Business Standard

Negligence on faulty implants

Guilty must be held accountabl­e

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An expert committee report on faulty hip prosthetic­s sold by a subsidiary of the US firm Johnson & Johnson has revealed incriminat­ing details about its negligence in dealing with Indian patients. The report, commission­ed by the Union health ministry in 2017, was published this week. Though it restricts its criticism to J&J, the report makes it clear that the Central Drugs Standard Control Organisati­on also failed in its job of protecting Indian patients. It began in 2006, when DePuy Internatio­nal Ltd., a subsidiary of J&J, registered three types of articular surface replacemen­t implants with the CDSCO. By 2007, the first indication that something was wrong came from the Australian Orthopaedi­c Associatio­n National Joint Replacemen­t Registry. It emerged that the device was leaking cobalt and chromium, causing sideeffect­s. Australia recalled the product in 2009.

Yet, the report says, J&J did not inform the Indian regulator and Indians kept using the implants until the firm began a voluntary global recall in 2010. J&J paid $2.47 billion in claims to about 8,000 patients in the US, but no Indian patient received compensati­on. Though the global recall occurred in 2010, the drug regulator did not issue an alert until 2013. The authoritie­s must show that when private corporatio­ns fail to protect patient interests, they will be held accountabl­e.

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