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Monday, October 19, 2020

Submit status of global compensation: DCGI tells J&J

Despite two written requests by the state FDA, the request has not been approved in the last six months.

Written by Tabassum Barnagarwala | Mumbai | December 23, 2014 1:52:29 am

Taking cognisance of a three-year-old ‘faulty’ hip implants case of pharmaceutical giant Johnson and Johnson Company, the Drug Controller General of India (DCGI) has directed the company to present the status of global compensation offered by them and action taken for victims, following a complaint by a Mumbai-resident who underwent the implant and suffered medical complications.

In October and November this year, Vijay Vojhala (40) sent letters to DCGI and the Ministry of Health and Family Welfare (MoHFW) to draw their attention towards the alleged faulty metal-on-metal Articulate Surface Replacement (ASR) implant that 4,500 Indians had undergone until 2010, when J&J finally recalled all its implants globally. The DCGI, a week ago, forwarded Vojhala’s complaints to J&J and demanded an action report on the case.

In reply to an email query by Newsline, J&J’s spoekesperson said, “We confirm receiving a letter from DCGI seeking certain details relating to the ASR product and requesting clarifications pertaining to an email recently sent to them (DCGI) by a patient in India. Patient safety is our top priority, and since the ASR recall decision was made in August 2010, DePuy has kept DCGI informed of all key actions and has worked to provide patients and surgeons with the information and support they need. In this instance also, we will be providing our response to DCGI shortly.”

In 2010, the pharma giant and its Indian subsidiary, Depuy Medical Private Limited, recalled 1,295 ASR implants from India following a global outcry on the metal toxicity caused by the implant due to leaching of cobalt and chromium ions into the body. While in December 2013, J&J paid a significant compensation of $2.5 billion or Rs 15,000 crore to 8,000 American litigants, in India, the case is still under investigation for the past three years with the Mahim police.

“I decided to file a consumer case against the company and its subsidiary as we have been given no compensation so far in this case. Ever since I underwent the implant in 2008, my medical condition has worsened,” said Vojhala, a Dombivali resident.

According to Vojhala’s medical reports, there was a chromium deposition of 85.8 parts per billion (ppb) and cobalt deposition of 171.8 ppb in his blood, dangerously above the normal levels of seven ppb in blood.

Despite two written requests by the state Food and Drug Administration (FDA) to the state home department to transfer the case to the Central Bureau of Investigation (CBI), the request has not been approved in the last six months. State’s Additional Chief Secretary (Home), Amitabh Rajan, said, “It’s an old case. It is being actively probed.” Rajan, however, refused to comment on whether the case will be handed over to CBI. Meanwhile,Mahim Police is now awaiting a report on medical effects of the implant from state-run JJ Hospital.

J&J’s spokesperson, in their email reply, also said that in India, till date, approximately 175 patients have undergone revision surgery, “which have been registered and supported by the reimbursement system set up by DePuy.”

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