Medical Devices Notified as Drugs: Regulation and Impact (UPSC Indian Society)

In a long-delayed but consequential move, the Union Health Ministry notified that medical equipment would qualify as "drugs" under Section 3 of the Drugs and Cosmetics Act, 1940, with effect from 1 April 2020. The notification brought into the regulated fold a wide range of implantable and diagnostic devices — knee implants, orthopaedic screws, CT scanners, MRI equipment, dialysis machines, stents, catheters, surgical masks and many others. The decision was forced by years of controversy over faulty hip implants marketed by Johnson & Johnson that left thousands of Indian patients with lasting injuries and inadequate compensation, exposing a glaring regulatory gap.

Until this notification, only a narrow list of 37 categories of medical devices was regulated. Everything else — including most high-risk implants — operated in a grey zone where manufacturers were not required to register with the Central Drugs Standard Control Organisation (CDSCO), report adverse events, or meet quality standards enforceable by law. That gap is now, at least in principle, closed.

Why Medical Devices Were Brought Under the Drugs Act

The Drugs and Cosmetics Act gives the Central government wide powers to define "drug" through notification. By using that authority to include devices, the Health Ministry achieved three things without needing fresh legislation: it made the CDSCO the national regulator for devices, activated the Medical Devices Rules, 2017, as the operational framework, and brought Indian practice closer to international models such as the US FDA and the EU Medical Device Regulation.

The move has several important consequences:

• Patient safety: For the first time, patients have a legal expectation that an implant or diagnostic machine used on them has met defined standards of quality and efficacy.
• Accountability of manufacturers and importers: Companies marketing devices in India must now register, maintain quality management systems, report adverse events, and face penalties for non-compliance.
• Consistent standards: Manufacturers have to align with Indian Standards or harmonised international standards such as ISO 13485 for quality management and IEC 60601 for electrical safety.
• FDI and investment signal: A clear regulatory regime is a prerequisite for foreign investment in device manufacturing, which the Production Linked Incentive (PLI) scheme for medical devices has sought to attract.
• Ease of doing business: Paradoxically, clear rules reduce uncertainty for compliant manufacturers and create a level playing field.
• Global integration: Alignment with International Medical Device Regulators Forum (IMDRF) principles helps Indian manufacturers export to regulated markets.

Significance for Public Health

India is the world's fourth-largest medical device market in Asia and the value of the sector is projected to exceed USD 50 billion by 2030. Yet the country imports roughly 70 per cent of its medical devices. Poor-quality imports and unverified domestic manufacture have historically led to device failures — faulty stents, defective pacemakers, unsterilised surgical instruments — that are detected only when patients are harmed. Regulation under the Drugs Act means that every notified device must be licensed, each manufacturing facility audited, and each adverse event investigated under Materiovigilance Programme of India (MvPI) protocols.

The classification also enables risk-based regulation. Devices are categorised into Class A (low risk — thermometers), Class B (low-moderate risk — syringes), Class C (moderate-high risk — implantable devices) and Class D (high risk — heart valves, implants). Each class has proportionate licensing, testing and post-market surveillance requirements.

Concerns That Need to Be Addressed

Industry bodies and health policy experts have flagged several issues with fitting devices into a framework originally designed for drugs:

• Conceptual mismatch: Devices are engineering products — their safety depends on design, materials and manufacturing processes rather than on chemical composition. Treating a ventilator like a tablet risks regulatory mis-fit.
• Flexibility for low-risk devices: Small manufacturers making Class A devices such as bandages or syringes should not face the same compliance burden as manufacturers of life-critical implants.
• Need for device-specific law: The government has been drafting a separate Medical Devices Bill to create a standalone regulator with device-specific expertise. Until that Bill becomes law, the current structure remains a stopgap.
• Capacity building: MSME manufacturers, which form the backbone of Indian device production, need technical hand-holding, training and transition time to meet the new standards.
• Testing infrastructure: India has too few NABL-accredited labs capable of testing high-risk devices, leading to delays in licensing.

Government Initiatives Beyond the Notification

• Medical Devices Rules, 2017: Operationalises the risk-based classification and licensing.
• Materiovigilance Programme of India (MvPI): Nationwide adverse event reporting for devices, anchored at IPC Ghaziabad.
• PLI Scheme for Medical Devices: Financial incentives for domestic manufacture of high-value devices such as linear accelerators, MRI and CT machines.
• National Medical Device Policy, 2023: Sets the aspiration of a 10–12 per cent share in the global medical devices market within the next 25 years, with focused clusters in Andhra Pradesh, Telangana, Tamil Nadu and Himachal Pradesh.

Latest Developments (2024–26)

The Department of Pharmaceuticals released draft amendments in 2024 to the Medical Devices Rules that tighten post-market surveillance and bring software-as-a-medical-device (SaMD) and AI/ML-based diagnostic tools into the licensing net — a necessary update given the rise of AI-driven radiology and pathology tools. The Ministry of Health also notified labelling requirements for repackaged and refurbished devices and released guidelines for clinical evaluation of high-risk implants. The long-awaited Drugs, Medical Devices and Cosmetics Bill, 2024 was circulated for public consultation; it proposes a separate chapter and a dedicated regulator for devices, clinical trial reforms, and stronger penalties for substandard and spurious devices. In parallel, the Supreme Court continued to monitor compensation claims by victims of the faulty J&J ASR hip implants, pushing the company to complete payouts and pushing the Central government to improve device recall mechanisms.

UPSC Relevance

This topic sits at the intersection of GS Paper II (health governance, regulatory bodies, consumer rights) and GS Paper III (Indian economy, manufacturing, IPR). Questions typically ask candidates to evaluate India’s medical device regulatory framework, discuss whether devices need a separate law, and examine the balance between strict safety standards and ease of doing business for MSMEs. For Mains, candidates should be ready to cite the Drugs and Cosmetics Act, Medical Devices Rules 2017, the J&J case, CDSCO’s role, the PLI scheme and the 2023 National Medical Device Policy. Prelims aspirants should remember the classification scheme (Class A–D) and the date of notification (1 April 2020). The subject also connects with broader themes of patient rights, product liability and India’s ambition to become a global manufacturing hub.

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