The Drugs and Cosmetics Act, 1940

About Drugs and Cosmetics Act, 1940:

• It regulates the import, manufacture and sale or distribution of drugs and cosmetics through licences and permits. 
• Its main objective is to ensure that the drugs and cosmetics marketed in India are reliable, efficient and in compliance with national standards.
• The associated Drugs and Cosmetics Rules, 1945, which were formulated in association with the 1940 Act, provide provisions for classifying medications into schedules and instructions for the storage, sale, presentation, and prescription of each schedule.  
• What is a drug?
  • A drug includes medicines or medical devices for external or internal use for 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.
  • Drugs are extracts of certain plants, animal parts, herbs, or minerals. A drug is any chemical substance (natural or man-made) that alters biological structure or functioning when absorbed.
• What is a cosmetic? The term cosmetic refers to any substance or product used to rub, pour, sprinkle or spray on, or introduce into, or otherwise apply to, the body or any part of any object for cleansing, beautifying, or improving the appearance.
• Objectives:
  • It oversees medication imports into India, ensuring that no substandard or counterfeit drugs enter the country.
  • It prohibits the production of inferior or counterfeit pharmaceuticals in the country.
  • It requires only qualified and competent personnel to sell and distribute medicines, as well as the manufacture, sale, and distribution of Ayurvedic, Siddha, Unani, and Homeopathic drugs.
  • The provisions of the Act control the import, manufacture, sale, and distribution of cosmetics.
  • To have drug inspectors visit licensed premises regularly. Monitoring pharmaceutical and cosmetic standards by collecting samples and analyzing them in accredited laboratories.
  • Creating distinctive regulations to control the manufacture, standardization, and storage of biological and special products, as well as prescribing how different types of drugs and cosmetics should be labeled and packed.
  • To form a Drugs Technical Advisory Board (DTAB) and Drugs Consultative Committees (DCC)for allopathic and allied drugs, as well as cosmetics.
• Salient Features:
  • The maximum penalty is life imprisonment and a fine of Rs. 10 lakhs or three times the confiscated goods’ value, whichever is greater.
  • Other gazette officers, in addition to officers from the Drug Controller’s Office, are authorised to initiate prosecution under the Act; some of the offences are cognizable and non-bailable;
  • Specialised courts for the trial of offences covered by the Act;
  • Provision for the aggregation of minor offences.