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in 1937 was withdrawn due to heavy criticism and later on the Drugs Bill was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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