In­stead of be­ing proac­tive, com­pa­nies shield them­selves be­hind in­ad­e­quate reg­u­la­tions and by keep­ing the drug reg­u­la­tory au­thor­i­ties “in­formed”.

De­vices, not drugs

“De­vices are not medicines made from a ho­mo­ge­neous chem­i­cal batch with very long life­cy­cles but usu­ally an assem­bly of pre­ci­sio­nengi­neered com­po­nents with an ever-evolv­ing, in­no­va­tive, short­term prod­uct life­cy­cle,” ex­plains Ra­jiv Nath, with the As­so­ci­a­tion for In­dian Med­i­cal De­vice In­dus­try (AiMED). Be­sides, pa­tient safety is more com­plex with de­vices, he says, where it is “a shared re­spon­si­bil­ity of the man­u­fac­turer, med­i­cal prac­ti­tion­ers, prod­uct user and the reg­u­la­tor.”

Stress­ing the need to de-link med­i­cal de­vices from phar­ma­ceu­ti­cals, Ad­vaMed’s Abby Pratt says, “there is no need to rein­vent the wheel here”, as there are global bench­marks and a task force to help har­monise rules.

Pratt rep­re­sents for­eign de­vice mak­ers and re­ply­ing to the global in­ves­ti­ga­tion, she says it gave the in­dus­try an op­por­tu­nity to ex­plain the na­ture of their prod­ucts and chal­lenges. For in­stance, re­port­ing ad­verse events on a prod­uct was not a neg­a­tive fea­ture. Such feed­back is used by the man­u­fac­turer to in­no­vate fur­ther and bring out a bet­ter, safer prod­uct, she ex­plains. Prod­ucts with global cer­ti­fi­ca­tions leave a trail in terms of reg­is­tra­tions, etc, she says, cau­tion­ing on lo­cal com­pa­nies who sold prod­ucts with­out hav­ing even reg­is­tra­tions.

Will­ing­ness ab­sent

For­mer Ma­ha­rash­tra FDA Com­mis­sioner Ma­hesh Za­gade says med­i­cal de­vices are not strin­gently reg­u­lated be­cause of the “lack of will­ing­ness,” at ad­min­is­tra­tive/po­lit­i­cal lev­els. “Money”, he al­leges, pre­vents the sys­tem from act­ing in pa­tient in­ter­est and hold­ing com­pa­nies ac­count­able. Za­gade had pro­ceeded against J&J on the faulty hip im­plants (2013).

The Cen­tre ‘s re­cent com­mit­tee for pa­tient com­pen­sa­tion could have been done when the is­sue first sur­faced years ago, he says. The laws are ad­e­quate and Cen­tral reg­u­la­tors could have done much more, if they wanted to, he adds. His pre­scrip­tion for greater op­er­a­tional trans­parency is for pa­tients and civil so­ci­ety to pres­sure their elected representatives to ask ques­tions of the ad­min­is­tra­tion and get them to work in the in­ter­est of pa­tients.

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