D&C Act §3(b) — The Legal Definition
The amendment that brought in devices
The Drugs and Cosmetics Act 1940 was originally enacted to regulate drugs and cosmetics. Medical devices were formally brought under its scope through the Drugs and Cosmetics (Amendment) Act 2008 and subsequent gazette notifications, with the comprehensive Medical Devices Rules 2017 providing the detailed regulatory framework.
Section 3(b) — Full text (as amended)
Section 3(b)(iv) of the D&C Act defines "drug" to include:
"such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette, after consultation with the Board."
The Medical Devices Rules 2017 (Rule 3) provide the operative definition for regulatory purposes:
"medical device" means any instrument, apparatus, appliance, implant, material, or other article, including a software, whether used alone or in combination, including any accessories and the software intended by its manufacturer to be used specifically for diagnostic or therapeutic purposes, intended by the manufacturer to be used for human beings for one or more specific medical purposes.
Key elements of the definition
| Element | Significance |
|---|---|
| Instrument, apparatus, appliance, implant, material | Broad catch-all of physical forms |
| Including software | SaMD explicitly captured |
| Used alone or in combination | Combination products included |
| Intended by the manufacturer | Intended use test applies |
| Specific medical purpose | Distinguished from general wellness |
| Does not achieve principal action through pharmacological means | Excludes drugs |
Official source
The current consolidated text is available at CDSCO — Acts & Rules.