MAHARASHTRA STATE BOARD OF TECHNICAL EDUCATION

(Autonomous)
(ISO/IEC - 27001 - 2005 Certified)
MODEL ANSWER
WINTER– 19 EXAMINATION
Subject Title: Pharmaceutical Jurisprudence Subject Code: 0814
__________________________________________________________________________________________________

Important Instructions to examiners:

1) The answers should be examined by key words and not as word-to-word as given in the model answer
scheme.
2) The model answer and the answer written by candidate may vary but the examiner may try to assess the
understanding level of the candidate.
3) The language errors such as grammatical, spelling errors should not be given more Importance (Not
applicable for subject English and Communication Skills.
4) While assessing figures, examiner may give credit for principal components indicated in the figure. The
figures drawn by candidate and model answer may vary. The examiner may give credit for anyequivalent
figure drawn.
5) Credits may be given step wise for numerical problems. In some cases, the assumed constant values may
vary and there may be some difference in the candidate’s answers and model answer.
6) In case of some questions credit may be given by judgement on part of examiner of relevant answer based
on candidate’s understanding.
7) For programming language papers, credit may be given to any other program based on equivalent concept.

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 MAHARASHTRA STATE BOARD OF TECHNICAL EDUCATION
(Autonomous)
(ISO/IEC - 27001 - 2005 Certified)
MODEL ANSWER
WINTER– 19 EXAMINATION
Subject Title: Pharmaceutical Jurisprudence Subject Code: 0814
__________________________________________________________________________________________________

Q. Sub Answer Marking

No Q. N. Scheme
1 Answer any Eight of the followings: 16M

1 a) Define ‘Adulterated Drug’. 2M

A drug shall deemed to be adulterated ( Any 2)
i)If it consists, in whole or in part, of any filthy, putrid or decomposed substance, or,
ii) If it has been prepared, packed or stored under insanitary conditions whereby it may
have been contaminated with filth or whereby it may have been rendered injurious to
health, or,
iii)If its container is composed in whole or in part, of any poisonous or deleterious
substance which may render the contents injurious to health; or
iv) If it bears or contains, a colour other than prescribed which may be used for the
purpose of colouring only; or
v) If it contains any harmful or toxic substance which may render it injurious to health; or
vi) If any substance mixed with it so as to render its quality or strength.
1 b) Define law. What are the objectives of Pharmaceutical Legislation?
Law- Rules of human conduct binding on all persons in a state or nation. 1M Def.

Objectives- 1M
1) To promote health care by regulating the manufacture, supply & distribution of good Object.
quality drugs. (Any 2)
2) To make these drugs available to the public at reasonable prices & through qualified
person.
3) To safeguard the people from misleading & false advertisements relating to drugs &
remedies
4) To regulate the profession of pharmacy.
5) To promote the Indigenous research technology.

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 MAHARASHTRA STATE BOARD OF TECHNICAL EDUCATION
(Autonomous)
(ISO/IEC - 27001 - 2005 Certified)
MODEL ANSWER
WINTER– 19 EXAMINATION
Subject Title: Pharmaceutical Jurisprudence Subject Code: 0814
__________________________________________________________________________________________________

1 c) Define drug store and chemists as per D and C Act 1940. 1M Each

Drug Store:
Licensed premises for the sale of drugs, which do not require the services of a qualified
Person.
Chemist and Druggist
Licensed premises for the sale of drugs which require the services of a “Qualified Person”
but where the drugs are not compounded against the prescriptions.
1 d) Write the functions of Narcotic commissioner of state. 2M
Functions:-
i) Supervision of cultivation of opium poppy
ii) Supervision of production of opium
iii) Any other functions as may be performed to him by Government.

1 e) Define Poison. Write objective of Poison Act 1919. 1M Def.

Definition:- Any substance specified as a poison in a rule made or notification issued
Under the Poison Act,1919 shall be deemed to be a poison for the purpose of this Act.
Objective:- 1M
i) To regulate & control import, possession & sale of poisons. Object
ii) According to the provision of Poison Act,1919 Central Govt. has been authorized to
regulate the import of poisons in India. & State Govt. has been authorized to make rules
to regulate possession & sale of poison within their respective areas.
1 f) What are education regulations? 2M
Subject to the provision of section 10 of Pharmacy Act, 1948, Central Council after
approval of Central Government may make regulations prescribing the minimum standard
of education required for qualification as a pharmacist is called Education Regulations
Education Regulations may prescribe –
i) Minimum qualification for admission to the course.
ii) Nature & period of course of study.
iii) Nature and period of practical training to be undertaken after the completion of

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 MAHARASHTRA STATE BOARD OF TECHNICAL EDUCATION
(Autonomous)
(ISO/IEC - 27001 - 2005 Certified)
MODEL ANSWER
WINTER– 19 EXAMINATION
Subject Title: Pharmaceutical Jurisprudence Subject Code: 0814
__________________________________________________________________________________________________

regular course. (Not less than 500 hrs. covered in a minimum of 3 months in an
Institution, Hospital, Pharmacy or Dispensary recognized by Central Govt.)
iv) The subjects of examination and the standards to be attained therein.
v) The equipment and facilities to be provided by the institutions for the students
undergoing approved course of study.
vi) Conditions to be fulfilled by institutions giving practical training.
vii) Conditions to be fulfilled by authorities holding approved examinations.
1 g) Mention different sale licence required for retail and wholesale of schedule C and C1
drugs.
Retail sale: 1M Each
(i)For drugs those specified in schedule C and C1: Form-21
Wholesale sale:
(i)For drugs specified in schedule C and C1: Form -21B
1 h) Define ‘Dutiable goods’, under medicinal and toilet preparations Act, 1955. 2M
Definition of Dutiable goods:
It includes the medicinal and toilet preparations specified in the schedule as being subject
to the duties of excise levied under this Act.
1 i) Enlist the objectives of drug and magic remedy Act ,1954(any two) 2M,
The Drugs and Magic Remedies Act passed with following main object: Any2
i) To control certain types of advertisement related to drugs.
ii) To prohibit certain kinds of advertisements relating to magic remedies; which falsely
claim and mislead the public, and
iii) To provide for matters related therewith.
1 j) Define under pharmacy Act 1948 ‘Registered Pharmacist’. 2M
Registered Pharmacist: means a person whose name for the time being is entered in the
register of the pharmacists of the state in which he is for the time being residing or
carrying on his profession or business of pharmacy.

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 MAHARASHTRA STATE BOARD OF TECHNICAL EDUCATION
(Autonomous)
(ISO/IEC - 27001 - 2005 Certified)
MODEL ANSWER
WINTER– 19 EXAMINATION
Subject Title: Pharmaceutical Jurisprudence Subject Code: 0814
__________________________________________________________________________________________________

1 k) Give the objectives of drugs and price control order 1995. 2M

Objectives of DPCO 1995:
i) To achieve adequate production.
ii) To secure or regulate the equitable distribution.
iii) To maintain and increase the supplies of bulk drugs and formulations and
iv) To make these available at fair prices.
1 l) Mention ex-officio members of P.C.I. 2M
Ex-officio members of PCI:
i)The Director General of Health Services.
ii)The Drugs Controller of India.
iii)The Director of the Central Drugs Laboratory.
2 Attempt any FOUR of the followings 12M
2 a) What are “Loan licenses” and “Restricted licenses” under D and C Act, 1940?
(i) Loan licence: 1½M
It means a licence which a licensing authority may issue to an applicant who does not Each
have his own arrangements for manufacture but who intends to avail himself of the
manufacturing facilities owned by another licensee/ manufacturer.
(i)Application for the grant or renewal of loan licences to manufacture for sale or for
distribution of drugs other than those specified in Schedule C, Schedule C (1) & Sch. X
shall be made up to ten items for each category of drugs shall be made in Form 24-A
accompanied by a licence fee of rupees 6000/- & an inspection fee of rupees 1500/- to the
licensing authority.
(ii)The Licensing Authority shall, before the grant of a loan licence, satisfy himself that
the manufacturing unit has adequate equipment, staff, capacity for manufacture, &
facilities for testing, to undertake the manufacture on the behalf of the applicant for a loan
licence
(iii)Application for manufacture of more than ten items for each category of drug on a
loan licence shall be accompanied by an addition fee of rupees 300/- per additional item
specified in Schedule M.& M-III
(iv)If the Licensing Authority is satisfied that a loan licence is defaced, damaged or lost

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 MAHARASHTRA STATE BOARD OF TECHNICAL EDUCATION
(Autonomous)
(ISO/IEC - 27001 - 2005 Certified)
MODEL ANSWER
WINTER– 19 EXAMINATION
Subject Title: Pharmaceutical Jurisprudence Subject Code: 0814
__________________________________________________________________________________________________

or otherwise rendered useless he may, on payment of a 1000/- Rs issue a duplicate

licence.
(v)An original licence or a renewed licence in Form 25 valid for a period of five years on
which it is granted or renewed.

(ii)Restricted licences :
(i)Restricted licences shall be issued subject to the discretion of the Licensing Authority,
to dealers or persons in respect of drugs whose sale does not require the supervision of a
qualified person.
(ii)Licences to itinerant vendors shall be issued only in exceptional circumstances for
bonafide traveling agents of firms dealing in drugs or for a vendor who purchases drugs
from a licensed dealer for distribution in rural areas where other channels of distribution
of drugs are not available.
(iii)For restricted licence, applicant has to make an application in Form-19A and the
licence issued for drugs other than those specified in schedule C,C(1),and X in Form 20A
and for drugs specified in schedule C, C(1) in Form 21-A
The restricted licence in Form 21-A may also issued to a travelling agent of a firm for
drugs specified in Schedule C.
(iv)Such licence is not needed for venders for the specific purpose of distribution to
medical practioner or dealers.
(v)Such licence in not needed to traveling agents of licensed manufacturers, agents of
such manufacturers and importers of drugs engaged in free distribution of samples of
medicine among members of the medical profession, hospitals, dispensaries and the
medical or research institutions

2 b) State the particulars required to be mentioned on label of ophthalmic preparations

under D and C Act, 1940.
Ophthalmic Solutions and Suspensions – 2M
The following additional particulars shall be shown on the label of container
i)The statement ‘Use the solution within one month after opening the container’.

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 MAHARASHTRA STATE BOARD OF TECHNICAL EDUCATION
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MODEL ANSWER
WINTER– 19 EXAMINATION
Subject Title: Pharmaceutical Jurisprudence Subject Code: 0814
__________________________________________________________________________________________________

ii) Name and concentration of the preservative used.

iii) The words ‘NOT FOR INJECTION’.
iv) Special instructions regarding storage, wherever applicable.
v) A cautionary legend reading as:
WARNING
i)If irritation persists or increases, discontinue the use & consult physician.
ii) Do not touch the dropper tip or other dispensing tip to any surface since this may
Contaminate solutions”.
Ophthalmic Ointments 1M
i) Special instructions regarding storage wherever applicable.
ii) A cautionary legend reading
Warning - If irritation persists or increases discontinue the use and consult physicians.
2 c) Give the classes of advertisements which are prohibited under drug and magic 3M
remedies Act,1954.
Classes of prohibited advertisements under Drugs & Magic Remedies Act and Rules:
1) Advertisement of drugs which may lead to its/ their use for the treatment of
certain diseases and disorders:
i) For procurement of miscarriage or prevention of conception in women; or
ii) For the correction of menstrual disorders in women; or
iii) For the maintenance or improvement of the power of human beings for sexual
pleasure or
iv) For diagnosis, cure, alleviation, treatment or prevention of any disease or disorder or
condition specified in the schedule or in rules made under the act.

2) Advertisement of Magic Remedies for treatment of certain diseases or disorders

which may claim to be efficacious for any of the purposes specified in I as above.

3) Misleading advertisements in relation to drugs, which:

i) Directly or indirectly gives false impression regarding true character of drug or drugs;
or

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 MAHARASHTRA STATE BOARD OF TECHNICAL EDUCATION
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MODEL ANSWER
WINTER– 19 EXAMINATION
Subject Title: Pharmaceutical Jurisprudence Subject Code: 0814
__________________________________________________________________________________________________

ii) Make any false claims for such drug or drugs

iii) Is otherwise false or misleading in any material particularly.
iv) Ayurvedic remedies to cure liver disorders & memory enhancement.

4) Prohibition of advertisements of Magic Remedies for the treatment of certain

diseases.
Publication of any advertisement related to any Magic Remedy which directly or
indirectly claim to be effective for any of the purposes is prohibited.

2 d) What are the requirements of bonded manufactory or laboratory? 3M

Requirements of bonded manufactory
1)A Spirit store, (if a distillery or a rectified spirit warehouse from which rectified spirit
is made available, is not attached with the laboratory).
2) Separate room/ rooms for the manufacture of medicinal preparations and toilet
preparations.
3) Separate room/ rooms for storage of the finished medicinal preparations and finished
toilet preparations.
4) Accommodation near the entrance for the officer-in-charge with necessary furniture.
5) The pipes of sink or wash-basins should be connected with general drainage of the
laboratory.
6) The gas and electric connection supply should be such that their supply can be cut-off
at the end of day's work.
7) Every room should bear a board indicating the name of room and serial numbers.
8) Every window would be provided with specific arrangements of malleable iron rods of
prescribed dimensions and window should be covered on the inside with strong wire
netting of mesh not exceeding 25mm.
9) There shall be only one entrance to the laboratory and one door to each of its
compartments. All the doors shall be secured with excise ticket locks in the absence of
officer in-charge.
10) All vessels intended to hold alcohol and other liquid preparations should bear a

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 MAHARASHTRA STATE BOARD OF TECHNICAL EDUCATION
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MODEL ANSWER
WINTER– 19 EXAMINATION
Subject Title: Pharmaceutical Jurisprudence Subject Code: 0814
__________________________________________________________________________________________________

distinctive serial numbers and full capacity.

11) The vessels for storage of alcohol, opium, Indian hemp and other narcotic drugs and
all the finished preparations on which duty has not been paid should bear excise ticket
locks.
2 e) Describe the offences and penalties under NDPS Act, 1985.
Offences and penalties
1. Punishment for contravention in relation to poppy straw. -Whoever, in 1 ½ M
contravention of any provisions of this Act or any rule or order made or condition of a Offences,
license granted thereunder, produces, possesses, transports, imports inter-State, exports any 3
inter-State, sells, purchases, uses or omits to warehouse poppy straw or removes or does
any act in respect of warehoused poppy straw shall be punishable,- 1½M
(a) where the contravention involves small quantity, with rigorous imprisonment for a Penalties,
term which may extend to one year, or with fine which may extend to ten thousand rupees any 3
or with both;
(b) where the contravention involves quantity lesser than commercial quantity but greater
than small quantity, with rigorous imprisonment for a term which may extend to ten years
and with fine which may extend to one lakh rupees;
(c) where the contravention involves commercial quantity, with rigorous imprisonment
for a term which shall not be less than ten years but which may extend to twenty years
and shall also be liable to fine which shall not be less than one lakh rupees but which may
extend to two lakh rupees.
Provided that the court may, for reasons to be recorded in the judgment, impose a fine
exceeding two lakh rupee
2. Punishment for contravention in relation to coca plant and coca leaves.-Whoever,
in contravention of any provision of this Act or any rule or order made or condition of
license granted thereunder, cultivates any coca plant or gathers any portion of a coca plant
or produces, possesses, sells, purchases, transports, imports inter-State, exports inter-State
or uses coca leaves shall be punishable with rigorous imprisonment for a term which may
extend to ten years or with fine which may extend to one lakh rupees.
3.Punishment for contravention in relation to prepared opium :-Whoever, in

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 MAHARASHTRA STATE BOARD OF TECHNICAL EDUCATION
(Autonomous)
(ISO/IEC - 27001 - 2005 Certified)
MODEL ANSWER
WINTER– 19 EXAMINATION
Subject Title: Pharmaceutical Jurisprudence Subject Code: 0814
__________________________________________________________________________________________________

contravention of any provision of this Act or any rule or order made or condition of
license granted there under ,manufactures, possesses, sells, purchases, transports, imports
inter- State, exports inter-State or uses prepared opium shall be punishable,
(a) where the contravention involves small quantity, with rigorous imprisonment for a
term which may extend to one year, or with fine which may extend to ten thousand
rupees, or with both;
(b) where the contravention involves quantity lesser than commercial quantity but greater
than small quantity, with rigorous imprisonment for a term which may extend to ten years
and with fine which may extend to one lakh rupees; or
(c) where the contravention involves commercial quantity, with rigorous imprisonment
for a term which shall not be less than ten years but which may extend to twenty years
and shall also be liable to fine which shall not be less than one lakh rupees which may
extend to two lakh rupees:
Provided that the court may, for reasons to be recorded in the judgment, impose a fine
exceeding two lakh rupees
4. Punishment for contravention in relation to opium poppy and opium: -Whoever,
in contravention of any provision of this Act or any rule or order made or condition of
license granted there under, cultivates the opium poppy or produces, manufactures,
possesses, sells, purchases, transports, imports inter-State, exports inter-State or uses
opium shall be punishable,
(a) where the contravention involves small quantity, with rigorous imprisonment for a
term which may extend to one year, or with fine which may extend to ten thousand
rupees, or with both;
(b) where the contravention involves commercial quantity, with rigorous imprisonment
for a term which shall not be less than ten years but which may extend to twenty years
and shall also be liable to fine which shall not be less than one lakh rupees which may
extend to two lakh rupees:
Provided that the court may, for reasons to be recorded in the judgment, impose a fine
exceeding two lakh rupees;
(c) in any other case, with rigorous imprisonment which may extend to ten years and with

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 MAHARASHTRA STATE BOARD OF TECHNICAL EDUCATION
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MODEL ANSWER
WINTER– 19 EXAMINATION
Subject Title: Pharmaceutical Jurisprudence Subject Code: 0814
__________________________________________________________________________________________________

fine which may extend to one lakh rupees.

5. Punishment for embezzlement of opium by cultivator. -Any cultivator licensed to
cultivate the opium poppy on account of the Central Government who embezzles or
otherwise illegally disposes of the opium produced or any part thereof, shall be
punishable with rigorous imprisonment for a term which shall not be less than ten years
but which may extend to twenty years and shall also be liable to fine which shall not be
less than one lakh but which may extend to two lakh rupees:
Provided that the court may, for reasons to be recorded in the judgment, impose a fine
exceeding two lakh rupees.
6. Punishment for contravention in relation to cannabis plant and cannabis.-
Whoever, in contravention of any provisions of this Act or any rule or order made or
condition of license granted there under,
(a) cultivates any cannabis plant; or
(b) produces, manufactures, possesses, sells, purchases, transports, imports inter- State,
exports inter-State or uses cannabis, shall be punishable
[(i) where such contravention relates to clause (a) with rigorous imprisonment for a term
which may extend to ten years and shall also be liable to fine which may extend to one
lakh rupees; and
(ii) where such contravention relates to sub-clause (b),-
(a) and involves small quantity, with rigorous imprisonment for a term which may extend
to, one year or with fine, which may extend to ten thousand rupees, or with both;
(b) and involves quantity lesser than commercial quantity but greater than small quantity,
with rigorous imprisonment for a term which may extend to ten years, and with fine
which may extend to one lakh rupees.
(c) and involves commercial quantity, with rigorous imprisonment for a term which shall
not be less than ten years but which may extend to twenty years and shall also be liable to
fine which shall not be less than one lakh rupees but which may extend to two lakh
rupees:
Provided that the court may, for reasons to be recorded in the judgment, impose a fine
exceeding two lakh rupees.]

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 MAHARASHTRA STATE BOARD OF TECHNICAL EDUCATION
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MODEL ANSWER
WINTER– 19 EXAMINATION
Subject Title: Pharmaceutical Jurisprudence Subject Code: 0814
__________________________________________________________________________________________________

7.Punishment for contravention in relation to manufactured drugs and

preparations.- Whoever, in contravention of any provision of this Act or any rule or
order made or condition of license granted thereunder, manufactures, possesses, sells,
purchases, transports, imports inter-State, exports inter-State or uses any manufactured
drug or any preparation containing any manufactured drug shall be punishable,
(a) where the contravention involves small quantity, with rigorous imprisonment for a
term which may extend to one year, or with fine which may extend to ten thousand
rupees, or with both;
(b) where the contravention involves quantity, lesser than commercial quantity but greater
than small quantity, with rigorous imprisonment for a term which may extend to ten
years, and with fine which may extend to one lakh rupees;
(c) where the contravention involves commercial quantity, with rigorous imprisonment
for a term which shall not be less than ten years but which may extend to twenty years
and shall also be liable to fine which shall not be less than one lakh rupees but which may
extend to two lakh rupees:
Provided that the court may, for reasons to be recorded in the judgment, impose a
Fine exceeding two lakh rupees.
8.Punishment for contravention in relation to psychotropic substances:-Whoever, in
contravention of any provision of this Act or any rule or order made or condition of
license granted thereunder, manufactures, possesses, sells, purchases, transports, imports
inter-State, exports inter-State or uses any psychotropic substance shall be punishable,
(a) where the contravention involves small quantity, with rigorous imprisonment for a
term which may extend to one year , or with fine which may extend to ten thousand
rupees or with both;
(b) where the contravention involves quantity lesser than commercial quantity but greater
than small quantity, with rigorous imprisonment for a term which may extend to ten years
and with fine which may extend to one lakh rupees; Exceeding two lakh rupees.
9.Punishment for illegal import in to India, export from India or transhipment of
narcotic drugs and psychotropic substances.-Whoever, in contravention of any
provision of this Act or any rule or order made or condition of license or permit granted

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 MAHARASHTRA STATE BOARD OF TECHNICAL EDUCATION
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WINTER– 19 EXAMINATION
Subject Title: Pharmaceutical Jurisprudence Subject Code: 0814
__________________________________________________________________________________________________

or certificate or authorization issued thereunder, imports into India or exports from India
or tranships any narcotic drug or psychotropic substance shall be punishable,-
(a) where the contravention involves small quantity, with rigorous imprisonment for a
term which may extend to one year, or with fine, which may extend to ten thousand
rupees or with both;
(b) where the contravention involves quantity lesser than commercial quantity but greater
than small quantity, with rigorous imprisonment- for a term which may extend to ten
years, and with fine; which may extend to one lakh rupees;
(c) where the contravention involves commercial quantity, with rigorous imprisonment
for a term which shall not be less than ten years but which may extend to twenty years
and shall also be liable to fine which shall not be less than one lakh rupees but which may
extend to two lakh rupees:
Provided that the court may, for reasons to be recorded in the judgment, impose a fine
exceeding two lakh rupees.]
10. Punishment for external dealings in narcotic drugs and psychotropic substances
in contravention of section 12.-Whoever engages in or controls any trade whereby a
narcotic drug or a psychotropic substance is obtained outside India and supplied to any
person outside India without the previous authorization of the Central Government or
otherwise than in accordance with the conditions (if any) of such authorization granted
under section 12, shall be punishable with rigorous imprisonment for a term which shall
not be less than ten years but which may extend to twenty years and shall also be liable to
fine which shall not be less than one lakh rupees but may extend to two lakh rupees:
Provided that the court may, for reasons to be recorded in the judgment, impose a fine
exceeding two lakh rupees
11. Punishment for allowing premises, etc., to be used for commission of an offence.-
Whoever, being the owner or occupier or having the control or use of any house, room,
enclosure, space, place, animal or conveyance, knowingly permits it to be used for the
commission by any other person of an offence punishable under any provision of this Act,
shall be punishable with the punishment provided for that offence.]

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 MAHARASHTRA STATE BOARD OF TECHNICAL EDUCATION
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Subject Title: Pharmaceutical Jurisprudence Subject Code: 0814
__________________________________________________________________________________________________

12. Punishment for contravention of orders made under section 9A. –If any person
contravenes an order made under section 9A, he shall be punishable with rigorous
imprisonment for a term which may extend to ten years and shall also be liable to fine
which may extend to one lakh rupees:
Provided that the court may, for reasons to be recorded in the judgment, impose a fine
exceeding one lakh rupees.]
13.Punishment for certain acts by licensee or his servants.-If the holder of any license,
permit or authorization granted under this Act or any rule or order made thereunder or
any person in his employ and acting on his behalf-
(a) omits, without any reasonable cause, to maintain accounts or to submit any return in
accordance with the provisions of this Act, or any rule made thereunder;
(b) fails to produce without any reasonable cause such license, permit or authorization on
demand of any officer authorized by the Central Government or State Government in this
behalf;
(c) keeps any accounts or makes any statement which is false or which he knows or has
reasons to believe to be incorrect; or
(d) willfully and knowingly does any act in breach of any of the conditions of license,
permit or authorization for which a penalty is not prescribed elsewhere in this Act,
he shall be punishable with imprisonment for a term which may extend to three years or
with fine or with both.
14. Punishment for consumption of any narcotic drug or psychotropic substance.-
Whoever, consumes any narcotic drug or psychotropic substance shall be punishable,-
(a)where the narcotic drug or psychotropic substance consumed is cocaine ,morphine,
diacetylmorphine or any other narcotic drug or any psychotropic substance as may be
specified in this behalf by the Central Government by notification in the Official Gazette,
with rigorous imprisonment for a term which may extend to one year, or with fine which
may extend to twenty thousand rupees; or with both; and
(b) where the narcotic drug or psychotropic substance consumed is other than those
specified in or under clause (a), with imprisonment for a term which may extend to six
months, or with fine which may extend to ten thousand rupees or with both.

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 MAHARASHTRA STATE BOARD OF TECHNICAL EDUCATION
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Subject Title: Pharmaceutical Jurisprudence Subject Code: 0814
__________________________________________________________________________________________________

15. Punishment for financing illicit traffic and harbouring offenders.-Whoever

indulges in financing, directly or indirectly, any of the activities specified in sub-clauses
(i) to (v) of clause (viii) of section 2 or harbours any person engaged in any of the
aforementioned activities, shall be punishable with rigorous imprisonment for a term
which shall not be less than ten years but which may extend to twenty years and shall also
be liable to fine which shall not be less than one lakh rupees but which may extend to two
lakh rupees:
Provided that the court may, for reasons to be recorded in the judgment, impose a fine
exceeding two lakh rupees].
16. Punishment for contravention of section 8-A-Whoever contravenes the provision of
section 8-A shall be punishable with rigorous imprisonment for a term which shall not be
less than three years but which may extend to ten years and shall also be liable ti fine.
17. Punishment for attempts to commit offences.-Whoever attempts to commit any
offence punishable under this Chapter or to cause such offence to be committed and in
such attempt does any act towards the commission of the offence shall be punishable with
the punishment provided for the offence.
18. Punishment for abetment and criminal conspiracy.-(l) Whoever abets, or is a party
to a criminal conspiracy to commit an offence punishable under this Chapter, shall,
whether such offence be or be not committed in consequence of such abetment or in
pursuance of such criminal conspiracy, and notwithstanding anything contained in section
116 of the Indian Penal Code (45of 1860), be punishable with the punishment provided
for the offence.
(2) A person abets, or is a party to a criminal conspiracy to commit, an offence, within the
meaning of this section, who, in India abets or is a party to the criminal conspiracy to the
commission of any act in a place without and beyond India which-
(a) would constitute an offence if committed within India; or
(b) under the laws of such place, is an offence relating to narcotic drugs or psychotropic
substances having all the legal conditions required to constitute it such an offence the
same as or analogous to the legal conditions required to constitute it an offence
punishable under this Chapter, if committed within India.

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19. Preparation.-If any person makes preparation to do or omits to do anything Which

constitutes an offence punishable under any of the provisions of[sections 19,24 and
27Aand for offences involving commercial quantity of narcotic drug or psychotropic
substance and from the circumstances of the case, it may be reasonably inferred that he
was determined to carry out his intention to commit the offence but had been prevented
by circumstances independent of his will, he shall be punishable with rigorous
imprisonment for a term which shall not be less than one-half of the minimum term (if
any), but which may extend to one-half of the maximum term, of imprisonment with
which he would have been punishable in the event of his having committed such offence,
and also with fine which shall not be less than one-half of the minimum amount (if any),
of fine with which he would have been punishable, but which may extend to one-half of
the maximum amount of fine with which he would have ordinarily (that is to say in the
absence of special reasons) been punishable, in the event aforesaid:
Provided that the court may, for reasons to be recorded in the judgment, impose a higher
fine.
20. Enhanced punishment for offences after previous conviction.-(l) If any person
who has been convicted of the commission of, or attempt to commit, or abetment of, or
criminal conspiracy to commit, any of the offences punishable under this Act is
subsequently convicted of the commission of, or attempt to commit, or abetment of, or
criminal conspiracy to commit, an offence punishable under this Act with the same
amount of punishment shall be punished for the second and every subsequent offence
with rigorous imprisonment for a term which may extend to one-half of the maximum
term of imprisonment and also be liable to fine which shall extend to one-half of the
maximum amount of fine.
(2) Where the person referred to in sub-section (1) is liable to be punished with a
minimum term of imprisonment and to a minimum amount of fine, the minimum
punishment for such person shall be one-half of the minimum term of imprisonment and
one-half of the minimum amount of fine:
Provided that the court may, for reasons to be recorded in the judgment, impose a fine
exceeding the fine for which a person is liable.

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(3) Where any person is convicted by a competent court of criminal jurisdiction outside
India under any corresponding law, such person, in respect of such conviction, shall be
dealt with for the purposes of sub-sections (1) and (2) as if he had been convicted by a
court in India.]
21-A-Death penalty for certain offences after previous conviction.-
(l) Notwithstanding anything contained in section 31, if any person who has been
convicted of the commission of, or attempt to commit, or abetment of, or criminal
conspiracy to commit, any of the offences punishable under39[section 19, section 24,
section 27-A and for offences involving commercial quantity of any narcotic drug or
psychotropic substance] is subsequently convicted of the commission of or attempt to
commit or abetment of or criminal conspiracy to commit an offence relating to-
(2) where any person is convicted by a competent court of criminal jurisdiction outside
India under any law corresponding to the provisions of[section 19, section 24 or section
27 A and for offences involving commercial quantity of any narcotic drug or
psychotropic substance], such person, in respect of such conviction, shall be dealt with for
the purposes of sub-section (1) as if he had been convicted by a court in India.]
22. Punishment for offence for which no punishment is provided.-Whoever
contravenes any provision of this Act or any rule or order made, or any condition of any
license, permit or authorization issued thereunder for which no punishment is separately
provided in this Chapter, shall be punishable with imprisonment for a term which may
extend to six months, or with fine, or with both.
2 f) Define: 1½M
(i)Alcohol Each
(ii)Medicinal opium
(i)Alcohol: Alcohol means ethyl alcohol of any strength and purity having chemical
composition C2H5OH.
(ii)Medicinal opium: Opium which has undergone the processes necessary to adapt it for
medicinal use in accordance with the requirements of the Indian Pharmacopoeia or any
other Pharmacopoeia notify in this behalf by the Central Government, whether in powder
form or granulated or otherwise or mixed with neutral materials;

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3 Attempt any FOUR of the followings 12M

3 a) Give constitution and function of DTAB. 2M
Ex-officio members. Constitut
i) The Director General of Health Services, who is the Chairman of the board. ion
ii) The Drugs Controller of India. 1M
iii) The Director of the Central Drugs Laboratory, Calcutta. function
iv) The Director of the Central Research Institute, Kasauli.
v) The Director of Indian Veterinary Research Institute, Izatnagar.
vi) The Director of Central Drug Research Institute, Lucknow.
vii) The President of Medical Council of India.
viii) The President of the Pharmacy Council of India.
Nominated Members -Following members nominated by Central Government.
i) Two persons from among persons who are in-charge of the drugs control in the states
ii) One person from the pharmaceutical industry.
iii) Two Government Analysts.

Elected Members
i) One teacher in Pharmacy, Pharmaceutical Chemistry or Pharmacognosy on the staff of
an university or affiliated college elected by the Executive Committee of Pharmacy
Council of India.
ii) One teacher in medicine or therapeutics on the staff of an university or affiliated
college elected by the Executive Committee of Medical Council of India.
iii) One Pharmacologist, elected by the Governing Body of the Indian Council of Medical
Research.
iv) One person elected by the Central Council of Indian Medical Association.
v) One person elected by the Council of the Indian Pharmaceutical Association.
Functions of DTAB:
i)To advice the Central Govt. & state Govt. On technical matters arising out of the
administration of this Act.
ii)To carry out the other functions assigned to it by this act.

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3 b) Define ‘Drug’ under D and C Act, 1940. 3M

Drugs : it includes
1. All medicines for internal or external use of human beings or animals and all
substances intended to be used for; or in the diagnosis, treatment, mitigation or prevention
of any disease or disorder in human beings or animals, including preparations applied on
human body for the purpose of repelling insects like mosquitoes.
2. Such substances other than food intended to affect the structure or any function of the
human body or intended to be used for the destruction of vermin or insects which cause
disease in the human beings or animals.
3. All substances intended for use as components of a drug including empty gelatin
capsules and
4. Such devices intended for internal or external use in diagnosis, treatment, mitigation or
prevention of diseases or disorders in human beings or animals.

3 c) What does Schedule Y and Schedule H to the D and C rules prescribes? 1½M
Schedule Y: Requirements and Guidelines for permission to import and / or manufacture Each
of new drugs for sale or to undertake clinical trials.

Schedule H: Prescriptions drugs which are required to be sold by retail only on

prescription of Registered Medical Practitioner.

3 d) As per as code of ethics explain, how pharmacist is a link between medical 3M

profession and public.
A pharmacist under no circumstances, should practice medicine, that is diagnosing
diseases and prescribing medicines. However in case of accidents or emergencies, he may
render first aid services.
A pharmacist should not recommend any particular medical practitioner, unless specially
asked for. Pharmacist should never enter into secret agreements with the medical
profession, physicians, dentist, and veterinary surgeons to offer them commission or gifts
by recommending his dispensary or drug store. Pharmacist should not have any

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clandestine or underhand arrangement with any physician.

Pharmacist is a link between medical profession and public. He should be constantly in
touch with the modern developments in pharmacy and allied fields. He should be expert
in the field of pharmacy so that he may advice the physician on pharmaceutical matters.
By enlarging his store of knowledge he may be able to educate the public to maintain
their health. Pharmacists should neither discuss physician’s prescription with customers
nor disclose to them the composition of the prescriptions.
3 e) Why DEC was formed? Give recommendations of DEC. 1M
Why DEC was formed (1M) DEC
In the dealing of drugs and medicines, profit rather than service became the main motive.
Spurious, substandard and adulterated drugs become more common than standard and the
genuine ones. Outside India, drugs were manufactured specifically for India
which were of inferior quality. India become platform for quack medicines and
adulterated drugs manufactured in all parts of the world. There were very occurrences of
offences related to drugs. There was no authority to control such activities.
The Indian Government formed a ‘Drug Enquiry Committee’ (D.E.C. or Chopra
Committee) in 1930 under the Chairmanship of Lt. Col. R. N. Chopra was formed to
study problems related to drugs in India.

Recommendations of DEC (2M) 2M ,

1)Formation of Central Pharmacy Council and the Provincial (State) Pharmacy Council Any4
which would look after the education and training of professionals. These councils would
maintain the register containing the names and addresses of registered pharmacist.

2)It suggested the creation of drug control machinery (departments) at the centre with the
branches in all the states.

3)Recommended the establishment of a well-equipped CDL with competent staff and

experts for an efficient and speedy working of Drug Ctrl Department. It also suggested
small laboratories which would work under the guidance of CDL.

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4)Setting of test laboratories in all states to control the quality of production of drugs and
pharmaceuticals.
5)Appointment of Advisory board to advise Government in making rules.
6)The drugs industry in India should be developed.
7)Setting of courses for training in pharmacy.
8)Prescribing minimum qualification for registration of pharmacist.

3 f) Write the difference between Law and Ethics.

Sr. No Law Ethics 3M,

Definition- Rules by which a profession Any 3
Definition- Rules of human conduct regulates action & sets standards for all
1
binding on all persons in a state. its members.

Law may prevent one from causing

injury to another but it cannot force Helping the neighbour is the function
2
him to help his neighbour in hours of of ethics.
need.
Ethics is how society expects you to
3 A law is something you must obey
behave.
Law deals with actions that are
4 Ethics deals with right & wrong.
punishable.
Ethics are also written words but they
Laws are written & approved
5 are not carrying legal status
documents.

If rules of ethics are broken, the

If law is broken, a violator may be professional body may subject the
6 subjected to punishment, a fine or violator to loss of professional
imprisonment. privileges

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4 Attempt any FOUR of the followings 12M

4 a) Differentiate between bonded and non-bonded manufactory or laboratory 3M ,
Sr. Bonded Laboratory Non-bonded Laboratory Any 3
No
1. It means the premises or any part It means the premises or any part of
of the premises approved & the premises approved & licensed
licensed for the manufacture & for the manufacture & storage of
storage of medicinal & toilet medicinal & toilet preparations
preparations containing alcohol, containing alcohol, opium, Indian
opium, Indian hemp & other hemp & other narcotic drugs or
narcotic drugs or narcotics on narcotics on which duty has been
which duty has not been paid. paid.
2. Excise duty payable on removal Excise duty payable at the time of
of goods from bonded laboratory. spirit purchase.
3. Bonded laboratory to function No excise staff is required.
under Excise staff.
4. License required should be License required should be
obtained from Excise obtained from the officer as the
Commissioner State Government may authorize on
this behalf
5. Suitable for large scale Suitable for small scale
manufacture manufacture
4 b) What procedure should be followed by drug Inspectors while sending the samples 3M
for test or analysis?
Following is the procedure to be followed by the drug Inspector while sending the
samples for test or analysis-
An Inspector taking any samples should pay its fair price and may require a written
acknowledgement for the same. If the price tendered is refused or where the Inspector
seizes the stock of any drug or cosmetic, he should issue a receipt for the same in the

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prescribed form. He should also inform the purpose of taking the samples unless he will
fully absents himself and divide the samples into four parts in his presence. Each portion
is then sealed effectively and suitably marked. The person from whom the sample is taken
should be permitted to add his own seal and mark to all or any of the portions sealed or
marked. If the sample is taken from manufacturing premises, it should be divided into
three portions only. Where the sample is made up in containers in small volume or is
likely to deteriorate or be damaged by exposure, the Inspector should take three or four
such containers after suitably marking them and when necessary, sealing them. One
portion of the sample should be restored to the person from whom it was taken, the
second portion is sent to the Government Analyst for test or analysis, the third one is
preserved for production before the court if required, and the fourth portion is sent to the
warrantor, if any.

4 c) Mention the duties of government analyst. 3M

1) To analyze or test the samples of drugs & cosmetics sent to him by Drug Inspectors or
other persons or
2) To furnish reports of results of such analysis & test.
3) Research work- To forward to the Govt., the report of Analytical & Research work
with view to their publication
4 d) Define the following as per DPCO, 1995. 1½M
(i)Bulk drug- means any pharmaceutical, chemical, biological or plant product including Each
its salts, esters, isomers, analogues and derivatives, conforming to pharmacopoeial or
other standards specified in the second schedule to the Drugs and Cosmetics Act and
which is used as such or as an ingredient in any formulation.
(ii)Formulation- means a medicine processed out of, or containing one or more bulk drug
or drugs with or without the use of any pharmaceutical aids, for internal or external use in
the diagnosis, treatment, mitigation or prevention of disease in human beings or animals,
but it does not include –
(a) any medicine included in any bonafide Ayurvedic (including Sidha) or Unani (Tibb)
systems of medicines.

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(b) any medicine included in the Homeopathic system of medicine; and

(c) any substance to which the provisions of the Drugs and Cosmetics Act, 1940 (23 of
1940) do not apply.
4 e) Give the offences and penalties under DPCO, 1995 3M
Penalties.―Any contravention of any of the provisions of this order shall be punishable
in accordance with the provisions of the essential commodities act.
(1) If any person contravenes any order made under Section 3,
(a) he shall be punishable,―
(i) in the case of an order made with reference to clause (h) or clause (i) of sub-section (2)
of that section, with imprisonment for a term which may extend to one year and shall also
be liable to fine, and
(ii) in the case of any other order, with imprisonment for a term which shall not be less
than three months but which may extend to seven years and shall also be liable to fine:
Provided that the court may, for any adequate and special reasons to be mentioned in the
judgment, impose a sentence of imprisonment for a term of less than three months;
(b) any property in respect of which the order has been contravened shall be forfeited to
the Government;
(2) If any person to whom a direction is given under clause (b) of sub-section(4) of
section 3 fails to comply with the direction, he shall be punishable with imprisonment for
a term which shall not be less than three months but which may extend to seven years and
shall also be liable to fine:
Provided that the court may, for any adequate and special reasons to be mentioned in the
judgment, impose a sentence of imprisonment for a term of less than three months. or six
months, as the case may be.
(3) Where a person having been convicted of an offence under sub-section (1) is again
convicted of an offence under that sub-section for contravention of an order in respect of
an essential commodity, the court by which such person is convicted shall, in addition to
any penalty which may be imposed on him under that sub-section, by order, direct that
that person shall not carry on any business in that essential commodity for such period,
not being less than six months, as may be specified by the Court in the Order.

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4 f) What qualifications are required for a person to be appointed as “Government 3M

Analyst”?
For the appointment as a Government Analyst, a person should be:-
1. A graduate in medicine/science/ pharmacy/pharmaceutical chemistry of a recognized
University, and has had not less than five years post graduate experience in the testing of
drugs in a laboratory under the control of
i) a Government Analyst or
ii) head of an approved institution or testing laboratory or has completed two years
training on testing of drugs, including items stated in Schedule C, in Central Drugs
Laboratory, or
2. A post graduate in medicine/science/ pharmacy/pharmaceutical chemistry of a
recognized University or Associateship Diploma of the Institution of Chemists (India)
obtained by passing the said examination with Analysis of Drugs and Pharmaceuticals as
one of the subjects with at least three years of experience in the testing of drugs in the
laboratory under the control of
i) a Government Analyst or
ii) head of an approved institution or testing laboratory or has completed two years
training on testing of drugs, including items stated in Schedule C, in Central Drugs
Laboratory.
5 Attempt any FOUR of the followings 12M
5 a) What do schedule R, schedule J and schedule X to D and C Act,1940 prescribe?

Schedule R- Standards for condoms made up of rubber latex intended for single use and 1M Each
other mechanical contraceptives.

Schedule J- List of diseases and aliments which a drug may not claim to prevent or cure .

Schedule X- List of habit forming, psychotropic and other such drugs.

5 b) Give the schedules for following drugs:

(i)Vasopressin

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(ii)Tolbutamide
(iii)Insulin
(iv)Ibuprofen
(v)Barbituric acid
(vi)Betamethasone
½ Mark
(i)Vasopressin - Schedule H each
(ii)Tolbutamide – Schedule G
(iii)Insulin - Schedule C , Schedule G
(iv)Ibuprofen – Schedule H
(v)Barbituric acid – Schedule H
(vi)Betamethasone – Schedule H

5 c) Define the following terms as per MTP Act,1971

(i)Guardian-
(ii)Minor

(i) Guardian Definition of "Guardian" 1½

means a person having the care of a minor or a lunatic. Mark
OR Each
Person having the care of the ‘person of minor’ or a ‘mentally ill person’ {Sec. 2(a)}

(ii)Minor Means a person who, under the provisions of the Indian Majority Act, 1875 is
to be deemed not to have attained his majority.
5 d) How retail price of drug is to be calculated under DPCO 1995?
By applying the following formula, the retail price of the formulation is calculated by the
Government.
R.P.= (M.C.+ C.C.+ P.M. + P.C.) x (1+ MAPE/100) + ED
Where, R.P.:- Means retail price.
M.C.:- means material cost which includes the cost of drugs and other pharmaceutical 1M

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aids with overages, if any, plus process loss thereon in accordance with the norms Formula
specified from time to time by notification in the official Gazette. 2M
C.C.:- means conversion cost worked out in accordance with such norms as may be Explanat
specified by the Government from time to time by notification in the official Gazette. ion
P.M.:- means the cost of packing material including process loss thereon worked out in
accordance with such norms as may be specified by the Government from time to time.
P.C.:- means packing charges worked out in accordance with such norms as may be
specified by Government every year by notification in the Official Gazette.
MAPE :- Maximum allowable post manufacturing expenses.
In means all the cost incurred by the manufacturer from the stage of ex-factory cost of
retailing. It also includes trade margin and margin of manufacturer. MAPE shall not
exceed 100% for indigenously scheduled formulations.
E.D.:- means excise duty.
5 e) Give constitution of state pharmacy council. 3M
1)Elected members:
a) Six members, elected amongst themselves by Registered pharmacists of state.
b) One member elected by the members of Medical Council of the State amongst
themselves.
2)Nominated members:
a) Five members nominated by the State Government of whom at least three shall be
persons possessing a prescribed degree or diploma in pharmacy or pharmaceutical
chemistry or be a registered pharmacists.
3)Ex-officio members:
a) Chief administrative medical officer of the State.
b) The officer in charge of the drug control organization of the state; appointed under D.
& C. Act, 1940.
c) Government Analyst appointed under Drugs and Cosmetics Act, 1940. If there are
more than one such Analyst, one may be nominated by the Government

5 f) Mention the conditions under which name of the pharmacist can be removed from

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register of pharmacist.
The executive committee after giving opportunity to a person to explain his conduct and 3M
on sufficient inquiry if satisfied, orders to remove the name of registered pharmacist on
following conditions :-
(1) If his name has been entered in the register due to error, misrepresentation or
suppression of material fact. or

(2) If he is convicted of an offence in any professional respect, which in the opinion of

Executive Committee considered him unfit as a Registered Pharmacist. or

(3) If person employed to work under him in connection with any business of pharmacy
has been convicted of an offence or held guilty of an infamous conduct, if such person is
registered pharmacist, he is liable to remove his name from register.

The removal of names from the register may either be permanent or only for a specified
period of time. A person, whose name has been removed from the register is required to
surrender his certificate of registration to registrar of the State Pharmacy Council and
shall be published in official gazette.

6 Attempt any FOUR of the followings 16M

6 a) Explain Drug price equalisation account(DPEA) as per DPCO Act,1995 4M
Drugs price Equalisation Account (DPEA) –
The Government may recover the dues accrued under the provisions of the Drugs (Prices
Control) Order, 1979 from the manufacturer, importer or distributor as the case maybe &
deposit the same into an account known as Drugs Prices Equalization Account. The
amount, from Drugs Prices Equalisation Account shall be utilized for :
(i) Paying the shortfall between the retention price and the common selling price or the
pooled price as the case may be to the manufacturer or importer or distributor, to
increases the production, or to securing the equitable distribution and availability at fair
prices, of drugs.
(ii) Meeting the expenses incurred by the Government in discharging the functions under

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this provision &

(iii) Promoting higher education and research in Pharmaceutical Sciences and
Technology.

6 b) Explain what do schedule N to D and C Act,1940 prescribes?

Schedule N- List of Minimum equipment’s for efficient running of pharmacy: 4M
1) Entrance: The front of Pharmacy shall bear an inscription, “Pharmacy”.
2) Premises: The premises of Pharmacy shall be separate from rooms for private use. The
premises shall be well built, dry, well- lit and ventilated and of sufficient dimensions to
allow the goods in stock, especially medicaments and poisons to be kept in clearly visible
and appropriate manner. The area of the section to be used as dispensing department shall
not be less than 6 sq. meters for one pharmacist working there in with additional 2 square
meters for each additional pharmacist. The height of the premises shall be at least
2.5meters.
The floor of pharmacy shall be smooth & washable. The walls shall be plastered or tiled
or oil painted so as to maintain smooth, durable & washable surface devoid of holes,
cracks, crevices.
A pharmacy shall be provided with supply of good quality water. There shall be separate
dispensing department to prevent the admission of the public.
3) Furniture: A pharmacy shall contain furniture of required size & suitable apparatus.
Drugs, chemicals & medicaments shall be kept in a suitable room and suitable containers
so as to prevent any deterioration of the contents or of contents of container kept near
them. 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 of appropriate size easily readable with names of
medicaments as given in Pharmacopoeias.
A pharmacy shall be provided with dispensing bench having impervious and washable
top.
A pharmacy shall be provided with a cupboard with lock and key for storage of poison &

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shall be clearly marked with “POISON” in red letters on a white background.

Containers of all the concentrated solution shall bear the special labels or marking with
the words ”To be diluted”.
4) Apparatus and Equipment:
A pharmacy shall be provided with following minimum apparatus:
Balance-dispensing, sensitivity30 mg
Balance-counter, capacity 3 kg, sensitivity 1 kg
Beakers, lipped assorted sizes
Corks assorted sizes and toppers
Cork extractor
Evaporating dishes
Funnel –glass
Litmus paper-blue and red
Measuring glass cylinder 10, 25, 50, 100 & 500 ml
Mortar & pestle
Ointment slab, porcelain
Pipettes, graduated, 2ml, 5ml,& 10 ml
Scissors
Spatula, glass rods, thermometer, tripod stand, watch glasses, water distillation still, water
bath, weights, wire gauze, pill machine, pill boxes, suppository mould.
5) Books:
The pharmacopoeia (current edition)
National formulary of India (current edition)
The Drugs and Cosmetics Act, 1940 and Rules, 1945
The Pharmacy Act, 1948
Narcotic Drugs & Psychotropic Substances Act, 1985.
6) General Provisions: 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
pharmacy shall be properly kept and everything must be in good order & clean.

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All records and registers shall be maintained in accordance with the laws in force. Any
container taken from the poison should be replaced therein immediately after use &
cupboard is to be locked. The keys of cupboard shall be kept in personal custody of a
responsible person.
Medicament when supplied shall have labels conforming to the provisions of the laws in
force.

6 c) Write the functions of pharmacy council of India.

Functions of PCI:- 4M
1) To prescribe the minimum standard of education required for qualification as a (Any 4)
Pharmacist (This can be provided by making rules as Education Regulation which
prescribes minimum qualification for admission, duration of course, details of syllabus,
practical training, & examination, minimum facilities required for the conduct of course,
examination & practical training)
2) To regulate minimum educational standard. (for this purpose, Council appoints
Inspectors to inspect the institutions providing the minimum standards in education in
pharmacy & report on the facilities available & decides whether the institution should be
recognized or not)
3) To recognize qualification granted outside the territories to which Pharmacy Act,1948
extends for the purpose of qualifying for registration under the said Act
4) To compile & maintain a Central Register for Pharmacist containing names of all
persons for the time being entered in the state register.
5) Any other functions that may be assigned to the Central Council in the furtherance of
the objective of the Pharmacy Act,1948.

6 d) Give the conditions for approval of places for termination of pregnancies. State
offences and penalties under MTP Act,1971. 2M
Conditions for approval of places for termination of pregnancies – (2 marks) Conditio
Places where pregnancy may be terminated- n
i) A Govt. Hospital or

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Subject Title: Pharmaceutical Jurisprudence Subject Code: 0814
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ii) A place approved for the purpose of this Act of Govt.

Place for the termination of pregnancies shall be approved only if – Conditions :
1) The Government is satisfied that termination of pregnancies may be done therein
under safe and hygienic conditions and
2) The following facilities are provided -
a) An operation table and instruments for performing abdominal or gynaecological
surgery.
b) Anaesthetic equipment, resuscitation equipment and sterilization equipment.
c) Drugs and parenteral fluids for emergency use. 2M
Offences and penalties- (2 Marks ) Offences
As per the latest amendments in M.T.P. Act,1971 &
i) The termination of a pregnancy by a person who is not a registered medical practitioner Penalty
shall be an offence punishable with rigorous imprisonment for a term which shall not be (any 2)
less than two years but which may extend to seven years.
ii) Whoever terminates any pregnancy in a place other than that mentioned in sec.4 shall
be punishable with rigorous imprisonment for a term which shall not be less than two
years but which may extend to seven years.
iii) Any person being owner of a place which is not approved under clause (b) of sec.4
shall be punishable with rigorous imprisonment for a term which shall not be less than
two years but which may extend to seven years.

6 e) Describe duties of drug inspector in relation to manufacture of drugs and cosmetics. 4M

Duties of Drug Inspector in relation to manufacture of D&C Act,1940
1)To inspect atleast twice a year, all premises licenced for manufacturing of drugs within
the area allotted to him & to satisfy whether the conditions of licence & provisions of the
act and rules thereunder are being observed or not.
2) To inspect premises licenced for manufacturing of drugs, specified in Schedule-C &
C(1) & to observe process of manufacturing, means employed for standardization &
testing of drug & storage conditions & qualification of technical staff and employee & all
other details of location, construction, administration of establishment, other things which

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 MAHARASHTRA STATE BOARD OF TECHNICAL EDUCATION
(Autonomous)
(ISO/IEC - 27001 - 2005 Certified)
MODEL ANSWER
WINTER– 19 EXAMINATION
Subject Title: Pharmaceutical Jurisprudence Subject Code: 0814
__________________________________________________________________________________________________

may likely to affect potency & purity of the product.

3) To sent after each inspection a detailed report of inspection to the controlling authority
with which conditions of licence and provisions of the act & the rules thereunder being
observed and which being not observed.
4) To take sample of drugs manufactured in the premises and sent them for test or
analysis.
5) To check all the records & registers required to be maintained under the rules.
6) To institute prosecutions, in respect of breach of the act and rules.

6 f) Write the procedure for approval of institution running diploma / degree course in 4M
pharmacy
Application by institution/ authority to the Pharmacy Council of India (PCI): An
institution which conducts course of study or hold an examination for the pharmacist, has
to apply to the PCI for approval of the course or examination.
Inspection:
i)PCI after receiving such application appoints the inspectors to visit the institution &
confirm that whether the institution has the prescribed facilities as per the E R or not.
ii) Inspectors may also attend any examination, to judge its standards without interfering
with its conduct.
iii)The inspector then report to the PCI on the facilities available in the institution & on
the conduct & standard of the examinations held.
Approval:
i)On the reports of the inspectors if the PCI is satisfied that the course or examination
under consideration is in conformity with ER, it may grant approval to it &
ii)The said course of examination shall be considered as approved for qualifying for
registration as pharmacist under the act.
Declaration:
Declaration of approval made by resolution is passed at a meeting of the PCI &
published in the Official Gazette.

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