Textbook of forensic pharmacy C.K kotate

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TEXTbook of




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,

       recording or otherwise without the prior written permission

       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






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





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





Preface                                                     vii

Contents                                                     ix


  1. General Introduction
  2. History of Drug Legislation and

      Pharmacy profession in India                           4

  1. Pharmaceutical Ethics 15
  2. The Pharmacy Act, 1948                                19
  3. TheAll India Council for

      Technical Education Act, 1987                         35

  1. The University Grants Commission (U.G.e.) Act, 1956   39
  2. The Drugs and Magic Remedies

      (Objectionable Advertisements)

      Act, 1954 and Rules 1955                              42

  1. The Drugs and Cosmetics Act, 1940 and Rules, 1945     47
  2. The Narcotic Drugs and Psychotropic Substances

      Act, 1985 and Rules, 1985                             122


  1. Medicinal and Toilet Prepatations (Excise Duties)

      Act, 1955 and Rules, 1956                             135

  1. The Industries

      (Development and Regulations) Act, 1952               148


(x)                                                   Contents


  1. The Prevention of Food Adulteration Act, 1954

      and Rules, 1955                                    152

  1. National Blood Policy 159
  2. Pharmaceutical Policy, 2002 163
  3. The Drugs (Price Control) Order (DPCO), 1995 167
  4. 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



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



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,



          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



          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



          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



    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.

  1. 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)



        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.




         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



         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



     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



     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



     1981 Education Regulations ofP.C.I. notified on 11.7.1992.


     1985 Third Indian Pharmacopoeia published.


     1985 The Narcotic-Drugs & Psychotropic Substances Act



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



         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.



         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.