Tuesday, 4 September 2018

Great step: indian drug regulatory will launch mobile app for recall

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.