Stunted stents PDF Print E-mail
Wednesday, 28 November 2018 04:06
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Sarthak edit

The Indian Express (IE) report on the exposé by the International Consortium of Investigative Journalists (ICIJ)—IE is a part of the ICIJ—on the Indian market being plied with poor quality and over-priced medical devices puts forth some alarming details. First and foremost, there has been a steady increase in device-related complications in patients who received implants—from coronary stents to breast implants. While the Indian Pharmacopoeia Commission (IPC) data shows “medical device adverse events” rose from 40 in 2014 to 556 this year, bellwether medical device manufacturer Abbott, which had withdrawn its top-end coronary stents from the Indian market in a very well publicised response to the price caps set by the government, is linked to as many as 290 adverse events of the 556 this year. The lack of strong regulation, IE says, has let Johnson & Johnson (J&J), Medtronic, etc, flout standards that are mandatory in many developed jurisdictions and indulge in practices that are outlawed in these jurisdictions. J&J, for instance, has failed to trace 3,600 Indian patients of the 4,700 who received a toxic hip implant marketed in India by the pharma major even after eight years of the product being recalled globally and is yet to start paying compensation to even those who are now on its records. Amazingly, Medtronic, through NBFCs and NGOs, was offering financing for implant-surgeries.

But, surely a J&J/Medtronic/Abbott alone is not to blame, nor pharma companies as a whole? The chief reason why these companies have managed to get away with shoddy standards and dubious practices is poor regulation. For instance, the Indian regulatory architecture—involving the IPC that maintains data pertaining to adverse events and the Central Drugs Standard Control Organisation (CDSCO) that is the drugs and devices standards regulator—has failed to make public the details of devices recalled from the Indian market. While the CDSCO, as per the IE report, says it is yet to be informed by IPC of any “pattern” emerging from the adverse events, it maintains that it doesn’t want to “create a panic among the people” even when it does receive information. There are many other regulatory gaps—with standards of adverse-event reporting poor to begin with and the culture of reporting still to get a steady foothold, the reports themselves are of poor quality. A big part of the problem is that the IPC has not posted scientific associates at the monitoring centres as required. There is also very poor reporting from the metros—where the bulk of device-implants would likely be taking place—with doctors and surgeons averse to reporting malfunction. How the culture of pharma company incentives—and a doctor’s fear of implicating herself via reporting malfunctions—ties in with this is anybody’s guess. But, the over-arching problem is one of absent legislation. While there is no Act exclusively governing devices, the irony is that while the regulatory focus has been on prices, the real issues have been of quality.



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