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States yet to form panels to determine quantum of compensation in J&J hip implant imbroglio despite ministry directive
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Arun Sreenivasan, New Delhi
September 15 , 2018
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Though the Drug Controller General of India (DCGI) issued a public notice on September 11 asking all Indians who received the faulty hip implants of Johnson and Johnson (J&J) to approach central or state committees, most states and union territories are yet to form such panels to determine compensation for patients, it is learnt.
The DCGI notice is aimed at tracking all patients who received the faulty acetabular surface replacement (ASR) hip implants imported and marketed in India between 2006 and 2010 by J&J.
The health ministry formed a central committee and directed states to constitute panels so that aggrieved patients can easily approach them in their respective states. The ministry issued the order on August 30 in the wake of an expert committee report submitted to the government in February. “The patients can also be given preference to approach either of the two committees (central or state),” the circular stated.
In its letter, the ministry asked health secretaries of all states to constitute committees comprising two orthopaedic surgeons, one radiologist from the government medical college and a representative from the zonal office of drug regulator.
However, in most states, this state-level committee is still nonexistent and the drug controllers are yet to receive official communication on the matter. “We haven’t formed a panel yet and there is no official communication from the ministry regarding this,” Atul Kumar Nasa, Deputy Drug Controller at Delhi drugs control department, told Pharmabiz. Senior officials from Haryana, UP and Bihar drug control departments have also said the panel is not yet functional.
According to patient advocacy groups, the delay to form state panels is detrimental to the victims’ efforts to get justice from the pharmaceutical major as the central committee is expected to review the report of the state-level committees along with documents submitted by the patients before finalising the quantum of compensation.
The DCGI’s notice is urging patients to reach out to central or state panels. “Affected patients who are implanted faulty ASR hip implant suffering from disability and other issues may approach either the central expert committee or the state level committee. For reaching the central committee patients can email to legalcell@cdsco.nic.in. To approach state committees they can write to state drugs controllers who will be the member secretaries for the state level committee constituted to compensate patients affected by ASR hip implants in India," the notice says.
The Central committee to determine the quantum of compensation to patients is headed by RK Arya, Director at Safdurjung Hospital Sports Injury Centre. Two orthopaedic doctors, one professor of pharmacology and one law professor are the other members.
As many as 4,700 patients in India had received ASR hip implants manufactured by J&J subsidiary DePuy Orthopaedics Inc 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 and pose a risk to their health.
The expert panel had observed that the company 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. The report was made public after pressure from patients and several media reports on the issue.
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