A Central Expert Committee to examine the faulty ASR hip-implants issue and determine the compensation and medical management for affected-patients, has been reconstituted by the Union Health Ministry.
The ASR hip-implants in this case were manufactured by DePuy lnternational Limited, UK and imported by DePuy Medical Private – now Johnson & Johnson Private Limited, the Ministry said.
The development comes about 15 years after product-related complaints across the world led to a global recall by the company in 2010. The recast committee is now chaired by Dr Ajay Kumar Shukla, Professor of Orthopedics, RML Hospital, New Delhi.
“The affected patients who were implanted with faulty ASR Hip lmplant and are suffering from disability and other losses may approach either (the) Central Expert Committee or State Level Committee as per their convenience,” said a public notice from the Ministry signed by the Drugs. Controller General of India (DCGI). Affected patients who had already submitted claim applications before the State/UT Level Committee or Central Expert Committee, need not file fresh claim applications, the note said. Patients were also directed to the State Level Committee, for convenience.
In 2010, Depuy had undertaken a voluntary global recall of its ASR Hip System and, in 2013, it made a payment of $2.5 billion to about 8,000 patients in the US.
Local complaints
Patient complaints on the faulty product were flagged in India too, by patients and then Maharashtra Food and Drug Administration (FDA) Commissioner Mahesh Zagade, who escalated the issue to the DGCI’ office. The Maharashtra FDA chief had called for patient compensation in 2013.
Over the years, the issue has been through Government and legal scrutiny. Recent reports indicate, the company had been directed to pay Rs 35 lakh each, to two women who had allegedly suffered due to the faulty hip implants.