Section 9A of the Drugs and Cosmetics Act 1940 - Adulterated Drugs
Section 9A forms part of Chapter III of the Drugs and Cosmetics Act, 1940, which regulates the import of drugs and cosmetics. It specifies the circumstances in which a drug is legally deemed to be adulterated for the purposes of that Chapter.
Meaning of adulterated drug under Section 9A
A drug is treated as adulterated if it falls within any one of the six conditions stated in Section 9A. The provision addresses contamination, insanitary preparation or storage, unsafe containers, unauthorised colouring, harmful or toxic substances, and mixing that reduces quality or strength.
Section 9A - Statutory conditions
For the purposes of Chapter III, a drug shall be deemed to be adulterated if:
- it consists, wholly or partly, of any filthy, putrid or decomposed substance;
- it has been prepared, packed or stored under insanitary conditions that may contaminate it with filth or render it injurious to health;
- its container is made, wholly or partly, of a poisonous or deleterious substance that may render the contents injurious to health;
- it bears or contains, for colouring purposes only, a colour other than a prescribed colour;
- it contains a harmful or toxic substance that may render it injurious to health; or
- a substance has been mixed with it so as to reduce its quality or strength.
Clause-by-clause explanation
| Clause | What the provision covers |
|---|---|
| (a) | Physical adulteration by filthy, putrid or decomposed matter. |
| (b) | Preparation, packing or storage under insanitary conditions creating contamination or health risk. |
| (c) | A poisonous or deleterious container capable of making the drug injurious to health. |
| (d) | Use, for colouring only, of a colour that is not prescribed. |
| (e) | Presence of a harmful or toxic substance capable of making the drug injurious to health. |
| (f) | Mixing another substance with the drug in a manner that reduces its quality or strength. |
Legal effect in relation to import
Section 9A is a deeming provision for Chapter III. Its classification is important because Section 10 regulates and prohibits the import of specified drugs and cosmetics, including drugs that are not of standard quality or are misbranded, adulterated or spurious. Section 9A should therefore be read with the other provisions of Chapter III and the applicable rules.
Related provisions
Section 8: deals with standards of quality for the purposes of Chapter III.
Section 9: identifies when a drug is deemed to be misbranded.
Section 9B: identifies when a drug is deemed to be spurious.
Section 10: prohibits the import of specified drugs and cosmetics, subject to the Act.
Legislative note
Sections 9A and 9B were substituted by Section 6 of the Drugs and Cosmetics (Amendment) Act, 1982 (Act 68 of 1982), with effect from 1 February 1983.
Official legal resources
For the current statutory text and regulatory material, refer to the official India Code text of the Drugs and Cosmetics Act, 1940 and the Central Drugs Standard Control Organisation (CDSCO), Ministry of Health and Family Welfare.
India Code - Drugs and Cosmetics Act, 1940
CDSCO - Acts and Rules
CDSCO - Drug and quality alerts
This page is an informational guide to Section 9A. For a specific regulatory, prosecution, import or compliance issue, the current Act, applicable rules, notifications and case-specific facts should be checked.