Drug regulator to launch app on safety info, recalls

New Delhi: India’s drug regulatory authority will soon launch a mobile app, which will update users with safety information and product recall notices. Users will also be able to send messages and report injuries and problems related to medical devices, two people aware of the matter said.

The app is in line with the recommendations of an 11-member committee looking into the faulty hip implant case of Johnson and Johnson (J&J) Pvt. Ltd.

The panel had asked the government to strengthen India’s ‘materiovigilance programme’ aimed at monitoring problems arising from using medical devices.

“The medical device reporting (MDR) will be one of the postmarket surveillance tools that will be used by the Central Drug Standards Controller Organization (CDSCO) to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products,” said S. Eswara Reddy, drug controller general of India (DCGI).

The expert committee formed by the government last year to enquire into the issue of faulty hip implants had suggested that the government put in place a mechanism by which online information can be made available “about any withdrawal by regulatory agency, voluntarily withdrawal by the company of drug or devices, safety and efficacy issues of drug or devices”, said the report. This will “enable CDSCO to take immediate review of the situation and take remedial action well in time”, it added. The expert committee was looking into a seven-year-old case of patients who had undergone corrective surgeries after being fitted with faulty hip implants by multinational pharma giant Johnson and Johnson (J&J).

It found the ASR (articular surface replacement) hip implants manufactured by DePuy International Ltd to be faulty and had resulted in higher instances of revision surgeries globally, including in India. According to the DCGI, the new mechanism will avoid such situations.

“We will encourages healthcare professionals, patient, and consumers to submit voluntary reports about serious adverse events that may be associated with a medical device, as well as use errors, product quality issues. These reports, along with data from other sources, can provide critical information that will help improve patient safety.”

The committee had also suggested establishment of an independent registry for tracking use of high-risk medical devices by the health ministry. “Provisions may be introduced under the law to have legal backing for issuing alerts and warnings to a manufacturer. The registry will also help in providing a trend analysis of performance and usage of various medical devices in India annually.”

The committee, after deliberations on the issues and review of the documents had found the firm to be “evasive” in providing the information regarding the design of the ASR, and patient details.

“The committee is of the considered view that the patients have to live a restricted lifestyle with a compromised physical state, thus putting them at pain and agony throughout their life, will also have a bearing on their dependents apart from loss of work. Though no amount of money can fill this void, however, the committee feels that an adequate compensation needs to be provided to each and every patient who had undergone revision surgery to mitigate some of the pain and sufferings.” Mint has reviewed a copy of the report.