TEXTbook of
FORENSic PI-IARMACY
TEXTbook of
FORENSic PhARMACY
C.K. Kokate
Former Vice-Chancellor, Kakatiya University,
Former President, Pharmacy Council of India,
Former E.C. Member & Chairman ,
All India Board of Pharmacy, AI.C.T.E.
S.B. Gokhale
Coordinator, R.C. Patel College of Pharmacy,
Shirpur, Maharashtra .
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Pharma Book Syndlcat.
PharmaMed Press
An imprint of Pharma Book Syndicate
4-4-316, Giriraj Lane,
Sultan Bazar, Hyderabad – 500 095.
Copyright © 2008, by Publisher
All rights reserved
No part of this book or parts thereof may be reproduced,
stored in a retrieval system or transmitted in any language
or by any means, electronic, mechanical, photocopying,
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of the publishers.
Published by :
PharmaMed Press
Illii~U~~ : An imprint of Pharma Book Syndicate
4-4-316, Giriraj Lane, Sultan Bazar, Hyderabad – SOO 09S.
Phone: 040-2344560S, 2344S688; Fax: 91+40-23445611
An Imp.in. “I E-mail: [email protected]
Ph.””” Book Syndicate
www.pharmamedpress.com/pharmamedpress.net
ISBN: 978-81-88449-48-2
To my wife
Mrs. Kanan – a pharmacist by profession – who has
always encouraged me to aim at academic and
professional excellence.
Dr. Chandrakant Kokate
Preface
As a teacher of Forensic Pharmacy for more than three decades at the
Bombay College of Pharmacy, Mumbai and University College of
Pharmaceutical Sciences, Kakatiya University, Warangal, I have
developed passion for learning more about the Regulations, Associations
and their activities, as well as, ethical boundaries of our noble and sacred
profession. This profession gives us one time opportunity in our lives to
serve the cause of humanity by making our humble contributions to the
health care system of the country.
During my tenures as President, Pharmacy Council oflndia; Member,
Drugs Technical Advisory Board; Executive Committee Member, All
India Council for Technical Education and Chairman, All India Board of
Pharmacy AICTE, I was associated with most of the Statutory Bodies
governing and regulating profession of pharmacy in the country. I had
good opportunity of interacting with different segments of our profession
and policy-makers of the country. I had an access to the write-ups of
professional meetings, deliberations and amendments to Acts for several
years. It is with this strength of confidence backed by my teaching
experience of several years, I have ventured to write this book on Forensic
Pharmacy with my colleague and trusted friend Prof. S.B. Gokhale for
the benefit of students of degree and diploma classes in pharmacy. The
book is written in simple and lucid manner with understandable
interpretation of various Acts and Rules, without diluting overall impact
of the subject.
The text of Forensic Pharmacy is ever-changing and our efforts were
to add commas to the text of the subject thus, facilitating free flow of the
knowledge oflegal principles regulating our profession.
(viii) Preface
The historical milestones of various pharma-events and salient features
of different Acts and Rules pertaining to profession are integral
component of the text. The students of pharmacy, we are sure, will find
contents of the book interesting and educative.
We thank management of Pharma Book Syndicate especially,
Mr. Anil Shah for his efforts in publishing this book.
C.K. Kokate
Ably assisted and Co-authored by
S.B. Gokhale
Contents
Preface vii
Contents ix
- General Introduction
- History of Drug Legislation and
Pharmacy profession in India 4
- Pharmaceutical Ethics 15
- The Pharmacy Act, 1948 19
- TheAll India Council for
Technical Education Act, 1987 35
- The University Grants Commission (U.G.e.) Act, 1956 39
- The Drugs and Magic Remedies
(Objectionable Advertisements)
Act, 1954 and Rules 1955 42
- The Drugs and Cosmetics Act, 1940 and Rules, 1945 47
- The Narcotic Drugs and Psychotropic Substances
Act, 1985 and Rules, 1985 122
- Medicinal and Toilet Prepatations (Excise Duties)
Act, 1955 and Rules, 1956 135
- The Industries
(Development and Regulations) Act, 1952 148
(x) Contents
- The Prevention of Food Adulteration Act, 1954
and Rules, 1955 152
- National Blood Policy 159
- Pharmaceutical Policy, 2002 163
- The Drugs (Price Control) Order (DPCO), 1995 167
- WTO, GATS and
The Indian Patents Act, 1970 with Amendments 176
Index 185
References 189
CHAPTER 1
General Introduction
The word Forensic is derived from Latin term Forencis means a
forum, a place for interaction or deliberations. Jurisprudence means
study offundamentallaws and in case of pharmaceutical Jurisprudence,
it is laws relating to pharmacy.
Forensic Pharmacy or Pharmaceutical Jurisprudence is that branch
of pharmacy, which deals with various legislations pertaining to, drugs
and pharmaceuticals and profession of pharmacy. This subject
encompasses the knowledge ofvariOl~s Acts, Rules, Statues, Schedules,
Sections etc., which directly or indirectly infiuet]cc the profession of
pharmacy in the country and variolls operations pertaining to procw·ement.
manufacture and gistribution of different kinds of dosage forms.
The knowledge of Forensic Pharmacy is essential to understand the
legal”aspects pertaining to practice of pharmacy. The qualified persons,
are required to profess and should also be engaged in manufacturing,
sale and distribution of drugs. Pharmacy is a noble and dedicated
profession with a commitment to the cause of health care system of the
country. In order to ensure this professional role of pharmacist, there
has to be an ethical framework within which a pharmacist is supposed
2 Textbook of Forensic Pharmacy
to function. He/she should be familiar with the types oflaws governing
his/her profession and also the developments that have contributed to
the current status of pharma education, pharmacy practice and
pharmaceutical industry.
Since ancient times, the human race has been depending upon the
plant-derived drugs for the treatment of different human diseases. Apart
from our own civilization Chinese, Greek, Arabian and Tibetian civilization
have contributed significantly to the knowledge of medicinal plants. In
our country Ayurveda, the Ancient Science of Life, based on ‘Tridosh’
theory of Vaat(wind), Pitta (bile) and Kapha(phlegm) is practiced from
time immemorial. Our treaties or documents such as ‘Vedas’ and
‘Upanishadas’ are full of information pertaining to medicinal plants. In
ancient days, the medical care was in the able hands of ‘Maharshis’ and
‘Vaids’ who had a special status in the society. There was also the Siddha
medicine mainly practiced in southern regions of the country.
With the advent of Moghul rulers specially Babur, there came in a
new system of medicine practiced by Hakims called as Unani System
of Medicine, which got patronage during the rule of Shahjahan and
Aurangazeb. With the arrival of East India and other European companies
and thereafter, British rule in Nineteenth Century .the Indian population
was first introduced to the Allopathic System of Medicine more commonly
known as “Vilayati Medicines”. The modern system of medicine was
introduced in India by the Dutch, the French, the Portugese and East
India trading companies and the missionaries from European countries.
Until the end of the Nineteenth Century, the medicines of different
systems were mostly derived from plants or other natural sources like
animals and minerals. These drugs were in the form of extracts, tinctures,
pills and pastes and most of them were freshly prepared. The Ayurvedic
medical practitioners were mostly hereditary and they were following
Guru-Shishya parampara, which was also true of Siddha and Unani
practitioners (Hakims). The Homeopaths were self-taught and relied
mostly on Iiterature from Germany. In the absence of legal requirements
of registration as doctor, a large number of quacks surfaced in medical
profession.
General Introduction 3
The hospital facilities were almost non-existent in rural areas. The
railway administration and plantations provided good services to their
employees. The missionaries and charity hospitals for communities were
serving limited cause of health care.
In British India, the European establishments like Kemp and Company;
Bliss and Cotton; and Frank Ross and Company were the important
pharmacies. The Indian companies in British India were Popular
Pharmacy at Bombay. Dadha and Company, Wilfred Perira Ltd, and
Appah and Company at Madras; H.C. Sen and Company and The Young
Friends and Company at Delhi; Beli Ram and Brothers, The Punjab
Medical Hall and Narayan Das Bhagwan Das and Company at Lahore;
and Butto Kristo Paul and Company and M. Bhattacharya and Company
at Calcutta.
There were no legally controlled systematic manufacturing efforts in
the country for the manufacturing of different drug formulations to be
used for a longer period. It was only when plant drugs were further
processed/purified, and synthetic, as well as, semi-synthetic compounds
of medicinal utility were manufactured and formulated in different dosage
forms, the need to enact the laws to govern various operations of
manufacture, sale and distribution was acutely felt.
CHAPTER 2
History of Drug Legislation and
Pharmacy Profession in India
During 1920-1930 there were number of reports ofharmful substitutes
and adulterants being marketed in place of genuine drugs and toxic effects
of such drugs were published in Indian press from time to time. According
to reports of Indian Medical Gazette during this period, there was
absolutely no control over the manufacturing, sale and distribution of
drugs in India. Several deaths were reported due to spurious drugs. In
place of eye drops, croton oil was used. Chalk powder was frequently
found to be used for adulteration of drug formulations. There were toxicity
reports due to overdose of mercury compounds. In the absence of
effective Acts and Rules related to drugs and pharmaceuticals in the
country, there was a rat race for manufacturing of sub-standard, spurious
and adulterated formulations.
As a result of alarming adverse reports, deaths due to spurious and
adulterated drugs and in view of protests within and outside the country
concerned with poor medical facilities offered by British rulers in India
finally, on 9th March, 1927, The British Government was forced to
initiate action for drug legislations. The Council of State in British India
headed by the Viceroy passed a resolution to counter or check
malpractices in drug dispensation and medication. On 11th August,
1930, Drugs Enquiry Committee (D.E.C.) was constituted under the
Chairmanship of Col. R. N. Chopra which was a historic development
History of Drug Legislation and Pharmacy Profession in India 5
signall ing beginning of new era of drug legislation in our country. Prior to
the constitution of this Committee, there was no significant piece of
legislation regulating the import, manufacture, sale and distribution of
medicine. No Act was in vogue prescribing qualification of a pharmacist
and there was no systematic procedure adopted for registration as
pharmacists.
Important Milestones in Drug Legislations and
Pharmacy Profession
(Education, Practice, and Industry)
PRE-INDEPENDENCE ERA
1664 The first hospital was opened at Fort St. George,
Madras.
1811 Young Scotch named Mr. Bathgate came to India
with East India Company and opened Chemist’s shop
in Calcutta.
1820 Lord Cornwallis started Opium factory at Ghazipur
(U.P.).
1824 Hindustani versions (Devnagri and persion scripts)
of the London Pharmacopoeia were prescribed.
1824 The East India Company decided to impart knowledge
of medical science-both European and Indian.
1835 First two medical colleges established at calcutta and
Madras.
1857 Few sections oflndian Penal Code were applicable
for drugs.
1857, 1878 The Opium Act enacted.
1860 The beginning of pharmaceutical instructions in British
India at Madras Medical College.
6 Textbook of Forensic Pharmacy
1868 The Pharmacopoeia of India published under the
authority of Secretary of State for India.
1885 British Pharmacopoeia was made the sole authority
for pharmacy profession.
1889 The Indian Merchandi~e Marks Act enacted.
1894 The Indian Tariff Act enacted.
1898 The Sea Customs Act enacted.
1899 The Compounders training course started in Madras.
1899 Achary P.c. Roy along with Kartic Chandra Bose
established Bengal Chemical and Pharmaceutical
Works at Calcutta.
1905 Gajjar and Co. established at Bombay which also
started drug manufacturing.
1906 In U.S.A. – Federal Food & Drugs Act introduced.
1919 The Poisons Act enacted.
1920 All India Compounders and Dispensers Association
was established.
1920 In Canada – Food and Drugs Act introduced.
1924 The Cantonment Act enacted.
1925 In U.K. – The Therapeutic Substance Act
introduced.
9-3-1927 Resolution of Council of States in India regarding
health services.
1928 In U.K. Drug Adulteration Act enacted.
1928 The state medical faculty of Bengal introduced two
years course for compounders.
11-8-1930 Drugs Enquiry Committee (D.E.C.) headed by Col.
- N. Chopra constituted.
History of Drug Legislation and Pharmacy Profession in India 7
1931 Report submitted by D.E.C. to Central Government.
1932 A two year Degree Course in Pharmaceutical
Chemistry for B.Sc. – Beginning of pharmacy
education at Banaras Hindu University by
Prof. Mahadev Lal Schroff (Father of Pharmacy
Education in country).
1-11-1933 The Indian Medical Council Act enacted.
1935 United Provinces Pharmaceutical Association
(UPPA) established at Banaras by Prof. Mahadev
Lal Schroff.
1937 Import of Drugs Bill introduced in the Parli~ment
(British India) and later withdrawn due to criticism.
1937 Biological Standardization Laboratory (B.S.L.)
established at Calcutta.
1939 United Provinces Pharmaceutical Association
(U.P.P.A) was renamed as Indian Pharmaceutical
Association (I.P.A). Publication ofIndian Journal of
pharmacy started.
1940 Drugs Bill introduced in the Parliament and Drugs
Act later amended to Drugs & Cosmetic Act
(D.C.A) was enacted.
1940 Biological Standardization Laboratory was named as
Central Drugs Laboratory (COL) under DCA.
1941 First Drugs Technical Advisory Board (DTAB)
constituted.
1941 First All India Pharmaceutical Conference was held
at B.H.U, Varanasi under the Presidentship of Prof.
Mahadev Lal Schroff.
1943 Health Survey and Development Committee
constituted under the chairmanship of Sir Justice
Joseph Bhore.
8 Textbook of Forensic Pharmacy
1944 First I. P. Committee constituted.
1945 Pharmacy Bill introduced in the Parliament.
1945 Justice Joseph Bhore submitted report.
1945 Rules for Drugs & Cosmetic Act framed.
1946 Indian Pharmaceutical Codex (I.P.C) published.
POST-INDEPENDENCE ERA
1947 The Indian Nursing Council Act enacted.
1948 The Pharmacy Act, 1948 enacted.
1948 The Dentists Act, 1948 enacted.
9-11-1949 First ‘Pharmacy Council OJ India’ (P.C.I.)
constituted under the Pharmacy Act.
1949 Dr. K.C.K.E. Raja was nominated by the Central
Government as the first President of Pharmacy
Counciiofindia.
1951 The Industries Act enacted.
11-7-1953 First Education Regulations (E.R) as approved by
the Ministry of Health & F.W., Government ofindia
were notified.
1954 The Drugs and Magic Remedies (Objectionable
Advertisements) Act enacted.
1954 The Pharmaceutical Enquiry Committee
recommended appointment of graduates in Pharmacy
as Chief Pharmacists for all large hospitals.
1954 The first B. Pharmacy Course approved by
Pharmacy Council ofindia at Birla College, Pilani.
1955 The first Diploma in Pharmacy Course approved by
P.C.I. at Government Medical College, Amritsar.
History of Drug Legislation and Pharmacy Profession in India 9
1955 First Indian Pharmacopoeia published.
1955 The Medicinal and Toilet Preparations (Excise
Duties) Act.
1956 Essential Commodities Act enacted.
1956 The University Grants Commission Act enacted.
1957 Dangerous Drugs (Import, Export & Transshipment)
Rules framed.
1960 Prevention of Cruelty to Animals Act passed.
1960-70 Indian Drugs & Pharmaceuticals Ltd. (I.D.P.L.)
established at five places in the country.
1962 The Central Manufactured Drugs Rules framed.
1962 Beginning of National Pharmacy week celebrations
in third week of November every year.
1963 Pharma Times Publication of I.P.A as professional
monthly publication.
1963 The Indian Hospitals Pharmacists Association
(IHPA) was launched at Pilani, Rajasthan.
1964 The Indian Journal of Hospitals Pharmacy was started
by Prof. B.D. Miglani for IHPA.
1966 Second Indian Pharmacopoeia published.
1968 Insecticides Act enacted.
1970 First DPCO (Drugs Price Control Order), Later on
in 1979 and 1987, 1995 published.
1970 Indian Patents Act enacted.
1971 Medicinal Termination of Pregnancy Act enacted.
10 Textbook of Forensic Pharmacy
1972 Education Regulations of P.C.I. 1972 (notified on
6-1-1973).
1973 Homoeopathy Central Council Act enacted.
1974 Committee ofM.P.s with Jaisukhlal Hathi as chairman
for drugs and pharmaceuticals constituted.
1975 Hathi Committee Report Submitted. The Committee
recommended that a Chief Pharmacist with atleast
a graduate in pharmacy degree should be appointed
for maintaining quality of drugs supplied to patients
in hospitals.
1975 All India Organisation of Chemists and Druggists
(AIOCD) established with Mr. VL. Theagaraj as
President.
1976 The Dentists (Code of Ethics) Regulations framed.
1977 Indian Pharmaceutical Congress along with
Conference of Commonwealth Pharmaceutical
Association was held under the Presidentship of Dr.
J.N. Banerjee at Mumbai.
1978 Drug Policy was announced based on Hathi
Committee report.
1979 Indian Journal of pharmacy was named as Indian
Journal of Pharmaceutical Sciences (Bi-monthly
publication).
1981 Education Regulations ofP.C.I. notified on 11.7.1992.
1985 Third Indian Pharmacopoeia published.
1985 The Narcotic-Drugs & Psychotropic Substances Act
enacted.
History of Drug Legislation and Pharmacy Profession in India 11
1986 Consumer Protection Act enacted.
1986 Revised Drug Policy was announced.
23-12-1987 The All India Council for Technical Education
(AICTE) Act covering pharmacy education enacted.
1989 Golden Jubilee ofIndian Pharmaceutical Association
celebrated.
1991 Education Regulations ofP.C.1. notified in 1993.
1994 Modifications in Drug Policy, 1994.
1996 Hon. Supreme Court directed Government to come
out with National Policy on Blood Programme.
Subsequently, National Blood Policy of NACO
(National AIDS Control Organization) brought out.
1998 Golden Jubilee of Indian Pharmaceutical Congress
alongwith Conference of Federation of Asian
Pharmaceutical Association (FAPA) was held at
Mumbai under the presidentship of Prof. C.K.
Kokate.
1999 Golden Jubilee Year of Pharmacy Council ofIndia
celebrated throughout the country.
2001 The first pharmacist (Prof. C.K. Kokate) appointed
as Vice-Chancellor ofIndian University, (Kakatiya
University A.P.).
2002 Pharmaceutical Policy announced by Ministry of
Chemicals and Fertilizers, Department of Chemicals.
2005 In Post-WTO era, new patent regime (Product
Patent) has started.