maharashtra state board of technical education (autonomous...

MAHARASHTRA STATE BOARD OF TECHNICAL EDUCATION (Autonomous)

(ISO/IEC - 27001 - 2005 Certified)

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WINTER– 14 EXAMINATION

Subject Code: 0814 Model Answer Page No: 1/26

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 any equivalent 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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WINTER – 14 EXAMINATION


Q.1 Attempt any EIGHT of the following: 16Marks

a) Differentiate between law and ethics (any four points). (4 points, 2 marks)

Sr.no. Law Ethics

1. Definition- Rules of human conduct binding

on all persons in a state.

Definition- Rules by which a profession regulates

action & sets standards for all its members.

2. Law may prevent one from causing injury to

another but it cannot force him to help his

neighbor in hours of need.

Helping the neighbor is the function of ethics.

3. A law is something you must obey Ethics is how society expects you to behave.

4. Law deals with actions that are punishable. Ethics deals with right & wrong.

5. Laws are written & approved documents.

Ethics are also written words but they are not

carrying legal status.

6. If law is broken, a violator may be subjected

to punishment, a fine or imprisonment.

If rules of ethics are broken, the professional body

may subject the violator to loss of professional

privileges.

b) Define 'Registered Pharmacist' as per Pharmacy Act, 1948. (2 marks)

Registered Pharmacist:-A person whose name for the time being is entered in the register of

pharmacist of the State ,in which he is for the time being residing or carrying on his

profession or business of pharmacy.

c) State the objective of Pharmacy Act, 1948. (2 points, 2 marks)

Ans. The Pharmacy Act, 1948 is passed with the main object

1) To regulate the profession and practice of pharmacy and

2) To raise the status of profession of pharmacy in India.



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d) Define the term 'Pharmacy' under D and C act and rules thereunder 1945. ( 2 marks)

Ans. Pharmacy: Licensed premises for the sale of drugs, which require the services of a

“Qualified Person” and where the drugs are compounded against the prescriptions.

e) What does Sch G and Sch Q prescribe under the Drugs Rules, 1945. ( each sch 1 mark)

Ans. Sch G: List of substances required to be taken only under the supervision of a Registered

Medical Practitioner.

Sch Q: List of coal tar colours permitted to be used in cosmetics and list of colours

permitted to be used in soaps.

f) Give any two classes of advertisements exempted under the Drugs and Magic Remedies

(O.A) Act, 1954. ( any 2 classes, 2 points)

Ans. Classes of exempted advertisements:

1. Any advertisements relating to the drugs printed or published by the Government or any other

person with prior permission of the Government.

2. Any advertisement relating to a drug which is sent confidentially in the prescribed manner to

registered medical practitioner.

3. Advertisements including any book or treatise dealing with any matter relating to the diseases,

disorders or conditions which are otherwise prohibited provided published from bonafide

scientific or social point of view.

4. Displayed signboards or notices by registered medical practitioners on his premises indicating

that the treatment is undertaken for any any disease, disorders or conditions specified in the

schedule to this Act or in the rules made under this Act.

5. Advertisements relating to the drugs which comply with the required conditions as follows:

(a) Leaflets or literature along with packing of drugs; or advertisements of drugs in medicinal,

pharmaceutical, scientific and technical journals



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(b) Therapeutic index or price list published by licensed manufacturer, importer or distributer of

drugs or medical literature distributed by medical representatives.

With conditions that:

i) The advertisement should contain only the information required for the guidance of registered

medical practitioner regarding:

(a) therapeutic indications;

(b) route of administration;

(c) dosage and side effects of such drug or drugs; and

(d) the precautions to be taken in treatment with the drug

ii) The distribution of such literature should be given to registered medical practitioner,

dispensaries, hospitals, medical and research institutions, chemists and druggists or pharmacies.

g) Give the functions of Narcotic Drugs and Psychotropic Substances Consultative

Committee (NDPSCC). ( 2 marks)

Ans. The committee shall advise the Central Government on the matters relating to the

administration of Narcotic Drugs and Psychotropic Substances Act.

h) Define the term 'Maximum Allowable Post manufacturing Expenses (MAPE) as per

Drugs (P.C.) Order, 1995. (2 marks)

Ans. MAPE means all the costs incurred by the manufacturer from the stage of ex-factory cost

of retailing. It also includes trade margin and margin of manufacturer.

i) Define 'Specified Poison' and give two poisons from list A under the Poisons Act, 1919.

Ans. Specified poison: (1 mark) Any substance specified as a poison in a rule made or notified

issued under the Poison Act,1919 shall be deemed to be a poison for the purpose of this Act.



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List A poisons: (1 mark, any 2 e.g.) Aconite, Aconine, Arsenic, Atropine, Balladonna,

Cantharides, Chloral hydrate, Coca, Corrosive sublimate, Potassium cyanide, Diamorphine

(Heroin), Diethyl barbituric acid, Digitalis, Ecogonine, Ergot of Rye, Lead, Nux vomica,

Strychnine, Morphine, Pectrotoxine, Prussic acid, Savin and its oils, Stramonillan, Stropanthus,

Tartar emetic, Tetraethyl lead.

j) Define the term 'Restricted Preparations' as per medicinal and toilet preparations (E.D.)

Act. 1955. (2 marks)

Ans. Restricted preparations: These are medicinal preparations which are considered as

capable of being misused as ordinary alcoholic beverages.

k) Give places for medical termination of pregnancy under the M.T.P. Act, 1971.

(2 points, 2 marks)

Ans. Approved places for termination of pregnancy:

The pregnancy may be terminated by RMP only at

1. A hospital established or maintained by Government

2. A place for the time being approved for the purpose of this Act by the Government.

3. A place approved by ‘District Level Committee’ (D.L.C.)

l) List facilities provided for approval of place for Medical Termination of Pregnancy

Act, 1971. Facilities :- (2 marks)

Upto 12 weeks MTP : Places may be approved with following facilities :{Rule-5(l) (ii)}

.Gynaecology Examination Table/ Labour Table,

. Resuscitation and Sterilisation equipment,

.Drugs & Parental Fluids,

.Backup facilities for treatment of shock, &

. Facilities for Transportation.



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Upto 20 weeks MTP : Places may be approved with following facilities :{Rule-5(l)

(ii)a,b,c}

i. An operation table and

ii. instruments for performing abdominal or Gynecological surgery.

iii. Anaesthetic Equipments, Resuscitation and Sterilisation equipment.

iv. Drugs and parenteral fluids for emergency use, as notified by Government of

India from time to time

Q.2 Attempt any FOUR of the following 12marks

a) Define the term 'Pharmaceutical Ethics' and explain the role of pharmacist in relation to

his job.

Ans. Pharmaceutical Ethics: - (1 mark) It is defined as character or moral principles of

pharmacist.

Role of pharmacist in relation to his job: (2 marks)

Pharmaceutical services:

i) Provide efficient and reasonably comprehensive pharmaceutical services.

ii) Such services should include supply of commonly required medicines without undue

delay and furnishing the emergency supply at all times.

Pharmacy/Drug Store:

i) There should be a qualified pharmacist.

ii) A pharmacy should be planned in such a way that there is no accidental contamination in

the preparation, dispensing and supply of medicines.

iii) The appearance of premises should reflect the professional character of pharmacy.



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Prescriptions:

i) Prescriptions should not be discussed with patients or others regarding the merits and

demerits of their therapeutic efficiency.

ii) A pharmacist should not show any expression on his face after receiving the Rx.

iii) No addition, omission or substitution of ingredients in a Rx should be made without the

consent of prescriber whenever possible except in an emergency.

iv) In case of error, Rx should be referred back to the prescriber for necessary correction.

v) If at all change in Rx is necessary, it should affect the reputation of physician.

vi) A pharmacist should not recommend any particular prescriber unless he is specially asked

to do so.

Drugs/Ingredients:

i) While dispensing, the drugs or ingredients should be weighed or measured correctly.

ii) Pharmacist should always use drugs and medicinal preparations of standard quality.

iii) Drugs likely to cause addiction or abuse should not be supplied when there is reason to

suppose that it is required for such purpose.

Practical Training:

i) While imparting training, the incharge pharmacist should see that the trainees acquire

sufficient technique and skill.

ii) No certificate should be granted to the trainee pharmacist before completion of prescribed

period of training or without undergoing practical training or unless the trainee acquires

sufficient knowledge.



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b) Give the qualifications for entry of a name of a person on first register u/s 31 of

Pharmacy Act, 1948. (3 marks)

Ans. A person who has attained age of 18 years, entitled to have his name to be entered

in first register on payment of prescribed fees & should have the following qualification:

i) A degree or diploma in pharmacy, or pharmaceutical chemistry, or chemist or druggist

diploma of an Indian University or a State Govt.

ii) A degree of an Indian University other than a degree in Pharmacy or Pharmaceutical

chemistry & is engaged in the compounding of drugs in a hospital or dispensary or other

place where drugs are regularly dispensed on the prescription of RMP for total period of

not less than 3 years, OR

iii) Has passed an examination recognized as adequate by the State Govt. for

compounders & dispensers.

iv) Has not less than 5 years experience of compounding & dispensing in a hospital or

dispensary or other place where drugs are regularly dispensed on the prescription of

RMP.

c) Define i) Advertisement ii) Magic Remedies as per DMR (O.A.) Act, 1954.

(each definition 1.5 marks)

Ans. Advertisement: It includes

i) any notice, circular, label, wrapper or otherwise such document, and

ii) any announcement made orally or by means of producing or transmitting light, sound

or smoke.

Magic Remedies: It includes a Talisman, Mantra, Kavacha and any other charm claiming

to possess miraculous powers:

i) for diagnosis, treatment and prevention of any disease in human beings or animals, or

ii)for affecting or altering the structure or organic function of the body of human being

or animal.



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d) Define 'Opium' and 'Opium derivatives' as per the Narcotic Drugs and

Psychotropic Substances Act, 1985.

Ans. Opium: It means the coagulated juice of the opium poppy and it's mixture with or

without neutral material, ( excluding the preparations containing less than 0.2 % of

morphine) ( 1 mark)

Opium derivatives: It includes: ( 2 marks)

(i) Medicinal opium

(ii) Prepared opium

(iii) Phenanthrene alkaloids such as morphine, codeine, thebaine and their salts

(iv) Diacetyl morphine (heroin) and its salts

(v) All preparations containing more than 0.2% of morphine or any amount of diacetyl

morphine.

e) Explain how 'record of retail supply of schedule X drugs' kept by a pharmacist.

(3 marks)

Ans. The drugs specified in schedule X shall be supplied only on a prescription of a

Registered Medical Practitioner and such prescription should be in duplicate, one copy of

which retained by licensee and preserved at least for two years. Unless otherwise stated

in the prescriber, such drugs should not be dispensed more than once.

The supply of drugs specified in schedule X shall be recorded at the time of supply in a

bound and serially page numbered register, specially maintained for the purpose and

separate pages shall be allotted for each drug and the following particulars shall be

entered in the register.

1. Date of transaction

2. Quantity received, if any; the name and address of the supplier and relevant

licence number held by him.

3. Name of the drugs.



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4. Quantity supplied.

5. Manufacturer's name

6. Batch number or lot number

7. Name and address of the purchaser/patient

8. Reference number of the prescription against which supplies were made

9. Bill number and date in respect of purchases and supplies made by him

10.Signature of the person under whose supervision the drugs have been supplied.

f) Give 'conditions of license' for retail sale of schedule X drugs. ( 3 marks)

Ans. Conditions of licence in form 20F (retail sale of schedule X drugs):

1. The license shall be displayed in a prominent place of the premises open to the public.

2. The licensee shall comply with the provisions of the Drugs and Cosmetics Act,1940

and rules and thereunder.

3. No drug shall be sold unless such drug is purchased under cash or credit memo from a

duly licensed dealer or a duly licensed manufacturer.

4. Substance specified in Schedule X should be sold only in accordance with the

prescription of RMP. In case of substance specified in Schedule X, the prescription

should be in duplicate, one copy of which is retained by licensee and preserved atleast for

two years.

5. A prescription of a RMP against which, drugs from schedule X supplied should

i) Be in writing and signed by the person giving it with his usual signatures and be dated.

ii) Specify the name and address of the patient or name and address or the owner of the

animal if drug is for veterinary use.

iii) Indicate total amount of drug supplied and doses to be taken.



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Subject Code: 0814 Model Answer Page No. 11/26

Q 3. Answer any FOUR of the following: 12 marks

a) Explain the role of Pharmacist in relation to his ‘trade’. (3 marks)

A] Price Structure-

•Prices of drugs & medicinal preparations charged from the customers should be fair &

including dispensing & compounding charges without unduly taxing the purchaser.

B] Fair trade practice-

•A pharmacist should not make any attempt to capture the business of fellow pharmacist by

unhealthy competition i.e. by offering reduced price, gifts, prizes etc.

•Trade mark, labels, symbols or any other signs of other pharmacist should not be copied or

imitated.

•Drugs or other ingredients required should always be purchased from reputable sources.

C] Hawking of drugs & other-

• Hawking of drugs & medicines should not be practised & any attempt should not be made to

collect the orders from door to door.

• Self servicing method in the pharmacy or drug stores should not be allowed as it would

encourage self medication which is undesirable & dangerous.

D] Advertisement & display-

• There should not be any display or advertisement on the premises, in the newspaper or

elsewhere regarding the abilities & services provided by the pharmacy.

• The pharmacist should not make such advertisement which contains:

(i) Misleading or exaggerated statements

(ii) A guarantee of therapeutic efficiency.

(iii) The word ‘cure’ in reference to an ailments or symptoms of ill-health.



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E) Purchase of drugs:-

Pharmacist should purchase drugs of standard quality only. He should purchase drugs under cash

or credit memo from a duly licensed manufacturers and dealers. He should not purchase

substandard quality, adulterated drugs or misbranded drugs.

b) Define ‘Central Register’ and explain how ‘Central Register’ is prepared and

maintained u/s 15A of the Pharmacy Act, 1948.

Ans.) Definition- (1 mark) Register of pharmacists maintained by the Central Council.

Preparation of Central Register – (2 marks)

Under the provision of section 15-A of the amendment in 1976, Central Council has to

Maintain in a prescribed manner a register of pharmacist known as ‘Central Register. It

contains names of all persons whose name is for the time being entered in registers of different

States. Registrar of each State Council is required to supply five copies of its register to the

Central Council as soon as after the 1st

April every year. All additions or amendments in the

State register are to be informed by the Registrars of each State Council to the Central Council

from time to time. Thus Central Register is a compilation of all State registers.

Registrar of the Central Council is duty bound to keep the Central Register in the manner

prescribed by the Council. He is also required to revise the Central register from time to time

and publish the same in the Gazette of India. The Central Register is deemed to be a public

document within the meaning of the Indian Evidence Act, 1872.

c) Define the term ‘Bulk Drug’ and ‘Formulation’ as per the (P.C.) order, 1995.

Bulk drug :- (1 marks)

It means any pharmaceutical, chemical, biological or plant product including its salts, esters,

stereoisomer’s and derivatives, conforming to pharmacopoeial or other standards specified in the

Second Schedule to the Drugs and Cosmetics Act, 1940 and which is used as such or as an

ingredient in any formulation.



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Formulation :- (2 marks)

It means a medicine processes 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 or 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 medicine)

(b) Any medicine included in the Homeopathic system of medicine and

(c) Any substance of which the provisions of Drugs and Cosmetics Act, 1940 (23 of

1940) do not apply.

d) Give aim and object of the drugs (P.C.) order 1995 and formula for calculation of retail

price of formula for calculation of retail price of formula under DPCO 1995.

Aim: (1/2 mark): To exercise Governmental control over the prices of bulk drugs as well as

drug formulations

Objectives of DPCO 1995: (1/2 mark, any 2 points)

i) In order 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.

Calculation of retail price of formulation:(formula-1 mark,terms-1 marks)

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) + E.D.

Where R.P.:- Means retail price.

M.C.:- means material cost which includes the cost of drugs and other pharmaceutical aids with

overages , if any, plus process loss thereon in accordance with the norms specified from

time to time by notification in the official Gazette.



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C.C.:- means conversion cost worked out in accordance with such norms as may be specified by

the Government from time to time by notification in the official Gazette.

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.

e) How ‘Veterinary Drugs and schedule X drugs’ are stored in a medical store?

Ans. ‘Veterinary Drugs’ (1.5 marks)

Veterinary Drugs should be stored:-

i) In a cupboard or drawer reserved for storage of veterinary drugs and shall be labeled with

direction, “NOT FOR HUMEN USE” for the treatment of animals only.; or

ii) In a portion of the premises separated from the remainder of the premises to which

customers are not permitted to have access.

‘Schedule X drugs’ ( 1.5 marks)

‘Schedule X drugs’ should be stored under lock and key in cupboard or drawer reserved

solely for the storage of these substances; or in a part of the premises separate from the

remainder of the premises and to which only responsible persons have access.



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f) Give duties of Drug Inspector in relation to manufacture of drugs and cosmetics.

Ans. Duties of Drug Inspector-(Each point carries ½ mark, 3 marks)

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 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.

Q 4 Answer any FOUR of the following: 12 marks

a) Explain the role of pharmacist in relation to the ‘Medical Profession’.(3 marks)

I) Limitation of professional activity-

Pharmacist should not interfere with the duties of physician. He should carry out only his own

duties that is compounding and dispensing. Under no circumstances, he should diagnose the

patient and prescribe the remedies even though requested by the patient. In emergency, he should

provide first aid services to victim.

II) Clandestine arrangement-

Pharmacist should not enter into any secret agreement or contract with physician that is by

offering commission for recommending his medical store.

III) Liaison with public-

Pharmacist is a link between doctor and patient. He should have up-to-date knowledge about the

developments in pharmacy profession. For this purpose he should be always in constant touch

with the periodicals, journals, magazines related to the pharmacy profession which are published

from time to time. He should advice to physician on the pharmaceuticals. Also, he should

educate the patient regarding certain techniques of administration of drugs.



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b) How ‘State Pharmacy Council’ is constituted under the Pharmacy Act 1948?(3 marks)

Ans. Constitution of State Pharmacy Council:

1. 6 members, elected amongst themselves (delete ‘by’) registered pharmacists of State.

2. 5 members nominated by the State Government of whom at least 3 should possess

(delete ‘ing’) a prescribed degree or diploma in pharmacy or pharmaceutical chemistry or

shall be a registered pharmacists of State.

3. One member elected from amongst themselves the members of Medical Council of the

State.

The following are the ex-officio members:

4. Chief Administrative Medical Officer of the State.

5. The Officer Incharge of the drug control organization in the state; appointed under D.&C.

Act,1940.

6. Government Analyst appointed under Drugs and Cosmetics Act 1940. If there are more

than one such Analyst, one may be nominated by the State government.

(c) Define: (each definition 1½ marks)

Ans.

Medicinal preparation: It includes the drugs used as a remedy or prescription prepared for

internal or external use of human beings or animals and all substances intended to be used for or

in treatment, mitigation or prevention of disease in human being or animals.

Toilet preparation: The preparation intended to be used in the toilet of human body or in

perfuming apparel of any description, or any substance intended to cleanse, improve or alter the

complexion, skin, hair or teeth, and includes deodorants and perfumes.



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a) Differentiate between Bonded and Non-bonded laboratory (Three points) as per

M.T.P. Act 1955. (each point 1 mark, any 3 points)

Sr.

No

Bonded Laboratory Non-bonded Laboratory

1. It means the premises or any part of the

premises approved & licensed for the

manufacture & storage of medicinal &

toilet preparations containing alcohol,

opium,Indian hemp & other narcotic

drugs or narcotics on which duty has not

been paid.

It means the premises or any part of the

premises approved & licensed for the

manufacture & storage of medicinal &

toilet preparations containing alcohol,

opium, Indian hemp & other narcotic

drugs or narcotics on which duty has

been paid.

2. Excise duty payable on removal of

goods from bonded laboratory.

Excise duty payable at the time of spirit

purchase.

3. Alcohol on which duty has not been paid

shall be used under the excise supervision

Only the alcohol on which duty has

already been paid shall be used

4. Preparations are deemed to be

manufactured

in bond when they are manufactured in

premises licensed for this purpose.

Preparations are deemed to be

manufactured outside bond when they

are manufactured in premises licensed

for this purpose

5 Bonded laboratory to function under

excise staff.

No excise staff is required.

6 License required should be obtained

from Excise Commissioner.

License required should be obtained

from the officer as the State

Government may authorize on this

behalf.

7 Suitable for large scale manufacture. Suitable for small scale manufacture.



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e) Penalty for :

i) Using a report of Government analyst for advertising purpose.(1 ½ mark)

whoever uses any report of a test or analysis made by the Central Drug Laboratory or by a

Government Analyst, or any extract from such report , for the purpose of advertising any drug

shall be punishable with fine which may extend to 5000/- Rs on first conviction. &whoever

having been convicted of an offence under the sec.29 is again convicted of an offence shall be

punishable with two years imprisonment, or with fine which shall not be less than 10,000/- Rs or

with both .

ii) Non disclosure of name of the manufacturer. (1 ½ mark)

Whoever contravenes the provisions of Section 18-A shall be punishable with imprisonment for

a term which may extend to one year, or with fine which shall be less than 20,000/- Rs or with

both.

f) Ex-Officio members of Drug Technical Advisory Board ( 3 marks )

i) The Director-General of Health Services, who is the chairman of the Board.

ii) The Drug Controller of India

iii) The Director of the Central Drug Laboratory, Calcutta.

iv) The Director of the Central Research Institute, Kasauli.

v) The Director of the Central Drug Research Institute, Lucknow.

vi) The Director of the Indian Veterinary Research Institute, Izatnagar.

vii) The President, Pharmacy Council of India.

viii) The President, Medical Council of India.



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QUE. 5 Attempt any FOUR of the following (Each question carries THREE marks)

a) Education Regulations: ( 3 marks) Subject to the provision of section 10 of the Pharmacy

Act, 1948, Central Council after approval of the Central Government may make regulations

prescribing the minimum standard of education required for qualification as pharmacist called

Education Regulations and prescribe:

1. Minimum qualification for admission to the course.

2. Nature and period of course of study.

3. Nature and period of practical training to be undertaken after completion of regular course

(Not less than 500 hours covered in a minimum of 3 months in an institution, hospital, pharmacy

or dispensary recognized by Central Council).

4. Subjects of examination and standards attained therein.

5. Equipment and facilities to be provided by institutions for students undergoing approved

course of study.

6. Conditions to be fulfilled by institutions giving practical training.

7. Conditions to be fulfilled by authorities holding approved examinations.

b) Procedure for obtaining Rectified spirit for a Bonded Laboratory (3 marks )

The spirit required for the manufacture in bond shall be obtained on an indent in triplicate

countersigned by the officer-in-charge of the laboratory approved spirit store or distillery. On the

receipt of such indent, distillery or warehouse officer shall issue the spirit under appropriate

permit and send advise portion of such permit to officer-in-charge. Excise officer of bonded

manufactory shall verify the strength and volume of rectified spirit. He shall make the entry of

such supply in register. Rectified spirit shall be then verified in volume, strength, entered in the

register and then store in spirit store. Spirit shall be stored in permanent vessels of spirit stores of

bonded laboratory. The cost of rectified spirit shall be paid by the licensee to the respective

distillery or warehouse officer.



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c) Offences & Penalties under Medical Termination of Pregnancy Act,1971

(Offence 11/2

marks & Penalties 11/2

marks)

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 shall

be an offence punishable with rigorous imprisonment for a term which shall not be 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.

d) Issue of alcoholic preparation for sale from Bonded Laboratory-( 3 marks)

Alcoholic preparations from a bonded laboratory can be taken out by a manufacturer by making

an application to the Excise Officer in the prescribed form after paying duty on it. The Excise

Officer after checking the entries and realising the duty payable, allows the required quantities to

be removed after issuing a permit. Preparations issued to bonded warehouse or for export or to

institutions entitled to receive duty free preparations, may be issued without payment of duty.

Instead of paying duty on every consignment, an advance sum may be deposited to the credit of

the collecting Government. The licensee is required to maintain accounts in proper forms and

registers. He should also deliver to the officer-in-charge, by the 5th of each months, a return of

transaction of business in respect of the preceding month. Supervisory staff for a bonded

laboratory is decided by the Excise Commissioner in consultation with the licensee. Excise

Officer especially empowered in this behalf, shall inspect the manufactory and submit the report.

Dutiable goods cannot be delivered from a bonded manufactory or a bonded warehouse before 6

a.m. and after 6 p.m. nor at any hour on Sundays or other holidays.



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The licensee of a bonded manufactory or warehouse shall be held responsible for removal of

dutiable goods by any person and shall be liable to be dealt with as if he had removed the good

himself.

e) Penalties: ( Each penalties 11/2

marks)

(i) Any drug deemed to be spurious but which is not likely to cause death or any grievous hurt to

health as per D&C Act,1940 shall be punishable with imprisonment not less than seven years but

which may extend to imprisionment for life and with fine not less than 3 lakh on first conviction

and with imprisonment not less than ten years which may extend to imprisionment for life with

fine not less than 3 lakh on subsequent conviction. or three times value of the drugs confiscated,

whichever is more.

(ii) Sale of drug without valid license- on first conviction Imprisonment 3- 5 years &

Fine not less than 1 lakh rupees. On subsequent conviction Imprisonment 7 – 10 yrs &

Fine not less than 2 lakh rupees or three times value of the drugs confiscated, whichever is

more.

f) Duties of Government Analyst- (11/2

marks)

(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

Procedure for dispatch of sample to the Government Analyst from Drug Inspector-

(11/2

marks)

1. The portion of sample or the container sent by an inspector to the government analyst for

test or analysis under subsection(4) of section 23 of the Act shall be sent by registered

post or by hand in a sealed packet, enclosed together with a memorandum in form 18,in

an outer cover addressed to the Government Analyst.



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Subject Code: 0814 Model Answer Page No. 22/ 26

2. A copy of the memorandum and a specimen impression of the seal used to seal the packet

shall be sent to the Government Analyst separately by registered post or by hand.

Procedure on receipt of sample from Drug Inspector-

(1) Government Analyst compares the seals on the package or an portion of samples or

container with the specimen impression of the seal received separately & note the

conditions of the seal on the package.

(2) On completion of test or analysis, he supplies to the Inspector a report of analysis

in triplicate in form 13 together with full protocol of the test applied

(3) If purchaser wants to analyze or test drug or cosmetics, he has to make an

application for test or analysis in form 14-A accompanied with prescribed fees

(4) Report of test or analysis of such Drug or Cosmetic is to be supplied in in form 14

B by Govt. Analyst.

Que.6 Attempt any FOUR of the following (Each question carries four marks)

a) Objectives and scope of pharmaceutical legislation:

Objectives- (any 4 points, 2 mark )

1) To promote health care system by regulating the manufacture, supply & distribution of good

quality drugs.

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

Scope of pharmaceutical legislation in India ( any 4 points, 2marks )

1) It is related with legal system which regulate the conduct of pharmacy business & practice of

profession of pharmacy.

2) A thorough understanding of all laws pertaining to pharmacy is essential & all legal aspects

must be satisfied by those who wish to practice the pharmacy business.



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3) It helps the pharmacist to understand their legal & ethical responsibilities & their by avoid the

danger of unnecessary legal proceedings.

4) The patient should gets the drugs of good quality which are tested & evaluated for safety

purpose.

5) It also covers the legal aspect relating to manufacture of drugs in Pharmaceutical industries,

their storage, sale, distribution.

6) The Pharmaceutical Legislation safeguards the health of the people by making right

medication by controlling pharmacy business & profession.

Due considerations should be given to the following points rather than general points

Drugs and Cosmetics Act, 1940 came into existence to control the import, manufacture,

distribution and sale of drugs and cosmetics.

To regulate profession and business of pharmacy, the Pharmacy Act, 1940 came into existence.

Drugs and Magic Remedy (Objectionable Advertisements) Act, 1954 came into existence to

control the advertisements in certain cases and to prohibit the advertisements in certain purposes

of magic remedy.

To regulate an equitable distribution of bulk drugs and to make drugs available, Drugs and Price

Control Order, 1995 came into existence.

To provide for levy and collection of duties of excise on medicinal and toilet preparations, MTP

Act, 1955 came into existence.

ND and PS Act, 1985 came into existence to consolidate and amend the laws related to narcotic

drugs and psychotropic substances and to make stringent provisions for control of various

operations related to such substances.



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b) Define the term:

(i) ‘Drug’- ( 2marks)

a) 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;

b) 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 human beings or animals.

c) All substances intended for use as components of a drug including empty gelatin

capsules; and

d) Such devices intended for internal or external use in the diagnosis, 'treatment, mitigation

or prevention of disease or disorders in human beings or animals.

ii) (any one definition 2 marks)

PATENT OR PROPRIETARY MEDICINE (Except Ayurvedic Siddha and Unani):

means -

A drug for internal or external administration of human beings or animals prepared according to

the formulae other than those included in the I.P. or any other pharmacopoeia or official book.

OR

PATENT OR PROPRIETARY MEDICINE (Ayurvedic, Siddha or Unani):

All formulations containing only such ingredients mentioned in the formulae described in the

authoritative books of Ayurveda, Siddha, or Unani systems of medicine specified in the First

schedule but does not include medicines for parenteral use and a formulation included in the

authoritative books listed in the First schedule.



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C) List of Licenses ( with form number)

Licence Issued Drugs other than sch. C, C(1)

For retail sale- Form 20 ( 2 marks )

For wholesale- Form 20-B (2 marks)

d) Offences & Penalties under Drugs & Magic Remedies (O.A.) Act,1954

(2 mark for offences & 2 mark for penalties)

Offence- 1) Contravention of any of the provision of this Act or Rules-

Penalties : Imprisonment 6 month or with fine or with both on 1st convection .

Imprisonment 1 year or with fine or with both on subsequent convection

Offence- 2) 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 in-charge of & was responsible for the

conduct of company business shall be deemed to be guilty & liable for the punishment

However, such person is not liable for the punishment if he proves that the offence was

committed without his knowledge or he has taken all the precautions to prevent that the

commission of such offence.

e) Operations controlled by Central government under N.D.P.S. Act, 1985 (4 marks)

i) Government shall fix from time to time the limits within which licences may be given for the

cultivation of opium poppy.

ii) All opium, the product of land cultivated with the opium poppy shall be delivered by the

cultivators to the officers authorized on behalf of Central Government.

iii) The Central Government may from time to time fix the price to be paid to the cultivators

from the opium delivered.

iv) The rules may prescribe the forms and conditions of licences or permits for the manufacture,

possession, transport, import inter-state, export inter-state, sale, purchase, consumption or use of



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psychotropic substances. The rules may also prescribe the authorities granted and the fees that

may be charged therefor.

v) The rules may prescribe the forms and conditions of licences for cultivation of the opium

poppy and for the production and manufacture of opium. The rules may also prescribe the fees

that may be charged therefore the authorites by which such licences may be granted, withheld,

refused or cancelled and the authorities before which appeals against the orders of withholding,

refusal or cancellation of licences shall lie.

vi) The rules may prescribe that opium shall be weighed, examined and classified according to

its quality and consistence by the officers authorized in this behalf by the Central government in

the presence of the cultivator at the time of delivery by the cultivator.

vii) The rules may provide for the weighment, examination and classification according to the

quality and consistence of the opium received at the factory and the deductions from or addition

to the standard price to be made in accordance with the result of such examinations.

f) Possession & Sale of specified poisons : (4 marks)

The State Govt. may regulate the Possession & Sale of poison within the state. The sale may be

wholesale or retail. The rules may be applicable for the whole or any part of the territories under

the administration of the state.

Such a rules may provide for-

i) Grant of licenses for the possession of any specified poison for sale, either wholesale or retail.

ii) Fixing of fees to be charged for such a licenses

iii) The classes of persons to whom the licenses for the possession & Sale of poisons are to be

granted.

iv) Maximum quantity of such poison which may be sold any person

v) Maintenance of Register for the sale of poisons & inspection of the same.

vi) Safe custody of poisons & the labeling of the vessel, coverings or packages in which such

poison is sold or stored for sale.

vii) Inspection & Examination of any such poison possessed for sale by any vendor



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maharashtra state board of technical education (autonomous...

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