The Drug Controller General of India (DCGI) has come down hard on Johnson and Johnson Private Ltd (J&J). In a string of communication, the DCGI has asked the company to explain what it was doing to ease the process of compensation for patients who had undergone a re-surgery in cases where the controversial Articular Surface Replacement (ASR) hip implant was used.

While 289 claimants raised demands for compensation with DCGI, the authority, while vetting, found that only 93 of the claims were valid.

“J&J, in the Delhi High Court, voluntarily agreed to pay ₹25 lakh each to 67 of these patients. We will write to the company demanding to know as to what happened to the rest of the 26 claims,” a senior DCGI official told BusinessLine.

The court on May 30 fixed a two-week deadline for J&J to make interim payment to patients, which ends on June 14.

The payments are non-refundable and interim, as the court is mulling over the government-appointed RK Arya committee’s formula of providing a compensation of between ₹30 lakh-₹1.23 crore to patients, which J&J has legally challenged.

Despite the fact that the DCGI has received up to 93 claim requests from patients, J&J already has a list of 295 patients who, as per the company’s records, underwent the ASR-related re-surgery.

While every patient who has undergone re-surgery needs to be paid a minimum of ₹25 lakh, officials at the DCGI said that they do not understand why the company was not initiating the process of compensation on its own, and waiting for the authority to send in names.

Tracking patients

Furthermore, while J&J had supplied ASR implants for a total of 4,700 surgeries in India between 2006-2010, it has maintained data of only 1,800 patients. “We are asking the company what steps have they taken to track and trace the whereabouts of the rest of the 2,900 patients, who remain out of bounds till date,” said the official.

J&J had recalled the ASR implants after the failure rate in patients was as high as 30 per cent.

The failed implant led to leaching of chromium and cobalt in the patient’s blood stream as the implant wore off.

This has led to various levels of disabilities in patients where implants failed and even deaths in multiple cases.

DCGI S Eswara Reddy confirmed the orders, and told BusinessLine : “While the court matter is sub-judice, we are taking appropriate action in compliance to court orders.”

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