Drug and Cosmetics Act 1940
Introduction
British misrule providing poor health care system to Indian citizens. This observation
made by Drug Enquiry Committee, which consists team of Indian Medical Association's
members.
On 10 April,1940 the Indian Legislative assembly has passed the important legislation
to regulates the import ,manufacture, distribution and sale of drugs and Cosmetics.
The Act was enacted to ensure the safety, efficacy, and quality of drugs and Cosmetics
,and to prevent the use of substandard, spurious, and adulterated products.
The rules of this act was passed in 1945
The first amendment was made by Indian
Parliament in1955 and then after several more amendment were made in1960,1962,1964,1972,1982,1986,1995,2008,2011,and 2018.
Objective of D&C Act
- The Act regulates the import, manufacture, distribution, and sales of drugs.
- This Act also insure that manufacture, distribution, and sales of drugs and Cosmetics is done by only qualified persons.
- To prevent substandard in drug &Cosmetic.
- To regulates the manufacture and sales of Ayurvedic, Siddhartha and Unani drugs.
- To establish Drug Technical Advisory Board(DTAB), and Drug Consultative Committee (DCC) for Allopathic and Allied drugs and Cosmetics.
Drugs
All medicines for internal or external use of human beings or animals and all
substances extended to be used for or in the diagnosis, treatment, mitigation or
prevention of any disease or disorder in human beings or animals including preparation
applied on human body for the purpose of repelling insects like mosquitoes.
Cosmetics
Any articles intended to the rubbed, poured, sprinkled or sprayed on ,or
Introduction into or otherwise applied to the human body or any parts of there of for
cleaning, beautifying, promoting attractiveness or altering the appearance , and includes
any article intended for use as component of Cosmetic.
Drug & Cosmetic Act Rules 1945
In addition to the Drugs and Cosmetics Act 1940, there are several rules and
regulations that have been enacted to provide detailed guidance on the implementation
of the Act.
These rules provide detailed guidance on the licensing and registration of drugs and
Cosmetics, import and export of drugs and Cosmetics ,standards of quality for drugs
and Cosmetics, labeling and packaging requirements, and the procedure for the
inspection and testing of drugs and Cosmetics.
The rules has been divided into 18 parts, each dealing with the particular subjects .
There are two schedule of this act -
Schedule of Act which consists of two Schedule
Schedule of rules which consists of 23 Schedules
Schedule of Act
A- First schedule :- It prescribed the list of books specified in Ayurvedic, Siddha, Unani system of medicine.
B- Second schedule :- It prescribes the standards to be complied with by imported
drugs and by the drugs manufactured for sales ,sold ,stocked or exhibited for sale or
distribution.
Author :- Mohd. Salim
