Origin of

UNIT 6 ORIGIN OF Pharmaceutical

Legislation
PHARMACEUTICAL
LEGISLATION
Structure

6.1 Introduction
Objectives
6.2 History of Pharmaceutical Legislation in India
Genesis of Modern Medicine and Pharmacy
Pharmacy in the 19th and Early 20th Centuries in India
6.3 Regulations in the Western Countries
Legislations during the British Rule
6.4 Drugs Enquiry Committee
6.5 Genesis of the Drugs Act 1940
Pharmacy Act and Other Legislations
Aims of Pharmacy Act 1948
6.6 Pharmacy Council of India (PCI)
Education Regulations of Pharmacy Council of India
State Pharmacy Council
6.7 Summary
6.8 Terminal Questions
6.9 Answers

6.1 INTRODUCTION

In the earlier Units, we have studied the process of drugs approval and some
other aspects related the approval process. In this Unit the history, origin of
pharmaceutical legislation and the Pharmacy Act will be discussed. We can
also see the role of various committees and organizations in the development of
pharmacy legislation in India.

Objectives

After studying this unit, you should be able to:

• understand the origin of modern medicine in India;

• explain the genesis and development of pharmacy legislation;
• compare the status pharmacy in India with other countries before the
appointment of the Chopra committee;
• mention the important recommendations of Chopra Committee;
• genesis of the Drugs Act 1940;
• know the role of Bhore Committee in the introduction of Pharmacy Act;
and
• understand the salient features of Pharmacy Act 1948 107
Drugs Regulatory
Affairs
6.2 HISTORY OF PHARMACEUTICAL LEGISLATION
IN INDIA

The laws related to pharmacy are always taught to the students of pharmacy.
Once has to know the background under which the relevant laws were made in
order to understand the provisions of the law in its real sense. The professional
students are always taught about the important legislations governing their
profession and its activities. In case of pharmacy such aspects are taught under
the subject of forensic pharmacy or pharmaceutical jurisprudence. In the past it
was the subject of forensic pharmacy that covered the pharmacy related laws
including Acts, Rules, Orders, Regulations and other similar aspects. The
subject of professional ethics is also taught as part of the forensic pharmacy.
Now the term forensic pharmacy is often replaced by more appealing term –
pharmaceutical jurisprudence.

6.2.1 Genesis of Modern Medicine and Pharmacy

In ancient days, medicines in India were made from natural resources, mainly
from vegetables and plants and their products. Animal and mineral items were
also used in certain conditions. Ayurveda was the Indian system of practice of
medicine. Drugs were not at all potent in those days compared to our modern
medicines. Their manufacture, storage and use were not in an organised and
scientific manner and very little specialised techniques were used in those
aspects. Medicines were prepared in those day based on empirical concepts.
For all these reasons there was no legislative control on medicines and their
manufacture and sales. In fact there was not much need for such controls.

The modern system of medicine (which is also known as allopathic system of

medicine) was introduced in India by the British traders who later became the
rulers during the later part of the 19th century. During their rule the British
intentionally gave a patronage to the allopathic system. In the beginning the
allopathic or the western system of medicine was principally meant for the
ruling class and by the end of the 19th century it became popular among the
people of India.

SAQ 1

When and how the allopathic system of medicine was brought to India?

…………………………………………………………………………………...

…………………………………………………………………………………...

…………………………………………………………………………………...

…………………………………………………………………………………...

…………………………………………………………………………………...

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108 …………………………………………………………………………………...
6.2.2 Pharmacy in the 19th and Early 20th Centuries in India Origin of
Pharmaceutical
Though the western system of medicine became popular in India by the 19th Legislation
century, it was having a commercial outlook and interest with very little
service and professional concepts. The allopathic medicines were known by
various names like western medicine, modern medicine and allopathic
medicines. However the most popular name was the “English medicines”
mainly due to the fact that most of these medicines were brought from England
and were practiced by the English traders and business men.

By the advancement of the 20th century, in addition to the business interests,

service concepts too became an important component of modern medicine
practice including its sales. Unfortunately during the same time substandard,
fake and other spurious medicines became very common in the country and on
many occasions, they were more common than the genuine and standard
quality items. Many times drugs were manufactured in other countries
exclusively for the Indian market, which were of low quality compared to their
own domestic market items.

It was no wonder India soon became a good dumping market place for a
variety of quack (fake), low quality and spurious medicines manufactured in all
parts of the world. All sorts of harmful, low quality and useless medicines were
marketed in India by unqualified people with the only motive of business
interest. India was described as a land of quacks, quack doctors, quack dentists,
quack opticians, quack pharmacists, and quack faith healers. Unscrupulous
importers used to bring medicines which were condemned in the countries
where they were manufactured.

There was no mechanism in India to control or govern the bad situation and
catch hold of the business racket in the area of medicines. Identification and
determination of the genuineness of medicines available in the Indian market
was outside the scope of the practitioners of medicine. For all practical
purposes, with the exception of the Poison Act 1919, there were no laws in
India to control and govern the import, manufacture and sale of therapeutic
agents of any kind, no matter potent or inert. It was true that there were certain
provisions in the Indian Penal Code referring to the noxious drugs, but were
not effective to control the situation. All real practitioners of medicine looked
to the rulers and the state for guidance and help. There was a strong demand
for legislation with reference to drugs used in modern medicine to protect the
interest of the patients and to ensure that the patients will receive quality items
as intended by the doctors.

SAQ 2

What is “English medicine”?

…………………………………………………………………………………...

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…………………………………………………………………………………... 109
Drugs Regulatory …………………………………………………………………………………...
Affairs
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SAQ 3

Why there was a strong demand for pharmacy legislation in India in the early
part of the 20th century?

…………………………………………………………………………………...

…………………………………………………………………………………...

…………………………………………………………………………………...

…………………………………………………………………………………...

…………………………………………………………………………………...

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6.3 REGULATIONS IN THE WESTERN COUNTRIES

In England, the Pharmaceutical Society of Great Britain was responsible for

the control of the profession of pharmacy and in United States of America by
the state laws. Only well qualified and licensed pharmacists could dispense,
compound or sell medicines and other pharmaceutical preparations in these
countries. By 1920s the countries like United States of America and UK could
implement stringent laws against unethical aspects in the manufacture and
sales of spurious and low quality medicines. The Therapeutic Substance Act
1925 and the Food and Drugs (Adulteration) Act 1928 in the United Kingdom
fully safeguarded the interests of the British people by adequately controlling
almost all activities related to medicines and pharmaceuticals. In USA, the
Federal Food and Drugs Act 1906 was amended successively in 1912, 1913
and 1927 to effectively prevent manufacture, sale and trans-shipment of
adulterated, misbranded, poisonous or deleterious drugs and medicines. In
Canada, the Food and Drugs Act 1920 and the Patent and Proprietary
Medicines Act helped to regulate and control drugs and other medicinal
preparations in an efficient manner. In fact, the Western countries and other
free countries in the world could exercise a rigid control over the nature and
quality of drugs placed on their market by early part of the 20th century.

SAQ 4

In what way the Indian drug regulation system was different from other
countries like England during the British rule, particularly in the early part of
20th century?

…………………………………………………………………………………...
110 …………………………………………………………………………………...
…………………………………………………………………………………... Origin of
Pharmaceutical
…………………………………………………………………………………... Legislation
…………………………………………………………………………………...

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6.3.1 Legislations during the British Rule

The following were some of the legislations existing in India during the 19th
and early 20th centuries which were having some control or connection with the
medicines and other therapeutic agents.

Indian Penal Code (IPC) which refers to intentional adulteration of any drug in
order to lessen its efficacy or make it noxious or change its operation. Only
adulteration which render a drug ‘noxious’ or ‘lessened its efficacy’ or
‘changed its operation’ was made punishable under the provisions of the
Indian Penal Code.

The Opium Act 1978 regulated the cultivation of poppy, and the manufacture,
possession, transport, export, import and sale of opium.

Indian Merchandise Act 1889 which was concerned with the misbranding of
goods in general and the punishment for such offences.

The Indian Tariff Act 1894 and The Sea Customs Act 1898 provide for the
levy of customs duty on goods including drugs, medicines, chemicals and
foods imported to India or exported from India.

The Poisons Act 1919 simply regulated the import, possession and sale of
poisons.

The Cantonment Act 1924 empowered cantonment authorities to enter into any
shop and seize any drug or medicine which is ‘adulterated’. However there was
no precise definition for an adulteration or adulterated drug.

The Dangerous Drugs Act 1930 was enacted to control various operations like
cultivation and manufacturing, possession, import, export, transport and sale of
dangerous drugs like Coca, Hemp and Opium. It incorporated certain
provisions of the Opium Act 1878.

There were many state enactments like the Bengal Food Adulteration Act
1919, the Bengal Excise Act 1909, the Madras Prevention of Adulteration Act
1919, The Bombay Prevention of Adulteration Act 1925, the United Provinces
(now Uttar Pradesh) Prevention of Adulteration Act 1912 and the Bihar and
Orissa Prevention of Adulteration Act 1919. However they all failed to touch
the various regulatory aspects of drugs and pharmaceuticals.
111
Drugs Regulatory
Affairs
6.4 DRUGS ENQUIRY COMMITTEE

The government of India appointed a committee styled as the Drug Enquiry

Committee under the Chairmanship of Col. R.N. Chopra on 11th August 1930
to study the issues related to the profession of pharmacy and its various aspects
in India. This Drug Enquiry Committee was later known by the name ‘Chopra
Committee’. The important terms of reference for the Committee were:

i) To study the details regarding the extent to which drugs and chemicals of
impure quality or defective strength, particularly those recognized by the
British Pharmacopoeia are imported, manufactured or sold in British India
and to make necessary recommendation for controlling such activities in
the interest of the public.

ii) To report how far and to what extent the above recommendations should be
extended to medicinal preparations used in the indigenous systems of
medicines.

iii) To study and examine the necessity of legislation for restricting the
profession of pharmacy to duly qualified persons and make
recommendations to that effect.

The Chopra Committee took up the challenge of studying the problems and
making recommendations with all its seriousness and professional significance.
They travelled various centers of the country and studied the situations. The
committee submitted its report in 1931.

The committee report made it clear that till that time there was no organised
and self contained profession of pharmacy in India as compared to other parts
of the world. The profession is represented by a group of people known as
compounders whose status, functions and duties are ill defined and improperly
understood. They handle drugs and poisons with utmost ease and freedom and
in many cases in ignorance of their properties. The committee also observed
that no stress is laid down on the basic qualification except in the revised
compounders course in Bengal and the Chemists and Druggists course in
Madras made in the late 1920s. The mere ability to read the prescriptions
written in English was considered sufficient to practice pharmacy. The Drugs
Enquiry Committee also recommended for the compilation of the Indian
Pharmacopoeia with monographs on drugs and pharmaceuticals in common
use including those of the indigenous origin.

The Government of India could not act immediately on the Chopra Committee
report. The World War II was one of the major reasons for the delay in the
immediate implementation of the recommendations of the Chopra Committee.
However the pharmacy education in an organised and well designed manner
was started immediately after the committee submitted its report. Prof.
Mahadeva Lal Schroff initiated pharmacy education at the University level in
India at Banaras Hindu University (BHU) in 1932. Several other universities
followed the suit and started pharmacy degree courses. The United Provinces
112 Pharmaceutical Association was started in 1935 at BHU with the support of
Prof. Schroff and this association later became the Indian Pharmaceutical Origin of
Association (IPA). The professional publication ‘Indian and Eastern Chemist’ Pharmaceutical
which was originally published from London started publishing from Calcutta Legislation
also. The Pharmaceutical Journal and the Chemist and Druggist of England
came forward to support the demand of pharmacy profession in India.

SAQ 5

What is significance of Chopra Committee in the history of pharmaceutical

legislation in India?

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6.5 GENESIS OF THE DRUGS ACT 1940

Based on the recommendations of the Chopra Committee Report, the

Government of India brought forth the ‘Import of Drugs Bill’ in 1937. Lot of
criticism in strong words and language came against the government’s
initiative to introduce the Bill for import of drugs ignoring the other major
recommendations. The Indian and Eastern Chemist (February 1938 page 53)
wrote: “What exactly is the reason the government consistently declines to take
adequate action on the basis of the report of the Drugs Enquiry Committee
submitted in 1931? The evidence put forward in that report more than justified
immediate legislation, yet it has taken seven years for the government to
produce a Bill which barely touches the fringe of the problem and leaves the
quacks, the fakes, the tricksters to pursue their unscrupulous way to
incalculable danger of the public”. The Government finally withdrew the
Import of Drugs Bill.

In 1940 the Drugs Bill came with the objective of regulating the import,
manufacture, sale and distribution of drugs in British India. It was first
published for seeking public opinion and then submitted to a select committee
and was finally adopted as the Drugs Act 1940. In 1945 the Drug Rules under
the Drugs Act 1940 were published. In 1962, the Drugs Act became Drugs and
Cosmetics Act by incorporating cosmetics also within its purview. The Drugs
and Cosmetics Act has been amended several times since then.
113
Drugs Regulatory 6.5.1 Pharmacy Act and Other Legislations
Affairs
In 1946, the Health Survey and Development Committee under the
chairmanship of Sir Joseph Bhore (Bhore Committee) published its report. An
important recommendation of the Bhore Committee was to have an enactment
(Act) with the objective of raising the interests of qualified pharmacists and
thereby protect the interests of public. It was made as the committee found that
incompetent people were handling drugs and doing harm to the society. The
Bhore Committee also suggested that the profession of pharmacy should be
reserved for the pharmacists and the pharmacists should restrict their work to
the professional activities of their profession. It was also suggested that the
pharmacists should not be permitted to undertake functions like prescription of
medicines and administration of anaesthetics. The committee also
recommended for a revision of the pharmacy education in the country as the
standard of training for those entering into the practice of pharmacy was
unsatisfactory.
Based on the recommendations of the Chopra Committee and the interim
findings of the Bhore Committee the Government of India brought forth the
Pharmacy Bill in 1945 and after three years continuous efforts and discussions
at various levels, it took the shape of Pharmacy Act 1948. The first Pharmacy
Council of India was constituted in 1949 under the provisions of the Pharmacy
Act.
It was provided in the Pharmacy Act that within three years of its coming into
force, the States should constitute their Pharmacy Councils and within three
years of that the Education Regulations would take effect. Hence the first
Education Regulations under the Pharmacy Act should have come in force in
all states in India by 1954 and those who are not qualified to enter the
profession of pharmacy as per the Education Regulations should not have been
allow to enter. However the situation was different. Many states took their own
time to constitute the Pharmacy Councils. Even after the Pharmacy Act the
profession of pharmacy has not been able to make much headway in the
country.
In 1944 a committee was appointed once again under the chairmanship of
Col. R.N. Chopra to prepare the material for the list of drugs in use in India
irrespective of whether or not such items are included in the British
Pharmacopoeia. The Indian Pharmacopoeial list, a prelude to the Indian
Pharmacopoeia, was published in 1946 under the auspices of the above
committee. In 1948 a full fledged Indian Pharmacopoeia Committee was
constituted under the chairmanship of Dr. B.N. Ghosh of Calcutta and several
sub committees were also set up. The committee took seven years to complete
the task and in 1955 the first edition of Indian Pharmacopoeia was published.
(You will study the other pharmacy legislations in Unit 8 of this course.)

6.5.2 Aims of Pharmacy Act 1948

The Pharmacy Act 1948 was passed with the objective of regulating the
114 practice of pharmacy in India and thereby raising the status of profession of
pharmacy. It also aims to provide uniform quality education for those who Origin of
enter the profession of pharmacy. Pharmaceutical
Legislation
Pharmacy is responsible for the production, storage, compounding and
dispensing of medicines to the patients. The profession pharmacy also has a
responsibility to ensure that quality drugs are given to the patients with proper
directions and information so that they can use the medicines in the right
manner. The practice of pharmacy therefore requires specialised knowledge,
skills and training and the people who enter the profession shall have the
required education and training to equip them to shoulder the responsibility.
This basic fact has been understood and followed in other countries since long
and in India it was recognised only through the Pharmacy Act in 1948. The
Pharmacy Act was brought into existence with the desire to restore to the
profession of pharmacy its due place in health services of the country.

6.6 PHARMACY COUNCIL OF INDIA (PCI)

The Pharmacy Council of India (PCI) is the Central Council constituted as per
the provisions of the Pharmacy Act 1948. The first Council was constituted in
1949 and is constituted every 5 years. There are three categories of members in
the Pharmacy Council- Ex-officio members, elected members and nominated
members. Both the Central Government and the state Governments can
nominate members to the PCI as per the provisions of the Act. The state
pharmacy councils and bodies like University Grants Commission (UGC) can
elect their representatives to the Central Council. The Director General of
Health Services and Drugs Control General of India are examples of persons
who become members of the PCI because of their official capacity (that is they
are ex-officio members). The elected and nominated members shall hold office
for a period of 5 years and are eligible for re-election and re-nomination.
The Pharmacy Council of India shall have an elected President and Vice-
President and also an Executive Committee elected by the members. The
Pharmacy Council of India can appoint a Secretary who can also act as
Treasurer of the Council. The Council has to furnish copies of its minutes and
those of the Executive Committee together with a summary of annual activities
and accounts to the Central Government.

6.6.1 Education Regulations of Pharmacy Council of India

The Pharmacy Act empowers the Pharmacy Council of India to frame the
standards known as ‘Education Regulations’ (ER) and submit to the Central
Government for approval. Through the ER, the PCI can prescribe the minimum
qualification for admission to the courses (D. Pharm, B. Pharm, M. Pharm
etc.), duration of the course, nature and period of the practical training, the
subjects to be taught to the students, equipments and facilities to be provided
by the institution, conditions to be fulfilled by academic institutions,
examination authorities and those providing practical training to the students.
115
Drugs Regulatory The PCI has to approve the institutions that run the course or conduct
Affairs examinations. The institutions have to apply to the PCI for the same. The PCI
shall appoint inspectors for conducting inspection of academic and other
related institutions to find out the facilities provided and the their compliance
with the norms and conditions of the ER.

6.6.2 State Pharmacy Councils

The Pharmacy Act 1948 provides for the constitution of a Pharmacy Council
for every state. The Act also provide for the constitution of a Joint State
Pharmacy Councils for a definite or indefinite period of time. The State
Pharmacy council shall have three types of members as in the case of PCI-
elected, nominate and ex-officio. Six members are elected by the registered
pharmacists of the state from among themselves and 5 members are nominated
by the state government. The registration of the pharmacists is the important
responsibility of the state pharmacy councils. According to the currently
existing norms, the minimum qualification for registration as a pharmacist in
India is Diploma in Pharmacy (D.Pharm). Those registered pharmacists who
are found guilty of offences as specified in the Pharmacy Act can be removed
from the register.

SAQ 6

Fill in the blanks:

i) PCI was constituted in ……………

ii) ……………… of PCI can also act as treasurer.
iii) PCI is constituted after every ……….. years.
iv) The minimum qualification for pharmacist is ………………….
v) The Pharmacy Act empowers the Pharmacy Council of India to frame the
standards known as ………………………..

6.7 SUMMARY

In this unit, we have studied about the history, origin of pharmaceutical

legislation and pharmacy act. The modern system of medicine was introduced
by Britishians in later part of 19th century. After that various Act (mainly Drugs
& Cosmetics Act) were introduced. Later in 1930, Col. R.N. Chopra
Committee was established for taking up the issues of profession of pharmacy.
And in 1948, Pharmacy Council of India constituted with the education
regulation throughout India and is responsible for pharmacy education standard
in the country.

6.8 TERMINAL QUESTIONS

1. Briefly mention the genesis of modern medicine system in India during the
116 British rule period?
2. Discuss the regulation of pharmacy in western countries. Origin of
Pharmaceutical
3. Discuss in brief about the recommendations of the Chopra Committee Legislation
regarding the pharmaceutical legislation in India?
4. Discuss the genesis of Drug Act, 1940.
5. Discuss the constitution of Pharmacy Council of India.

6.9 ANSWERS

Self Assessment Questions

1. The allopathic system of medicine which is also known as modern

medicine, was brought to India by the British traders and the rulers during
the colonial period. It was during the later part of the 19th century that the
allopathic system of medicine became popular in India.

2. English medicine is the name commonly used by the Indians to denote the
allopathic or modern system of medicine. During the period British rulers,
most of the allopathic medicines were imported from England. Till then the
indigenous systems of medicine like ayurveda, siddha and unani popular in
India. In order to distinguish the western medicines (modern medicine)
from the Indian medicines the people started to call the modern medicine as
English medicine. Later this name became very popular in India.

3. By the early 20th century, India literally became a dumping place for a
quacks, low quality and spurious medicines manufactured in all parts of the
world. All sorts of useless medicines were given to Indian people by
unqualified people with the only motive of business interest. India was
described as a land of quacks, quack doctors, quack dentists, quack
opticians, quack pharmacists, and quack faith healers. It was because of
these reasons that the demand for an effective pharmacy legislation to
control such bad practices became strong in India during the early part of
20th century.

4. In other countries there were specific legislations to control the

manufacture, import, sales and use of medicines. In United Kingdom, they
made two enactments namely the Therapeutic Substance Act of 1925 and
the Food and Drugs (Adulteration) Act of 1928 with the objective of fully
safeguarding the interests of the British people through the control of
almost all activities related to medicines and pharmaceuticals. However in
India there was no legislation to control the activities related to medicines.
This has resulted in dumping spurious and substandard medicines in large
quantities in India and the quacks were permitted to treat the patients.

5. The Drug Enquiry Committee under the Chairmanship of Col. R.N. Chopra
was constituted by the Government of India in August 1930 to study the
issues related to drugs and the profession of pharmacy and other related
matters. During those days the Indian market was flooded with spurious 117
Drugs Regulatory and substandard medicines and there was no legislation to monitor and
Affairs control the situation. The Committee submitted its Report in 1931 after
having a thorough analysis and study of the prevailing situation in the
country. Since the Committee was headed by Col. R.N. Chopra, that Report
is known as Chopra Committee Report. The findings and recommendations
of the Committee were responsible for the genesis of pharmaceutical
legislation in India. Acts like the Drugs Act 1940 (which later became the
Drugs and Cosmetics Act) and the Pharmacy Act 1948 were enacted
because of the recommendations of the Chopra Committee. The Chopra
Committee Report has played an important role in the evolvement of
pharmaceutical legislation in India.

6. i) 1949 ii) Secretary iii) 5

iv) D. Pharm v) Education Regulations

Terminal Questions
1. During the Muslim rule the Indian system of medicine declined and the
Arabic or the Unani Tibbi system was brought into India. The modern
system of medicine (which is also known as allopathic system of medicine)
was introduced in India by the British traders who later became the rulers
during the later part of the 19th century. During their rule the British
intentionally gave a patronage to the allopathic system. In the beginning the
allopathic or the western system of medicine was principally meant for the
ruling class and by the end of the 19th century it became popular among the
people of India.

2. In England, the Pharmaceutical Society of Great Britain was responsible

for the control of the profession of pharmacy and in United States of
America by the state laws. Only well qualified and licensed pharmacists
could dispense, compound or sell medicines and other pharmaceutical
preparations in these countries. By 1920s the countries like United States of
America and UK could implement stringent laws against unethical aspects
in the manufacture and sales of spurious and low quality medicines. The
Therapeutic Substance Act 1925 and the Food and Drugs (Adulteration)
Act 1928 in the United Kingdom fully safeguarded the interests of the
British people by adequately controlling almost all activities related to
medicines and pharmaceuticals. In USA, the Federal Food and Drugs Act
1906 was amended successively in 1912, 1913 and 1927 to effectively
prevent manufacture, sale and trans-shipment of adulterated, misbranded,
poisonous or deleterious drugs and medicines. In Canada, the Food and
Drugs Act 1920 and the Patent and Proprietary Medicines Act helped to
regulate and control drugs and other medicinal preparations in an efficient
manner. In fact, the Western countries and other free countries in the world
could exercise a rigid control over the nature and quality of drugs placed on
their market by early part of the 20th century.

3. The Chopra Committee took up the challenge of studying the problems and
making recommendations with all its seriousness and professional
118
 significance. They travelled various centers of the country and studied the Origin of
situations. The Committee submitted its report in 1931. Pharmaceutical
Legislation
The Committee report made it clear that till that time there was no
organised and self contained profession of pharmacy in India as compared
to other parts of the world. The profession is represented by a group of
people known as compounders whose status, functions and duties are ill
defined and improperly understood. They handle drugs and poisons with
utmost ease and freedom and in many cases in ignorance of their
properties. The Committee also observed that no stress is laid down on the
basic qualification except in the revised compounders course in Bengal and
the Chemists and Druggists course in Madras made in the late 1920s. The
mere ability to read the prescriptions written in English was considered
sufficient to practice pharmacy. The Drugs Enquiry Committee also
recommended for the compilation of the Indian Pharmacopoeia with
monographs on drugs and pharmaceuticals in common use including those
of the indigenous origin.

4. In 1940 the Drugs Bill came with the objective of regulating the import,
manufacture, sale and distribution of drugs in British India. It was first
published for seeking public opinion and then submitted to a select
committee and was finally adopted as the Drugs Act 1940. In 1945 the
Drug Rules under the Drugs Act 1940 were published. In 1962, the Drugs
Act became Drugs and Cosmetics Act by incorporating cosmetics also
within its purview. The Drugs and Cosmetics Act has been amended
several times since then.

5. The Pharmacy Council of India (PCI) is the Central Council constituted as

per the provisions of the Pharmacy Act 1948. The first Council was
constituted in 1949 and is constituted every 5 years. There are three
categories of members in the Pharmacy Council- Ex-officio members,
elected members and nominated members. Both the Central Government
and the state Governments can nominate members to the PCI as per the
provisions of the Act. The state pharmacy councils and bodies like
University Grants Commission (UGC) can elect their representatives to the
Central Council. The Director General of Health Services and Drugs
Control General of India are examples of persons who become members of
the PCI because of their official capacity (that is they are ex-officio
members). The elected and nominated members shall hold office for a
period of 5 years and are eligible for re-election and re-nomination.

SUGGESTED READINGS

1. Drugs Enquiry Committee Report 1931

2. The Pharmacy Act 1948

3. A Text Book of Forensic Pharmacy: B.M. Mithal

119