Even after knowing about the faulty hip implants of Johnson and Johnson, it took almost two years for the Indian authorities to suspend its licence and impose a ban on its import, reveals the official records by obtained by a leading publication.
Further, the report says that the company recalled its implant globally on August 24, 2010, and the Central Drugs Standard Control Organisation, which comes under the Ministry of Health and Family Welfare, was informed about it the same year, reports The Indian Express.
As many as 3,600 patients had undergone the implant surgeries, but could not be traced leading to delay in cancelling the licence.
While the licence of the device, ASR XL Acetabular Hip System and ASR Hip Resurfacing system, was renewed in 2010 ahead of the global recall, the warning bells had begun to ring as early as 2009. The Australian regulators had then flagged it red and withdrew the product the same year.
"That should be investigated in the public interest and accountability fixed," Mahesh Zagade, former Maharashtra FDA told IE when asked about the reason for the delay.
The device was first introduced in India in 2006. Since then, at least 4,700 surgeries have been performed and according to Johnson and Johnson's own admission, there were 121 "serious adverse events" between January 2014 and June 2017, the report said.
As per the documents, the then Drug Controller General G N Singh issued a show-cause notice to the firm on April 11, 2012 asking it "to stop import" of the device "with immediate effect till further orders in public interest." The implant was alleged of violating the Drugs and Cosmetics Act.
Before this, the Joint Commissioner, Food and Drugs Agency, Maharashtra, had filed a complaint to the regulator body stating that the firm has not taken any remedial measures and also did not inform patients about the ill-effects due to these defective implant.
