Drug and Cosmetics Act 1940 and Rules 1945

Drug:

1. 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.

1. Such substances (other than food) intend to affect the structure or any function of the human body or are intended to be used for the destruction of vermin or insects which cause disease in human beings or animals.

2. All substances intended for use as components of a drug including empty gelatin capsules; and

3. Such devices are intended for internal or external use in the diagnosis, treatment, mitigation, or prevention of disease or disorder in human beings or animals.

Ayurvedic, Siddha, or Unani Drug:

It includes all medicines intended for internal or external use of human beings or animals for diagnosis, treatment, mitigation, or prevention of disease or disorder by the formulae described in the authoritative books of Ayurvedic, Siddha, and Unani Tibb system of medicine, specified in the first schedule.

Misbranded Drugs:

A drug shall be deemed to be misbranded:

1. 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

2. If it is not labeled in a prescribed manner; or

3. 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:

A drug shall be deemed to be adulterated:

1. If it consists, in whole or in part, of any filthy, putrid or decomposed substance; or

2. If it has been prepared, packed, or stored under insanitary conditions whereby it may have been contaminated with filthy or whereby it may have been rendered injurious to health; or

3. 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

4. If it bears or contains, for purposes of coloring only, a color other than one which is prescribed.

5. If it contains any harmful or toxic substance which may render it injurious to health; or

6. If any substance has been mixed therewith to reduce its quality or strength.

Spurious Drugs:

A drug shall be deemed to be spurious:

1. If it is manufactured under a name that belongs to another drug; or

2. If it is an imitation of, or is 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 or conspicuously marked to reveal its true character and its lack of identity with such other drug; or

3. If the label or 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

4. If it has been substituted wholly or in part by another drug or substance., or

5. If it purports to be the product of a manufacturer of whom it is not truly a product.

Drug Inspector:

A Drug Inspector appointed by the Central Government or a State Government who is an expert and qualified to monitor the safety, utility, efficacy, and quality of a drug from its manufacturing till its sale at the retail shop.

Cosmetic:

Any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applied to, the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and includes any article intended for use as a component of cosmetic.

Misbranded Cosmetics:

A cosmetic shall be deemed to be misbranded:

1. If it contains a color that is not prescribed; or

2. If it is not labeled in a prescribed manner; or

3. If the label or container or anything accompanying the cosmetic bears any statement which is false or misleading in any particular.

Spurious Cosmetics:

A cosmetic shall be deemed to be spurious:

1. If it is imported under a name that belongs to another cosmetic; or

2. 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 upon its label or container the name of another cosmetic, unless it is plainly and conspicuously marked to reveal its true character and its lack of identity with such other cosmetic; or

3. 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.

4. If it is an imitation of, or is a substitute for, another drug or re-not truly a product.

Drug Store:

Licensed premises for the sale of drugs, a retail store that does not require the services of a qualified person and sells both prescription and non-prescription drugs.

Pharmacy:

Licensed premises for the sale of drugs, which require the services of a qualified person but where the drugs are not compounded against prescriptions.

Qualified Person:

1. He is a person holding a diploma or degree in Pharmacy or Pharmaceutical Chemistry.

2. Is a registered pharmacist, (under Pharmacy Act, 1948).

3. Has minimum 4 years experience of dispensing and has been approved by licensing authority as a ‘Qualified Person’ on or before 31st Dec 1969.

Government Analyst:

A Government Analyst appointed by the Central Government or a State Government who shall analyze or test or cause to be analyzed or tested such samples of drugs as may be sent to him by Inspectors or any other persons or authority authorized by the Central Government or a State Government and shall furnish reports of the results of test or analysis by these rules.

Further, shall from time to time forward to the Government reports giving the results of analytical work and research with a view to their publication at the discretion of the Government.

Manufacture:

In relation 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: Means to bring into India.

Patent or Proprietary Medicine:

In relation 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.

In relation to any other systems of medicine, a drug for internal or external administration of human beings or animals and which is not included in the edition of the Indian Pharmacopoeia or any other Pharmacopoeia or official books.