GLOBALLY, Johnson & Johnson recalled its faulty hip implant on August 24, 2010 but it took Indian regulators almost two years to ban its import and cancel its licence, official records obtained by The Indian Express reveal.
This despite the fact that the regulator, Central Drugs Standard Control Organisation, which comes under the Ministry of Health and Family Welfare, was informed of the global recall in 2010 itself.
The delay in cancelling the licence assumes significance as the firm told the expert committee — appointed by the Union Health Ministry in February 2017 — that it cannot trace as many as 3,600 patients who underwent the surgeries involving the faulty implant. The device, ASR XL Acetabular Hip System and ASR Hip resurfacing system, was first introduced in India in 2006 and its licence was renewed in 2010 before the global recall.
But warning bells had begun to ring as early as 2009 itself when Australian regulators red-flagged the high rate of revision surgeries and withdrew the product that year itself.
In India, however, there have been at least 4,700 surgeries since 2006 and as per Johnson & Johnson’s own admission, there were 121 “serious adverse events” between January 2014 and June 2017.
Documents reveal that it was only on April 11, 2012, that the then Drug Controller General G N Singh issued a show-cause notice to the firm asking it “to stop import” of the device “with immediate effect till further orders in public interest.” The notice sought an explanation from the firm as to why its import licence should not be cancelled for allegedly violating the Drugs and Cosmetics Act on the issue of faulty ASR hip implants.
This move by CDSCO came only after it was prodded by a complaint filed by Joint Commissioner, Food and Drugs Agency, Maharashtra, which informed the Central regulator that the firm has not taken any remedial measures and that it had not informed patients about the serious and defective implant and its ill-effects.
In the faulty implants, accelerated wear of metal on metal resulted in higher levels of cobalt and chromium in the blood which lead to toxicity. Metal ions damage tissues and organs, experts found.
Records reveal that Johnson & Johnson denied any wrongdoing but surrendered its licence on April 26, 2012 almost two years after its global recall.
“Whether the product is globally recalled or not, as long the import licence of the firm is not cancelled, they are entitled to get the product in India. In many meetings, I raised the issue that it should be done (cancel the licence). In fact, it was not necessary for Maharashtra FDA to communicate to them to cancel the licence. It is their (CDSCO) duty to see whether the importer is following conditions mentioned in the importing licence. CDSCO failed in its basic duty. If a competent authority like Maharashtra FDA is complaining to CDSCO – the licence should have been cancelled in a day or two. But clearly this was not done,” Mahesh Zagade, the former Maharashtra FDA, told The Indian Express.
Asked what could be the reason for the delay, Zagade said: “That should be investigated in the public interest and accountability fixed.”
Drug Controller General of India S Eswara Reddy did not respond the calls and messages.
Records show that the Maharashtra FDA’s complaint came on January 30, 2012, when Zagade’s deputy, Joint Commissioner of Maharashtra FDA P R Uttarvar, wrote to the Drug Controller General, CDSCO, that the firm’s licence should be cancelled.
The letter was clear: “It was found that the company had not taken proper remedial measure so that all the patients who had undergone ASR implant surgery will have awareness that, the recall is because of defect of the subjected implant, its serious consequences for their health and the reimbursement offer by the company for the corrective action…this office recommends the cancellation of import licence (issued in 2009) with respect to ASR hip implant,” FDA Maharashtra told DGCI.
In fact, this was prescient — the expert committee came to the similar conclusion that the firm did not “adequately warn” patients about the “harm” posed by the implant; it also observed that the firm advertised the recall in newspapers five years after the recall – which it said “shows the negligent behaviour of the firm to reach out to the affected patients.”
In fact, it was only after the FDA complaint that on April 11, 2012, then Drug Controller General G N Singh issued a show-cause notice to Johnson & Johnson: “..Keeping in view the seriousness of matter, you are hereby directed to submit your reply within 10 days, otherwise it will be presumed that you have nothing to say in the matter and action deemed fit will be initiated against your under the provisions of Drugs and Cosmetics Act without making any reference. As this matter is serious, your are also directed to stop the import of ASR XL Acetabular System and ASR Hip Resurfacing System with immediate effect till further orders in public interest,” the communication by Singh to the firm said.
Last week, The Indian Express reported how the firm “suppressed” key facts on the harmful aftermath of surgeries conducted on hundreds of patients in the country. The expert committee found that it did not inform the national regulator about the exact number of patients who used these devices, the adverse reports following such surgeries and corrective operations subsequently conducted.
Last Tuesday, accepting the recommendations of the expert panel with some modifications, the Union Health Ministry formed a Central committee and directed states to form committees at their level to determine the size of compensation to patients who have been affected due to faulty hip implants of Johnson & Johnson.