Section 9 of Drugs and Cosmetics Act 1940 - Misbranded Drugs
Section 9 explains when a drug is treated as "misbranded" for the purposes of Chapter III of the Drugs and Cosmetics Act, 1940. The provision focuses on deceptive appearance, non-compliant labelling and false or misleading claims.
Text and meaning of Section 9
For the purposes of this Chapter, a drug shall be deemed to be misbranded -
(a) if it is so coloured, coated, powdered or polished that damage is concealed or if it is made to appear of better or greater therapeutic value than it really is; or
(b) if it is not labelled in the prescribed manner; or
(c) if its label or container or anything accompanying the drug bears any statement, design or device which makes any false claim for the drug or which is false or misleading in any particular.
What is a "drug" for this provision?
Section 9 uses the expression "drug" in the statutory sense. Section 3(b) of the Act contains the definition of "drug" and broadly covers medicines for internal or external use in human beings or animals, specified substances intended for diagnosis, treatment, mitigation or prevention of disease or disorder, specified substances affecting the structure or functions of the body, components of drugs, and specified medical devices. The precise statutory definition and applicable notifications should be checked for the product concerned.
When is a drug misbranded under Section 9?
1. Concealment of damage or exaggerated therapeutic appearance
Clause (a) applies where colouring, coating, powdering or polishing conceals damage, or where the treatment of the product makes it appear to possess better or greater therapeutic value than it actually has. The provision therefore addresses presentation that disguises the true condition or therapeutic character of a drug.
2. Failure to comply with prescribed labelling
Clause (b) treats a drug as misbranded if it is not labelled in the prescribed manner. The detailed labelling framework is found principally in the Drugs Rules, 1945. Rule 95 deals with the prohibition on sale or distribution unless a drug is labelled in accordance with the Rules, while Rule 96 contains general requirements concerning the manner of labelling. Product-specific requirements and schedules may also apply.
3. False or misleading claim, statement, design or device
Clause (c) covers a false claim or any statement, design or device on the label, container or material accompanying the drug that is false or misleading in any particular. This limb is wider than the printed label alone because it expressly extends to the container and material accompanying the drug.
Section 9 and related import provisions
Section 9 appears in Chapter III of the Act, which regulates import of drugs and cosmetics. Section 10 contains prohibitions relating to import of specified drugs and cosmetics, including categories linked to statutory quality, misbranding, adulteration and spuriousness. Section 9 should therefore be read with the surrounding provisions of Chapter III and the applicable Drugs Rules, 1945.
Difference from adulterated and spurious drugs
The Act separately deals with adulterated drugs in Section 9A and spurious drugs in Section 9B. Section 9 is directed principally at deceptive presentation, defective labelling and false or misleading claims. Whether a product falls within more than one statutory category depends on its facts and the applicable provisions.
Amendment note
Section 9 was substituted by Section 5 of the Drugs and Cosmetics (Amendment) Act, 1982 (Act 68 of 1982), with effect from 1 February 1983.
Practical compliance point
Manufacturers, importers and persons responsible for drug labelling should verify both the Act and the currently applicable Drugs Rules and notifications. A label may comply with the general requirements but still be subject to additional product-specific declarations, warnings, schedules or regulatory restrictions.