Home > Drugs and Cosmetics Act 1940 > Section 33E

Section 33E of the Drugs and Cosmetics Act, 1940: Misbranded Ayurvedic, Siddha or Unani Drugs

Section 33E forms part of Chapter IVA of the Drugs and Cosmetics Act, 1940 and defines when an Ayurvedic, Siddha or Unani drug is deemed to be misbranded. The provision focuses on deceptive appearance, failure to comply with prescribed labelling requirements, and false or misleading claims made on or with the drug.

Meaning of Ayurvedic, Siddha or Unani drug: Section 3 of the Act contains the statutory definition for these drugs. In general terms, the definition covers medicines intended for specified medicinal purposes that are manufactured exclusively in accordance with formulae described in the authoritative books of the relevant systems specified in the First Schedule.

Text and meaning of Section 33E

Section 33E - Misbranded drugs. For the purposes of Chapter IVA, an Ayurvedic, Siddha or Unani drug is deemed to be misbranded in any of the following circumstances:

(a) where it is coloured, coated, powdered or polished so as to conceal damage, or is made to appear to possess better or greater therapeutic value than it actually has;

(b) where it is not labelled in the prescribed manner; or

(c) where its label, container, or anything accompanying the drug bears a statement, design or device that makes a false claim for the drug, or is false or misleading in any particular.

What makes a drug misbranded under Section 33E?

1. Concealing damage or exaggerating therapeutic value

Clause (a) addresses presentation that disguises the true condition of the drug. Colouring, coating, powdering or polishing becomes relevant where it conceals damage or creates a misleading impression that the drug has better or greater therapeutic value than it really possesses.

2. Failure to follow prescribed labelling requirements

Clause (b) makes compliance with the prescribed labelling rules part of the statutory test. The Drugs and Cosmetics Rules, 1945 contain specific requirements for the labelling and packing of Ayurvedic, Siddha and Unani drugs. Rule 161 is particularly relevant to labels, ingredients and other prescribed particulars. Where applicable, Schedule E(1) ingredients also attract the prescribed medical-supervision caution.

3. False or misleading claim on label, container or accompanying material

Clause (c) is wider than the label alone. A false claim, or a statement, design or device that is false or misleading in any particular, may bring the drug within Section 33E when it appears on the label, container or material accompanying the drug.

Section 33E compared with adulterated and spurious drugs

Provision	Category	Main statutory focus
Section 33E	Misbranded drug	Deceptive appearance, improper labelling, or false or misleading claims.
Section 33EE	Adulterated drug	Contamination, insanitary preparation or storage, harmful substances, improper colouring, or reduction of quality or strength.
Section 33EEA	Spurious drug	Imitation, substitution, false identity, fictitious manufacturer, or sale under the name of another drug.

Penalty connected with misbranded Ayurvedic, Siddha or Unani drugs

Section 33I provides the penal consequences for specified contraventions under Chapter IVA. A person who manufactures for sale or distribution an Ayurvedic, Siddha or Unani drug deemed to be misbranded under Section 33E is covered by the penalty provision in Section 33I(1)(a). The statutory text provides for imprisonment which may extend to one year and a fine that shall not be less than twenty thousand rupees or three times the value of the drugs confiscated, whichever is more.

Practical point: Whether a particular product is misbranded depends on the statutory provision, the applicable rules, the actual label and accompanying claims, and the facts of manufacture, sale or distribution. Section 33E should therefore be read with the current Drugs and Cosmetics Rules, 1945 and the other provisions of Chapter IVA.

Related provisions

Section 33E should be read in the context of Section 33B on the application of Chapter IVA, Section 33EE on adulterated drugs, Section 33EEA on spurious drugs, Section 33EEC on prohibited manufacture and sale, and Section 33I on penalties.

Official legal resources

For the current statutory text and regulatory material, consult the official India Code page for the Drugs and Cosmetics Act, 1940, the CDSCO Drugs and Cosmetics Act page, and the CDSCO Traditional Drugs resource.

Last reviewed: 25 September 2026. This page is intended as a legal information resource. Always verify the current Act, Rules, notifications and applicable regulatory directions before relying on the provision in a specific matter.