Forensic Pharmacy

Some questions ……
• What do you know about pharmacy education regulations?
• What do you know about pharmacy practice?
• Regulation of pharmaceutical industry for product development, export,
import etc.
• Which govt ministry and department regulate the pharmaceuticals
• What do you know about medical facilities of state and central govt to
public?
• How can you protect society from Narcotic and Psychotropic Substances ?
• What you know about pregnancy termination rules and regulations?
• What you know about Objectionable advertisements and where to
complaint?
• What is generic medicines?
• What about USFDA regulatory approval process for generic drugs
 Scope and Objective of the Course:
• This course is designed to impart a working knowledge of the
various legislations that have a direct bearing on the medical
and pharmaceutical professions.
• These laws embrace various fields such as manufacturing
pharmacy, professional pharmacy, pharmaceutical education,
drug administration and patenting etc.
• A professional pharmaceutical scientist, whatever be his field
of activity in later life, is bound to work within the framework
of these laws.
• Therefore, it is essential for every graduate in pharmacy to be
familiar with the outlines of these laws and that is what this
course aims to achieve. The course also includes a brief
discussion on the ethics of the pharmaceutical profession.
1 Introduction and Growth of modern pharmacy & pharmaceutical industry

2 Pharmacy Act

3 Laws under Drugs and Cosmetics Act and Rules

4 Provisions of Drug Price Control Order

5 Narcotic and Psychotropic Substances Act

6 Medicinal and Toilet Preparations Act

7 Drugs and Magic Remedies Act; Objectionable advertisements

8 The Medical Termination of Pregnancy Act

9 Committee for the purpose of control and supervision of experiments on animals

(CPCSEA)
10 Provision of Insecticide Act

11 Consumer protection Act

12 New Drug Approval Process

13 Branded and Generic medicines

 .

Introduction and Importance of Forensic

Pharmacy

BITS Pilani, Pilani Campus

Introduction

The word Forensic is derived from Latin term Forencis = forum,

a place for interaction or deliberations.

Jurisprudence means study of fundamental laws

Forensic Pharmacy or Pharmaceutical Jurisprudence is that

branch of pharmacy, which deals with various legislations
pertaining to, drugs and pharmaceuticals and profession of
pharmacy.

BITS Pilani, Pilani Campus

Introduction

This subject encompasses the knowledge of various Acts,

Rules, Statues, Schedules, Sections etc., which directly or
indirectly influence the profession of pharmacy in the country
and various operations pertaining to procurement,
manufacture and distribution of different kinds of drugs and
dosage forms.

BITS Pilani, Pilani Campus

Introduction

The knowledge of Forensic Pharmacy is essential to understand

the ‘legal’ aspects pertaining to practice of pharmacy.

The qualified persons for 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 to function.
BITS Pilani, Pilani Campus
Introduction

He/she should be familiar with the types of laws governing

his/her profession and also the developments that have
contributed to the current status of pharma education,
pharmacy practice and pharmaceutical industry.

BITS Pilani, Pilani Campus

Introduction

Since ancient times,

In our country Ayurveda: ancient Science of Life, based on 'Tridosh‘ theory of
Vaat(wind), Pitta (bile) and Kapha(phlegm).

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.

BITS Pilani, Pilani Campus

Introduction

Moghul rulers specially Babur, there came in a new system of

medicine practiced by Hakims called as Unani System

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 Homeopaths were self-taught and relied mostly on literature

from Germany.

BITS Pilani, Pilani Campus

 Introduction

• The Indian System of Medicine is the culmination of

Indian thought of medicine which represents a way
of healthy living valued with a long and unique
cultural history

– Greece (resulting in Unani Medicine),

– Germany (Homeopathy) or
– Our sages (which gave us the science of Ayurveda,
Siddha as also Yoga & Naturopathy).
 Ayurveda

• Ayurveda is a classical system of healthcare originating from

the Vedas documented around 5000 years ago.
• Around 1000 B.C. the knowledge of Ayurveda was first
comprehensively documented in the compendia called Charak
Samhita and Sushruta Samhita.
• As per the fundamental basis of Ayurveda, all objects and living
bodies are composed of five basic elements, called the Pancha
Mahabhootas, namely:
– Prithvi (earth), Jal (water), Agni (fire), Vayu (air) and
Akash(ether).
 Ayurveda
• Ayurveda imbibes the theory of Tridosha-
– Vata (ether + air), : arthritis., joint pain
– Pitta (fire) and : acidity, indigestion, piles, migraine
– Kapha (earth + water): allergy, asthma
which are considered as the three physiological
entities in living beings responsible for all metabolic
functions.
• The mental characters of human beings are
attributable to Satva, Rajas and Tamas, which are the
psychological properties of life collectively terms as
‘Triguna’.
• Rajas guna-Due to the quality of rajas guna, there is
presence of all the wishes, desire, fickle mindedness
and ambitions.
• Satwa guna is characterized by the clarity,
consciousness, lightness and pleasure. Satwa guna
dominant individuals (Satwika) are spiritual and noble.
• Tamas guna is characterized by immunity and
heaviness. Those individuals who have dominance of
tamas guna are generally lethargic and dull.
 Ayurveda

• The curative treatment consists of Aushadhi (drugs),

Ahara (diet) and Vihara (life style).
• Ayurveda largely uses plants as raw materials for the
manufacture of drugs, though materials of animal
and marine origin, metals and minerals are also
used.
• Ayurvedic medicines are generally safe and have
little or no known adverse side-effects, if
manufactured properly and consumed judiciously
following necessary DOs and DON’Ts.
 Unani
• As the name indicates, Unani system
originated in Greece.
• The foundation of Unani system was
laid by Hippocrates.
• It was introduced in India by the
Arabs and Persians sometime around
the eleventh century.
• During 13th and 17th century A.D.
Unani Medicine had its hey-day in
India.
 Unani

• The basic theory of Unani system is based upon the

well- known four- humour theory of Hippocrates.
 Unani

• The human body is considered to be made up of the following seven

components are:

– Arkan (Elements)

– Mizaj (Temperament)

– Akhlat (Humors)

– Aaza (Organs)

– Arwah (Spirits or vital breaths)

– Quwa (energy)

– Afaal (Functions)
 Unani

• Unani system of Medicine has been found to be efficacious in

conditions like

– Rheumatoid Arthritis,

– Jaundice,

– Nervous Debility,

– Skin Diseases like Vitiligo & Eczema,

– Sinusitis and Bronchial Asthma.

 Siddha

• The Siddha System of medicine is one of the ancient systems of

medicine in India having its close bend with Dravidian culture.

• The term Siddha means achievements and Siddhars are those

who have achieved results in medicine.
 Siddha

• The Siddha system of Medicine emphasizes on the patient,

environment, age, sex, race, habits, mental frame work, habitat,
diet, appetite, physical condition, physiological constitution of
the diseases for its treatment which is individualistic in nature.

• Generally the basic concepts of the Siddha medicine are almost

similar to ayurveda. The only difference appears to be that the
siddha medicine recognizes predominance of
vata, pitta and kapha in childhood, adulthood and old age,
respectively, whereas in ayurveda, it is totally reversed : kapam
is dominant in childhood, vata in old age and pitham in adults.
 Siddha

• Diagnosis of diseases are done through examination of

pulse, urine, eyes, study of voice, colour of body,
tongue and status of the digestion of individual
patients.

• System has unique treasure for the conversion of

metals and minerals as drugs and many infective
diseases are treated with the medicines containing
specially processed mercury, silver, arsenic, lead and
sulphur without any side effects.
 Siddha

• The strength of the Siddha system lies in providing very

effective therapy in the case of
– Psoriasis,
– Rheumatic disorders,
– Chronic liver disorders,
– Benign prostate hypertrophy,
– Bleeding piles,
– Peptic ulcer
– Various kinds of Dermatological disorders of non psoriatic
nature.
 Yoga
• The word "Yoga" comes from the Sanskrit word "yuj"
which means "to unite or integrate.“
• Yoga is about the union of a person's own
consciousness and the universal consciousness.

• It is primarily a way of life, first propounded by

Patanjali in systematic form.
• Yoga is a promotive, preventive rehabilitative and
curative intervention for overall enhancement of
health status.
 Yoga
• It consists of eight components namely,

– Restraint (Yama),

– observance of austerity (Niyama),

– physical postures (Asana),

– breathing exercise (Pranayam),

– restraining of sense organs (Pratyahar),

– contemplation (Dharna),

– Meditation (Dhyan) and

– Deep meditation (Samadhi).

• Yama- Ahimsa (non-violence), Satya (Truth, non-lying), Asteya
(non-covetousness), Brahmacharya (non-sensuality, celibacy),
and Aparigraha (non-possessiveness).
• Niyama-Shaucha(purity), Santosha(contentment), Tapas
(austerity), Svadhyaya (study of the Vedic scriptures to know
about God and the soul), and Ishvara-Pranidhana (surrender
to God).,
• Asana- seated position used for meditation.
• Pranayam("Suspending Breath")-control of the life force,
• Pratyahar-Withdrawal of the sense organs from external
objects
• Dharna-Fixing the attention on a single object,
• Dhyan-Meditation,
• Samadhi-merging consciousness with the object of meditation
• Austerity-refraining from worldly pleasures,
 Yoga

– These steps in the practice of Yoga have the potential to

improve social and personal behavior and to promote physical
health by better circulation of oxygenated blood in the body,
restraining the sense organs and thereby inducing tranquillity
and serenity of mind (serenity-The absence of mental stress
or anxiety).

• The practice of Yoga has also been found to be useful in the

prevention of certain psychosomatic diseases and improves
individual resistance and ability to endure stressful situations
(Face and withstand with courage).
 Naturopathy

• Naturopathy advocates living in harmony with constructive

principles of Nature on the physical, mental, moral and spiritual
planes.
• Naturopathy promotes healing by stimulating the body’s
inherent power to regain health with the help of five elements
of nature – Earth, Water, Air, Fire and Ether.
• Naturopathy advocates ‘Better Health without Medicines’.
• It is reported to be effective in chronic, allergic autoimmune and
stress related disorders.
 Naturopathy

• The theory and practice of Naturopathy are based on a

holistic view point with particular attention to
– simple eating and living habits,
– fasting,
– hydrotherapy-body packs, baths
– mud packs, massages,
– Under Water Exercises,
– Air therapy
– Magnet Therapy, Chromo-therapy,
– Acupuncture, Acupressure etc.
 Homoeopathy
• The Physicians from the time of Hippocrates (around 400 B.C.)
have observed that certain substances could produce symptoms
of a disease in healthy people similar to those of people
suffering from the disease.
• homoeo='similar', and pathos='suffering'.
• Dr. Christian Friedrich Samuel Hahnemann, a German physician,
scientifically examined this phenomenon and codified the
fundamental principles of Homoeopathy.
• Homoeopathy was brought into India around 1810 A.D. by
European missionaries and received official recognition in 1948
by the Parliament.
 Homoeopathy

• Homoeopathy is based on the assumption that the causation

of a disease mainly depends upon the susceptibility or
proneness of an individual to the incidence of the particular
disease in addition to the action of external agents like
bacteria, viruses, etc.
• Homoeopathic medicines are prepared mainly from natural
substances such as plant products, minerals and from animal
sources.
• Homoeopathy has its own areas of strength in therapeutics
and it is particularly useful in treatment for allergies,
autoimmune disorders and viral infections.
 AYUSH
• With an increase in lifestyle related disorders there is a world
wide resurgence of interest in holistic systems of health care,
particularly with respect to the prevention and management
of chronic, non-communicable and systemic diseases.

• It is increasingly understood that no single health care system

can provide satisfactory answers to all the health needs of
modern society.

• Evidently there is a need for a new inclusive and integrated

health care regime that should guide health policies and
programmes in future.
 AYUSH
• A separate Department of Indian Systems of Medicine and
Homoeopathy (ISM&H) was set up in 1995 to ensure the
optimal development and propagation of these holistic and
traditional system of heath care.
• The Department of ISM&H was re-named as the Department
of AYUSH (an acronym for - Ayurveda, Yoga and
Naturopathy, Unani, Siddha, Homoeopathy) in November
2003.
• The Ministry of AYUSH was formed with effect from 9
November 2014 by elevation of the Department of AYUSH.
 Bodies under AYUSH
Research councils:
• Central Council for Research in Ayurvedic Science(CCRAS)
• Central Council for Research in Siddha Medicine (CCRS)
• Central Council for Research in Unani Medicine (CCRUM)
• Central Council for Research in Homoeopathy Medicine(CCRH)
• Central Council for Research in Yoga and Naturopathy Medicine
(CCRYN)
• Pharmacopoeial Laboratory for Indian Medicine (PLIM)
• Homoeopathic Pharmacopoeia Laboratory (HPL)
• DRUG MANUFACTURING UNIT:
Indian Medicine Pharmaceutical Corporation Ltd. (IMPCL)
Mohan(Almora),Via Ramnagar-244715
(Uttarakhand)
• National Institutes:
• National Institute of Ayurveda, Jaipur (NIA)
• National Institute of Siddha, Chennai (NIS)
• National Institute of Homoeopathy, Kolkata (NIH)
• National Institute of Naturopathy, Pune (NIN)
• National Institute of Unani Medicine, Banglore (NIUM)
• Institute of Post Graduate Teaching and Research in Ayurveda
Medicine, Jamnagar, Gujarat (IPGTR)
• Rashtriya Ayurveda Vidyapeeth (National Ayurveda
University), New Delhi (RAV)
• Morarji Desai National Institute of Yoga Science, New Delhi (MDNIY)
• North Eastern Institute of Ayurveda and Homeopathy (NEIAH)
• All India Institute of Ayurveda, Delhi.
Difference between conventional medicine and
alternative medicine
Conventional Medicine Alternative Medicine
1 based on scientific knowledge of the based on the belief that a medical care
body and uses treatments that have provider has to treat the whole person
been proven effective through scientific — body, mind, and spirit.
research.
2 Associated with side effects Relatively free of side effects
3 Larger manpower and infrastructure Relatively less resources required
required
4 Services mostly curative Services mostly preventive
5 Costly Relatively cheap
6 More effective for acute diseases More effective for chronic diseases
7 Depends on diagnostic tests for Don’t depend so much on diagnostic
treatment tests.

3
7
Part-2
Introduction

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.
Mfg of modern drugs in India started with
 Bengal chemical and pharmaceutical works Calcutta 1901 by P
C Ray
 A small factory at Parel Mumbai 1903 By Prof T K Gajjar
 Alembic chemical works Vadodara 1907 by Prof Rajmitra

After first world war: import of drugs without restriction on

quality of drugs

BITS Pilani, Pilani Campus

Introduction

During 1920-1930 there were number of reports of harmful substitutes and

adulterants being marketed in place of genuine drugs.

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.

India became an excellent dumping ground of every variety of quack medicines

Several deaths were reported due to spurious drugs.

BITS Pilani, Pilani Campus

 Introduction
• Poison due to quinine overdose
• Croton oil instead of atropine eye drops
• Selling chalk tablets instead of quinine tablets
• All preparations were sold without standards
• Pharmacological lab Calcutta tested various medicines and found faulty
medicines.
• One of the leading German company withdrawn drugs in Europe but India
continued
• Alkaloidal drugs were having more than label amount, some of them were only
excipient
• Indian medical gazette published as quack medicine, quack doctors, quack
opticians and so on
• Only poison act 1919 was existing
• No rules to govern import, manufacturing and store of medicines including
marketing
BITS Pilani, Pilani Campus
Early measures

• Indian merchandise act 1889 was concerned with misbranding

of goods.
• Sea custom act 1898 and Indian tariff act 1894 for custom
duties
• Opium act 1878 dealt with cultivation, import and sale of
opium.
• Bengal municipal act 1884, Bengal food adulteration act 1919,
Bombay municipal act 1888 and so on
• Various state municipal act
• Brief and superficial enactments

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Early measures

• In contrast to half way measures to control in India,

Therapeutic Substances Act 1925 and Food and Drugs
Adulteration act 1928 in the United Kingdom fully safe
guarded the interest of British people by controlling the
import, manufacture of vaccine, sera , toxins, etc.

• United States Federal Food and Drugs Act 1906, amended

1912, 1913, 1927 effectively prohibited the malpractice.

• Canada also had Food and Drugs act 1920 also control drugs
preparations.

BITS Pilani, Pilani Campus

Early measures
Contrast of pharmacy affairs between India and free countries of world.
March 9, 1927 Sir Haroon Zaffer moved a resolution in the Council of States.
Lt Col. H.A.J Gidney on Sept 4, 1928: demanded for control of adulterated drugs.
During Indian Science Congress at Lahore 1927: strong appeal for steps for
spurious drugs.
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 and Dr. B. Mukherjee as assistant secretary
which was a historic development signaling 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. BITS Pilani, Pilani Campus
• Efforts of R N Chopra
committee
• He is considered as “Father of
Indian Pharmacology” since
he was the first to establish a
center of study and research in
pharmacology of India, at
Calcutta School of Tropical
Medicine.

BITS Pilani, Pilani Campus

Drugs Enquiry Committee (D.E.C.), 1930

The terms of references for the Committee were as follows:

I. To enquire into extent to which drugs and chemicals of impure quality, that are
being imported, manufactured and sold especially, those which are official in
B.P. and necessity, in the public interest, of controlling such import, mfg and
sale and to make recommendation.

2. To report how far the recommendation made in 1 may be extended to know and
approved medicinal preparation other than referred to medicine made from
indigenous drugs and chemicals.

3. To enquire into the necessity of legislation to restrict the profession of

pharmacy to duly qualified persons and to make recommendations.

BITS Pilani, Pilani Campus

Contribution of Chopra committee

• Committee submitted report in 1931.

• “ No organized self contained profession of pharmacy in India as
compared to other parts of world
• Profession is represented by compounders and duties are ill
defined . They carry dispensing, compounding and selling of
drugs
• They handle the poisons and drugs with ignorance
• Some of them act as physicians and surgeons to earn money
• No basic qualification except compounders course. Poor
prescription writing”

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The committee made following recommendations to the Government:

The report of committee was published in 1931

1. Central legislation to control drugs and pharmacy

2. Setting up of testing laboratories in all states to control the quality of production

of drugs production and control the quality imported drugs

3. Appointment of an Advisory Board to advise Govt

4. Setting up courses for training of pharmacy and prescribing min qualification for
registration of pharmacist.

5. Registration of every patent and medicine of undisclosed formula

6. Control on crude and indigenous medicines

7. The drug Industry in India should be developed

8. The manufacturing in Medical Stores Depots should be gradually reduced

9. Steps should be taken for compile an Indian Pharmacopoeia

10. The cinchona department should cultivate cinchona.

BITS Pilani, Pilani Campus
Evolution of Pharmacy profession

• Efforts of R N Chopra
committee
• He is considered as “Father of
Indian Pharmacology” since
he was the first to establish a
center of study and research in
pharmacology of India, at
Calcutta School of Tropical
Medicine.

BITS Pilani, Pilani Campus

Ram Nath Chopra 1983 stamp of India

BITS Pilani, Pilani Campus

Contribution of ML Schroff

Born on March 6, 1902 at Darbhanga in

Bihar, Schroff had his schooling from
Bhagalpur and passed the Intermediate
Examination in 1920.
He joined Engineering College Banaras
Hindu University for his studies and was
inspired by the talk delivered by Swamy
Satya Deo at BHU in 1921.
Joined Cornell University and got his
degree in Arts (AB) with honours in
Chemistry, in 1925.
Further, he obtained his MS in Chemistry
and Microbiology from Massachusetts
Institute of Technology (MIT) in 1927.

BITS Pilani, Pilani Campus

After returning to India in 1929, he took up a job with Birla Brothers Ltd. He was
very much frustrated with the trade and self-interest of the society and
momentarily thought of going back to the United States.
Meeting with with Jamnalal Bajaj transformed his attitude towards patriotism for
his country and involved himself in the movement for freedom.
Meeting with the Vice Chancellor of Banaras Hindu University. Pt. Madan
Mohan Malviyaji,
he was invited to join BHU as a staff in an honorary capacity.

In 1932, at BHU, Prof. Schroff, with his chemical technology background urged
Pt. M.M. Malaviyaji to start a separate branch (section) of Pharmaceutical
Sciences at BHU.
Pt. Malaviyaji realized its importance and Schroff was given the green signal to
organise this new discipline in India, for the first time.

BITS Pilani, Pilani Campus

Prof. Schroff introduced Pharmaceutical Chemistry as the principal
Subject in the B.Sc. course in 1932 in BHU.

From 1934 an integrated 2-year BSc. Course with the subjects --

pharma chemistry, pharmacy and pharmacognosy, was introduced,
which later from 1937 was turned into a full-fledged three-year B
Pharm course at BHU for the first time in India.

This was the first and the foremost creation of Prof M L Schroff,
which earned him the title of the pioneer and father of Indian
pharmaceutical education.
BITS Pilani, Pilani Campus
Contribution of ML Schroff

• After publication of the report of drugs enquiry committee

• Prof. Mahadev lal Schroff in 1932 initiated pharmaceutical
education in Banaras Hindu University
• United Province Pharmaceutical Association was organized at
BHU in 1935 which took the shape of Indian Pharmaceutical
Association in 1939
• Indian journal of pharmacy (IJPS)was started in 1939
• IPA convention 1940
• Prof Schroff started the M Pharm Education in 1940 at BHU with
his efforts.
• 1943, joined Birla Brothers as their Chief Chemist and Research
Officer and served as Secretary to the Birla Laboratories till 1949
at Calcutta
BITS Pilani, Pilani Campus
he was given the position and responsibility as principal at
Birla College, Pilani, where for the next five years he organized
Pharmacy education at intermediate and degree level
successfully.

BITS Pilani, Pilani Campus

Pharmacy Institute evolution

BITS Pilani, Pilani Campus

Bits pharmacy at glance

• In 1950 department of pharmacy was started as a part of Birla

college of science and pharmacy under the guidance of Late
ML Schroff
• 1951 I. Pharm
• 1953 B. Pharm
• 1964 M.PHARM
• 1973 PhD

BITS Pilani, Pilani Campus

Name Year
Dr. Pabrai, PR 1950-1953
Dr. Roy 1953-1954
Dr. Santra, DK 1955-1966
Dr. Mithal BM 1966-1973

Dr. Parimoo, P 1991-1998

Dr. Saha, RN 1998-2002
Dr. R Mahesh 2002-2010
Dr. S Y Charde 2010-2012
Dr. Hemant R Jadhav 2012-2014
Dr. S Murugeshan 2014- 2016
Dr. Anil Gaikwad 2016-2018

BITS Pilani, Pilani Campus

Evolution of Pharmacy
profession
EFFORTS OF M.L SCHROFF SIR
Prof. M. L. Schroff is renowned for the title of pioneer and father of
Indian Pharmacy Education.
1932: Introduced ‘Pharmaceutical Chemistry’ as the principal
Subject in the B.Sc. course
1937: Full fledged B pharm course at BHU
1939: Edited Indian Journal of Pharmacy
1935: Started United Provinces Pharma Association.
1940: Stated M.Pharm at BHU
1945: started periodical "Indian Pharmacist
1946: Elected as president of Bengal Pharmaceutical
Association.
BITS Pilani, Pilani Campus
Evolution of Pharmacy
profession
EFFORTS OF M.L SCHROFF SIR
1949: Joined Birla Laboratories
1950 Birla college
1959: HOD ( Dept of Pharmacy )at University of Saugar
1964: HOD Javadpur University
1965-1971: Indian Journal of Pharmaceutical
Education

BITS Pilani, Pilani Campus

‘Import of Drugs’ bill 1937
Control on import of drugs
Bill barely touches the problems
Criticism raised against the bill

The Drugs Act 1940

To regulate import, mfg, distribution and sale of drugs
Drugs Technical Advisory board (DTAB) under this act
was constituted in 1941.
Biochemical standardization laboratory , Calcutta was
reconstituted as Central Drug Laboratory.

BITS Pilani, Pilani Campus

 The Health Survey and Development Committee, 1943
constituted under the Chairmanship of Sir Joseph Bhore
also re-emphasized the need for the qualified and trained
pharmacists and registration of pharmacists,

 formation of Councils to govern the profession at Centre

and in Provinces,

 strengthening of the provisions of Drugs Act, more drug

control laboratories for strengthening of infrastructure for
drug regulation, etc.

 The govt brought Pharmacy bill in 1945……Pharmacy act

1948. BITS Pilani, Pilani Campus
 The recommendations of Drugs Enquiry Committee and
Health Survey and Development Committee were
responsible for laying the foundation for the Pharmacy
Act, 1948.

 The Pharmacy Council of India was constituted in

1948 and the minimum qualification for registration as
pharmacist was prescribed and process for registration
described….state pharmacy council…1954

BITS Pilani, Pilani Campus

 The Pharmaceutical Enquiry Committee 1953: Major General
S.S. Bhatia: enquiry into the working of pharmaceutical
industry. Committee submitted report in 1954 with 212
recommendations.

 Indian Pharmacopoeia committee: 1948

 First edition of Indian Pharmacopoeia: 1955

 Later: 1966, 1985, 1996, 2007, 2010, 2014, 2018.

BITS Pilani, Pilani Campus

 After independence, it was felt to regulate the advertisements of drugs, which
were in exaggerated form and misleading.

 A number of manufacturers were making exaggerated claims for their

medicines and also exploiting the human weaknesses especially, in relation
with advertisements pertaining to sexually transmitted diseases, menstrual
disorders, stamina, etc. The magic remedies were freely advertised for the
cure of epilepsy , asthma, nervous weakness, diabetes and number of other
diseases.

 It is to control such objectionable trends, "The Drugs & Magic Remedies

(Objectionable Advertisements) Act" was passed by the Parliament in 1954
and enforced.
BITS Pilani, Pilani Campus
 At the time of independence, manufacturing, sale and distribution of
alcohol was controlled by provinces/states. The rates charged by the
provinces/states in the form of excise duties were different for different
regions.

 Price difference of sprit based products

 Restriction of transport of spirituous medicinal products

 Alcohol was also being misused and it was drug of abuse. It is to

regulate the production, sale and distribution of alcohol and to bring
uniformity in the excise duties to be paid, the Medicinal and Toilet
preparations (Excise Duties) Act 1955 was introduced .

BITS Pilani, Pilani Campus

The Drugs Price Control Order, 1970 and thereafter at subsequent

intervals was aimed at fixing the prices for the drugs and their
formulations categorized into essential and non-essential groups so
that uniform retail rates for certain categories of drugs can be
maintained and the drugs prices of life saving drugs can be
controlled.

The Indian Patents Act 1970 which was process patent based
gave an impetus to Indian pharmaceutical industry which resulted
increased indigenous production of drugs and pharmaceuticals.

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Next…..Pharmacy Act

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