A high-profile hip implant case offers a timely reminder that without structural reforms, India’s medical device ecosystem remains vulnerable to regulatory failure and patient harm.
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In 2003, a unit of a major multinational company launched an Articular Surface Replacement (ASR) metal-on-metal hip implant. However, within a few years, this device proved faulty, shedding toxic metal debris into patients’ bodies and causing high failure rates. In August 2010, facing mounting evidence of harm, the company globally recalled the ASR implants and later paid a US$2.5 billion settlement to thousands of affected patients in the United States (US). In India, most of the roughly 4,700 Indian patients implanted with ASR hips learned of the recall only long after the fact, if at all. Many of those from poorer backgrounds were left to endure piling medical expenses for revision procedures and complications without support or compensation in a timely manner. The recently published book, "The Johnson & Johnson Files: The Indian Secrets of a Global Giant," is one such investigation, conducted by journalist Kaunain Sheriff M., into this medical scandal and how corporate complacency and deregulation put Indian patients specifically at risk.
The book, based on investigative reports, reveals that the company failed to inform Indian regulators how many patients received the implants or report adverse outcomes, and over 3,600 patients remained untraceable due to poor follow-up. The ASR case has thus become a stark illustration of India’s weak medical device oversight and how some multinationals have treated Indian patients worse than those in richer countries. It also highlights systemic gaps in regulation, post-market surveillance, patient safety, and institutional capacity that persist in India’s medical device ecosystem.
The ASR failure is reflective of a larger regulatory failure in India's medical device environment. India previously controlled medical devices as drugs under the 1940 Drugs and Cosmetics Act, which was not suitable for the distinct risks of devices. Only in recent years has India adopted device-specific regulations, with the Medical Devices Rules, 2017 being one such instance. Nonetheless, the regulatory framework is still evolving. Challenges such as fragmented governance, insufficient enforcement capabilities, and delays in establishing a standalone medical devices law have obstructed consistency and clarity. A recent Occasional Paper by the Observer Research Foundation , “Building a Smarter Medical Devices Ecosystem in India,” notes that despite new frameworks, issues persist in post-market surveillance and patient safety.
Crucially, India still lacks a centralised, publicly accessible system to report device failures, adverse events, and recalls. In contrast to the US Food and Drug Administration’s (US FDA) Manufacturer and User Facility Device Experience (MAUDE) database or the European Union’s (EU) European Database on Medical Devices (EUDAMED) system, Indian regulators and patients have no unified tracker for device safety incidents. The Materiovigilance Programme of India (MvPI), launched in 2015 to gather adverse event reports, does not share its findings online. Without real-time surveillance and openness, issues only reach the forefront once damage has already been caused to patients, such as in the case of the ASR implants.
Only 1,032 Indian patients (~22 percent of the total) had registered on the company’s helpline by 2017 (nearly seven years after the fiasco), a number the inquiry deemed a lack of seriousness in reaching all affected patients.
In the ASR episode, years passed before Indian authorities grasped the scale of injuries. A government inquiry found that the company had not effectively tracked or even notified thousands of recipients, reflecting a broader failure of post-market vigilance. Only 1,032 Indian patients (~22 percent of the total) had registered on the company’s helpline by 2017 (nearly seven years after the fiasco), a number the inquiry deemed a lack of seriousness in reaching all affected patients. For an international comparison, by 2011, the company had tracked about 60 percent of US recipients, ~50 percent of Australian patients, and ~55% percent of South African patients, in comparison to the mere 1 percent of Indian patients. This gap highlights how patient safety was relegated to an afterthought against the backdrop of weak enforcement.
Compounding the issue is limited institutional capacity and unclear accountability. Oversight of devices still falls under the Central Drugs Standard Control Organisation (CDSCO) and Drug Controller General of India, bodies traditionally oriented toward pharmaceuticals. India has no independent medical devices regulator, and regulators often lack specialised expertise in medical technology. This has created inefficiency and delayed responses, particularly for new or high-risk devices. Regulatory processes depend upon foreign clearances and do not mandate rigorous local clinical trials for a majority of imported devices. For example, the ASR implants received clearance in India based on the assumption of perfect foreign clearances. They were even marketed before the official clearance of 2006, demonstrating weaknesses in the pre-market process. Once devices are in use, post-market surveillance remains the weak link, as evidenced by the inability to trace ASR failures swiftly.
Recent analyses argue that without systemic reforms, the country’s rapid growth in medical devices—projected to be a US$50 billion industry by 2030—will continue to outpace the evolution of its safety and oversight frameworks. Thus, the ASR case serves as a clarion call to the urgent need to bolster India’s medical device regulations, strengthen surveillance, and recall systems.
India’s experience is not a sequestered one. Even in countries with ostensibly stronger regulators, significant oversight lapses have occurred. Investigative reporter Gardiner Harris’s recent book, “No More Tears: The Dark Secrets of Johnson & Johnson,” chronicles how major firms have at times bypassed or overwhelmed oversight in the US as well. Harris opens with the example of the company’s iconic talcum baby powder, a product marketed as gentle for infants yet later found to be contaminated with asbestos fibres. For decades, neither the company nor regulators—who classify talcum as a cosmetic—adequately warned consumers, illustrating how even benign products can slip through regulatory cracks.
Such cross-national analogies suggest a systemic problem: regulatory regimes globally can struggle to rein in profit-seeking firms, particularly where control mechanisms are lax or industry penetration is deeply entrenched.
The FDA’s vigilance was undermined by corporate influence and slow responses; Harris also concludes that the FDA ignored, enabled, or encouraged every major safety debacle he documents. Even the ASR hip replacement appeared in his work as one of the heavily marketed devices to US orthopaedic surgeons despite early evidence of abnormally high failure rates. Such cross-national analogies suggest a systemic problem: regulatory regimes globally can struggle to rein in profit-seeking firms, particularly where control mechanisms are lax or industry penetration is deeply entrenched. Strong laws on paper are of no use without successive enforcement and transparency. For India, learning from these international models brings to light the urgency of not merely catching up with global regulatory best practices but also of protecting against complacency or capture of rules that can plague even advanced systems.
The ASR implant scandal has also shed light on India's regulatory system for medical devices, and that piecemeal fixes may be attempted, but they are no substitute for radical change. To restore patient safety and confidence, India will have to make comprehensive reforms that reach the root causes of regulatory failure and could include the following priorities:
Closing these gaps will not only necessitate new regulations but also a change in the culture of regulation toward proactiveness, transparency, and patient-centricity. India will need to strengthen its regulatory agencies and inculcate accountability so that medical innovation does not come at the cost of patient lives. Through systemic reforms and international lessons, India can reinvent the regulation of medical devices from being an afterthought to becoming a gold standard that puts the patient first, facilitates ethical innovation, and keeps global multinationals in check.
K.S. Uplabdh Gopal is an Associate Fellow with the Health Initiative at the Observer Research Foundation.
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Dr. K. S. Uplabdh Gopal is an Associate Fellow with the Health Initiative at the Observer Research Foundation. He writes and researches on how India’s ...
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