The Drugs and Cosmetics Act, 1940 was enacted by the Department of Health under the Ministry of Health and Family Welfare after receiving the assent of the Governor General on April 10, 1940 and came into force on April 1, 1947. The intention of the enactment was to regulate and control the import, production, allocation and trade of drugs and cosmetics. The Act defines the term ‘cosmetics’ and ‘drugs’ under the interpretation clause.

The Act empowers the Central Government to establish the Drugs Technical Advisory Board to provide guidance to the Central and the State Government on the technical issues that arise out of the management of this legislation and perform other responsibilities allotted to the Board under the Act. The Board shall comprise of eight ex-officio members including the Director General of Health Services, Controller of Drugs, Director of Central Research Institute, Director of Central Drugs Laboratory, President of the Indian Pharmacy Council etc. Other members shall include persons recommended by the Central Government who are in duty of the State Drug control, elected representatives by the Pharmacy Council of India, Medical Council of India, Indian Medical Association and Indian Pharmaceutical Association and nominated members by the Central Government, pharmacologist etc.

The Board is authorized under the Act to formulate bye-laws by determining quorums and control its own proceedings and the transactions carried out for its functions with the prior permission of the Central Government. The Central Government shall appoint the Secretary of the Board and appoint clerks and other employees if necessary to discharge the functions under the Act. The Central Government shall also constitute the Central Drugs Laboratory under the superintendence and direction of the Director appointed by the Central Government and to discharge functions and responsibilities assigned to it under the enactment or any rules framed there under. The functions of certain category of drugs or cosmetics shall be carried out under the Central Research Institute or any other Laboratory specified by the Central Government. The functions entrusted to the Director of Central Drugs Laboratory for certain drugs or cosmetics shall be performed by the Director of that Institute or Laboratory.

The Central Government shall formulate rules on discussion with Board on the following matters:

  • The functions and responsibilities of the Central Drugs Laboratory;
  • The procedure to be followed to submit samples of drugs and cosmetics for examination or tests to the laboratory and the outline of laboratory report;
  • Matters essential for the effective performance of the functions of the laboratory etc.

The Central Government may form the Drugs Consultative Committee which shall act as an advisory body to instruct the Central and the State Government and the Drugs Technical Advisory Board for the purpose of unifying the management of the Act. The Committee shall comprise of representatives of the Central Government and proposed members from the State Government. The Act prohibits the import of certain categories of drugs and cosmetics that are listed below:

  • Drugs that are not of average value and quality;
  • Misbranded drugs or cosmetics;
  • Defiled or unauthentic drugs;
  • Drugs that have not obtained license;
  • Any patent or proprietary drug unless demonstrated on the label or the container in the specified manner;
  • The drugs containing any statement, plan or equipment together with it or any other method that claim to cure any disease or disorder etc.

The Act provides for the appointment of Inspectors with specified qualification by the Central and State Government. The powers of the Inspector, the responsibilities to be fulfilled and the procedure to be followed shall be as specified under the Act.

The Central Government has formulated The Drugs and Cosmetics Rules, 1945 which was amended several times including 2003. The Drugs and Cosmetics Act, 1940 was amended and changes were made many times in 1955, 1960 and in 1995. Recently, The Drugs and Cosmetics (Amendment) Bill, 2013 has been initiated which is pending for approval of the Parliament.