10 lakh Indians get life-saving implants annually: Calls grow for national registry

India is witnessing a surge in the use of life-saving medical implants, with more than 10 lakh patients every year receiving devices such as cardiac stents, pacemakers, orthopaedic joints, spinal implants, heart valves and neurovascular devices.

But alongside this medical progress, experts are warning of a major gap in patient safety – the absence of a National Medical Implant Registry.

Industry leaders say the lack of a nationwide tracking system leaves millions of Indians vulnerable if implants fail or are recalled globally. They argue that while India has expanded access to advanced healthcare technologies, it still cannot reliably trace which patient received a particular implant, where it was used, or whether complications have emerged over time.

“A patient today cannot easily find out whether the implant inside his or her body has been recalled internationally or linked to failures elsewhere,” said Rajiv Nath, forum coordinator of the All India Association of Medical Device Industry (AiMeD).

In a letter to the Union health ministry, the network of medical device makers in the country has proposed that the Central Drugs Standard Control Organisation (CDCSO) establish the registry under the Materiovigilance Programme of India.

The proposal recommends beginning with high-risk implants such as cardiac, orthopaedic and neurovascular devices before gradually expanding coverage.

“This is not merely an administrative issue. It is a serious patient-safety risk that India can no longer ignore.”

The demand for a National Implant Registry has gained urgency in the wake of past controversies, especially the Johnson & Johnson ASR metal-on-metal hip implant case, which exposed major gaps in India’s healthcare monitoring systems.

It also found support from some independent clinicians.

“An implant registry would help monitor long-term outcomes, failure rates, revision surgeries, infections, and implant durability across different populations. In orthopaedics especially, outcomes may become evident only years after surgery,” Dr Sunil Kumar Dash, senior orthopaedic with Manipal Hospitals told India Today.

LESSONS FROM RECALL

Globally, the ASR hip implant was found to have unusually high failure rates, with patients suffering severe pain, tissue damage and repeated surgeries after metal debris entered their bodies.

Countries such as Australia and the UK were able to identify the problem early through implant registries that tracked revision surgeries and patient outcomes.

India, however, lacked any centralised database.

According to Nath, regulators struggled even to determine how many Indians had received the implant. Many patients reportedly remained unaware that their symptoms were linked to a global recall, while others underwent expensive revision surgeries without compensation.

“The J&J hip implant episode should never be repeated,” Nath said. “If India had a proper implant registry, every affected patient could have been identified quickly and followed up in time.”

Healthcare experts say such registries are standard practice in many developed healthcare systems. Countries including the US, Germany, Sweden and Australia have long relied on implant registries to monitor safety, identify device failures early and issue rapid alerts during recalls.

NEED FOR TRACEABILITY

The proposed National Implant Registry would digitally record every high-risk implant used in the country and track it throughout its life cycle.

Advocates say such a system would enable real-time safety alerts, faster recall responses, improved monitoring of device performance and stronger safeguards against substandard imports.

India has already introduced Unique Device Identification (UDI) norms for medical devices, but experts say labels alone are insufficient without an integrated national database connecting devices to hospitals, surgeons and patients.

“When UDI is linked with ABHA IDs – unique digital identification of a patient – under the Ayushman Bharat Digital Mission (ABDM), India can achieve true end-to-end traceability,” Nath said. “That will build trust for patients, hospitals, insurers and ethical manufacturers alike.”

Experts also point out that India currently lacks long-term clinical data on how implants perform in Indian patients. A national registry could generate real-world evidence such as which orthopaedic implants last longer, which cardiac devices work best for diabetic patients and which technologies result in fewer revision surgeries.

“India uses implants from multiple manufacturers, ranging from premium imported systems to low-cost alternatives. A registry would help establish transparency regarding performance and safety, ensuring that substandard devices do not continue in circulation unnoticed,” Dr Dash pointed out.