Important Definitions

Important Definitions

1. Drug

It Includes:

(i) All medicines for internal or external use of human beings or animals and substances used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals including, preparations applied on human body for the purpose of repelling insects like mosquitoes.

(ii) The substances other than food which may affect the structure or any function of the human body or used for the destruction of insects or vermin which cause disease in human beings or animals as specified from time to time by the Central Government by notification in the Official Gazette.

(iii) The substances used as components of a drug including, empty gelatin capsules.

(iv) The devices used for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette after consultation with the Drugs Technical Advisory Board (DTAB).

2. Cosmetic

It means any article intended to be sprayed, poured, rubbed or sprinkled on, or introduced into, or applied to the human body or its any part for cleansing, beautifying, promoting attractiveness or altering the appearance. It also includes any articles intended for use as a component of cosmetic.

3. Ayurvedic, Siddha or Unani Drugs

These include all medicines used for internal or external purposes or used in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals and manufactured exclusively in accordance with the formulae described in the authoritative books of Ayurvedic, Siddha and Unani Tibby Systems of Medicines specified in the First Schedule to the Drugs and Cosmetics Act, 1940.

4. Gudakhu

It is a tobacco product used for rubbing against human teeth. It contains tobacco powder, lime and molasses along with red mineral matter. It is a cosmetic within the provisions of the Act.

5. Patent or Proprietary Medicine

It means:

(i) In relation to Ayurvedic, Siddha or Unani System of Medicine, all formulations containing only such ingredients mentioned in the formulae described in the authoritative books of Ayurvedic, Siddha or Unani System of Medicine specified in First Schedule to the Act but does not include the medicine .administered by parenteral route.

(ii) In relation to any other system of medicine including, allopathic, a drug presented in a form ready for internal or external administration of human beings or animals and which is not included for the time being in the editions of Indian Pharmacopoeia or any other Pharmacopoeia.

6. Misbranded Drug

A drug is considered as a misbranded drug:

(i) if it is not labeled in the prescribed manner,

or

(ii) if it is so coloured, coated, powdered or polished that damage is concealed or it is made to appear of better or greater therapeutic value than it really is,

or

(iii) if the label or container or anything accompanying the drug bears any statement, design or device which makes any false claim for the drug or gives misleading information.

7. Adulterated Drug

A drug is considered to be adulterated:

(i) if it consists in whole or in part of any filthy, putrid, or decomposed substance,

or

(ii) if it has been prepared, packed or stored under poor sanitary conditions whereby, it may have been contaminated with filth and rendered injurious to health,

or

(iii) if container of the drug is composed in whole or in part of any poisonous substance which may render the contents injurious to health,

or

(iv) if it contains a colour other than one which is prescribed,

or

(v) if the drug contains any harmful or toxic substance which may render it injurious to health,

or

(vi) if the drug)s admixed with any substance so as to ~edu(.e its quality or strength.

8. Manufacture in relation to Drug or Cosmetic

Any process fully or partly used for making, altering, ornamenting, finishing packing, labeling, breaking up or otherwise treating or adopting any drug/cosmetic with a view to its sale or distribution but, does not include the compounding or dispensing of any drug or the packing of any drug or cosmetic in the ordinary course of retail business.

9. Spurious Drug

A drug is deemed to be a spurious drug:

(i) if it is imported under a name which belongs to another drug,

or

(ii) if it is an imitation of or a substitute for another drug or if it resembles another drug in a manner likely to deceive or bears upon it or its label or container the name of another drug,

or

(iii) if it has been substituted wholely or in part by another drug substance,

or

(iv) if it claims to be the product of a manufacturer or company of whom it is not truly a product.

10. Misbranded Cosmetic

A cosmetic shall be deemed to be misbranded:

(i) if it contains a colour which is not prescribed,

or

(ii) if it is not labelled in prescribed manner,

or

(iii) if the label or container or anything accompanying the cosmetic bears any statement which is false or misleading.

11. Spurious Cosmetic

A cosmetic shall be deemed to be spurious:

(i) if it is imported under a name which belongs to another cosmetic,

or

(ii) if it is an imitation of or a substitute for another cosmetic; resembles another cosmetic in a manner likely to deceive; or bears upon it or upon its label or container the name of another cosmetic,

or

(iii) if the label or container bears the name of an individual or a company purporting to be the manufacturer of the cosmetic which individual or company is fictitious or does not exist,

or

(iv) if it purports to be the product of a manufacturer of whom it is not truly a product.