Reassessing India's Medical Device Recall Framework: Regulatory Gaps And The Case For Reform

"Wherever the art of medicine is loved, there is also a love of humanity"- Hippocrates

Introduction

The global medical device industry is undergoing remarkable expansion, driven by technological innovation, rising healthcare demands, and increased investment across markets. However, this rapid growth has also heightened concerns around product quality and safety. As more devices enter the marketplace, the risk of defective or non‑compliant products reaching patients has likewise increased. For example, between fiscal years 2020 and 2024, the United States Food and Drug Administration oversaw 3,934 medical device recalls, underscoring the urgent need for stronger oversight and more robust quality‑management practices across the sector.¹ Thus, even India's growing reliance on medical devices in today's healthcare postulates the need for a strong regulatory framework, not just for the pre-market approvals but also for their post-market safety. While the Medical Devices Rules, 2017, regulate the licensing and reporting compliances for medical devices in India, Materiovigilance which refers to the monitoring of adverse events caused by medical devices, remains largely voluntary and unregulated.

This paper explores the legal vacuum in India's medical device recall procedure and proposes legal reforms to ensure that patient safety is not compromised due to ineffective medical device recalls.

Regulatory Framework

The Ministry of Health Family and Welfare ("MoHFW") is the apex regulatory body for the healthcare sector in India, and is entrusted with the formulation of healthcare legislations, implementing government schemes, and maintaining public health standards. The legislative enactments governing the quality, safety, licensing, and efficacy of medical devices - the Medical Device Rules, 2017, Drugs and Cosmetics Act of 1940 and the Drugs Rules, 1945, have been promulgated under the aegis of the MoHFW. Operational responsibility for administering and enforcing this statutory framework vests with the Central Drugs Standard Control Organisation ("CDSCO") which serves as India's national regulatory authority for drugs, medical devices, and cosmetics in India. The CDSCO is empowered to grant marketing approvals, conduct inspections of manufacturing and distribution facilities, ensuring statutory compliance, and administer adverse event reporting and post market surveillance mechanisms.²

Previously, medical devices were regulated under the same umbrella as drugs; however, as medical devices grew more sophisticated, the need for a dedicated regulatory framework became the need of the hour. In response, the MoHFW introduced the Medical Device Rules, 2017 ("MDR"), specifically to regulate medical devices in India. These rules recognise that, although medical devices share certain attributes with drugs, they necessitate a distinct regulatory mechanism to address device-specific risks and licensing requirements. Under the MDR, the CDSCO, not only reviews pre-market applications but also undertakes post-market surveillance to monitor device performance over time. A medical device recall falls within the ambit of post market surveillance and is governed by Rule 89 of the MDR, which mandates manufacturers to initiate recalls where a medical device is likely to pose a risk to patient health.³ In the medical device context, a recall means any action taken by the medical device's manufacturer or authorised agent or supplier to remove the medical device from the market or to retrieve the medical device from any person to whom it has been supplied, since the medical device is hazardous to health; or fails to conform to any claim made by its manufacturer relating to its quality, safety or efficacy; or does not meet the requirements prescribed by the Drugs and Cosmetics Act, 1940 and the MDR.⁴

The Johnson & Johnson ASR hip implants recall incident demonstrates the regulatory vacuum that existed in India in relation to post-market surveillance and medical device recalls. In 2006, M/s DePuy International Limited, now known as M/s Johnson & Johnson Pvt. Ltd. ("Firm") had registered orthopaedic implants named, ASR" XL Acetabular Hip System and ASR " Hip Resurfacing System ("ASR Hip Implants") for import and marketing in India under the provisions of the Drugs and Cosmetics Act, 1940. Subsequently, a significant number of patients implanted with these devices experienced serious adverse effects, often requiring revision surgeries. In view of the adverse outcomes and revision procedures reported globally, the Firm ultimately withdrew the ASR Hip Implants from markets worldwide. Thus, around 2009 and 2010, the ASR Hip Implants were withdrawn from the markets of United States, Canada, United Kingdom, Brazil and Australia. Even though, the Firm made efforts to recall the ASR Hip Implants in India, it was only in December 2013 when the CDSCO issued a medical device alert in public interest informing the public about the defective ASR Hip Implants.⁵ However, approximately 4,700 surgeries had already been performed using these implants, with only about 882 of affected patients traceable for follow-up corrective measures.⁶ Owing to the widespread adverse consequences arising from the defective ASR Hip Implants, aggrieved patients filed cases against the Firm and pursued legal remedies across various forums.⁷ Consequently, an Expert Committee chaired by Dr. Arun Kumar Agarwal, was formed by the MoHFW to assess the issue of the faulty ASR Hip Implants in India and to recommend a compensation mechanism for affected patients.⁸

The regulatory lag in Johnson & Johnson ASR Hip Implants recall incident not only jeopardised patient safety but also exposed the systemic legal and ethical vulnerabilities within the healthcare framework. In response to such deleterious consequences caused by defective medical devices, India undertook steps to strengthen its medical device regulatory ecosystem. The introduction of the Medical Device Rules in 2017 marked a significant milestone complemented by the Materiovigilance Programme of India ("MvPI"), which was launched in 2015. The Indian Pharmacopeia Commission ("IPC") acts as the National Coordination Centre for the MvPI and has issued the "Guidance Document Materiovigilance Programme of India (MvPI) Version 1.2" ("Guidance Document"). The objective of the Guidance Document is to facilitate the systematic collection, analysis, and regulatory response to adverse events associated with medical devices thereby enabling continuous post market surveillance across the device lifecycle.⁹

Chapters 8 and 9 of the Guidance Document provide a limited articulation of the medical device recall process, primarily addressing recalling classifications and reporting requirements. Chapter 8 stipulates that recalls must be categorised based on the degree of the health hazards posed, classifying them as Type I, Type II, and Type III recalls, with corresponding descriptions of the risks associated with each category.¹⁰ Chapter 9 mandates the submission of a Field Safety Corrective Action ("FSCA") notification form to inform the regulatory authorities and consignees of any corrective action or recall initiated by the manufacturer to mitigate serious adverse reaction associated with the use of medical devices. Upon initiating an FSCA, manufacturers are required to issue aField Safety Notice ("FSN") which serves as the principal communication instrument to notify users and other stakeholders of the corrective measures undertaken. In addition, the CDSCO usually publishes a medical alert on its website to enhance public awareness. Manufacturers are obligated to submit three categories of reports – namely, a preliminary report, follow-up or final report, and the FSCA notification – to keep the CDSCO apprised of the recall progress and enable regulatory intervention wherever necessary. Notably, the Guidance Document does not prescribe any legally binding timelines for recall completion, instead allowing manufacturers to determine recall timelines at their discretion.¹¹

Information Asymmetry

To initiate a recall, the CDSCO or the manufacturer must become aware of a defect, malfunction or potential risk associated with the device. This awareness typically arises through vigilant reporting by users of the medical devices who observe and communicate the adverse events related to the medical device. Such reporting is facilitated through the Medical Device Adverse Event ("MDAE") Reporting Form under the Guidance Document which enables healthcare professionals, patients, and manufacturers to report any adverse events, device malfunctions, or safety issues related to medical devices in India. Thus, the form helps IPC and CDSCO to collect post-market surveillance data, initiate recalls and issue alerts to raise public awareness about the adverse event associated with the medical device.

The MDAE reporting form can be filed for Serious Adverse Events ("SAEs"), Non-Serious Adverse Events ("NSAEs"), and Near-Miss Events— classified based on the severity and actual/potential harm caused by the medical device. As per Rule 26 (ii) of the MDR, a manufacturing licence holder must notify the relevant State or Central Licensing Authority, as applicable, within fifteen days of becoming aware of any suspected or unexpected serious adverse event, along with details of any actions taken, including recalls.¹² Similarly, marketing authorisation holders, manufacturers, importers, and distributors are required to report serious adverse events to the National Coordination Centre – IPC, and the CDSCO in accordance with Chapter 5 of the Guidance Document.

While reporting of SAEs is legally mandated under Rule 26 (ii), reporting of NSAEs and near-miss events is also encouraged under the Guidance Document.¹³ On the contrary, the "Pharmacovigilance Guidance Document for Marketing Authorization Holders of Pharmaceutical Products (Version: 2.0)" mandates reporting of all non-serious adverse events to the CDSCO and the National Coordination Centre, IPC within 90 calendar days of receipt of information regarding such an adverse event.¹⁴ The absence of a corresponding statutory mandate or prescribed timeline for reporting non-serious and near-miss events relating to medical devices exacerbates information asymmetry within the regulatory framework. To ensure transparency it is imperative that all types of adverse events be made mandatorily reportable within defined timelines. Consumers are entitled to be informed of any defect or potential risk, however minor, associated with the medical devices they use.

Lack of Recall Timelines

Therecall timelinesfor drugs are delineated under the"Guidelines on Recall and Rapid Alert System for Drugs" ("Recall Guidelines") issued by the CDSCO on 25 July 2024. Paragraph 5 of the Recall Guidelines classifies recalls into Class I, Class II, and Class III based on the relative degree of health hazard involved. For Class I recalls, the Recall Guidelines mandates cessation of sale or distribution within 24 hours and completion of physical recall within 72 hours. Class II and Class III recalls shall be completed by 10 days and 30 days, respectively.¹⁵

Although, all medical devices have been brought within the definition of 'drugs' since April 2020, the Recall Guidelines are framed exclusively in the context of pharmaceutical products. The extant document contains no reference to medical devices, MDR, or device-specific recall considerations. Further, the Recall Guidelines stipulate that destruction of recalled products be undertaken in accordance with the Bio Medical Waste Management Rules, 2016, without addressing the applicability of the E-Waste (Management) Rules, 2022 which govern the disposal of electronic medical devices. This regulatory silence creates ambiguity regarding the applicability of the Recall Guidelines to medical devices and reinforces uncertainty around recall timelines and post-recall obligations for device manufacturers.

In the absence of prescribed deadlines under the Guidance Document and the MDR, manufacturers may lack sufficient regulatory impetus to expeditiously complete recalls, particularly where risks are not immediately life-threatening. This may lead to prolonged circulation of unsafe devices, thereby undermining patient safety and public confidence in the healthcare system. Presently, the CDSCO, relies largely on voluntary disclosures from manufacturers to monitor recall progress, which may not always be timely or comprehensive. The lack of clear timelines also creates uncertainty regarding recall termination, potentially allowing recall procedures to continue indefinitely without regulatory closure.

Given the logistical complexities associated with medical device recalls, a rigid and uniform completion deadline may not be practical. Instead, the regulatory framework should mandate submission ofFSCA reportsat defined intervals by prescribing clear deadlines for each reporting stage. By way of comparison, the United States Food and Drug Administration ("FDA"), mandates the manufacturers and importers to report a removal of a product if it involves a risk to health with recall status report intervals typically ranging from two to four weeks under the United States Code of Federal Regulations (CFR), Title 21 Part 7.53 (21 CFR 7.53).¹⁶ A similar model may be adopted by the CDSCO to systematically track recall progress. Manufacturers should also be required to propose recall completion timelines, which the CDSCO may review, modify, and approve based on case-specific considerations. Once finalised, adherence to such timelines should be mandatory and subject to regulatory enforcement. Comparable oversight mechanisms exist in Australia, where the Therapeutic Goods Administration under the "Procedure for recalls, product alerts and product corrections" objectively reviews recall plans to ensure that proposed actions and timelines adequately mitigate device-related risks.¹⁷ Further, termination of recalls should rest solely with the CDSCO, once it is satisfied that all legally mandated and reasonable steps have been undertaken to remove the affected devices from the market. For instance, in the United States, as per 21 CFR 7.55, the manufacturers do not have autonomy to terminate the recall, they must get permission from the FDA, and the FDA must make an informed decision on whether the recall should be terminated.¹⁸

Recommendations

To improve regulatory oversight and safeguard public health, , the government may, with a view to strengthen the management of medical device recalls in India, implement the following:

• Due to the operational and logistical complexities involved in medical device recalls it may not be practical to prescribe a single, rigid deadline for the completion of all recalls. To address this, the MDR should be amended, or alternatively,a binding recall framework should be notified, mandating manufacturers to submitFSCA status reports at prescribed intervals to ensure regulatory monitoring of the recall process at all stages.
• Manufacturers should be required to propose a justified recall completion timeline as part of FSCA reporting ("Justified Recall Timeline"), under the statutory oversight of the CDSCO and the CDSCO can review, approve, or revise the Justified Recall Timeline based on risk and public health considerations.
• At present, there is significant regulatory ambiguity in India regarding when and how a medical device recall formally concludes, creating prolonged compliance obligations and commercial uncertainty for manufacturers. The regulatory framework should explicitly permit manufacturers and importers to apply to the CDSCO for recall closure, supported by documentary evidence of recall completion and risk mitigation. This mechanism is essential to ensure commercial viability, as indefinite recalls are not operationally or economically sustainable.

Thus, these proposed measures aim to strengthen the regulation of medical device recalls and address existing regulatory gaps.

Conclusion

India's medical device sector has expanded at a pace that far exceeds the evolution of its post-market regulatory safeguards. While the Medical Device Rules, 2017 and the Materiovigilance Programme of India represent important regulatory milestones, the absence of a statutorily time-bound, and enforceable recall completion timeline continues to undermine patient safety. The prevailing reliance on guidance documents and voluntary disclosures leaves critical aspects of recall governance—such as reporting thresholds, timelines, regulatory oversight, recall termination, and liability—insufficiently addressed. To remedy these systemic deficiencies, India must transition towards a comprehensive and legally binding recall regime tailored to the unique risk profile of medical devices. Embedding clear timelines, mandatory reporting obligations, and regulatory supervision of recall execution will strengthen patient protection, enhance regulatory certainty, and promote industry accountability. A robust and forward-looking recall mechanism is indispensable to ensuring that India's medical device regulatory ecosystem remains aligned with global best practices while effectively safeguarding public health.

Footnotes

1 U.S. Government Accountability Office 'Medical Device Recalls: HHS and FDA Should Address Limitations in Oversight of Recall Process' (GAO, 08 December 2025) < https://www.gao.gov/products/gao-26-107619 > accessed 03 February 2026

2 Drugs and Cosmetics Act 1945; Drugs Rules 1945

3 Medical Device Rules 2017, r 89

4 Ibid, r 3(zp)

5 'MEDICAL DEVICE ALERT' (CDSCO, 09 December 2013) < https://www.cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTk1 > accessed 03 February 2026

6 'Report of the Expert Committee to Address the Issue of Faulty ASR Hip Implants' (CDSCO, 19 February 2018) < https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/common_download.jsp?num_id_pk=ODQ0 > accessed 03 February 2026

7 Arun Kumar Goenka v. Union of India & Ors. WP(C) 1085/2018

8 'Report of the Expert Committee to Address the Issue of Faulty ASR Hip Implants' (CDSCO, 19 February 2018) < https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/common_download.jsp?num_id_pk=ODQ0 > accessed 03 February 2026, 7

9 'Guidance Document Materiovigilance Programme of India (MvPI) Version 1.2' (Indian Pharmacopoeia Commission) < https://ipc.gov.in/images/Guidance_Document_MvPI.pdf > accessed 03 February 2026

10 'Guidance Document Materiovigilance Programme of India (MvPI) Version 1.2' (Indian Pharmacopoeia Commission) < https://ipc.gov.in/images/Guidance_Document_MvPI.pdf > accessed 03 February 2026, 41

11 ibid

12 Medical Device Rules 2017, r 26(ii)

13 'Guidance Document Materiovigilance Programme of India (MvPI) Version 1.2' (Indian Pharmacopoeia Commission) < https://ipc.gov.in/images/Guidance_Document_MvPI.pdf > accessed 03 February 2026, 26

14 'Pharmacovigilance Guidance Document for Marketing Authorization Holders of Pharmaceutical Products (Version: 2.0)' (Google Drive, 17 September 2024) < https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/PSUR_PV_AEFI/Guidance_Documentpsur2.pdf > accessed 03 February 2026, 22

15 'GUIDELINES ON RECALL AND RAPID ALERT SYSTEM FOR DRUGS (Including Biologicals & Vaccines) VERSION: 2024' (CDSCO, 25 July 2024) < https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/biologicals/Guidelinerapid24.pdf > accessed 03 February 2026, 3

16 United States Code of Federal Regulations 1938, title 21 p 7.53

17 Procedure for recalls, product alerts and product corrections (Therapeutic Goods Administration, 05 March 2025) < https://www.tga.gov.au/safety/recalls-and-other-market-actions/procedure-recalls-product-alerts-and-product-corrections-prac > accessed 03 February 2026

18 United States Code of Federal Regulations 1938, title 21 p 7.55

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