The committee looking into the alleged faulty hip implants by a subsidiary of Johnson & Johnson (J&J) has said the company showed negligence. It has recommended that the government amend rules governing medical devices to ensure that there is better patient safety, compliance by device makers.
It also recommended that the Ministry of Health should consider setting up an independent registry for tracking usage of high-risk medical devices in India. Also, a detailed guidance document should be prepared by the Central Drugs Standard Control Organization (CDSCO) for effective recall of medical devices by the manufacturer or importer.
Since 2011, a number of people have complained that hip implants supplied by this company have been faulty. The Maharashtra Food and Drug Administration (FDA) took up the case and an FIR was filed in 2014, naming DePuy Synthes. But, the authorities could not push for compensation due to legal hassles. The case went to the Bombay High Court. The court advised the FDA to continue with the inquiry, but nothing has happened so far.
The committee, set up in 2017 by the Union health ministry to review the matter, submitted its report in February. In its report, made public on Tuesday, the panel said the company did not take any corrective action for patients suffering because of these implants.
It has also recommended a compensation of Rs 2 million per person. In the US, J&J had paid $2.5 billion for the same issue.
The committee has strongly recommended that the faulty hip implant reimbursement programme be extended till at least August 2025 since the average lifespan of orthopaedic hip implants is 15 years.
It also recommended that a central expert committee be constituted by the Ministry of Health for evaluation of claims made by patients in respect of disability and suffering caused due to faulty hip implant. Regional committees formed in various parts of India may conduct investigation and assessment of claims made by patients.
It also recommended that the health assessment of the affected patients be performed on a regular basis and should be reported once a year till 2025.
The committee is of the opinion that the costs of the entire investigation should be borne by the firm.
The committee also observed that the company failed to pass adequate information about faulty hip implants. It also said the central drug controller should recall devices of DePuy Synthes.
Sources said across the country there are 4,700 cases where the hip implants were used when the case was being investigated for the first time in 2011. Union Health Minister J P Nadda said the health ministry is deliberating on the expert committee’s recommendations.