Section 19 of the Drugs and Cosmetics Act, 1940 - Pleas
Section 19 sets out the pleas that are unavailable, the limited statutory exceptions relating to the quality or condition of a drug or cosmetic, and the conditions under which a person who is not the manufacturer or the manufacturer's distribution agent may avoid liability for a contravention of Section 18.
What Section 19 means
The provision limits certain defences in prosecutions under Chapter IV. Mere ignorance of the nature, substance or quality of the drug or cosmetic, or of the circumstances of its manufacture or import, is not by itself a defence. Likewise, it is not enough to argue that a purchaser who bought the product only for test or analysis suffered no prejudice.
At the same time, Section 19 recognizes specified situations in which a drug or cosmetic is not treated as defective merely because an innocuous ingredient was necessarily added for manufacture, preparation, carriage or consumption, or because an extraneous substance became unavoidably intermixed during manufacture, preparation or conveyance, subject to the statutory conditions.
Text and explanation of Section 19
Section 19(1): Ignorance is not by itself a defence
Subject to the exceptions contained in Section 19, it is no defence in a prosecution under the Chapter merely to prove that the accused was ignorant of the nature, substance or quality of the drug or cosmetic concerned, or of the circumstances of its manufacture or import. It is also no defence merely to show that a purchaser who bought the product only for test or analysis was not prejudiced by the sale.
Section 19(2): Limited protection concerning quality or intermixture
For the purposes of Section 18, a drug is not treated as misbranded, adulterated, spurious or below standard quality, and a cosmetic is not treated as misbranded or below standard quality, only because of either of the following circumstances:
(a) An innocuous substance or ingredient was added because it was required for the manufacture or preparation of the drug or cosmetic as an article of commerce fit for carriage or consumption, provided that the addition was not made to increase bulk, weight or measure or to conceal inferior quality or another defect.
(b) An extraneous substance became unavoidably intermixed during manufacture, preparation or conveyance. This protection does not apply to a sale or distribution occurring after the vendor or distributor became aware of the intermixture.
Section 19(3): Defence available to certain sellers and distributors
A person who is neither the manufacturer of the drug or cosmetic nor the manufacturer's agent for distribution is not liable for a contravention of Section 18 if that person proves all of the following:
(a) The drug or cosmetic was acquired from a duly licensed manufacturer, distributor or dealer.
(b) The person did not know, and could not with reasonable diligence have ascertained, that the drug or cosmetic contravened Section 18.
(c) While in that person's possession, the drug or cosmetic was properly stored and remained in the same state as when it was acquired.
Key requirements of the seller's defence under Section 19(3)
- The accused must fall within the class protected by Section 19(3), rather than being the manufacturer or the manufacturer's distribution agent.
- The source of acquisition must be a duly licensed manufacturer, distributor or dealer.
- Absence of actual knowledge alone is insufficient; the person must also establish that reasonable diligence would not have revealed the contravention.
- Proper storage and preservation of the product in the same state as acquired are independent statutory conditions.
- Because the subsection states that the person must prove these matters, records relating to purchase, licensing, storage and handling may be important to the statutory defence.
Relationship with Section 18
Section 18 of the Drugs and Cosmetics Act, 1940 contains the principal prohibitions governing specified manufacture, sale and distribution activities. Section 19 does not replace those prohibitions. Instead, it defines which pleas are insufficient and sets out limited statutory protections relevant to liability under Section 18.
Related definitions and provisions
The operation of Section 19 may depend on the classification of the product and the alleged contravention. Relevant provisions include Section 16 on standards of quality, Section 17 on misbranded drugs, Section 17A on adulterated drugs, Section 17B on spurious drugs, and the corresponding provisions dealing with cosmetics.
Official legal resources
For the authoritative statutory text and regulatory material, refer to the Drugs and Cosmetics Act, 1940 on India Code, the CDSCO Drugs and Cosmetics Act page, and the CDSCO Drugs Rules, 1945 page.
Legislative notes
The source page records amendments including the insertion of references to cosmetics by Act 21 of 1962, substitution of parts of Section 19 by Act 13 of 1964, substitution relating to adulterated or spurious drugs by Act 68 of 1982, omission of former clause (aa), and substitution of sub-section (3). For current legal use, the latest official statutory text should be checked.