September 22, 2019

Pharmaceutical jurisprudence notes

Pharmaceutical jurisprudence

Pharmaceutical jurisprudence is nothing but you can say a law of the pharmacy field.
Here we are going to cover some important points of Pharmaceutical jurisprudence notes.

This will help you to remember on an exam as well as for general knowledge.
We will start with all the chapters.
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1.PHARMACEUTICAL LEGISLATION IN INDIA

.PHARMACEUTINDIACAL LEGISLATION

This law is intended to regulate and control various aspects of social life.
The aspects are classified as social, economic and political legislation.
The purpose of this legislation is to make sure that the patients receive drugs of the required quality, tested and evaluated for safety as well as efficacy for their intended use.

ORIGIN

A chemist shop in INDIA was first opened in about 1811by MR. Bathgate, who came to INDIA with east India company in Calcutta. And after one hundred years(i.e in 1910)this firm started manufacture of tinctures and spirits.
Another firm Smith Starnistreet and co-started apothecary shop in 1821 and commenced the manufacturing in 1918.
Bengal Chemical and pharmaceutical works, a small factory was started in Calcutta in 1901, by Acharya Prafulla Chandra Ray.
These units were not sufficient to fulfill the requirement of INDIAN public

that’s why on those days most of the medicines are imported from abroad mainly from UK, FRANCE, and GERMANY.

Recommendation of Drug Enquiry Committee(IMP)

The committee submitted a comprehensive report of about 90 Recommendations
The main recommendations are as follows:
A. The committee recommended the formation of the central pharmacy council and the provincial(state) pharmacy councils which look after the education and training of professionals.
These councils would maintain the register containing the names and addresses of Registered Pharmacists

B. In the recommendations, the drug enquiry committee suggested the creation of drug control machinery (departments) at the center with branches in all the state.

C. The committee also recommended the establishment of well equipped Central Drug Laboratory(CDL) with competent staff and experts for the efficient and speedy working of the Drug Control Department.
It was also suggested that the small laboratories would work under the guidance of central Drug Laboratory.

Due to the second world war in 1939, there was a delay in the introduction of legislation.

SCOPE AND OBJECTIVES OF PHARMACEUTICAL LEGISLATION IN INDIA(VIMP)

A. The main object of this Act is to regulate the import, manufacture, distribution, and sale of Drugs and Cosmetics.
The Central Government has made a number of Rules for the manufacture, distribution, and sales of drugs and cosmetics in INDIA. that is “The Drugs and Cosmetics Rules 1945”.
These acts are amended from time to time.

B. THE PHARMACY Act 1948 was passed with the object to regulate the profession of pharmacy in INDIA.

C. IN, 1945 “The Drugs and Magical Remedies(OBJECTIONAL ADVERTISEMENT) Act,

was passed with the main aim to control certain types of advertisement related to Drugs and prohibit certain kinds of advertisement related to Magic
.
D. The medicinal and toilet preparations (Excise Duties )Act, 1955 was passed providing for the levy and collection of duties of excise on Medicinal and Toilet preparations
Containing alcohol, opium, Indian hemp or other narcotic drugs and narcotics.

The Central Government has framed certain rules under the provision of this act, called “The Medicinal and Toilet preparations(Excise Duty)Rules 1956.

AND

E. Under the essential commodities Act,1955, and in supersession of the Drug (prices control) Order, 1979 the central government made the Drugs(prices control)Order1987.

F. In, 1985 the Narcotic Drugs And Psychotropic substances Act, was passed along with the Rules repealing the Dangerous Drugs Act, 1930and Opium Act 1878.
The main object of this act is to consolidate and amend the law relating to narcotic drugs and to make stringent provisions for the control and regulations of operations relating to Narcotic Drugs And Psychotropic Substances and for the matters connected with
The prevention of Illicit Traffic in Narcotic Drugs and Psychotropic Substances, ordinance, 1988 is supplemented to this act.

There are some other acts which are directly or indirectly related to manufactures, distribution, and sales of drugs and pharmaceuticals in INDIA.
THEY ARE;

1.Prevention of Food Adulteration Act, 1954 and Rules.
2.The Industries (Development and Regulations)Act, 1951
3.The Industrial Employment (Standing Order) Act, 1946 and Rules.
4.Industrial Dispute Act, 1947
5.Factory Act, 1948
6.The INDIAN Patent and Design Act, 1897
7.The Trade and Merchandise Mark Act 1958
8.The Epidemic Disease Act,1897
9.Shops and Establishment Acts of respective statesRemedies

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