India took two years to ban the import of Johnson & Johnson’s hip implants after the company itself recalled the faulty devices globally in 2010, The Indian Express reported on Thursday, citing documents it has accessed.
The Central Drugs Standard Control Organisation knew of the global recall in 2010 but acted on it only in April 2012, over two months after Maharashtra’s drug regulator wrote to it, documents showed. Mahesh Zagade, the then head of the Maharashtra Food and Drugs Agency, told the newspaper that the reason for the delay should be investigated in public interest.
Even if a company recalls a product globally, it can still bring it into the country as long as its import licence is not cancelled, Zagade pointed out. Johnson & Johnson finally surrendered its import licence two weeks after the central regulator issued a show-cause notice in April 2012.
“If a competent authority like Maharashtra FDA is complaining to CDSCO, the licence should have been cancelled in a day or two,” Zagade was quoted as saying. “But clearly this was not done. [The reason for the delay] should be investigated in the public interest and accountability fixed.”
Over 3,600 patients with faulty implants are now untraceable, according to a report by an expert committee set up by the Ministry of Health and Family Welfare in February 2017. At least four people died after undergoing surgery to implant the devices. The company itself has admitted that there were 121 “serious adverse events” related to the surgeries in India between January 2014 and June 2017.
Zagade said: “In many meetings, I raised the issue that it should be done [licence cancelled]. In fact, it was not necessary for Maharashtra FDA to communicate to them to cancel the licence. It is their [CDSCO’s] duty to see whether the importer is following the conditions mentioned in the importing licence. CDSCO failed in its basic duty.”
The Centre has asked the regulator to set up committees in states to receive complaints from patients who were affected by the faulty devices. The central committee has recommended a compensation of at least Rs 20 lakh for patients.