The Drugs and Cosmetics Act (DCA) 1940 and Rules 1945

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Chapter: Forensic Pharmacy : The Drugs and Cosmetics Act (DCA) 1940 and Rules 1945

Drug is an essential commodity and is required to be regulated in terms of its import, manufacture, sale and distribution.


The Drugs and Cosmetics Act (DCA) 1940 and Rules 1945

Drug is an essential commodity and is required to be regulated in terms of its import, manufacture, sale and distribution. The Central Government and State Government are charged with the responsibility of providing the drugs of desired quality to the needy patients and in order to ensure this primary obligation of the Government, the network is required to be developed to root out adulterated, misbranded and spurious drugs from the society.

The origin of DCA has a very interesting historical background. The enactment of the Act was an outcome of a sustained struggle by the medical and pharmaceutical fraternity of the country in pre-independent era against the British misrule in providing poor health care system to Indian citizens. The observ.ation made by Drugs Enquiry Committee, representations made by Indian Medical Association, reports appeared in Indian Medical Gazette during 1920-30 and adverse press reports compelled the British rulers to initiate remedial measures for overcoming lacunae existing in the health care system. The Import of Drugs Bill introduced in 1937 was withdrawn due to heavy criticism and later on the Drugs Bill was introduced and the Drugs and Cosmetics Act, 1940 was enacted. The Rules were framed under this Act in 1945.

The Act is extended to whole of india including, State of Jammu and Kashmir. It is divided into 5 chapters.

Chapter I : Introductory

Chapter II  : Drugs Technical Advisory Board (DTAB), Central Drugs Laboratory (COL) and Drugs Consultative Committee

Chapter III  : Import of Drugs and Cosmetics

Chapter IV  : Manufacture, Sale and Distribution of Drugs and Cosmetics.

Chapter IV (A) : Provisions Relating to Ayurvedic, Siddha and Unani Drugs.

Chapter V  : Miscellaneous

There are 2 Schedules to the Act and 35 Schedules to the Rules framed under the Act.

It was in the year 1982, Schedules E, I and L were dropped, Schedules G and H were revised and Schedules X was introduced. In 1988, Schedule M incorporating GMP (Good Manufacturing Practices) was amended and Schedule Y Pertaining to clinical trials of newer drug formulations was incorporated. Schedules T of Ayurvedic Siddha and Unani medicines was introduced in 2000.

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