From Patchwork to Policy: The Urgent Need for a Unified Regulatory Vision in India
- Indira B N
- May 14
- 6 min read
India’s health sector today is overseen by a mosaic of agencies, each with its own mandates. FSSAI regulates foods and nutraceuticals, the CDSCO handles drugs, devices and diagnostics, cosmetics, BIS sets industrial/quality standards, AERB oversees radiation emitting products, MoEFCC oversees wastes, list goes on. In practice these domains collide. For example, the definition of “nutraceutical” under FSSAI overlaps parts of the Drugs & Cosmetics Act, creating confusion over whether a product is a “food supplement” or a drug. Similarly, medical devices are subject to CDSCO licensing and to BIS quality certifications when standards exist. This fragmented regime leaves companies juggling multiple approvals and often unclear guidance.
Nutraceuticals and Food Supplements: Conflicting Jurisdictions
A stark illustration is India’s booming nutraceuticals industry. Under current law, dietary supplements fall under the Food Safety Act (FSSAI), but many products make drug-like claims. A government committee recently noted “multiple regulatory overlaps” on dosage and claims between the FSSAI rules and the Drugs & Cosmetics Act. Unscrupulous firms have exploited this ambiguity by reclassifying drugs as “health foods” to escape stricter controls. For instance, the Telangana Drugs Control Administration raided shops and seized Neurocad-G tablets that were falsely marketed as a food supplement under an FSSAI license. Such cases show how dual regulators can undermine enforcement: products slip into the market under the softer food laws until caught by drug authorities.
An inter-ministerial committee has proposed amendments to clarify FSSAI vs CDSCO roles, but even well-intentioned reforms risk confusion. Some experts warn that moving more supplements under CDSCO’s purview could “complicate compliance” and stifle growth. Instead, leading nutraceutical manufacturers advocate a single coherent regime – for example, strengthening FSSAI’s mandate and enforcement rather than duplicating authorities. Recommendations include clearer product definitions, sector-specific GMP standards, and giving FSSAI the power to act on misleading health claims flagged by advertising watchdogs.
Medical Devices: Dual Standards, Refurbished Devices, and Reform Efforts
The medical devices sector faces its own tangle of rules. Under the 2017 Medical Devices Rules (MDR), India adopted a risk-based classification: low-risk (Class A/B) devices can be licensed by state regulators, while high-risk devices (Class C/D) require CDSCO approval for manufacturing, while all classes are licensed by CDSCO for Imports. At the same time, the Bureau of Indian Standards (BIS) publishes hundreds of medical-device standards and now requires manufacturers to comply when standards exist. In fact, BIS has over 1,200 published standards for critical devices and plans 214 more by late 2025. The MDR explicitly mandates that manufacturers must adhere to any applicable BIS standard or the device is deemed “not of standard quality.” In practice, this means a firm may need both a CDSCO license and a BIS certification for the same product, adding time and cost.
A recent point of contention has been refurbished medical devices. In 2023, the Ministry of Environment, Forest and Climate Change proposed a ban on import of pre-owned and refurbished medical devices under e-waste rules—citing concerns about dumping. However, CDSCO’s current regulatory framework lacks clarity on such devices. Industry players raised concerns that such conflicting stances would severely restrict access to affordable high-end equipment in tier-2, 3 & 4 cities. The lack of alignment between ministries risks paralyzing a segment that helps bridge India’s healthcare access gap.
Recently, policymakers have sought to harmonize device regulation. The National Medical Devices Policy, 2023 (notified by MoHFW) emphasizes safety and faster market access, aiming to “foster innovation and streamline market entry” for Indian manufacturers. Likewise, India joined the International Medical Device Regulators Forum (IMDRF) to align with global norms and reduce redundant tests. These steps show an awareness that a balanced framework is needed. But on the ground, startups still report slow approvals and uncertainty.
Diagnostics and Digital Health: Overlapping and Emerging Regimes
Diagnostics in India are regulated as devices by the CDSCO – yet in practice multiple bodies intervene. During COVID-19, for instance, the Indian Council of Medical Research (ICMR) issued emergency approvals for test kits and is now working with CDSCO on validation protocols. ICMR has even launched the “MedTech Mitra” platform (with CDSCO and NITI Aayog) to help innovators conduct clinical evaluations and meet regulatory requirements. This is a useful bridge, but it also highlights the complex chain: an IVD developer must deal with an ICMR-led initiative, CDSCO licensing, and sometimes state lab regulations. Meanwhile, laboratory services themselves (pathology labs, etc.) are governed separately under state clinical establishment laws and accreditation standards, meaning diagnostic products and services have little unified oversight.
Healthtech and telehealth face similar fragmentation. The National Digital Health Mission (now Ayushman Bharat Digital Mission) was launched to create interoperable health IDs and EHR registries, explicitly to overcome “fragmented and inaccessible” health data. Yet India still lacks comprehensive laws for digital health. The 2020 Telemedicine Practice Guidelines (MoHFW/NMC) provide a framework for online consultations, but no standalone legislation; patient privacy is only partially protected under the forthcoming Digital Personal Data Protection Act. In short, “current laws that regulate technology do not explicitly address telehealth, nor are there adequate data protection laws” for the volumes of health data expected. This regulatory gap means that telehealth platforms, AI diagnostics, and mobile health apps operate in a gray zone – risking both patient privacy and uneven standards of care.
Further, the e-pharmacy sector has become a major regulatory flashpoint. While these platforms enable wider medicine access, especially in remote areas, they currently operate in a legal vacuum. The Drugs and Cosmetics Act does not clearly define or regulate online pharmacies. In 2023, the Ministry of Health issued show-cause notices to major e-pharmacy players for alleged violations, such as selling prescription drugs without verification. Meanwhile, multiple court cases and contradictory state actions have left the sector in limbo. Stakeholders await a comprehensive e-pharmacy regulation—expected to be included in the upcoming Drugs, Medical Devices and Cosmetics Bill—that can resolve the ambiguity, ensure consumer protection, and promote responsible innovation.
Consequences for Industry and Public Health
This patchwork of regulations has real costs. Health startups and manufacturers face higher barriers and uncertainty when seeking approvals. Conflicting guidance can force them to duplicate submissions or even hold off on launches. In some cases companies have simply relabeled products to fit the lighter-touch regime, as with nutraceuticals. In other instances, firms that choose the wrong pathway end up in legal trouble (or market delays) if regulators disagree on classification. The Institute for Competitiveness has noted that ease-of-doing-business in pharma and devices is hurt by such unclear lines.
For consumers and public health, the risks are serious. Misleading products can proliferate when enforcement is spotty. The Telangana seizures show how dangerous claims slip through: drugs were being sold as “nutraceuticals” with unproven disease-curing claims. Fragmentation also slows the adoption of beneficial technologies. For example, imported hi-tech devices may face bottlenecks if both CDSCO and BIS review them, delaying patient access. Meanwhile, health data silos undermine care coordination: without integrated digital records, critical patient information may not follow the individual between hospitals, hurting outcomes. As one health-policy analysis concluded, India’s goal of universal, efficient care depends on “address[ing] information fragmentation” and building an integrated digital health infrastructure.
Steps Toward Coordination: Recent Reforms and Initiatives
Fortunately, authorities are increasingly aware of these gaps. MoHFW and the Department of Pharmaceuticals have tabled sweeping reforms. In July 2022 the government introduced a draft Drugs, Medical Devices and Cosmetics Bill, 2022 to replace the antiquated Drugs & Cosmetics Act of 1940; this new law would expressly cover e-pharmacies, medical devices, and even some AYUSH products. In April 2023 the National Medical Devices Policy, 2023 was notified, emphasizing patient-centric regulation and innovation-friendly processes. On the nutrition side, FSSAI in 2022 overhauled its nutraceutical regulations, and an inter-ministerial committee has been meeting to clarify which claims should fall under CDSCO vs FSSAI.
Meanwhile, digital health is a national priority. The Ayushman Bharat Digital Mission (formerly NDHM) is building standards for interoperable records and unique health IDs – aiming to connect government health programs, private hospitals, and even insurance systems. The Personal Data Protection Bill (passed by Parliament in 2023) will finally codify safeguards for all personal data, including health information. Even industry collaborations are multiplying: India’s partnership with the IMDRF seeks to harmonize medical-device requirements globally, and forums like MedTech Mitra offer one-stop support for innovators. These steps show momentum – but they need further coordination to bridge gaps between agencies.
Recommendations: Toward a Unified Regulatory Vision
To move from patchwork to policy, India should:
Clearly delineate authority by product category
Strengthen inter-agency coordination bodies
Modernize and consolidate legislation
Single-window clearance system
Harmonize with global best practices
Enhance enforcement and public outreach
Foster public-private collaboration
A unified vision is not just bureaucratic housekeeping: it is essential for innovation and public health. By clarifying agency roles, streamlining approvals, and focusing on interoperability, India can turn its patchwork regulations into a cohesive framework. The prize is high – faster access to safe, affordable medicines and technologies, and a healthier population empowered by a truly integrated system.
Disclaimer: The content of this article represents the author's personal perspective and is intended for informational purposes only.
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