Medical Devices as Drugs in India: Section 3(b)(iv) and Penalties

1. Key takeaways

India has no independent medical device act. A medical device falls within the scope of the Drugs and Cosmetics Act, 1940 only after the Central Government notifies it as a drug in the Official Gazette, pursuant to s.3(b)(iv) of the Act. The consequence is far-reaching: the criminal penalties of the drugs law apply directly to devices. Manufacturing or selling without a licence is punishable under s.27(b) with imprisonment for 3 to 5 years and a fine of not less than INR 100,000 or 3 times the value of the goods confiscated, whichever is higher. Foreign manufacturers who treat device regulation in India as a light-touch formality are therefore misreading the legal architecture at its foundation, because the enforcement framework they face is the one built for pharmaceuticals. The notification mechanism also means the scope of regulated devices expands in steps as new categories are notified, so the first question for any product is whether it has in fact been notified into the system at all.

• Devices become regulated through the s.3(b)(iv) drug definition, not a device act.
• Unlicensed manufacture or sale carries 3 to 5 years imprisonment under s.27(b).
• The fine is INR 100,000 or three times the value of the goods, whichever is higher.
• Confiscation can extend to machinery, packaging and conveyance.
• Liability reaches responsible individuals, not only the company.

2. Legal basis

The penal framework operates as a graduated ladder: the heavier provisions attach to the conduct that the law treats as most dangerous, namely operating entirely outside licensing, while the lighter provisions cover other contraventions of the Act and the Rules. The table below sets out the provisions, based on the consolidated compilations of the cited third-level sources, and every risk assessment for an Indian project should reference these sections directly rather than relying on paraphrases.

(The penalty provisions above are based on the compilations in AZB & Partners, Pharma & Medical Device Regulation 2026, and the section list prepared by Standphill India. These are third-level sources; the text of the sections themselves prevails when citing.)

3. Expert insights

Insight one: regulation as drugs is not a metaphor but a legal-technical route. Section 3(b)(iv) works as an interface clause. Each time the Central Government notifies a batch of devices, that batch automatically acquires the status of a drug and thereby inherits the full set of obligations and penalties of the drugs law. This is why the punishment intensity for devices in India is far higher than in many comparable markets. It also explains the drafting style of the device rules: they are constructed as subordinate legislation under a pharmaceutical statute, and their enforcement machinery — inspectors, seizures, prosecutions — is the machinery of the drugs administration rather than a bespoke device inspectorate.

Insight two: the three-times-value calculation bites harder than the headline fine. The fine under s.27(b) is the higher of INR 100,000 and 3 times the value of the goods confiscated. For a consignment of imaging equipment or implants with a high unit value, three times the value far exceeds the fixed floor, and confiscation can extend to the production equipment as well. The economics of an unlicensed shipment therefore deteriorate faster than most commercial teams assume: the exposure is not a modest administrative fine measured against the consignment, but a multiple of the consignment value layered on top of the loss of the goods themselves and, potentially, of the tools used to make them.

Insight three: responsibility attaches to natural persons. Under s.30 and the related provisions, corporate violations are pursued against the responsible senior personnel; the corporate form is not a shield. Directors and managers who sign off on import or distribution arrangements should understand that “the company did it” is not a defence recognised by this framework, and that repeat conduct attracts substantially enhanced imprisonment. This personal dimension changes how compliance sign-offs should be documented and who should be accountable for them. It also means that any restructuring of the Indian chain — changing importers, distributors or agents — should be reviewed for its effect on who is the responsible person under the notified framework, because liability follows the notified roles rather than the commercial paperwork.

4. Practical recommendations

• A common error among Chinese enterprises in India is to ship first and licence later, assuming device enforcement is softer than pharmaceutical enforcement and that a detected gap ends in a fine. GRZAN’s operating principle is the opposite.
• No commercial import takes place before the MD-15 import registration certificate is in hand.
• Where samples genuinely must enter India, use the test licence route (Form MD-16 → MD-17) and state the non-commercial purpose explicitly in the documentation.
• Require, in the Indian distribution agreement, an express licensing precondition so that the risk of unlicensed selling is isolated from the manufacturer’s side of the chain.
• Treat any internal reading of the penalty ranges as a practical estimate pending verification against the current statutory text, since the compilations relied on are third-level sources.

5. Verification checklist

• □ The product has been notified by the Central Government in the Gazette as a medical device (otherwise device obligations do not attach).
• □ The MD-15 has been obtained before any commercial import.
• □ Non-commercial samples have been switched to the MD-16 → MD-17 test licence route.
• □ The distribution agreement contains the licensing precondition.
• □ The sentencing range of s.27(b) is understood by the project team.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support across South Asia, including India. Our team prepares dossiers to CDSCO expectations, manages SUGAM submissions and deficiency responses, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com

Regulatory information verified as of 27 October 2026.