Jurisprudence
Jurisprudence is the science and the philosophy of Law. The
course ‘Pharmaceutical jurisprudence’ for the Pharmacy students is designed to introduce them to basic elements of the legal system, which is pertinent to conducting their business and practicing in the profession.
All aspects of everyday living are controlled by or
subjected to ruling of the legal system.
In modern society there is very little that is not covered
in one way or another by our system of law which reveals the law is a mechanism of social control.
The purpose of introducing this subject in the curriculum of
Pharmacy students is twofold-
1. To serve as a text providing the students with some
insight into the legal aspects of the practice of his profession.
2. To aid practicing pharmacist to understand their legal
and ethical responsibilities and thereby to avoid the pitfalls that leads to legislation.
Pharmaceutical Legislation In India
Pharmaceutical Legislation
Law intends to regulate and control various aspects of social life. The aspects may be classified a social, economic and political legislation. The pharmaceutical Legislation is such a mixed legislation which overlapping covers both social and economic aspects of the society.
The purpose of pharmaceutical Legislation is to ensure that
the patients receive drugs of required quantity tested and evaluated for safety. As well as efficacy for their intended use it means that pharmaceutical Legislation is associated with the health of the society.
Origin
For the first time in India a chemists shop was opened in
about 1811 by Scotch M Bathgate. Who come to India with East India Company in Calcutta. After one hundred years this firm started manufacturer of tinctures and spirits.
Another firm Smith stanistreet and co. Started apothecary by 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.
In 1903 under the leadership of Prof. TK. Gajjar, a small
factory at parcel was started which led to the development of other pharmaceutical units the alembic chemical work Ltd. at Baroda.
These units were not sufficient to fulfill the requirements
of Indian public. In those days most of the medicines were being imported from abroad mainly from U.K, France and Germany.
Then the situation was changed with the First World War also increasing demands for indigenous drugs. The Indian and Foreign concerns entered in competition grew up and the Indian market got flooded with inferior substandard and even harmful drugs.
With this issue, the public made the Government to take
notice of such situation of drug trade and industry and to think of introducing effective legislation to control the import, manufacturer distribution and sale of the drugs.
In those day opium Act 1878 poison Act 1919 and Dangerous Act 1930 where in existence. Thus as such there was no legal control on Pharmacy profession at the beginning of this century with rapid Expansion in Pharmaceutical industries and market more comprehensive legislation was required hence to have a comprehensive legislation the Indian Government appointed a “Drug Enquiring committee” (DEC) under the chairmanship of Lt col R.N. Chopra in 1931.
The committee was asked to make enquiries in the said matter and then to make recommendation for smooth control of manufacture, import, distribution and sell of drugs in the interest of public health.
Recommendation of drug enquiry committee (DEC):
The committee submitted a comprehensive report with about 90 recommendations.
The main recommendations are as follows….
1. The committee recommended the formation of Central
Pharmacy Council (CPC) and Provincial Pharmacy Council (PPC) which would look after the education and training of professional. These councils would maintain the register Containing the Name, Address of the register Pharmacist.
2. In the recommendation the drug enquiry committee
suggested the creation of drug control machine (Department) at the center with branches in all state.
3. The committee also recommended in the establishment of well-equipped control drug laboratory with competent staff and exports for an efficient and speedily working of drug control department.
4. It was also suggested that the small laboratories good
work under the guidance of control drug laboratories.
Scope and Objective
The drug bill was introduced in 1940 in the legislative
assembly. After considering the report of select committee. The bill was passed 1940.
It comes into force as drug act 1940. After 7 year that is
in 1947.
Drug act has been amended many times at present time act
cover the provisions released to drug, cosmetic, Ayurvedic including unani and homeopathic medicine.
The present and cosmetic act in an improved version over the drug act 1940.
The main objective of this act is regulating to the import
manufacturer distribution sell of cosmetic.
The central government has made a number of rules for
manufacturer, distribution and sell of drug and cosmetic in India in tilled.
The Pharmacy act 1948 was passed with the object to regulate the profession of Pharmacy in India.
In 1954 the drug and magic Remedies (Objectionable
advertisement ads) act was passed with the main aim to control certain type of ads Related to drug and to prohibit the magic Remedies.
Medicinal and toilet preparation Act 1955 (Excise duty) was
passed providing for the collection of duties of excise on medicinal and toilet preparation containing alcohol, Opium, Indian hemp or other narcotic drug.
The drug price control orders in 1955 but supersession in
1979 the central government made the drug price control order 1987.
In 1885 the narcotic drug and psychotropic substance act was passed along with the rule ripping the dangerous act 1930 and opium Act 1878.
The main object of this act is consolidate and amend the law repeating to narcotic drug.
There are also some elements which are directly or
indirectly related to manufacture, direction distribution and selling of the pharmaceutical drug in India…
i. Preparation of food adulteration Act 1954
ii. Development and regulation Act 1951
iii. Industrial employment (Standing order)Act 1946
iv. Industrial dispute Act 1947
v. Factory Act 1948
vi. Indian patent and design Act 1970
vii. Trade and merchandise mark Act 1958
viii. Epidemic disease Act 1897
ix. Shops stablisments, Act of respective State
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