Drugs and Cosmetics Act 1940 / Section 33EE

Section 33EE of Drugs and Cosmetics Act 1940 - Adulterated Drugs

Section 33EE forms part of Chapter IVA of the Drugs and Cosmetics Act, 1940 and defines when an Ayurvedic, Siddha or Unani drug is legally deemed to be adulterated.

Meaning of adulterated drug under Section 33EE: The provision focuses on contamination, insanitary preparation or storage, harmful containers or substances, impermissible colouring, and mixing that reduces the quality or strength of an Ayurvedic, Siddha or Unani drug.

Text and requirements of Section 33EE

For the purposes of Chapter IVA, an Ayurvedic, Siddha or Unani drug is deemed to be adulterated if any of the following statutory conditions applies:

  1. it consists, wholly or partly, of a filthy, putrid or decomposed substance;
  2. it has been prepared, packed or stored under insanitary conditions by which it may have been contaminated with filth or rendered injurious to health;
  3. its container consists, wholly or partly, of a poisonous or deleterious substance capable of making the contents injurious to health;
  4. it bears or contains, for colouring purposes, a colour other than a prescribed colour;
  5. it contains a harmful or toxic substance which may make it injurious to health; or
  6. a substance has been mixed with it so as to reduce its quality or strength.

Explanation relating to natural decomposition

The Explanation to Section 33EE qualifies clause (a). A drug is not treated as consisting of a decomposed substance merely because the substance results from the natural decomposition of the drug.

That protection applies only where the decomposition is not attributable to negligence by the manufacturer or dealer and the decomposition does not render the drug injurious to health.

How Section 33EE operates

The section is a statutory definition. If an Ayurvedic, Siddha or Unani drug satisfies any one of clauses (a) to (f), it falls within the category of an adulterated drug for the purposes of Chapter IVA. The provision therefore covers both contamination that can make a drug unsafe and adulteration that reduces its quality or strength.

Related legal provisions

Section 33EE should be read with the surrounding provisions governing Ayurvedic, Siddha and Unani drugs. Section 33E deals with misbranded drugs, Section 33EEA defines spurious drugs, Section 33EEB concerns prescribed standards for manufacture for sale or distribution, and Section 33EEC prohibits manufacture and sale in specified circumstances. Penalties for manufacture for sale or distribution of an Ayurvedic, Siddha or Unani drug deemed adulterated under Section 33EE are dealt with in Section 33-I.

Section 33E
Misbranded drugs Section 33EEA
Spurious drugs Section 33EEB
Regulation of manufacture for sale Section 33EEC
Prohibition of manufacture and sale Section 33-I
Penalty provisions Drugs and Cosmetics Act 1940
Act overview

Official legal sources

For the current statutory text and regulatory material, readers should verify the provision from official Government sources, particularly India Code and the Central Drugs Standard Control Organisation. AYUSH drug quality and regulatory information is also published by the Ministry of Ayush.

Legal information on this page is intended for general reference. For a specific compliance, enforcement or prosecution issue, the current Act, applicable Rules, notifications and facts of the case should be examined.