Section 28A Drugs and Cosmetics Act 1940 - Penalty for Records and Information
Section 28A deals with the consequence of contravening Section 18B of the Drugs and Cosmetics Act, 1940 without reasonable cause or excuse. Section 18B concerns maintenance of prescribed records, registers and other documents and furnishing prescribed information.
What Section 28A provides
Section 28A - Penalty for not keeping documents, etc., and for non-disclosure of information.
In substance, a person who, without reasonable cause or excuse, contravenes Section 18B is presently punishable with imprisonment for a term that may extend to one year, or with a fine of not less than Rs. 20,000, or with both.
Meaning and scope of Section 28A
The provision is linked directly to Section 18B - Maintenance of records and furnishing of information. Section 18B requires a person holding a licence under clause (c) of Section 18 to keep and maintain prescribed records, registers and other documents and to furnish prescribed information to the prescribed authority.
Accordingly, Section 28A is a compliance-enforcement provision. Its application depends on a contravention of the obligations imposed through Section 18B and the applicable rules. The statutory words "without reasonable cause or excuse" are important because the penalty provision itself recognises that a contravention accompanied by a legally sufficient reasonable cause or excuse stands on a different footing.
Current penalty under Section 28A
| Requirement | Current position |
|---|---|
| Underlying contravention | Contravention of Section 18B without reasonable cause or excuse |
| Imprisonment | May extend to one year |
| Fine | Not less than Rs. 20,000 |
| Combined punishment | Imprisonment and fine may both be imposed |
Jan Vishwas amendment: change from 30 June 2027
The Jan Vishwas (Amendment of Provisions) Act, 2026 substitutes the existing criminal punishment in Section 28A with an administrative monetary penalty. Under the amended provision, the contravention will be liable to a penalty of not less than Rs. 3 lakh and up to Rs. 5 lakh.
However, that substituted penalty is not yet the operative Section 28A penalty on 25 September 2026. Notification S.O. 3286(E), dated 22 June 2026, appoints 30 June 2027 as the commencement date for the relevant amendments concerning the Drugs and Cosmetics Act, 1940.
Legislative history
Section 28A was inserted by the Drugs and Cosmetics (Amendment) Act, 1982 (Act 68 of 1982), with effect from 1 February 1983. The fine provision was later substituted by the Drugs and Cosmetics (Amendment) Act, 2008 (Act 26 of 2008), with effect from 10 August 2009. The Jan Vishwas (Amendment of Provisions) Act, 2026 makes the further change described above, scheduled to commence on 30 June 2027.
Related provisions
Readers may also refer to Section 28 - Penalty for non-disclosure of the name of the manufacturer, Section 28B - Contravention of Section 26A, and Drugs and Cosmetics Act, 1940.
Official legal resources
For authoritative and updated text, consult the official India Code - Drugs and Cosmetics Act, 1940, the CDSCO Acts and Rules page, and the e-Gazette of India.
Disclaimer: This page is for legal information and general reference. Always verify the latest statutory text, commencement notifications, rules and applicable judicial decisions before relying on a provision in a specific matter.