GS 2 – GOVERNANCE
The Drugs and Cosmetics Act, 1940 regulates the import, production, sale, and distribution of drugs and cosmetics in India through licenses and permits.
Purpose:
The Act ensures that drugs and cosmetics in India are safe, effective, and meet national standards.
Associated Rules (1945):
The Drugs and Cosmetics Rules, 1945 outline how drugs are classified into different schedules and provide guidelines for their storage, sale, labeling, and prescription.
Definitions:
- Drug: Medicines or medical devices for humans or animals used to diagnose, treat, or prevent diseases. Drugs can be derived from plants, animals, minerals, or chemicals and affect biological functions.
- Cosmetic: Products applied to the body to clean, beautify, or enhance appearance, such as lotions, creams, and perfumes.
Objectives:
- Regulating Drug Imports: Prevents substandard or counterfeit drugs from entering India.
- Prohibiting Inferior Products: Bans the manufacture of fake or low-quality drugs.
- Qualified Personnel: Ensures only certified professionals handle drug production, sale, and distribution, including Ayurvedic and Homeopathic medicines.
- Cosmetic Regulation: Controls the import, production, and sale of cosmetics.
- Inspection: Drug inspectors regularly check licensed premises and collect samples for testing.
- Biological Standards: Sets rules for producing, standardizing, and storing biological products, including labeling and packaging.
- Advisory Bodies: Establishes advisory boards to oversee the regulation of drugs and cosmetics.
Key Features:
- Severe Penalties: Punishments include life imprisonment and a fine of ₹10 lakhs or three times the value of confiscated goods.
- Expanded Authority: Other officials can prosecute under the Act; some offences are non-bailable.
- Specialized Courts: Courts specifically handle offences under this Act.
- Minor Offences: Allows minor offences to be consolidated for easier legal processing.