Ethics Law

Ethics means moral principles. These are the ruling

principles.
Ethics is defined a ‘Rules by Law is defined as ‘Rules of
which a profession regulates human conduct binding all
actions and sets standards for persons in a state or nation’.
all its members.

Ethics rules are decided by Laws rules are decided by

particular profession
If rules of ethics are broken it
will affect an image of that
profession.
Help to others is an ethics of
Govt. which are binding to all
persons of nation or state.
If law is broken there is
punishment or fine.
Law is universal change
Pharmaceutical Legislation In India
Law intends to regulate & control various aspects of
social life . The aspects may be classified as social ,
economical and political legislation . The
Pharmaceutical Legislation is such mixed
Legislation ,which overlapping covers both social &
economic aspects of the society.
The purpose of pharmaceutical legislation is to ensure
that the patient receive drugs of required quality ,
tested and evaluate for safety as well as efficacy for
their intended use. It means that pharmaceutical
legislation is associated with the health of the society.
 History

• For the first time in India , a chemists shop

was opened in about 1811 by Mr. Bathgate,
who came to India with company in calcutta.

• After one hundred years (i.e. in 1910) , this

firm started manufacture of tinctures and
spirits.
• Another firm smith stanistreet and Co. started
apothecary shop in 1821.

• 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. T .K .
Gajjar , a small factory at parel was started ,
which led to the development of other
pharmaceutical units , the Alembic chemical
works Ltd at Baroda in 1907.
• 1811 – First Chemist Shop in India By Mr.
Bathgate
• 1910 – (After 100 yrs)Started manufacturing
of spirits and tinctures
• 1821 – Smith Stanistreet & Co. Started
apothecary shop.
• 1918 - Started manufacturing
• 1901 – Bengal Chemical & P’ceutical Works by
Acharya Prafull Chandra Ray in Calcutta
• 1903 – Small factory converted to Alembic
Chemicals under leadership of T.K. Gajjar.
• These units were not sufficient to fulfil the
requirements of Indian public . In those days
most of the medicines were being imported
from abroad mainly from U.K. France and
Germany.
• The Indian and foreign concerns entered in
competition with imported medicines
producing cheaper drugs.

• As a results ,unhealthy competition grew up &

the Indian market got flooded with
inferior ,substandard & harmful drugs.
• With this issues , the public made the
Government to take notice of such situation of
drugs trade & industry & to think of
introducing effective legislation to control the
import, manufacture , distribution and sale of
drugs.
• As such those days was no legal control on
pharmacy profession at the beginning of this
century . with rapid expansion in
pharmaceutical industries.

• Hence , to have a comprehensive

legislation ,the Indian Government appointed a
‘Drug Enquiry Committee’ under the
Chairmanship of R.N Chopra in 1931 (D.E.C.
or Chopra Committee).
• In those days opium Act, 1878,poisons drug
Act,1919, and Dangerous Drugs Act,1930 were
in existence. But these acts were not
comprehensive enough to control the prevailing
chaotic & regrettable condition.
 Recommendations of Drugs Enquiry
Committee: (DEC)
• The Committee Recommendations the
formation of Central pharmacy Council and
the State pharmacy Council which would
look after the education & training of
professionals. These councils would maintain
the register containing the names & addresses
of the Registered pharmacists.
• In the recommendations , the drugs enquiry
committee suggested the creation of Drug
Control Departments at the center with
branches in all the states.
• Establishment of Advisory board to advice the
government in making rules.
• Compilation of Indian Pharmacopoeia.
• To reduce manufacturing in medical stores.
• The committee also recommended the
establishment of a well-equipped Central
Drug Laboratory (CDL) with competent staff
and experts for an efficient and speedy
working of drug control department . It was
also suggested that the small laboratories
would work under the guidance of central drug
laboratory.
• Due to second world war in 1939 , there was
delay in introduction of legislation as per the
recommendations of drugs enquiry committee ,
which was leads to introduction of Drug Bill
1940, who keeps control on import of drugs.
• Drug bill 1940 regulates the import,
manufacture, sale and distribution of drugs in
India.
• In 1941, the first Drug Technical Advisory
Board (D.T.A.B.) under this act was constituted.
CDL was established in Calcutta.
• In 1945 government introduced ‘Pharmacy
Bill’ to standardize the Pharmacy Education in
India.
• In 1948 Pharmacy Act 1948 was passed.
• In 1949 Pharmacy Council of India (P.C.I) was
developed.
• 1954 – Education Regulation come in to force
in some state as well as Drugs and Magic
Remedies (Objectionable Advertisements) Act
1954 was passed to stop misleading
advertisements.
• 1955 Medicinal and Toilet Preparations (Excise
Duties) Act 1955 was passed to provide
uniform duty for all states for alcohol products.
• 1985 - Narcotic and Psychotropic Substance
Act has been enacted to protect society from
the dangers of addictive drugs.

• 1937-1938 First B. Pharm college stated in

Banaras Hindu University (BHU) under the
leadership of Prof. ML Shroff, The Father of
Pharmacy profession in India.