Soon, India to get an app for drug recall notices, safety information

Indians may soon be able to get all safety-related information about medicines on their mobiles as the country's drug regulator is about to launch a mobile app in this regard.

Citing sources, a report in Mint stated that the app will also facilitate users to send messages, report injuries and problems related to 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,” S Eswara Reddy, drug controller general of India (DCGI) told the business daily.

The app will help the regulator to fulfil one of the recommendations of an 11-member committee looking into the faulty hip implant case of Johnson and Johnson.

The committee had called for making drug-related information such as withdrawal by regulatory agency, voluntarily withdrawal by the company of drug or devices, safety and efficacy issues of drug or devices available online.

The panel had recommended the Ministry of Health should consider setting up an independent registry for tracking usage of high-risk medical devices in India. It also called for a detailed guidance document to be prepared by the CDSCO for effective recall of medical devices by the manufacturer or importer.

The DCGI believes the app will help improve patient safety by providing critical information online.

“We will encourage 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 business daily quoted Reddy.