Section 10A of the Drugs and Cosmetics Act 1940: Power to Prohibit Import in Public Interest
Section 10A empowers the Central Government to prohibit the import of a drug or cosmetic when the statutory public-interest conditions in the section are satisfied. The provision forms part of Chapter III of the Drugs and Cosmetics Act, 1940, which regulates the import of drugs and cosmetics into India.
Reviewed against official India Code and CDSCO materials available in September 2026.
Text of Section 10A
10A. Power of Central Government to prohibit import of drugs and cosmetics in public interest. Without prejudice to any other provision contained in this Chapter, if the Central Government is satisfied that the use of any drug or cosmetic is likely to involve any risk to human beings or animals or that any drug does not have the therapeutic value claimed for it or contains ingredients and in such quantity for which there is no therapeutic justification and that in the public interest it is necessary or expedient so to do then, that Government may, by notification in the Official Gazette, prohibit the import of such drug or cosmetic.
Legislative history: Section 10A was inserted by section 8 of the Drugs and Cosmetics (Amendment) Act, 1982 and came into force on 1 February 1983.
Meaning and Scope of Section 10A
The section is an additional public-interest power. The opening words, "without prejudice to any other provision contained in this Chapter", mean that Section 10A operates alongside the other import controls in Chapter III, including Section 10.
The power belongs to the Central Government. A prohibition under Section 10A is made through a notification in the Official Gazette. The provision is therefore directed at specified drugs or cosmetics whose import the Central Government considers necessary or expedient to prohibit in the public interest after the statutory conditions are met.
When Can the Central Government Prohibit Import?
Section 10A identifies the grounds on which the power may be exercised. In substance, the Central Government must be satisfied about the relevant statutory concern and must also consider prohibition necessary or expedient in the public interest.
- Risk to humans or animals: use of the drug or cosmetic is likely to involve a risk to human beings or animals.
- Lack of claimed therapeutic value: a drug does not have the therapeutic value claimed for it.
- No therapeutic justification: a drug contains ingredients, and quantities of ingredients, for which there is no therapeutic justification.
- Public interest: prohibition must be considered necessary or expedient in the public interest.
- Official Gazette notification: the import prohibition is imposed by notification in the Official Gazette.
Relevant Definitions
Drug
Section 3(b) gives "drug" an extended statutory meaning. It includes medicines for internal or external use of human beings or animals, substances intended for use in diagnosis, treatment, mitigation or prevention of disease or disorder, specified substances affecting the structure or function of the human body or destroying disease-causing vermin or insects, substances intended as components of a drug, and notified medical devices falling within the statutory definition. For the precise and current wording, refer to Section 3 - Definitions.
Cosmetic
Under Section 3(aaa), "cosmetic" broadly covers an article intended to be rubbed, poured, sprinkled or sprayed on, introduced into, or otherwise applied to the human body or any part of it for cleansing, beautifying, promoting attractiveness or altering appearance, and includes an article intended for use as a component of a cosmetic.
Section 10 and Section 10A: How They Work Together
| Provision | Main function |
|---|---|
| Section 10 | Prohibits import of specified categories of drugs or cosmetics, including products that fail statutory quality, licensing or other requirements stated in that section. |
| Section 10A | Gives the Central Government an additional power to prohibit import by Official Gazette notification when the statutory risk, therapeutic-value or therapeutic-justification grounds and the public-interest requirement are satisfied. |
Effect of Contravening a Section 10A Notification
Section 13 separately addresses offences relating to import. Under Section 13(1)(c), import of a drug or cosmetic in contravention of a notification issued under Section 10A is punishable with imprisonment for a term which may extend to three years, or with fine which may extend to five thousand rupees, or with both. Other consequences under Chapter III, including confiscation where applicable, should also be considered.
Practical Importance
Section 10A is a protective import-control provision. It allows the Central Government to respond through a Gazette notification where an imported drug or cosmetic raises the type of risk or therapeutic concern described in the section and an import prohibition is considered necessary or expedient in the public interest. Importers should therefore check the Act, applicable rules, current Gazette notifications and CDSCO regulatory materials before importing a regulated product.
Legal note: This page explains the statutory provision for general information. For a particular product, always verify the latest Gazette notification, applicable rules, licence conditions and regulatory orders.