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While there is prevailing laxity in regulation of medical devices, the argument that the country lacks adequate regulations to take global pharmaceutical major Johnson & Johnson (J&J) to task over its faulty hip implant is ridiculously unreasonable, say industry experts.
As many as 4,700 patients in India received acetabular surface replacement (ASR) hip implants manufactured by J&J offshoot DePuy Orthopaedics between June 2004 and August 2010, until a global recall over concerns that the metallic implants could leak toxic cobalt and chromium into patents' bodies.
But it was only in 2017, seven years after the global recall, that the Indian government formed an expert committee to examine the problems with the device. The report was made public only last week after a lot of pressure from distressed patients. Since then, a central panel has been constituted to determine the compensation for patients who suffered.
“It is a clear case of regulatory failure. In fact, Section 17A and 17B of the Drugs and Cosmetics (D&C) Rules of 1940 have adequate provisions to take on companies that sell adulterated products or faulty devices. Those who say that it is impossible to consider a faulty medical device as ‘spurious’ or ‘adulterated’ drug are looking for legal loopholes. There are several instances where action has been taken against negligent manufacturers under these sections. The regulators should stop passing the buck,” former drug controller of Haryana Dr GL Singhal told Pharmabiz.
The expert panel has also acknowledged in its report that there is no provision as such for compensation to patients for faulty medical devices in the D&C Act, only fines and prosecution which can be initiated by the drug inspector or consumer associations, not patients. However, many domestic medical device manufacturers refuse to buy this view.
“Ask these drug regulators what they would have done if this was a domestic manufacturing company. They use these sections (17A and 17B) to harass us all the time. Now all of a sudden it is not applicable to medical devices,” a manufacturer said on condition of anonymity.
In its report, the panel observed that DePuy “appeared to have suppressed certain facts about the implants” from Indian regulators. It recommended that eligible patients should receive a "base amount" of Rs.20 lakh as compensation, and proposed mechanisms to identify eligible patients.
“Quality has to be guaranteed during lifetime of product -- in case of implant, the claimed life of implant. The high number of failure indicates substandard quality by way of product design and/or material used for intended purpose that caused blood poisoning in a high number of cases,” Association of Indian Medical Device Industry (AIMED) Forum Coordinator Rajiv Nath pointed out.
Legal experts have opined that the patients can invoke the Consumer Protection Act to claim damages. They can approach State Consumer Forum in Mumbai or the National Consumer Redressal Forum in New Delhi. The National Forum has the authority to hear all the cases together which have several common issues.
The government’s decision to constitute a Central committee and state panels to determine the compensation for patients has brought a ray of hope for patients. But majority of patients remain untraceable and won’t be able to access compensation until they are found.
“The track record of the government on transparency and accountability to patients in the process leading up to this has been abysmal. Moving forward from here, we need uttermost transparency. We ask that there is participation of patients in committees. Else this would lack credibility,” Vijay Vojhala, a Mumbai-resident who suffered due to the faulty implant, said.
The Campaign for Affordable and Dignified Healthcare (CADH), a forum of patients, civil society groups and health experts, calls for a system to be put in place for all devices and drugs that lead to adverse events after approval.
“Coming after unconscionable delay by the CDSCO, which has prolonged suffering of patients, we hope the compensation mechanism is enforceable. In fact the regulator should not have allowed a voluntary recall but rather a mandatory recall based on the high failure rate. It remains to be seen whether the compensation will be ‘just compensation’ as recommended by the expert committee as the quantum is likely to fall much short of what J&J compensated patients in the US,” the CADH said in a statement.
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