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UNIT 6 ORIGIN OF Origin of
Pharmaceutical
PHARMACEUTICAL Legislation
LEGISLATION
Structure
6.1 Introduction
Objectives
6.2 History of Pharmaceutical Legislation in India
Genesis of Modern Medicine and Pharmacy
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Pharmacy in the 19 and Early 20 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 6.2 HISTORY OF PHARMACEUTICAL LEGISLATION
Affairs 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
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rulers during the later part of the 19 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
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ruling class and by the end of the 19 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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6.2.2 Pharmacy in the 19 and Early 20 Centuries in India Origin of
th Pharmaceutical
Though the western system of medicine became popular in India by the 19 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.
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By the advancement of the 20 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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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
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quality of drugs placed on their market by early part of the 20 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
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20 century?
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