Drugs and Cosmetics Act 1940 Notes for Exam Forensic Science

Drugs and Cosmetics Act, 1940

The Drugs and Cosmetics Act, 1940 is an act enacted by the Indian Parliament to regulate the import, manufacture, distribution, and sale of drugs and cosmetics in India. The primary aim of the Act is to ensure that the drugs and cosmetics sold in India are safe, effective, and conform to the required quality standards. 

Objective of the Act 

1. To regulate import, manufacture, distribution, and sale of drugs and cosmetics. 
2. To ensure standard quality of drugs and cosmetics. 
3. To prohibit the sale of substandard, misbranded, adulterated or spurious drugs and cosmetics.
4. To ensure safety, efficacy, and quality of drugs and cosmetics being marketed.  

Structure of the Act

The Act is divided into chapters and schedules, with several rules under it (Drugs and Cosmetics Rules, 1945).

Chapter I: Introductory (Sections: 1 to 3A)  

• Title, extent & commencement (Section 1)
• Definitions (Section 3) 
• Presumptions as to poisonous substances (Section 4) 

Chapter II: Drugs Technical Advisory Board, Central Drugs Laboratory & Drugs 

• Consultative Committee
• Drugs Technical Advisory Board (Section 5) 
• Central Drug Laboratory (Section 6) 
• Drugs Consultative Committee (Section 7) 

Chapter III: Import of Drugs & Cosmetics  

•  Standards of quality (Section 8)
• Misbranded, adulterated and spurious drugs & cosmetics (Section 9A-D) 
• Prohibition of import of certain drugs or cosmetics (Section 10) 
• Central Government’s power to make rules and related provisions (Section 12-15) 

Chapter IV (A) : Manufacture, Sale & Distribution of Drugs & Cosmetics  

•  Regulates domestic manufacture, sale, and distribution of drugs and cosmetics.
•  Section 18: Prohibits manufacture or sale of substandard, misbranded, or spurious products. 
•  Drugs must meet standards specified in Indian Pharmacopoeia or other notified standards.
• Licenses are mandatory for manufacture and sale.
• Empowers Drug Inspectors to inspect, seize, and take action against offenders.
• Defines duties of Government Analysts.
• Section 27: Penalties for manufacture or sale of spurious/adulterated drugs   
•  Appeals and adjudication processes are also covered.

Chapter IV (B) : Provisions Relating to Ayurvedic, Siddha & Unani Drugs

• Section 33E to 33O: Applies to Ayurvedic, Siddha, and Unani drugs – similar rules for quality, licensing, and penalties. 
• Ayurvedic, Siddha & Unani Drugs Technical Advisory Board, Consultative

Chapter V: Miscellaneous (Sections: 33B to 38) 

• Cognizance of offences
• Protection of action taken in good faith (protects officials from legal action if duties performed honestly)  
•  Power to make rules – allows central and state governments to frame detailed rules under the Act (e.g., Drugs and Cosmetics Rules, 1945) 
• Section 33E to 33O: Applies to Ayurvedic, Siddha, and Unani drugs – similar rules for quality, licensing, and penalties. 

COSMETIC : 

"Cosmetic" means 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.

MANUFACTURE :

 "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 adapting any drug or cosmetic with a view to its sale or distribution. 

Commom Terminology For Drug & Cosmetics 

MISBRANDED DRUG : A drug is said to be misbranded if  

1. It is so coloured, coated, powdered, or polished that damage is concealed, or it appears of better or greater therapeutic value than it really is.
2. It is not labeled in the prescribed manner.
3. Its label or container or any accompanying literature bears any statement, design, or device which makes any false claim or is misleading in any particular. 

 ADULTRED DRUG:  A drug is deemed to be adulterated if 

1.  It consists, in whole or in part, of any filthy, putrid or decomposed substance.
2. It has been prepared, packed, or stored under insanitary conditions, whereby it may have become contaminated or rendered injurious to health.
3. Its container is composed of any poisonous or deleterious substance, which may make the contents harmful to health.
4. It bears or contains, for coloring only, a color other than one prescribed
5. It contains any harmful or toxic substance, which may render it injurious to health.
6. Any substance has been mixed with it to reduce its quality, strength, or make it appear better than it is (i.e., adulteration by dilution or substitution). 

SPURIOUS DRUG : A drug is considered spurious if 

1. It is manufactured under a name which belongs to another drug.
2. It is an imitation or substitute for another drug, or resembles another drug in a manner likely to deceive. 
3. The label or container bears the name of another drug manufacturer, falsely claiming it was made by them. 
4. It has been wholly or partly substituted with another substance. 
5. It falsely claims to be the product of a manufacturer who is not actually the maker. 

MISBRANDED COSMETIC :   A cosmetic is considered misbranded if 

1.  It contains a color which is not prescribed
2. It is not labeled in the prescribed manner.
3. Its label, container, or any accompanying literature carries false or misleading claims.

SPURIOUS COSMETIC :  A cosmetic is deemed to be spurious if

1.  It is manufactured under a name that belongs to another cosmetic.
2. It is an imitation of, or substitute for, another cosmetic or resembles another cosmetic in a manner likely to deceive the consumer. 
3. The label or container bears the name of another manufacturer, falsely claiming it was made by them. 
4. It has been wholly or partly substituted with another substance. 
5. It falsely claims to be the product of a manufacturer who is not actually the manufacturer.