Section 28B of the Drugs and Cosmetics Act 1940 - Penalty for Contravention of Section 26A

Section 28B of the Drugs and Cosmetics Act, 1940 provides the criminal penalty where a person manufactures, sells or distributes a drug or cosmetic in violation of a notification issued by the Central Government under Section 26A.

Text and effect of Section 28B

Section 28B applies where a person, either personally or through another person acting on his behalf, manufactures, sells or distributes a drug or cosmetic contrary to a notification issued under Section 26A. The prescribed punishment is imprisonment for a term which may extend to three years and a fine which may extend to five thousand rupees.

The section therefore operates together with Section 26A of the Drugs and Cosmetics Act, 1940. Before applying Section 28B, the relevant Section 26A notification and the precise activity regulated, restricted or prohibited by it should be identified.

What is Section 26A?

Section 26A empowers the Central Government, where the statutory public-interest conditions are satisfied, to regulate, restrict or prohibit by notification in the Official Gazette the manufacture, sale or distribution of a drug or cosmetic. The provision is used as a public-health measure and can apply to specified drugs, cosmetics or combinations covered by a particular notification.

The present wording of Section 26A reflects the amendment that expanded the provision from a power merely to prohibit to a power to regulate, restrict or prohibit. Accordingly, compliance depends on the exact terms and current legal status of the applicable Gazette notification.

Essential elements of an offence under Section 28B

There must be a notification issued under Section 26A.
The notification must cover the drug or cosmetic and the activity in question.
The accused must have manufactured, sold or distributed the drug or cosmetic personally or through another person acting on his behalf.
The manufacture, sale or distribution must be contrary to the applicable Section 26A notification.

Punishment under Section 28B

On contravention of a Section 26A notification, Section 28B provides for imprisonment which may extend to three years. The offender is also liable to a fine which may extend to Rs. 5,000.

Important: Section 28B is notification-linked. A current Gazette notification may prohibit or restrict a particular drug, cosmetic or fixed dose combination. Its wording, commencement, amendments, supersession and present status should therefore be checked before reaching a conclusion about compliance.

Section 26A notifications and prohibited fixed dose combinations

Section 26A continues to be used by the Central Government for public-health regulation. For example, official notifications have been issued to prohibit the manufacture for sale, sale and distribution for human use of specified fixed dose combinations. The Central Drugs Standard Control Organization publishes relevant statutory materials and lists concerning prohibited or restricted fixed dose combinations.

Legislative note

Section 28B was inserted by the Drugs and Cosmetics (Amendment) Act, 1982 (Act 68 of 1982), with effect from 1 February 1983.

Related provisions

Readers may also refer to Section 27 - penalties relating to drugs, Section 27A - penalties relating to cosmetics, Section 28A - penalty for failure concerning records and information, and Section 30 - penalty for subsequent offences.

This page is intended as a general legal reference. For a particular drug, cosmetic or fixed dose combination, verify the latest applicable Gazette notification and subsequent amendments or court orders.