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 In India


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.


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.

of drug enquiry committee (DEC):

The committee submitted a comprehensive report with about 90

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

The drug bill was introduced in 1940 in the legislative
assembly. After considering the report of select committee. The bill was passed

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

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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