Consumer health wearables blur the line between wellness and medicine. Examine the regulatory gaps in India with reference to neuro-wearables.

Neuro-wearables such as the head-worn "Temple" device are sold as brain-health trackers. In India, devices are regulated as "drugs" under the Drugs and Cosmetics Act, 1940, and only those the government notifies come under the Medical Devices Rules, 2017 [1][2]. A product that calls itself "wellness" can therefore make health-like claims without any medical-grade checks.

How the line blurs

• Claim-based classification: a "brain health" or "focus" claim avoids approval, while a "dementia screening" claim would need it. The device and its sensors are the same either way.
• Unproven signals: poor blood supply to the brain is linked to cognitive decline, but a reading taken through the skin is not a diagnosis. Without testing against MRI or ultrasound methods, a false alarm or false reassurance carries real health costs.

Regulatory gaps

• No separate device law: a 2013 bill with separate provisions for devices was sent to a standing committee. The government later chose to regulate devices through rules under the 1940 Act instead [3]. In 2022, the Standing Committee on Health's 138th Report said CDSCO in its current form cannot regulate the sector well. It asked for a separate law and a National Commission on Medical Devices [1].
• Software grey zone: a neuro-wearable is mostly a sensor plus an app that interprets the data. The Committee has asked CDSCO for clear approval routes for digital health and AI-based medical software [4].
• Neural data unprotected: the DPDP Act, 2023 handles all personal data under one set of rules. It has no special category for brain data. UNESCO's 2025 Recommendation on the Ethics of Neurotechnology also covers indirect neural data and calls for a ban on commercial targeting of people during sleep [5]. India has no matching rule.
• Weak policing of claims: no regulator checks what wellness products say about health, so a famous founder's endorsement can stand in for peer-reviewed evidence.

Way forward

• Bring wellness products under regulation according to the risk of what they claim. Any claim to screen for or diagnose a condition should need CDSCO approval.
• Pass a separate medical devices law, as the 138th Report recommended [1].
• Recognise neural data as sensitive data, using UNESCO's definitions as a guide [5].
• Require makers to publish validation studies before they make any health claims.

Neuro-wearables show how innovation can move ahead of a drugs-era legal framework. Regulation based on risk, protection for neural data and claims backed by evidence would let India support affordable early screening for an ageing population. It would also protect the right to health under Article 21 and advance SDG 3.