The human efforts have contributed immensely towards the advancement in healthcare and medicine. Numerous medicines have been developed to treat the incurable diseases. The Government regulates the commercialization of drugs and medical devices under the provisions of the Drugs and Cosmetics Act, 1940 under the authority of Central Drugs Standard Control Organisation (hereinafter referred to as “CDSCO”).
Johnson & Johnson scandal
Adverse reactions to “faulty” hip implants manufactured by a subsidiary of Johnson & Johnson had been reported by the victims of the same to the CDSCO. The key findings in the medical device adverse reports of patients suggest that the hip implant which was considered to last up to 15 years as per the data, revealed that many patients underwent revision surgeries earlier than the prescribed period.
The expert committee formed by the Government to enquire into the issue of faulty Johnson & Johnson 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, etc.
Drug safety App
As per the Government, the medical device reporting will be one of the post market surveillance tools that will be used by CDSCO to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products. In furtherance of the same, the CDSCO intends to launch a mobile app soon, 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.
In order to ensure adequate drugs and medical devices are available in the Indian market, the CDSCO may soon introduce a mobile app to make the users aware about the requisite details. This progressive step integrates technology with the public welfare.