Section 4 of the Drugs and Cosmetics Act, 1940 - Presumption as to Poisonous Substances

Section 4 creates a statutory presumption for substances that are specified as poisonous by rules made under the relevant chapters of the Drugs and Cosmetics Act, 1940. The provision gives such a rule-based specification legal effect for the chapter to which it applies.

At a glance: Section 4 does not itself provide a list of poisonous substances. It provides that a substance specified as poisonous by rules under Chapter III, Chapter IV or Chapter IVA is deemed to be poisonous for the purposes of the corresponding chapter.

Statutory text of Section 4

4. Presumption as to poisonous substances.
Any substance specified as poisonous by rule made under Chapter III or Chapter IV or Chapter IVA shall be deemed to be a poisonous substance for the purposes of Chapter III or Chapter IV or Chapter IVA, as the case may be.

The reference to Chapter IVA was inserted by Act 13 of 1964, section 3, with effect from 15 September 1964.

Meaning and legal effect

The expression "shall be deemed" creates a statutory deeming rule. Where a substance has been specified as poisonous by a valid rule under the relevant chapter, Section 4 directs that the substance be treated as poisonous for the purposes of that chapter. The operative classification therefore depends on the applicable rules made under the Act.

Chapters referred to in Section 4

Chapter III deals with import of drugs and cosmetics. Chapter IV contains provisions concerning manufacture, sale and distribution of drugs and cosmetics. Chapter IVA contains provisions relating to Ayurvedic, Siddha and Unani drugs. Section 4 connects a rule-based specification of a poisonous substance with the legal operation of the relevant chapter.

Why Section 4 matters

The provision avoids the need to reproduce a fixed list of poisonous substances in the Act itself. Instead, the Act permits the applicable rules to identify substances, while Section 4 supplies the statutory consequence of that identification. For compliance purposes, Section 4 should therefore be read together with the current rules and notifications applicable to the particular drug, cosmetic or traditional-drug context.

Important: This page explains Section 4 of the central Act. Regulatory requirements may also depend on the Drugs Rules, 1945, the Cosmetics Rules, 2020, the New Drugs and Clinical Trials Rules, 2019, other rules or notifications, and the nature of the product or activity involved.

Related provisions

For defined expressions used throughout the Act, see Section 3 - Definitions. For the statutory framework governing import, see Section 10 - Prohibition of import of certain drugs or cosmetics. The complete sequence of provisions is available on the Drugs and Cosmetics Act, 1940 page.

Official legal resources

For the current central statutory text and regulatory material, consult India Code and the CDSCO Acts and Rules portal. These official sources should be checked for amendments, rules, notifications and regulatory updates relevant to a particular matter.