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Pharmaceutical Jurisprudence Notes
Pharmaceutical Jurisprudence Notes
SYLLABUS
1. Origin and Nature of pharmaceutical legislation in India
2. Code of Pharmaceutical Ethics
3. The Pharmacy Act 1948
4. The Drug & Cosmetics Act 1940
5. The Drug and Magic Remedies Act 1954
6. Narcotic Drugs & Psychotropic Substances Act 1985
7. Drug Price Control Order
8. Medical Termination Of Pregnancy Act 1971
9. Medicinal & Toilet Preparation Act 1956
classics of Indian medicine are treatises by chakra and sushruta (500 to 600 A.D.)
which are primarily based on contents derived from the Vedic period.
Ayurvedic therapies use medicines of plant and animal origin as well as
those derived from metals, minerals, gems, jewels, etc. the ayurvedic system dealt
elaborately with the methods of preparation of drugs and flourished well till the
coming the unani system. TheUnanitibb system of medicine is based on the
teachings of Hippocrates and Galen and owes its origin to Greece although Arabs
gave it the scientific base. Another ancient Hindu system of traditional medicine
practiced primarily in Tamil Nadu, Sri Lanka and adjoining areas is the siddha
system. This traditional system of medicine is based on “three dosha” theory and
mainly uses minerals andmetals though some products of vegetable and animal
origin are also employed.
Homeopathic system of medicine even through not very old from the
pioneering work of Dr. Hahnemann is based on the principle “similasimli
buscuranter” (Like cures like). This system is widely practiced in India as well as
in Europe, U.S.A. etc.
The traditional systems of medicine suffered a setback with the advent of
the modern or the allopathic system of medicine which came along with the
Britishers. This is a scientific system of medicine where a drug has to be proved
safe and effective in the treatment of particular disease before it can be legally put
into market. However, the fact that despite the widespread use of Allopathy, the
traditional medical practice is still found to be use in India only confirms the deep
roots it has in the country even today.
The early pioneers of the Indian Pharmaceutical Industry were prof. P.C.
Ray of Calcutta and Rajmitra B.D. Amin of Baroda. It was prof. ray who started
the first Indian owned drug Firm, ‘The Bengal Chemicals and Pharmaceutical
Work’s in Calcutta in 1901. Prof. T.K. Gajjar started a small factory at parel,
Bombay in 1903 and Alembric Chemical works was started at Baroda in 1907.
The Beginning of modern drug research in India can be traced to early part of the
twentieth century. In 1920, Sir Sam Nath Chopra organized an active center of
research on Indian Medical plants at the school of tropical medicine, Calcutta.
This was the first coordinated effort to bring the vast knowledge of the traditional
systems of medicine into the mainstream of modern medicine.
Until the early part of 20th century, the number of drugs was limited and
drugs were mostly of vegetable, animal or mineral origin. Drugs were mostly
exported in crude from and imported in finished from. The situation, however,
deteriorated due to World War I when markets were flooded with indigenous and
imported, adulterated, spurious and substandard drugs. The drugs enquiry
committee was set up by the government of India in 1928 which ultimately led to
the passage of the drugs and cosmetics act in 1940 and the development of
pharmacy as a profession in India.
The Drugs and magic remedies (Objectionable Advertisements) Act was
passed in 1954 to control the increase in objectionable advertisements relating to
drug as alleged cures for venereal diseases, sexual stimulant and female diseases
being published in newspapers and magazines or otherwise. These advertisements
tend to cause the ignorant and the unwary to restart to self-medication with
potential for considerable harm to the individual. The bill, in public interest put a
stop to such undesirable advertisements.
The Medicinal and toilet preparations (Excise duties) Act was origin and
nature of pharmaceutical legislation in India.
Introduced in 1955 and contained detailed provisions for medicinal and toilet
preparations containing alcohol.
The narcotic drugs and psychotropic substances act, 1985 is a timely
legislation which provides for exemplary punishment for trafficking such
substances.
Q. 2. Briefly discuss the reasons for setting up of the Chopra committee, its
recommendations and actions taken by the government upon its
recommendations.
Ans: In the early part of the 20th century, there was practically no legislative
control on drugs as well as on the profession of pharmacy. Although the Opium
Act. 1878, the Poisons Act.1919 and the Dangerous Drugs Act.1930 were in
force, these were specific in nature and grossly inadequate in controlling the
chaotic conditions prevailing at that time. There were wide spread cases of
adulterated, spurious and substandard drugs being manufactured and imported into
the country. In 1927, a resolution was passed by the council of states to
recommend to the Governor-General in council to urge all provisional
governments to take immediate steps to control indiscriminate use of drugs and to
legislate for the standardization of the preparation and sale of drugs. The
government of India in pursuance to the resolution appointed a committee with
Col. R. N. Chopra as its Chairman in 1928 to:
i. Enquire the extent to which drugs of impure quality or defective strength
were being imported, manufactured or sold in India, and
ii. Recommend steps for controlling such import, manufacture and sale in
public interest.
iii. Enquire into the necessity of legislation to restrict the profession of
pharmacy to qualified persons and to make recommendations.
Recommendations of the Chopra Committee:
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The Pharmacy Act, 1948
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Q. 1. What are the aims and objectives of the pharmacy Act 1948?
Ans: The pharmacy Act 1948 was passed with the primary objective of regulating
and using the status of the profession of pharmacy in India. This was sought to
be achieved by:
i. Providing uniform education and training to the person willing to enter the
profession of pharmacy (objective achieved through pharmacy council of India).
ii.Maintaining control over persons entering the profession of Pharmacy by providing for
their registration in every state and union territory (objective achieved through state
Pharmacy council and joint Pharmacy council).
C. Ex-officio members:
i. The director general of health services.
ii. The director of central drugs laboratory.
iii. The drugs controller of India.
The president and vice-president of the pharmacy council are elected by its members
from amongst themselves. They have a term of office of five years. Any member
absenting without sufficient excuse is deemed to have vacated from the council. A casual
vacancy in the PCI is usually filled by fresh nomination or election and the person so
nominated or elected holds the office only for the remaining term. All members of the
council are eligible for re-election or re-nomination.
The council appoints:
i. A registrar who acts as its secretary and if necessary its treasurer as well
ii. Other officers and servants for carrying out its statutory functions.
iii. The executive committee of the PCI consisting of the president (Chairman of the
committee) and the vice-president and five other members elected by the central council
from amongst its members.
Functions of pharmacy council of India:- The pharmacy council of India has been
entrusted with the following functions:
i. To prescribe the minimum standards of education required for qualification as a
pharmacist.
ii. To regulate the minimum educational standards by inspecting the institutions.
iii. To recognize qualification granted outside the territory to which the pharmacy act, 1948
extends, for the purpose of qualifying for registration.
iv. To compile and maintain a central register for pharmacists containing names of all
registered persons.
v. Any other function required for the furtherance of objectives of pharmacy act, 1948
Ans: Education regulations (ER): The pharmacy council of India has laid down certain
minimum standards of education required for qualification as a pharmacist. These standards are
known as the education regulations and prescribe:
i. Minimum educational qualification required for admission to the course of pharmacy.
ii. Duration of course of study and training.
iii. Nature and period of practical training to be undertaken for after the completion of regular
course.
iv. Subjects of examination and the standards to be attained therein for qualification.
v. Minimum facilities required to be provided by an institution for the conduct of course
examination and practical training.
vi. Conditions to be fulfilled by the authorities holding approved examinations.
Practical training should be for a minimum of 500 hours spread over a period of not less
than three months out of which not less than 250 hours must be devoted to actual
dispensing of prescription
Ans: The pharmacy Act1948 provides for the constitution of a state pharmacy council in
each state. Two or more states can also enter into an agreement to form a joint state pharmacy
council or otherwise the state pharmacy council of one state may serve the needs of the other
participating states. The state pharmacy council and the joint state pharmacy council has the
following constitution:
i. The state pharmacy councils and joint state pharmacy councils with permission
from the respective state government may appoint sufficient number of
inspectors having prescribed qualification to:
a. Inspect any premises where drugs are compounded or dispensed.
b. Inquire regarding the registration of the person engaged in compounding and
dispensing.
c. Investigate any complaint made in writing regarding contravention of the act.
d. Institute prosecution under the direction of the executive committee of the state.
e. Exercise such other powers as may be deemed necessary in order to give effect to
certain provisions of the act.
Q. 5. What qualifications would entitle a person to register his name in the first and
subsequent register? How and under what circumstances can the name of a registered
pharmacist be removed from the register?
Ans: Qualification for entry into the first register: A person desirous of having his name
registered in the first register:
i. Should have attained the age of 18years.
ii. Should pay the prescribed fee.
iii. Should be a resident of the state or should carry out his business or profession of
pharmacy in the state.
iv. Should have the following qualifications:
a) A degree or diploma in pharmacy or pharmaceutical chemistry or a chemist and druggist
diploma of an Indian university or a state government or possess any other qualification
granted outside India which is recognized as adequate for registration, or.
b) A degree of an Indian university other a degree or diploma in pharmacy or pharmaceutical
chemistry along with an experience of not less than three years in dispensing and
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compounding of drugs in a hospital or dispensary or any other place where drugs are
regularly dispensed on the prescription of a registered medical practitioner, or
c) Should have passed an examination recognized by the state government as adequate for
compounders and dispensers, or
d) Should have an experience of not less than five years in dispensing and compounding of
drugs in a hospital or dispensary or any other place where drugs are regularly dispensed on
the prescription of a registered medical practitioner, prior to the date notified by the state
government for receipt of applications for entry of names on the first register.
Qualification for entry into the subsequent registers before education regulations
have taken effect:
After the preparation of the register and before the education regulations have taken
effect in a state, a person desirous of having his name registered in the register:
i. Should be at least 18 years of age.
ii. Should have paid the prescribed fee.
iii. Should be a resident of the state or should carry out his business or profession of pharmacy
in the state.
iv. should fulfill the following requirements:
a) requirements as prescribed for registration and where no such requirements have been
prescribed, possess the qualifications which would have entitled him to have his name
registered on the first register and is at least matriculate, or
b) is a registered pharmacist in another state, or
c) Possess a qualification granted outside India which is recognized as adequate for
registration and is at least matriculate.
Qualification for entry into the subsequent registers after education regulations
have taken effect:
After the education regulations have become effective in a state, a person is entitled for
registration if he:
i. Has attained at least 18 years of age.
ii. Is a resident of the state or is carrying out his business or profession of pharmacy in the
state.
iii. Fulfill the following requirements:
a) Has passed an approved examination, or
b) Possess a qualification granted outside India which is recognized as adequate for
registration, or
c) Is a registered pharmacist in another state?
Removal of names from the register: The name of a registered pharmacist may be removed
from the register on the following grounds:
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i. If his name has been entered into the register by error, misrepresentation or suppression of
facts.
ii. If he has been convicted of an offence in any professional respect which in the opinion of
executive committee renders him unfit to be on the register of pharmacists.
iii. If a person employed under him in connection with any business of pharmacy. Has been
convicted of any offence or has been found guilty of any infamous conduct, such that if he
himself was a register. However, under this section, action against the pharmacist can only
be taken if it is proved that:
a) The offence or infamous conduct was instigated or connived at by the registered
pharmacist, or
b) The registered pharmacist himself has been guilty of such an offence during the period of
12 months preceding the offence.
c) Any person employed by the pharmacist for purpose of business of pharmacy has been
guilty of similar offence during the preceding 12 months and the registered pharmacist had,
or reasonably ought to have had, knowledge of such previous offence.
d) The offence or infamous conduct had continued over a long period of time and the
pharmacist had or reasonably ought to have had the knowledge of the continuing offence.
e) The act is an offence under the drugs and cosmetics act, 1940 and the pharmacist had not
used his intelligence to ensure that the provisions of the act were being complied to at his
place of business and by persons employed by him or by persons under his control.
4
The Drugs and Cosmetics Act and Rules 1945
Q.1.What was the objectives of D&C Act?
Ans: The drugs and cosmetics bill was passed by the central legislative assembly and it
received the assent of the Governor General on 10th April, 1940 and thus became the Drugs and
Cosmetic Act 1940. This act seeks to:
i. Regulate import of drugs and cosmetics into the country in order to prevent entry of
substandard or harmful drugs and cosmetics.
ii. Exercise control over the manufacture of drugs and cosmetics in the country so that no
substandard or spurious drugs or cosmetics are produced.
iii. Provide for the regulation of sale and distribution of drugs and cosmetics whereby only
qualified and trained persons can undertake their handing, compounding and distribution.
iv. Regulate the manufacture and sale of ayurvedic, siddha and unani drugs, wherever
applicable.
The act also provides for the constitution of two “boards” namely the Drugs technical
advisory board and the Ayurvedic and unani drugs technical advisory board to advise the central
and state governments on technical matters arising out of the administration of this Act and to
carry out the other functions assigned to it by this Act.
Q. 2. Define the following terms according to the Drugs and Cosmetics Act 1940:
a) Drug
b) Cosmetic
c) Patent or proprietary medicine
Cosmetic means any article intended to be rubbed, poured, sprinkled or sprayed on, or
introduced into, or otherwise applied to, the human body or any part thereof for cleaning,
beautifying, promoting attractiveness, or altering the appearance and includes any article
intended for use as a component of cosmetic.
Q. 3. Define the terms ‘misbranded’, ‘Adulterated’ and spurious drugs according to the
Drugs and Cosmetics Act.
Ans: Misbranded drug: A drug is termed as misbranded:
i. If it is so coloured, coated, powered or polished that damage is concealed or if it is made
to appear of better or greater therapeutic value than it really is.
ii. If it is not labeled in the prescribed manner.
iii. If its label or container or anything accompanying the drug bears any statement, design
or device which makes any false claim for the drug or which makes any false claim for
the drug or which is false or misleading in any particular.
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Q. 4. Describe briely the contents of the various schedules to the Drugs and Cosmetics
Act and Rules.
Ans: Schedules to the drugs and cosmetics Act 1940: There are two schedules to the act
which give the following information:
First schedule : Names of books under ayurvedic and siddha systems.
Second schedule: Standards to be complied with by imported drugs and by drugs manufactured
for sale, sold, stocked or exhibited for sale or distribution.
Schedules to the rules:
The schedules to the rules provide the following:
Schedule A : Specimens of the prescribed forms for making application for licences,
issue and renewal of licenses, for sending memorandum, etc.
Schedule B : Rates of fees for test or analysis by the central drugs laboratory or the
government analyst.
Schedule C&CI : List of biological and other special products whose import, manufacture,
sale and distribution are governed by special provisions.
Schedule D : List of drugs that are exempted from certain provisions that are applicable
to the import of drugs.
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Schedule E (1) : List of poisonous substances under the ayurvedic, siddha and unani
systems of medicine.
Schedule F & FI : Special provisions applicable to the production, testing, storage, packing
and labeling of biological and other special products.
Schedule FII : Details of the standards for surgical dressings.
Schedule FIII : Details of the standards for sterilized umbical tapes
Schedule FF : Details of the standards for ophthalmic preparations.
Schedule G : List of substances that are required to be used only under medical
Supervision and which are required to be labeled accordingly.
Schedule H : List of substances that should be sold by retail only on the prescription
a registered medical practitioner.
Schedule J : List of diseases or ailments which a drug may not purport to prevent or
cure.
Schedule K : List of drugs that are exempted from certain provisions relating to the
facture of drugs.
Schedule M : Good manufacturing practices and requirements of factory premises, plants
requirements.
Schedule MI : Requirements of factory premises for the manufacture of cosmetics.
Schedule MII : Requirements of factory premises for the manufacture of cosmetics.
Schedule MIII : Requirements of factory premises for the manufacture of medical devices.
Schedule N : List of minimum equipment which a pharmacy should possess.
Schedule O : Provisions applicable to black disinfectant fluids.
Schedule P : Life periods of drugs.
Schedule Q : List of coal tar colours permitted to be used in cosmetics.
Schedule R : Standards for mechanical contraceptives.
Schedule S : Standards for cosmetics.
Schedule T : Requirements of factory premises and hygienic conditions for ayurvedic
(including siddha) and unani drugs.
Schedule U : Particulars to be shown in manufacturing, raw materials and analytical
records of drugs.
Schedule UI : Particulars to be shown in manufacturing, raw materials and analytical
: records of cosmetics.
Schedule V : Standards for patent and proprietary medicines.
Schedule W : List of drugs which can be marked under generic names only.
Schedule X : List of drugs whose import, manufacture and sale, labeling and packing are
governed by special provisions.
Schedule Y : Requirements and guidelines on clinical trials for import and manufacture
of new drugs.
Q. 5. Describe the conditions required to be fulfilled for the grant of licence for
the retail sale of drugs.
Ans: Two types of licenses are granted for the retail sale of drugs:
i. General licences
ii. Restricted licenses.
General licences: - General licences are granted to persons who have premises for the
business and who engage the services of a “Qualified person” to supervise the sale of drugs and
do the compounding and dispensing.
Conditions for the grant of general licences:
Separate licencesis required to be taken far the retail sale of schedule C and CI drugs,
schedule X drugs and drugs other than those listed in schedule C, CI and X. the following
conditions should be fulfilled for the grant of the licences:
a) Premises should be adequate (not less than 10 square meters) and equipped with facilities
for proper storage of drugs.
b) A competent qualified person should be incharge of sale and distribution.
c) Licence shall be displayed in a prominent place and will be produced on demend by
a drug inspector.
d) No drug shall be sold unless such drug is purchased under cash/or credit memo from
a duly licensed dealer.
e) No physician’s sample (not for sale) or expired drugs will be stocked on the sale
premises.
f) Drugs will be sold in accordance with the provisions of the drugs and cosmetics act.
g) The licence will be renewed as and when required.
h) Any change in ownership or “Qualified person” shall be notified to the licensing
authority within three months.
i) Drugs would be sold on a cash memo in which following details be recorded:
i. Serial number.
ii. Date of supply.
iii. Name and address of patient.
iv. Name and address of doctor.
v. Quantity and name of the drug, batch number, expiry, expiry date and price.
vi. Signature of the “Qualified person”.
j) No drug belonging to ESI, CGHS, armed forces medical store or a government hospital
shall be present in the licensed premises.
k) In case of a pharmacy, the compounding of the prescription would be done under the
personal supervision of a qualified person.
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All registers and records required to be maintained under the date act would be preserved
for a period of at least 2years form the date of the last entry therein.
Restricted licence:
Restricted licence is granted to:
a) Dealers or persons who deal in sale of drugs which do not require thye services of a
qualified person and hence do not engage a registered pharmacist.
b) Vendors of drugs who do not have their own premises to sell drugs but distribute them in a
specified area personally.
c) Travelling agents of a firm for the special purpose of distribution to medical practitioners
or dealers, for supply of biological and other special products specified in schedule C.
Q.6. What do you understand by the term pharmacy? Describe in brief the conditions to
be fulfilled to obtain a licence to start a dispensing pharmacy.
Ans: The term pharmacy means and includes every store or shop or other place:
i) Where drugs are dispensed.
ii) Where drugs are prepared.
iii) Where prescriptions are compounded.
iv) Which by sign, symbol or indication gives the impression that the operations mentioned
above are carried out in the premises.
v) Which has upon it or displayed within it or affixed to or used in connection with it a sign
bearing the works(s) “pharmacy”, “pharmacist”, and dispensing chemist ’or‘
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pharmaceutical chemist.
vi) Which is advertised in these terms
Before granting a licence for a pharmacy, the licensing authority may consider:
The average number of licences during the period of 3 years immediately proceeding.
The occupation, trade or business ordinarily carried out by such applicant during the
proceeding 3 years.
Schedule N Specifies the list of minimum requirements for running a pharmacy.
These include the following:
1. Entrance: The front of a pharmacy shall bear an inscription pharmacy.
2. Premises: The premises of pharmacy shall be separated from rooms for private use. The
premises shall be well built, dry, well-lit and ventilated and, of sufficient dimensions so
that all goods especially medicaments and poisons can be kept in a clearly visible and
appropriate manner. The area of dispensing department shall be not less than 6 sq. meters
for each additional pharmacist. The height of the premises shall be at least 2.5 meters.
The floor of the pharmacy shall be smooth and washable. The walls shall be plastered or
tiled or oil painted. A pharmacy department shall also be provided with sample quantity of good
quality water. The dispensing department should be separated by a barrier to prevent the
admission of the public.
3. Furniture: Drugs, chemicals and medicaments shall be kept in a room appropriate ton
their properties and in such special containers as will prevent any deterioration of the
contents. Drawers, glasses and other containers used for keeping medicaments shall be of
suitable size and capable of being closed tightly to prevent the entry of dust.Every
container shall bear a label an appropriate size, easily readable with names of medicaments
as given in the pharmacopoeias.
A pharmacy shall be provided with a dispensing bench, the top of which shall be covered
with washable and impervious material like stainless steel, laminated plastic, etc.
A pharmacy shall be provided with a cupboard with lock and key for the storage of poisons
and shall be clearly marked with the word poison in red letters on a white background.
4. Apparatus: A pharmacy shall be provided with the following minimum apparatus and books
necessary for making of official preparations and prescriptions:
Balance, dispensing, sensitivity 30 mg.
Balance, counter, capacity 3 kg, sensitivity 1 g.
Beakers, lipped, assorted sizes.
Bottles, prescriptions, un-graduated, assorted sizes.
Corks, assorted sizes and tapers.
Cork extractor.
Evaporating dishes, porcelain.
Filter paper.
Funnels, glass.
Litmus paper.
Litmus paper, blue and red.
Measure glasses, cylindrical, 10, 25, 100 and 500ml.
Mortars and pestles, glass.
Mortars and pestles, Wedgewood.
Ointment pots with Bakelite or suitable caps.
Ointment slab, proclein.
Pipettes, graduated, 2, 5 and 10 ml.
Ring, stand (retort) iron, complete with rings.
Rubber stamps and pad.
Scissors.
Spatulas, rubber or vulcanite.
Spatulas, stainless steel.
Sprit lamp.
Glass stirring rods.
Thermometer, 0o to 200o C.
Tripod stand.
Watch bath.
Water distillation still (if eye drops and lotions prepared) weights, metric 1 mg to 100mg.
Wire gauge.
Pill finisher boxwood
Pill machine
Pill boxes*
Suppository mould*
5. Books:
Indian pharmacopoeia (current edition).
National formulary of India (Current edition).
The drugs and cosmetics rules, 1945.
The pharmacy Act, 1948.
The drugs and cosmetics rules, 1945.
The pharmacy Act, 1948.
The narcotic drugs and psychotropic substances Act, 1985.
6. General: A pharmacy shall be conducted under the continuous personal supervision of a
registered pharmacist whose name shall be displayed conspicuously in the premises. The
pharmacist shall always put on clean white overalls. The premises and fittings of the pharmacy
shall be property kept and everything shall be in good order and clean. All records and registers
shall be maintained as required by the laws in force. Any container taken from the poison
cupboard shall be replaced therein immediately after use in the personal custody of the
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responsible person. Medicaments when supplied shall have the labels conforming to the
provisions of the laws in force.
Q.7. Give the qualification and powers of a drug inspector.
Ans: Qualification of drug inspector:
For appointment as the drugs inspector a person must possess the following qualifications.
i) A degree in pharmacy/pharmaceutical chemistry or a post graduate degree in chemistry
with pharmaceutics as a special subject of a recognized university or the associate ship
diploma of the institution of chemists (India) obtained by passing the examination with
analysis of drugs and pharmaceutical as one of the subjects.
ii) Pharmaceutical chemists diploma granted by the pharmaceutical society of Great Britain.
iii) A graduate in medicine/science of a recognized university having at least one year’s
graduate training in a laboratory under:
iv) A chemical examiner
v) Head of an institution specially approved by the appointing authority in this behalf.
Powers of drugs inspector: the drug inspector has been empowered to carry out the following
functions:
i) Inspection of premises where any drug or cosmetic is being manufactured and the means
employed for standardising and testing the drugs or cosmetics.
ii) Inspection of premises where any drug or cosmetic is being sold, or stocked or exhibited
or offered for sale or distributed.
iii) Taking samples of any or is stocked or exhibited or offered for sale or is being
distributed.
iv) Taking samples of drug or cosmetic from any person conveying delivering or preparing
to deliver such drug or cosmetic to a purchaser or a consignee.
v) At all reasonable times, with necessary assistance:
a) Search any person who has secreted about his person, any drug or cosmetic in respect of
which an offence relating to manufacture, sale or distribution has been or is being
committed.
b) Enter any place in which an offence relating to manufacture, sale or distribution of drugs
or cosmetics has been or is being committed.
c) Stop and search any vehicle, vessel or other conveyance being used for carrying and drug
or cosmetic in respect of which an offence has been or is being committed and order in
writing the person in possession of such drug or cosmetic not to dispose off any stock
thereof for a period not exceeding twenty days, or unless the alleged offence is such that
the defect may be removed by the possessor of the drug or cosmetic, seize the stock of
such drug or cosmetic and any substance or article by means of which the offence has been
or is being committed or which may be employed for the commission of such offence.
d) Examine any record, register, document or any other material object with any person or
in any place mentioned above and seize the same if it is likely to furnish the evidence of
an offence.
e) Require any person to produce any record, register or other document relating to
manufacture, sale or distribution of any drug or cosmetic in respect of which an offence
has been or is being committed.
f) Exercise such other powers as may be necessary for carrying out the purpose of the act or
the rules.
5
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Q. 1. How are the following defined according to the drugs and magic
remedies(objectionable advertisements) Act:
a) Advertisements
b) Drugs
c) Magic remedies
Ans: According to the drugs and magic remedies Act,
Advertisements include all notices, circulars, labels, wrappers or other documents and all
announcements made orally or by means of producing or transmitting light, sound or smoke.
Drugs include:
i) Medicines for the internal or external use of human beings or animals.
ii) Any substance intended to be used for or in the diagnosis, cure, mitigation, treatment or
prevention of disease in human beings or animals.
iii) Any article, other than food, intended to affect the body of human beings.
iv) Any article, intended for use as a component of any medicine, substance or article
referred to above.
Magic remedies: Include talismans, mantras, kavachas and any other charm of any kind which
is alleged to possess miraculous powers for or in the diagnosis, cure, mitigation, treatment or
prevention of any disease in human beings or animals or for affecting in any way the structure
or any organic function of the body of human beings or animals.
Q. 3. What types and classes of advertisements are exempted under the drugs and magic
remedies (objectionable advertisements) Act?
Ans: Exempted advertisements:
The following classes of advertisements and displays are exempted from the purview of
the act and hence can be made without any prohibition:
i) Sign boards or notices displayed by registered medical practitioner (RMP) indicating that
treatment is undertaken for the disease or disorder, advertisements relating to which are
otherwise prohibited.
ii) Books or treaties relating to the diseases or ailments which are otherwise prohibited to be
advertised provided published from bonafide scientific or social standing.
iii) Advertisements sent confidentially, in the prescribed manner, to RMP’s. However, such
advertisements should bear the following words on top, in a conspicuous manner: for the
use of RMP or a hospital or a laboratory.
iv) Any advertisement relating to a drug printed or published by the government or by any
person with the prior permission of the government.
v) Advertisements, labels or set of instructions which are permitted under the drugs and
cosmetics act or rules made thereunder.
The central government may also permit the advertisements of any drug which it feels
shall be in the interest of the public.
Advertisements exempted conditionally:
The following classes of advertisements have also been exempted conditionally:
Class of advertisement:
i) Leaflets or literature accompanying packing of drugs.
ii) Advertisements of drugs in medical, pharmaceutical, scientific and technical journals.
Conditions:
i) The advertisement contains only such information as is required for the guidance of
registered medical practitioner in respect of matters relating to:
a) Therapeutic indications of the drug.
b) Its administration.
c) Its dosage.
d) Its side effects.
e) The precautions to be observed in the treatment with the drug.
ii) The responsibility to prove that any claim made in the advertisement in respect of the
drug is not false, exaggerated or misleading, shall lie on the advertiser.
Q. 7. What are the offences and penalties for contravention of any provision of the Act?
Ans: Contravention of any provision of the Act is punishable with imprisonment up to six
months or fine or both on first conviction, and imprisonment up to one year or fine or both on any
subsequent conviction. Any document, article or thing in respect of which the contravention is
made can also be forfeited.
In case of contravention of the provisions of the Act by a company, every person who, at
the time of the commission of the offence, was incharge of the company and was responsible for
the conduct of its business, shall be deemed guilty of the offence, unless the can prove that the
offence was committed without his knowledge and that he had exercised due diligence to prevent
the commission of the offence.
Offences under the Act can be tried only in the courts in the courts of the presidency
magistrates or magistrates of the first class.
6
The narcotic drugs and psychotropic substances Act, 1985
Q. 2. Patel
Describe briefly
College the operations
of Pharmacy, which
Ramanagaram are32totally prohibited under the narcotic drugs
Page
[Pharmaceutical Jurisprudence] 2013-2014