Drugs and Cosmetics Act 1940 and Rules 1945, Objectives, Definitions of Drug, Manufacture, Import, Patent or Proprietary Medicine, Cosmetics, Misbranded drugs, Adulterated drugs, Spurious drugs, Misbranded cosmetics, Misbranded cosmetics, Spurious cosmetics.

• Drugs and Cosmetics Act 1940 and Rules 1945 and New Amendments

Regulate the Import, Manufacture, distribution, and sale of Drugs and cosmetics

Objectives

• 1. Regulate Import of Drugs and Cosmetics to stop the import of substandard and harmful drugs

• 2. Regulate the manufacture of drugs and cosmetics to stop the production of substandard drugs

• 3. Regulate the sale and distribution of drugs to allow qualified and trained personnel to handle compound and distribute drugs

• Ayurvedic, Unani, and Homeopathic drugs are exempted from provisions of the Drug and Cosmetic act 1940. However, some provisions are also applicable to these drugs and cosmetics.

Definitions

Drugs: Drugs include

• · All medicines for internal or external use of human beings or animals and

• · All substances intended to be used for or in the diagnosis, treatment, mitigation, or prevention of any disease or disorder in human beings or animals, including preparations applied on the human body to repel insects like mosquitoes;

• · such substances (other than food) intended to affect the structure or any function of the human body or

• · intended to be used for the destruction of vermins or insects which cause disease in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette

• · all substances intended for use as components of a drug including empty gelatin capsules

• · such devices intended 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 Board

Manufacture:

“Manufacture” to any drug or cosmetic includes any process or part of a process for making, altering, ornamenting, finishing, packing, labeling, breaking up, or otherwise treating or adopting any drug or 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.

Import: It means to bring into India

Patent or Proprietary Medicine: “Patent or proprietary medicine” means

• (i) To Ayurvedic, Siddha, or Unani Tibb systems of medicine all formulations containing only such ingredients mentioned in the formulae described in the authoritative books of Ayurveda, Siddha, or Unani Tibb systems of medicine specified in the First Schedule, but does not include a medicine which is administered by the parenteral route and also a formulation included in the authoritative books as specified in clause (a);

• (ii) To any other systems of medicine, a drug which is a remedy or prescription presented in a form ready for internal or external administration of human beings or animals and which is not included in the edition of Indian Pharmacopoeia for the time being or any other Pharmacopoeia authorized in this behalf by Central Government after consultation with the Drugs Technical Advisory Board constituted under section 5

Cosmetics:

Misbranded drugs (Section 9 of Drug and Cosmetic Act 1940) Drugs shall be deemed to be misbranded.

• · if it is so colored, coated, powdered, or polished that damage is concealed or

• · if it is made to appear of better or greater therapeutic value than it is; or

• · if it is not labeled in the prescribed manner; or

• · if its label or container or anything accompanying the drug bears any statement, design or device which makes any false claim for the drug or which is false or misleading in any particular

. Adulterated drugs: (Section 9 A of Drug and Cosmetic Act 1940) Drug shall be deemed to be adulterated:

• · if it consists, in whole or in part, of any filthy, putrid or decomposed substance; or

• · if it has been prepared, packed, or stored under insanitary conditions whereby it may have been contaminated with filth or whereby it may have been rendered injurious to health; or

• · if its container is composed in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or

• · if it bears or contains, for purposes of coloring only, a color other than one which is prescribed; or

• · if it contains any harmful or toxic substance which may render it injurious to health; or

• · if any substance has been mixed therewith to reduce its quality or strength.

Spurious drugs ((Section 9 B of the Drug and Cosmetic Act 1940)) a drug shall be deemed to be spurious

• · if it is imported under a name that belongs to another drug; or

• · if it is an imitation of, or a substitute for, another drug or resembles another drug in a manner likely to deceive or bears upon it or

• · upon its label or container the name of another drug unless it is plainly and conspicuously marked to reveal its true character and its lack of identity with such other drug; or

• · if the label or the container bears the name of an individual or company purporting to be the manufacturer of the drug, which individual or company is fictitious or does not exist; or

• · if it has been substituted wholly or in part by another drug or substance; or

• · if it purports to be the product of a manufacturer of whom it is not truly a product

Misbranded cosmetics (Section 9 C of Drug and Cosmetic Act 1940): a cosmetic shall be deemed to be misbranded

• · if it contains a color which is not prescribed; or

• · if it is not labeled in a prescribed manner; or

• · if the label or container or anything accompanying the cosmetic bears any statement that is false or misleading in any particular.

Spurious cosmetics (Section 9 D of Drug and Cosmetic Act 1940), a cosmetic shall be deemed to be spurious

• · if it is imported under the name that belongs to another cosmetic; or

• · if it is an imitation of, or is a substitute for, another cosmetic or resembles another cosmetic in a manner likely to deceive or bears upon it or its label or container the name of another cosmetic unless it is plainly or conspicuously marked to reveal its true character and its lack of identity with such other cosmetic; or

• · if the label or the container bears the name of an individual or company purporting to be the manufacturer of the cosmetic, which individual or company is fictitious or does not exist; or

• · if it purports to be the product of a manufacturer of whom it is not truly a product.

Alok Bains.