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After remaining tight-lipped for six months on Johnson and Johnson’s faulty hip-implant issue, the Union Health Ministry has broken its silence.
On August 30, the Union Health Ministry sent a communication to all States and Union Territories saying that the recommendations of the expert committee headed by former dean of Maulana Azad Medical College, Arun Agarwal have been accepted albeit with some ‘modifications’.
The communication has been viewed by BusinessLine.
The modification involves creation of State-level committees to decide relief for patients, rather than regional committees as recommended by the initial report.
The Ministry in its modification has said that all ASR hip-implant patients, irrespective of whether they have had a revision surgery or not, or that they suffer from disability or not, are eligible to make an application to the State-level or Central Committee.
Central Committee
The Central Committee will comprise a chairman, who will be the head of the department of a tertiary government medical college and an orthopaedician or a PMR specialist; two orthopaedic surgeons or PMR experts, one clinical pharmacologist and a legal expert.
The Central Committee will review the State-level committee reports of the patients who apply and determine the quantum pegged on a base amount of ₹20 lakhs, degree of disability, patient suffering monetary loss due to loss of wages and percentage disability.
The States have been instructed to constitute a committee with two orthopaedic surgeons or physical medical rehabilitation experts from a Government-run medical college and hospital; one radiologist from the Government medical college, and a Central Drugs Standard Control Organisation’s zonal or sub-zonal representative.
Ads in newspapers
The Ministry has also asked the States to advertise in newspapers for the affected patients to approach the State-level committees or concerned State’s Drugs Controller.
Almost 4,700 such implants were imported into India, from DePuy International Limited in the UK, a subsidiary of J&J. Nearly 1,295 were returned to the parent company after the recall. The rest of the 3,405 implants were implanted in patients. J&J has been able to trace only 833 patients.The Ministry has appealed to them to contact the Central or State-level committees.
After the implants failed in 40 per cent of the patients, J&J initiated a global recall of the implants in 2010.
Even as the Union Health Ministry has accepted the recommendations of the expert committee, former Food and Drug Administration Commissioner of Maharashtra, Mahesh Zagade questioned the legal standing of the committee and its recommendations.
“There are enough provisions in the law to bring the regulator — Drugs Controller General of India (DCGI) to book along with the company, as to how could DCGI renew the licence the company.
“There should be a CBI probe into this, as recommended by me in 2013, to the then Chief Secretary of Maharashtra. The narrative on the committee is an effort to divert attention from the real issue of justice,” Zagade said .
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