Recalled in Australia, but approved in India in the same month
New Delhi: Union Health Minister JP Nadda said his ministry is holding deliberations on an expert panel’s report on alleged faulty hip replacements surgeries by a multinational company in India and will take necessary steps.
“We are deliberating on it,” he told reporters here, without elaborating.
His comments came after reports appeared in the media, claiming pharma giant Johnson and Johnson “suppressed” facts on the harm caused by surgeries which were conducted on patients in India using “faulty” hip replacement systems.
The Indian Express, recently stated that the Indian arm of Johnson and Johnson obtained a fresh registration certificate for its ASR hip replacement implants in the same month from the Indian Regulator, when the Australian regulator had ordered a recall on the same product.
It also added that the company obtained the said fresh registration certificate from the national regulator for medical devices on December 23, 2009, without informing the authorities that the product had been recalled in Australia in December 2009. On January 11, 2010, the firm applied for an import licence on the basis of that certificate.
The daily has reported that as per the committee report, the documents submitted during its probe on the “faulty” implants, the global pharma major “themselves have admitted about the product failure”. The product was globally recalled on August 24, 2010.
The Government committee stated in its report it was informed of the recall by Australian authorities. It said that the company may have violated Indian laws by applying for a fresh licence later to sell the devices in the country.
“The firm had applied for import license on the basis of the registration certificate on 11 January, 2010. However, the fact the ASR was already recalled in Australia in December 2009, was not informed to the CDSCO even at the time of application for import licence. That the committee observes that there appears to be suppression of material facts by the firm to the CDSCO. This is construed as serious breach of a condition of approval,” the committee’s report states, the daily quoted.
Further, Reports quoting the expert committee findings say that over 3,600 patients with faulty implants remain untraceable and that at least four deaths have been reported among these patients.
According to reports, the expert committee, set up to investigate complaints about hip implant devices, has suggested that the company pay compensation of around Rs 20 lakh to the affected patients.
The compensation to the patients will be decided based on examinations done on them. Now we have to assess how many (patients) are affected due to it. That is why state committees will be formed.
“Apart from this, advertisements will also be put up in prominent newspapers so that the affected patients know about this and can approach the committee with their grievances,” the Drugs Controller General of India Eswara Reddy had told.
Sources in the Ministry said that once the state committees examine those affected, they will give their recommendations to the expert committee at the center and accordingly the company will be asked to compensate.