DCGI issues notice to trace 4,700 patients with J&J hip implants

Aditi Tandon

Tribune News Service

New Delhi, Sept 11

The government has begun its search for all Indians who received the faulty ARS system hip implants imported and marketed in India between 2006 and 2010 by the multinational giant Johnson and Johnson.

The Drug Controller General of India S Eswara Reddy tonight issued a public notice asking all Indians who have ever got these implants to approach the newly constituted central or state level government committees for adequate compensation in the matter.

Johnson and Johnson has so far paid medical damages to only 273 patients who reported revision surgeries on account of faulty implants which are believed to have left several patients debilitated. There is no mechanism to check which all patients got these implants as India has no national registry for orthopaedic implants or other high risk medical devices. The Government plans to have such registries soon.

The DCGI notice says, "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 wrote 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 said.

J&J implanted around 4,700 Indians with ASR hip systems between 2006 and 2010. After 2010 the firm voluntarily recalled its product following evidence of revision surgeries needed in many cases.

The Ministry of Health last year constituted an expert panel to look into the damages caused by ASR hi implants in Indian patients after patients of faulty surgeries directly approached the office of apex drug regulator. The committee recommended a formula for compensating all patients depending on degrees of damages and said each patient must anyway be paid Rs 20 lakh base compensation plus more depending on disability caused.

The central and state committees have now been formed by DCGI to determine the quantum of compensation for all patients who received faulty hip implants. The exercise involves tracing patients and assessing any damages they may have suffered after their hip replacement surgeries using J&J products.

J&J earlier recalled the same implants from markets in Australia, US and Canada.