Union Health Ministry is planning to introduce an independent registry to track use of Medical Devices, which have a higher risk of complications.
Once the registry is done, hospitals and doctors doing surgeries by using high-end medical devices like orthopedic implants and stents will have to report data of implant, its manufacturer and its side effects reported by patients post surgery.
The regulator can also order an immediate recall of the product if a significant number of complaints come against any product. A warning can also be issued, if effects are not severe.
The move follows recommendations of a government committee, under former dean, Dr. Arun K Agarwal, which examined the complaints regarding the J & J hip implants.
“Provisions may be introduced under the law for a legal backing for issuing alerts and warnings to the manufacturer,” the committee said in its report.
Such kind of convention is already in place in many developed countries and helping regulators an alarm in case of faulty products.