Overview
The Drugs and Cosmetics Act, 1940 regulates the import, manufacture, sale, and distribution of drugs and cosmetics in India through a system of licences and permits. Its core purpose is to ensure quality, safety, and efficacy of drugs and cosmetics available in the market.
Objectives
- Prevent import and manufacture of substandard or counterfeit drugs and cosmetics
- Ensure that medicines sold in India meet prescribed quality standards
- Regulate manufacture, sale, and distribution of Ayurvedic, Siddha, Unani, and Homeopathic drugs
- Control standards, labelling, packing, and storage of drugs and cosmetics
- Enable regular inspection and testing through authorised agencies
Scope of Regulation
The Act applies to:
- Import of drugs and cosmetics
- Manufacture, sale, and distribution within India
- Biological and special products
- Medical devices notified as drugs
Meaning of Drug
A drug includes:
- Medicines and medical devices for human or animal use
- Substances used for diagnosis, treatment, mitigation, or prevention of diseases
- Substances that alter biological structure or function when absorbed
- Products derived from plants, animals, minerals, or chemical synthesis
Meaning of Cosmetic
A cosmetic refers to any substance intended to be:
- Rubbed, poured, sprinkled, sprayed, or applied to the body
- Used for cleansing, beautifying, promoting attractiveness, or improving appearance
Regulatory Framework
- Drugs and Cosmetics Rules, 1945 provide detailed procedures for:
- Classification of drugs into schedules
- Storage, sale, prescription, labelling, and packaging norms
- Licensing system for manufacturers, sellers, and importers
- Regular inspections by Drug Inspectors
- Sample collection and testing in accredited laboratories
Advisory and Consultative Bodies
- Drugs Technical Advisory Board (DTAB)
- Advises on technical matters related to drugs and cosmetics
- Drugs Consultative Committee (DCC)
- Ensures coordination between Centre and States in enforcement
Salient Features
- Manufacture or sale of adulterated or spurious drugs is prohibited
- Certain offences are cognizable and non-bailable
- Authorisation for prosecution extended beyond Drug Controller officials
- Provision for special courts to try offences
- Minor offences may be compounded
- Maximum punishment includes:
- Life imprisonment
- Fine up to ₹10 lakh or three times the value of confiscated goods, whichever is higher
Enforcement Significance
- Strengthens public health protection
- Acts as the backbone of India’s pharmaceutical regulatory system
- Enables strict action against fake and unsafe medicines
- Supports uniform drug standards across states
The Drugs and Cosmetics Act, 1940 is the foundational law governing drug and cosmetic regulation in India, ensuring that public health is protected through strict quality control, licensing, inspection, and penal provisions.
