Question bank

III Pharm D
Pharmaceutical Jurisprudence
Chapter 1– Pharmaceutical legislation
5 marks questions
Q1. Give an account of pharmaceutical legislations in India.
 Government of India on 11th August 1930, appointed a committee under the chairmanship
of Late Col. R.N.Chopra to see into the problems of Pharmacy in India and recommend the
measures to be taken. This committee published its report in 1931. It was reported that there
was no recognized specialized profession of Pharmacy. A set of people known as
compounders were filling the gap.
Just after the publication of the report Prof. M.L.Schroff (Prof. Mahadeva Lal Schroff)
initiated pharmaceutical education at the university level in the Banaras Hindu University.
 In 1935 United Province Pharmaceutical Association was established which later converted
into Indian Pharmaceutical Association.
 The Indian Journal of Pharmacy was started by Prof. M.L. Schroff in 1939. All India
Pharmaceutical Congress Association was established in 1940. The Pharmaceutical
Conference held its sessions at different places to publicize Pharmacy as a whole.
 1937: Government of India brought ‘Import of Drugs Bill’; later it was withdrawn.
 1940: Govt. brought ‘Drugs Bill ‘to regulate the import, manufacture, sale and distribution
of
 drugs in British India. This Bill was finally adopted as ‘Drugs Act of 1940’.
 1941: The first Drugs Technical Advisory Board (D.T.A.B.) under this act was constituted.
Central Drugs Laboratory was established in Calcutta
1945: ‘Drugs Rule under the Drugs Act of 1940’ was established.

 The Drugs Act has been modified from time to time and at present the provisions of the Act
cover Cosmetics and Ayurvedic, Unani and Homeopathic medicines in some respects.
1945: Govt. brought the Pharmacy Bill to standardize the Pharmacy Education in
India
 1946: The Indian Pharmacopoeial List was published under the chairmanship of late
Col.R.N. Chopra. It contains lists of drugs in use in India at that time which were not
included in British Pharmacopoeia.
1948: Pharmacy Act 1948 published.
 1948: Indian Pharmacopoeial Committee was constituted under the chairmanship of late Dr.
B.N. Ghosh.
 1949: Pharmacy Council of India (P.C.I.) was established under Pharmacy Act 1948.
 1954: Education Regulation have come in force in some states but other states lagged
behind.
 1954: Drugs and Magic Remedies (Objectionable Advertisements) Act 1954 was passed to
stop misleading advertisements (e.g. Cure all pills)
  1955: Medicinal and Toilet Preparations (Excise Duties) Act 1955 was introduced to
enforce uniform duty for all states for alcohol products.
 1955: First Edition of Indian Pharmacopoeia was published.
 1985: Narcotic and Psychotropic Substances Act has been enacted to protect society from
the dangers of addictive drugs.
 Govt. of India controls the price of drugs in India by Drugs Price Order changed from time
to time.
2. Describe the recommendations made by Chopra committee
Government of India on 11th August 1930, appointed a committee under the chairmanship of Late
Col. R.N.Chopra to see into the problems of Pharmacy in India and recommend the measures to be
taken.
The recommendations of Chopra Committee(drugs enquiry committee) are as follows:
 Setting up the course of training of pharmacist and prescribe minimum qualification for the
registration as the pharmacist
 Appointment of advisory board to advice the government in making rules to carry out the
objectives of the act.
 Establishment of well-equipped CDL with competent staff and experts.
 Creation of drug control machinery departments at centre with branches in all states.
 The committee recommended the formation of Central Pharmacy council and the Provincial
(State) pharmacy councils which would look after the education and training of
professionals.
 It suggested the creation of drug control machinery (Department) at the centre with branches
in all states.
Establishment of well-equipped CDL with competent staff and experts for an efficient and speedy
working of Drug Control Department
3. Write contributions of Joseph Bhore committee to pharmacy profession
Bhore Committee was set up by Government of India in 1943. It was a health survey taken by a
development committee to assess health condition of India under the chairmanship of Sir Joseph
William Bhore.
The important recommendations of Bhore Committee were:
 Integration of preventive and curative services of all administrative levels
 Development of Primary Health Centres in 2 stages:
 Short-term measure – one primary health centre as suggested for a population of
40,000. Each PHC was to be manned by 2 doctors, one nurse, four midwifes, four
trained dais, two sanitary inspectors, two health assistants, one pharmacist and 15
other class IV employees.
 Secondary health centre was also envisages to provide support to PHC, and to
coordinate and supervise their functioning.
 A long-term programme (also called 3 million plan) of setting up primary health
units with 75-bedded hospitals for each 10,000 to 20,000 population and secondary
units with 650-bedded hospital, again regionalised around district hospitals with
2500 beds.
 Major changes in medical education which includes 3-month training in
preventive and social medicine to prepare social physicians
4. Write final recommendations of Drug Enquiry Committee.
Recommendations made by Drug Enquiry Committee
 Setting up the course of training of pharmacist and prescribe minimum qualification for the
registration as the pharmacist
 Appointment of advisory board to advice the government in making rules to carry out the
objectives of the act.
 Establishment of well-equipped CDL with competent staff and experts.
 Creation of drug control machinery departments at centre with branches in all states.
 The committee recommended the formation of Central Pharmacy council and the Provincial
(State) pharmacy councils which would look after the education and training of
professionals.
 It suggested the creation of drug control machinery (Department) at the centre with branches
in all states.
 Establishment of well-equipped CDL with competent staff and experts for an efficient and
speedy working of Drug Control Department

5. Discuss pre-independence pharmaceutical legislation of India

History of pharmacy legislation in India

- In the early part of the 20th century, there was practically no legislative control on drugs as well
as on the profession of pharmacy. Although the Opium Act, 1878, the poison act 1919 and the
dangerous drugs act, 1930 were in force, these were specific in nature and grossly inadequate in
controlling the chaotic conditions prevailing at that time. In 1927, a resolutions was passed by the
council of states to recommend to the Governor General in Council to usage all Provisional
Governments to take immediate steps to control indiscriminate use of drugs and to legislate for the
standardization of the preparation and sale of drugs. The government of India in pursuance to the
resolution appointed a committee known as the Drugs Enquiry Committee in 1928.

Government of India on 11th August 1930, appointed a committee under the chairmanship of Late
Col. R.N.Chopra to see into the problems of Pharmacy in India and recommend the measures to be
taken. This committee published its report in 1931. It was reported that there was no recognized
specialized profession of Pharmacy. A set of people known as compounders were filling the gap.
Just after the publication of the report Prof. M.L.Schroff (Prof. Mahadeva Lal Schroff) initiated
pharmaceutical education at the university level in the Banaras Hindu University.
In 1935 United Province Pharmaceutical Association was established which later converted into
Indian Pharmaceutical Association.
The Indian Journal of Pharmacy was started by Prof. M.L. Schroff in 1939. All India
Pharmaceutical Congress Association was established in 1940. The Pharmaceutical Conference
held its sessions at different places to publicize Pharmacy as a whole.
1937: Government of India brought ‘Import of Drugs Bill’; later it was withdrawn.
1940: Govt. brought ‘Drugs Bill ‘to regulate the import, manufacture, sale and distribution of
drugs in British India. This Bill was finally adopted as ‘Drugs Act of 1940’.
1941: The first Drugs Technical Advisory Board (D.T.A.B.) under this act was constituted. Central
Drugs Laboratory was established in Calcutta
1945: ‘Drugs Rule under the Drugs Act of 1940’ was established.

2 marks questions
1. Give the recommendations of ‘Hathi Committee’
The report of Hathi’s Committee (1935) is an important landmark in the
development of Indian pharmaceutical industry.
The report of the committee covered
 Licensing of drugs
 Price control
 Import
 Role of foreign sector
 Quality control
It encourages the development of indigenous industries.
It also further controlled price of large no; of drugs in the interest of the
consumer.
2. Give future trends in pharmaceutical legislation
There is always need of amendments in the present Act and Rules considering the
past experience, present conditions and future requirements.
The Drugs and Cosmetics Act 1940, and rules 1945 thereunder were amended many
a times to make and improve quality of pharmaceutical Schedule E, I and L were
deleted. Schedule G and H were revised and expanded. The new schedule X was
included. Schedule M and schedule Y were introduced in the drugs and cosmetics
act and rules thereunder in 1988. Good Manufacturing Practices (GMP) are means to
ensure the quality of drugs.
3. What is CDSCO
CDSCO stands for Central Drugs Standard Control Organisation.
It is the national regulatory body for Indian pharmaceuticals and medical devices which is under the
control of Drug Controller General of India (DCGI).
  The DCGI regulates pharmaceutical and medical devices, under the Government of
Ministry of Health and Family Welfare.

4. Give two recommendations made by Bhatia Committee

Government of India in 1953 appointed a committee under the chairmanship of Major General S.L
Bhatia which is called Bhatia Committee or Pharmaceutical Enquiry Committee.
Recommendations:
 Government Medical Store;
The manufacturing activities of government medical stores should be reorganised and their
method of management changed to confirm to commercial practices.
 Penicillin factory (Hindustan Abs.Ltd)
A well-equipped research laboratory and a pilot plant should be set up for carrying out
investigations side by side with manufacture to keep pace with rapid development in the
field of antibiotics.

5. List four key functions of CDSCO

 Laying down standards of drugs, cosmetics, diagnostics and devices.
 To regulate market authorisation of new drugs.
 To regulate clinical research in India
 Laying down regulatory measures, amendments to Acts and Rules.
 To regulate standards of imported drugs
6. Give two recommendations made by Drug Enquiry Committee
 Setting up the course of training of pharmacist and prescribe minimum qualification for the
registration as the pharmacist
 Appointment of advisory board to advice the government in making rules to carry out the
objectives of the act.
 Establishment of well-equipped CDL with competent staff and experts.
 Creation of drug control machinery departments at centre with branches in all states.

7. Give significance of Drug Enquiry committee.

 The committee recommended the formation of Central Pharmacy council and the Provincial
(State) pharmacy councils which would look after the education and training of
professionals.
 It suggested the creation of drug control machinery (Department) at the centre with branches
in all states.
 Establishment of well-equipped CDL with competent staff and experts for an efficient and
speedy working of Drug Control Department
8. Justify repealing of the ‘dangerous drugs act’ into Narcotics and Psychotropic substances act’.
The dangerous Drugs Act 1930 which was enacted in accordance with Geneva Agreement of
League of Nations of 1925.
 It failed to curb the measure of habit forming drugs like cocaine, morphine, ganga etc.
 As such as more comprehensive Act namely Narcotics and Psychotropic Substances Act
has been enacted by the Parliament in 1985 to protect society from dangerous to additive
drugs.
9. State importance of CDSCO.
Under the D&C Act, the regulation of manufacture, sale and distribution of drugs is primarily the
concern of State Authorities while the CDSCO are responsible for approval of:
 New drugs
 Clinical trials in the country
 Control over quality of imported drugs.
 Coordination of activities of State Drug Control Organisations
 Providing expert advice with a view of bringing about uniformity in the enforcement of
D&C Act.
10. State Indian drug Policy
The major drug laws of India are the Narcotic and Psychotropic Substances Act (1985) and the
Prevention of Illicit Trafficking in Narcotic Drugs and Psychotropic Substances Act (1985)
Under the NDPS Act, it is illegal for a person to produce/manufacture/cultivate , possess, sell,
purchase , transport, store, and/or consume any narcotic drug or psychotropic substance.
The Prevention of Illicit Trafficking in Narcotic Drugs and Psychotropic substances Act was
established to enable the full implementation and enforcement of the Narcotic Drugs and
Psychotropic Substances Act of 1985

Chapter 2- principle & significance of professional ethics

5 marks questions
1. Discuss the code of ethics for pharmacists in relation to his trade.

Ethics may be defined as “the code of moral principles” or as “the science of morals”. The
conduct of individuals in any society is governed by governmental controls as well as social
customs and duties. The code of ethics framed by the Pharmacy Council of India is meant to
guide the Indian Pharmacist as to how he should conduct himself in relation to himself, his
patrons and the general public, co-professionals, and members of the medical and other
health professions
 Following are the provisions which pharmacist should keep in mind while dealing with his
trade:
(i)Price structure
The prices charged should be fair keeping with the quality, quantity and labour or skill
required.
(ii)Fair trade practice
Fair practice should be adopted by a pharmacist in the trade without any attempt to capture
other pharmacist’s business.
If a customer brings a prescription (by mistake) which should be genuinely by some other
pharmacy the pharmacist should refuse to accept the prescription.
Imitation of copying of the labels, trade marks and other signs or symbols of other
pharmacy should not be done.
(iii)Purchase of drugs
Pharmacists should buy drugs from genuine and reputable sources.
(iv)Advertising and Displays
The sale of medicines or medical appliances or display of materials in undignified style on
the premises, in the press or elsewhere are prohibited
Q2. Discuss the code of ethics for pharmacists in relation to his job.

Ethics may be defined as “the code of moral principles” or as “the science of morals”. The conduct
of individuals in any society is governed by governmental controls as well as social customs and
duties. The code of ethics framed by the Pharmacy Council of India is meant to guide the Indian
Pharmacist as to how he should conduct himself in relation to himself, his patrons and the general
public, co-professionals, and members of the medical and other health professions

Pharmacist in relation to his job

A pharmacist should keep the following things in relation to his job.
(i)Pharmaceutical services
Pharmacy premises (medicine shops) should be registered. Emergency medicines and common
medicines should be supplied to the patients without any delay.
(ii)Conduct of the Pharmacy
Error of accidental contamination in the preparation, dispensing and supply of medicines should be
checked in a pharmacy.
(iii)Handling of Prescription
A pharmacist should receive a prescription without any comment on it that may cause anxiety to the
patient. No part of the prescription should be changed without the consent of the prescriber. In case
of changing the prescription should be referred back to the prescriber.
(iv)Handling of drugs
A prescription should always be dispensed correctly and carefully with standard quality drug or
excipients. Drugs that have abusive potential should not be supplied to any one.
(v)Apprentice Pharmacist
Experienced pharmacists should provide all the facilities for practical training of the apprentice
pharmacists. Until and unless the apprentice proves himself or herself certificate should not be
granted to him / her.
 Q3 Define Code of Ethics. Explain Receiving and Handling of prescription by pharmacist

Ethics may be defined as “the code of moral principles” or as “the science of morals”. The
conduct of individuals in any society is governed by governmental controls as well as social
customs and duties. The code of ethics framed by the Pharmacy Council of India is meant to
guide the Indian Pharmacist as to how he should conduct himself in relation to himself, his
patrons and the general public, co-professionals, and members of the medical and other
health professions. Profession of Pharmacy is a noble profession as it is indirectly healing
the persons to get well with the help of medical practitioners and other co-professionals.
Government has restricted the practice of Pharmacy to only Profession Pharmacists i.e.
registered Pharmacist under the Pharmacy Act 1948.

Receiving of prescription:
When a prescription is presented for dispensing, it should be received by a pharmacist without any
discussion or comment over it regarding the merits and demerits of its therapeutic efficiency. The
pharmacist should not even show any physiognomic expression of alarm or astonishment upon the
receipt of the prescription, as such things may cause anxiety in patients or their agents and may
even shake their faith in their physician.
Any question on a prescription should be answered with very caution and care; it should neither
offend a patron nor should it disclose any information which might have been intentionally
withheld from him.
It is not within the privilege of a pharmacist to add, omit or substitute any ingredient or alter the
composition of a prescription, without the consent of the prescriber unless the change is emergent
or is demanded purely by the technique of the pharmaceutical art and does not cause any alteration
in the therapeutic action of the recipe. In case of any obvious error in it, due to any omission,
incompatibility or over dosage, the prescription should be referred back to the prescriber for
correction of approval of change suggested. While such an act is imperative in the best interest of
the patients, in no case should it be done in a manner which may jeopardize the reputation of the
prescriber concerned.
In the manner of refilling prescriptions, a pharmacist should solely be guided by the instructions of
the prescriber and he should advise patients to use medicines or remedies, strictly in accordance
with the intension of the physician, as noted in the prescription.
Handling of prescription.
All possible care should be taken to dispense a prescription correctly, by weighing and measuring
all ingredients in correct proportions, by the help of scales and measures; visual estimations must be
avoided. Further, a pharmacist should always use drugs and medicinal preparations of standard
quality. He should never fill his prescriptions with spurious, substandard and unethical
preparations.
A pharmacist should be very judicious in dealing with drugs and medicinal preparations known to
be poisonous or to be used for addition or other abusive purposes.
Such drugs and prescriptions should not be supplied to anyone, if there is reason to suppose that is
required for such purposes.
Q4. Discuss the code of ethics for pharmacists in relation to his medical profession.
Regarding to the profession the following code of ethics should be fulfilled.
(i)Professional vigilance
A pharmacist must abide by the pharmaceutical laws and he/she should see that other pharmacists
are abiding it.
(ii)Law-abiding citizens
The pharmacists should have a fair knowledge of the laws of the country pertaining to food, drug,
pharmacy, health, sanitation etc.
(iii)Relationship with Professional Organizations
A pharmacist should be actively involved in professional organization, should advance the cause of
such organizations.
(iv)Decorum and Propriety
A pharmacist should not indulge in doing anything that goes against the decorum and propriety of
Pharmacy Profession.
(v)Pharmacists Oath
A young prospective pharmacist should feel no hesitation in assuming the following pharmacist’s
oath:
· “I promise to do all I can to protect and improve the physical and moral well-being of society,
holding the health and safety of my community above other considerations. I shall uphold the laws
and standards governing my profession, avoiding all forms of misinterpretation, and I shall
safeguard the distribution of medical and potent substances.
· Knowledge gained about patients, I shall hold in confidence and never divulge unless compelled
to do so by law.
· I shall strive to perfect and enlarge my knowledge to contribute to the advancements of pharmacy
and the public health.
· I furthermore promise to maintain my honour in all transactions and by my conduct never bring
discredit to myself or to my profession nor to do anything to diminish the trust reposed in my
professional brethren.
· May I prosper and live long in favour as I keep and hold to this, my Oath, but if violated these
sacred promises, may the reverse be my lot.”
Q5. Briefly mention about the code of ethics for pharmacists framed by PCI.
Pharmacists are health professionals who assist individuals in making the best use of medications.
This Code, prepared and supported by pharmacists, is intended to state publicly the principles that
form the fundamental basis of the roles and responsibilities of pharmacists. These principles, based
on moral obligations and virtues, are established to guide pharmacists in relationships with patients,
health professionals, and society.
The profession of pharmacy is noble in its ideals and pious in its character. Apart from being a
career for earning livelihood it has inherent in it the attitude of service and sacrifice in the interests
of the suffering humanity.
The nature of pharmaceutical practice is such that its demands may be beyond the capacity of the
individual to carry out or to carry out as quickly or as efficiently as the needs of the public require.
There should, therefore at all times, be a readiness to assist colleagues with information or advice.
The code of ethics adopted by Pharmacy council of India is as follows
1. Pharmacists in Relation to his Job
 Scope of Pharmaceutical Services
 Handling of Prescriptions
 Handling of Drugs
 Apprentice Pharmacists
2. Pharmacists in Relation to his trade& Price Structure
 Fair Trade Practices
 Purchase of Drugs
 Hawking of Drugs
 Advertising and Displays-
No display material either on the premises, in the press or elsewhere should be used by a
pharmacist in connection with the sale to the public of medicines or medical appliances which is
undignified in style or which contains:-

(a) Any wording design or illustration reflecting unfavorably on pharmacists collectivity or upon
any group or individual.
(b) A disparaging reference, direct of by implication to other suppliers
(c) Misleading, or exaggerated statements or claims.
(d) The word "Cure" in reference to an ailment or symptoms of ill-health.
(e)A guarantee of therapeutic efficacy.
(f) An appeal to fear,
(g) An offer to refund money paid.
(h) A prize, competition or similar scheme.
(i) Any reference to a medical practitioner or a hospital or the use of the terms "Doctor" or "Dr." or
"Nurse" in connection with the name of the preparation not already established.
(j) A reference to sexual weakness, premature ageing or loss of virility.
(k) A reference to complaints of sexual nature in terms which lack the reticence proper to the
subject.

3. Pharmacists in Relation to Medical Profession & Limitation of Professional Activity

 Clandestine Arrangements
 Liaison with Public
4. Pharmacist in Relation to his Profession Professional Vigilance
 Law-abiding Citizens
 Relationship with Professional Organizations
 Decorum and Propriety

2 marks questions
1. What are the limitations of professional activity for a pharmacist as per code of
Pharmaceutical ethics?
i)Limitation of professional activity
The professional activity of the medical practitioner as well as the pharmacists should be
confined to their own field only.
Medical practitioners should not possess drugs stores and pharmacists should not diagnose
diseases and prescribe remedies.
A pharmacist may, however, can deliver first aid to the victim in case of accident or
emergency.
2. State Clandestine Arrangement

(ii)Clandestine arrangement:
Clandestine arrangement refers to secret arrangements made by a pharmacist with the doctor
to provide him gifts, money or certain advantages by recommending his pharmacy shop to
the patient.
A pharmacist should not enter into a secret arrangement or contract with a physician by
offering him any commission or any advantages.
3. Describe Professional vigilance as Code of Pharmaceutical Ethics
Professional vigilance
Pharmaceutical vigilance refers to the process by which Pharmacist obeys all the pharmaceutical
law and become a law abiding citizen and it is also the duty of the pharmacist to make sure that
other pharmacists are also following the law. If it came to the notice of the pharmacist that any
fellow pharmacist is engaged in some illegal activities, he should report it to regulatory authorities.
4. Enlist Code of Pharmaceutical Ethics in relation to his profession
Pharmacist in Relation To his Profession
 Professional Vigilance
 Law-abiding Citizens
 Relationship with Professional Organisations
 Decorum and Propriety

5. Enlist Code of Pharmaceutical Ethics in relation to medical profession.

Following are the code of ethics of a pharmacist in relation to medical profession:
(i)Limitation of professional activity
The professional activity of the medical practitioner as well as the pharmacists should be
confined to their own field only.
Medical practitioners should not possess drugs stores and pharmacists should not diagnose
diseases and prescribe remedies.
(ii)Clandestine arrangement
A pharmacist should not enter into a secret arrangement or contract with a physician by
offering him any commission or any advantages.
(iii)Liaison with public.
6. Justify pharmacist to be liaison with public as per code of pharmaceutical ethics.
A pharmacist should always maintain proper link between physicians and people. He should
advise the physicians on pharmaceutical matters and should educate the people regarding
health and hygiene. The pharmacist should be keep himself / herself up-to-date with
pharmaceutical knowledge from various journals or publications.
Any information acquired by a pharmacist during his professional activities should not be
disclosed to any third party until and unless required to do so by law.

7. How should be ‘conduct of pharmacy’ as per code of pharmaceutical ethics.

Error of accidental contaminaton in the preparatonn dispensing and supply of medicines
should be checked in a pharmacy.
No display material either on the premises, in the press or elsewhere should be used by a
pharmacist in connection with the sale to the public of medicines or medical appliances
which is undignified in style or which contains:-

Any wording design or illustration reflecting unfavourably on pharmacists collectivity or

upon any group or individual
A disparaging reference, direct of by implication to other suppliers
Misleading, or exaggerated statements or claims.
 The word "Cure" in reference to an ailment or symptoms of ill-health.
A guarantee of therapeutic efficacy.
An offer to refund money paid.
A prize, competition or similar scheme.

8. Brief about’ Professional Vigilance’ as stated under code of pharmaceutical ethics.

*refer Q3(2marks)
9. How a pharmacist should follow’ fair trade practice’ as per code of pharmaceutical ethics.
Fair trade practice
Fair practice should be adopted by a pharmacist in the trade without any attempt to capture other
pharmacist’s business.
If a customer brings a prescription (by mistake) which should be genuinely by some other
pharmacy the pharmacist should refuse to accept the prescription.
Imitation of copying of the labels, trademarks and other signs or symbols of other pharmacy should
not be done.
10. Brief ‘Apprentice Pharmacist’ as code of pharmaceutical ethics

Apprentice Pharmacist:
Apprentice Pharmacist refers to pharmacist under training period.
Experienced pharmacists should provide all the facilities for practical training of the apprentice
pharmacists. Until and unless the apprentice proves himself or herself certificate should not be
granted to him / her.

Chapter 3- Drugs & cosmetics Act & its rules

10 marks questions
1. What are the precedents and subsequent conditions for grant of license to manufacture of drugs
specified in schedule C, C1 and X.

2. Write the qualifications, duties and responsibilities of drugs inspector. Explain the procedure for
taking of samples by drugs inspector.
3. Describe the good manufacturing practices to be followed as per schedule M specified under
Drugs and Cosmetics Act 1940.
4. Explain various provisions of Schedule Y as per Drugs and Cosmetics Act 1940.
5. What are the precedents and subsequent conditions for grant of license to manufacture of drugs
specified in schedule C, C1 and X.
5 marks questions
1. Give the labeling requirements and write the specimen label for ophthalmic preparation
(A)Ophthalmic solutions and Suspensions
(1) of the containers
(i) The statement ‘Use the solution within one month after opening the
container’.
(ii) Name and concentration of the preservative, if used.
(iii) The words ‘NOT FOR INJECTION’.

(2) of container or carton or package leaflet

(i) Special instructions regarding storage, wherever applicable.
(iii) A cautionary legend reading as
"WARNING” (i) if irritation persists regarding storage, wherever applicable.
(ii) Do not touch the dropper tip or other dispensing tip to any
surface since this may contaminate solutions”. “before fixing dropper there is a possibility
of touching it. Scrub hands with soap and rinse with water”
(B). Ophthalmic Ointments
Ophthalmic Ointments shall-
(c) in addition to complying with the provisions for labelling laid down in the
rules the following particulars shall be shown on the container or carton or
package leaflet-
(i) Special instructions regarding storage wherever applicable.
(ii) A cautionary legend reading
“Warning:- If irritation persists or increases discontinue the use and consult
physicians”

Specimen label:
3g
ATROPINE EYE OINTMENT

Each gram contains:

Atropine sulphate I P 1% w/w
Sterilised ointment base q.s.
FOR OPHTHALMIC USE ONLY
Store in a Cool dark place
Warning: If irritation persists or increases discontinue the use and consult physician
To be sold by retail on the prescription of a Registered Medical Practitioner only.
Dosage: As directed by the Physician.

Mfg.Lic. No. Batch No.

Retail price not to exceed Mfg. Date
Rs. L.T. Extra Exp. Date
 Made in India by BHARATH PHARMA

2. Mention the classes of Drugs Prohibited to be imported into India

From such date as may be fixed by the Central Government by notification in the Official
Gazette in this behalf, no person shall import—
(a) any drug [or cosmetic] which is not of standard quality;
(b) any misbranded drug or misbranded (or spurious) cosmetic;
(bb) any adulterated (or spurious) drug;
(c) any drug [or cosmetic] for the import of which a licence is prescribed, otherwise than
under, and in accordance with, such licence;
(d) any patent or proprietary medicine, unless there is displayed in the prescribed manner on
the label or container thereof (the true formula or list of active ingredients contained in it,
together with the quantities thereof);
(e) any drug which by means of any statement, design or device accompanying it or by any
other means, purports or claims to cure or mitigate any such disease or ailment, or to have
any such other effect, as may be prescribed;
(ee) any cosmetic containing any ingredient which may render it unsafe or harmful
for use under the directions indicated or recommended.

3. Give the qualification required for appointment of Government analyst. Add note on his
duties.
A person appointed as a Government Analyst
under the Act should have no financial interest in import manufacture or sale of drugs and
cosmetics and shall be a person who____
(a) is a graduate in medicine or science or pharmacy or pharmaceutical chemistry with at least five
years or a postgraduate in the above areas with at least 3 years’ experience under the control of’
(i) a Government Analyst appointed under the Act, or
(ii) the head of an Institution or
testing laboratory specially approved
(b) possesses a post-graduate degree in medicine or science or pharmacy or
Pharmaceutical chemistry or
possesses the 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 and has had after obtaining the said post-graduate degree or diploma
not less than three years’ experience in the testing of drugs in a laboratory under the
control of
(i) a Government Analyst appointed under the Act, or
(ii) the head of an Institution or testing laboratory approved for the purpose by the
appointing authority or has completed training on testing of drugs, including items
stated in Schedule C and should be able to produce evidence of training in physiology,
bacteriology, serology, pathology, pharmacology or microbiology and should possess at
least 3 years’ experience in the testing of these items in an approved laboratory.
Persons appointed analyst for veterinary biological products should be graduates in
veterinary science, general science, medicine or pharmacy with at least 5 years’
experience or post graduates in the above subjects with at least 3 years’ experience in
manufacture, storage, distribution and analysis of biological products for animal use.

Duties of Government Analysts.

(1) The Government Analyst shall cause to be analysed or tested such samples or drugs 1and
cosmetics as may be sent to him by Inspectors or
other persons and shall furnish reports of the results of test or analysis in accordance with these
Rules.
(2)A Government Analyst should engage in any research work possible and forward to the
government from time to time reports giving the result of analytical work and research with a view
to their publication at the discretion of Government

4 Name different types of licenses for the retail and wholesale of drugs
WHOLESALE

From shops From motor vehicles

License for License for drugs other License for C License for
Wholesale of than Schedule C & C1 & C1 drugs drugs other than
C & C1 C&C1
 RETAIL

From shops Vendors

Pharmacy Chemist Drug store only specific drugs in
&druggist specific areas

Separate license separate license separate license for

For C& C1 drug for X drugs other drugs

5. Give the labeling requirements and write the specimen label for ophthalmic preparation.
*refer Q 1(5marks)
6. Give licensing conditions for import of drugs other than CC1 and X.
drugs other than C, C1 and X are imported without any permit or license. However before such
drugs are imported into the country, their manufacturers or importers into the country, their
manufacturers or importers should submit a declaration to the Customs Collector that they comply
with all the provisions of the Drugs and Cosmetics Act regarding import of drugs.
Procedure for import of Drugs:
No drug can be imported unless it is packed and labelled in confirmatory with the prescribed rules.
All consignments of drugs to be imported should be accompanied by an invoice or other statements
showing the make and address of the manufacturer and the names and quantities of the drugs.
Before importing drugs for which a license is not required, a declaration signed by the manufacturer
on behalf of the importer that the drugs comply with the provisions of the Act and Rules should be
supplied to the custom Collector.
When customs Collector has reason to doubt whether any drugs comply with the provisions of the
Act and Rules, or if requested by an officer appointment for the purpose by the Central
Government, the custom collector shall take samples of any drugs in the consignment. The samples
are forwarded to the director of the laboratory appointed for this purpose by the Central
Government. Customs collector may detain the consignments of drugs of which samples have been
taken, unless the report of analysis on such sample is received. If the importer gives an undertaking
in writing not to dispose of the drugs without the consent of the custom collector, and to return the
consignment to him within 10 days of the receipt of the notice, the customs collector may make
over the consignment to him within 10 days of the receipt of the notice, the Custom Collector may
make over the consignment to the importer.
If the report of the analysis indicated that the drug in a consignment is not of standard quality or
contravenes any of the provisions of the Act and Rules thereunder and the contravention cannot be
remedied by the importer, the Customs collector may direct the importer to export the consignment
back to the manufacturer abroad within 2 months or forfeit the same to the Central government for
destruction. The aggrieved importer may make representation to the Customs collector who shall
forward the samples together with representation to the Licensing authority whose decision shall be
final. If the contravention is such that it can be remedied by the importer, the customs collector
shall permit the importer to import the drug on his undertaking not to dispose of the drug without
the permission of the officer authorised in this behalf by Central Government.

7. Explain Central Drugs laboratory under D &C Act.

The Central Government shall, as soon as may be, established a Central Drugs Laboratory under
the control of a Director to be appointed by the Central Government, to carry out the functions
entrusted to it by this Act or any rules made under this Chapter:
Provided that, if the Central Government so prescribes, the functions of the Central Drugs
Laboratory in respect of any drug or class of drugs [or cosmetic or class of cosmetics] shall be
carried out at the Central Research Institute, Kasauli, or at any other prescribed Laboratory and the
functions of the Director of the Central Drugs Laboratory in respect of such drug or class of drugs
[or such cosmetic or class of cosmetics] shall be exercised by the Director of that Institute or of that
other Laboratory, as the case may be.
(2) the Central Government may, after consultation with the Board, make rules prescribing—
(a) the functions of the Central Drugs Laboratory;
(d) the procedure for the submission to the said Laboratory [under Chapter IVor Chapter IVA]of
samples of drugs [or cosmetics] for analysis or test, the forms of Laboratory’s reports thereon and
the fees payable in respect of such reports;
(e) such other matters as may be necessary or expedient to enable the said Laboratory to carry out
its functions;
(f) the matters necessary to be prescribed for the purpose of the proviso to subsection.

8. Duties and responsibilities of drug inspector.

Functions
It shall be the function of the Laboratory
(i)to analyse or test such samples of drugs as may be sent to it
(ii) to carry out such other duties as may be entrusted to it by the Central Government
or, with the permission of the Central Government, by a State Government after
consultation with the Drugs Technical Advisory Board.
Duties of Inspectors of premises licensed for sale.___ Subject to the instructions of the
controlling authority, it shall be duty of an Inspector authorized to inspect premises licensed for
the sale of drugs____
(1) to inspect [not less than once a year] all establishments licensed for the sale of
drugs within the area assigned to him;
(2) to satisfy himself that the conditions of the licences are being observed;
(3) to procure and send for test or analysis, if necessary, imported packages which he
has reason to suspect contain drugs being sold or stocked or exhibited for sale in
contravention of the provisions of the Act or Rules thereunder;
(4) to investigate any complaint in writing which may be made to him;
(5) to institute prosecutions in respect of breaches of the Act and Rules thereunder;
(6) to maintain a record of all inspections made and action taken by him in the
performance of his duties, including the taking of samples and the seizure of
stocks, and to submit copies of such record to the controlling authority;
(7) to make such enquiries and inspections as may be necessary to detect the sale of
drugs in contravention to the Act;
Duties of Inspectors specially authorized to inspect the manufacture of 1[drugs or
cosmetics].__ Subject to the instructions of the controlling authority it shall be the duty of an
Inspector authorized to inspect the manufacture of drugs____
(1) to inspect [not less than once a year], all premises licensed for manufacture of
1[drugs or cosmetics] within the area allotted to him to satisfy himself that the
conditions of the licence and provisions of the Act and Rules thereunder are being
observed;
(2) in the case of establishments licensed to manufacture products specified in
Schedule C and C(1) to inspect the plant and the process of manufacture, the
means employed for standardizing and testing the 2[drugs or cosmetics], the
methods and place of storage, the technical qualifications of the staff employed
and all details of location, construction and administration of the establishment
likely to affect the potency or purity of the product;
(3) to send forthwith the controlling authority after each inspection a detailed report
indicating the conditions of the licence and provisions of the Act and Rules
thereunder which are being observed and the conditions and provisions, if any,
which are not being observed.
(4) to take samples of the 1[drugs or cosmetics] manufactured on the premises and
send them for test or analysis in accordance with these Rules;
(5) to institute prosecutions in respect of breaches of the Act and Rules thereunder.
9. Describe the procedure for import of drugs for examination, test, and analysis
A license is necessary for the import of small quantities of drugs for analytical purposes.
The application for the license is required to be made to the licensing authority, duly signed by the
head of the institution where the drug are to be used. The licensing authority has the right to call for
such further particulars as may be considered necessary before the issue of the license to the
prospective applicant. The license is issued subject to the following conditions:
(1) the licensee must use imported drugs exclusively for the purpose for which they are
imported and at places specified in the license. The licensing authority may, however,
authorise their use in any other place.
(2) The licensee must keep a record of the substances imported under the license with respect to
their quantities, names of the manufactures and the dates of their import and make report of
the details to the licensing authority.
(3) The licensee must allow an inspection to enter and inspect the premises where imported
drugs are kept, to check the records, to investigate the manner in which the drugs are being
used and to take samples thereof for check analysis.
(4) Licensee must comply with such further conditions as may be prescribed and of which he
has been given at least one month’s notice by the licensing authority. The licensee, however,
has the right of appeal to the Central government within 3 months of the date of such
cancellation.
10. Write the Qualification and Duties of Government Analyst.
*refer Q3 (5 marks)
11. Explain in detail about Schedule N as per the D&C Act.
SCHEDULE N

List of minimum equipment for the efficient runninig of a pharmacy:-

I. Entrance. - The front of a pharmacy shall bear an inscription “Pharmacy” in front.
II. Premises. - The premises of a pharmacy shall be separated 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 a clearly visible
and appropriate manner. The area of the section to be used as dispensing department shall be
not less than 6 square meters for one pharmacist working therein with additional 2 square
meters for each additional pharmacist. The height of the premises shall be at least 2.5 meters.
The floor of the pharmacy shall be smooth and washable. The walls shall be plastered or
tiled or oil painted so as to maintain smooth, durable and washable surface devoid of holes,
cracks and crevices.
A pharmacy shall be provided with ample supply of good quality water.
The dispensing department shall be separated by a barrier to prevent the admission of the
public.
III. Furniture and apparatus. - The furniture and apparatus of a pharmacy shall be
adapted to the uses for which they are intended and correspond to the size and requirements of
the establishment.
Drugs, chemicals, and medicaments shall be kept in a room appropriate to their properties
and in such special containers as will prevent any deterioration of the contents or of contents
of containers 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 the Pharmacopoeias.
A pharmacy shall be provided with a dispensing bench, the top of which shall be covered
with washable and impervious material like stainless steel, laminated or plastic, etc.
A pharmacy shall be provided with a cupboard with lock and key for the storage of
poisons and shall be clearly marked with the work ‘poison’ in red letters on a white
background.
Containers of all concentrated solution shall bear special label or marked with the works
“To be diluted”.
A Pharmacy shall be provided with the following minimum apparatus and books
necessary for making of official preparations and prescriptions:-
Apparatus: -
Balance, dispensing, sensitivity 30 mg.
Balance, counter, capacity 3 Kgm., sensitivity 1 gm etc
4. 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 fittings of the pharmacy shall be properly kept and everything shall be
in good order and clean.
All records and registers shall be maintained in accordance with the laws in force.
Any container taken from the poison cupboard shall be replaced therein immediately after
use and the cupboard locked. The keys of the poison cupboard shall be kept in the personal
custody of the responsible person.
Medicaments when supplied shall have labels conforming to the provisions of laws in
force.
12. What are the conditions for General and restricted license for sale of drugs?
The shops for retail sale of drugs have to be specified as follows:
(i) Chemist and Druggists establishments which function under the supervision of a
registered pharmacist but wherein drugs are not compounded
(ii) Pharmacies- establishments which function under the supervision of a registered
pharmacist and which engage in compounding of drugs also
(iii) Drug stores- which do not have a registered pharmacist and which can only sell drugs
specified as household remedies.
Chemists and Druggists and Pharmacies are required to obtain separate license for sale
of:
(a) Schedules C and C1 drugs
(b) Schedule X drugs
(c) Drugs other than those specified in Schedule C and C1 and schedule X

Licenses for chemists and druggist shop and pharmacies are granted subject to the
fulfilment of following conditions:
  The licensee must have adequate premises, equipped with facilities for the proper
storage of drugs and under the charge of a registered pharmacist competent to
supervise and control the sale and distribution of drugs.
 Requirements prescribed for a ‘pharmacy’ in schedule N must be fulfilled.
 If a person, licensed to sell Schedule C and C1 drugs, wishes to sell any additional
categories of such drugs as are not listed in his license, he must obtain the
permission of the licensing authority to do so and get his license endorsed
accordingly.
 All registers and records required to be maintained under the act should be
preserved for a period of at least 2 years from the date of the last entry therein.
 Licensee must allow an authorised inspector to inspect the premises and the register
and records for the purpose of ascertaining whether the provisions of the Act and
Rules are being observed.
 Licensee must report to the Licensing Authority any change in the qualified staff
within one month of such change.
 No Schedule C and C1 drugs should be sold or exhibited for sale, until due
precautions have been taken for their storage throughout the period during which
they were in the licensee’s possession.
13. Give labelling requirements and specimen label for schedule X drugs
If it contains a substance specified in Schedule X, be labeled with the symbol XRx
which shall be in red conspicuously displayed on the left top corner of the label
and be also labeled with the words : -
Schedule X drug -“Warning:-- To be sold by retail on the prescription of a
Registered Medical Practitioner only.”
Specimen label:
For 100 tablets of phenobarbitone(schedule X drug)

XRx
100 x 50mg.
Tablets of Phenobarbitone
Schedule X drug
Warning: To be sold by retailer on the prescription of a Registered Medical Practitioner only
 JOHN & JOHN LTD.
CHEMISTS
75, Park street, Calcutta
14. Define misbranded and adulterated drugs?
Misbranded
A drug is said to be misbranded if it is so coloured, coated, powdered or polished that damage is
concealed or if it is made to appear of better or greater therapeutic value than it really is; or
if it is not labelled in the prescribed manner; or if its label or container or anything accompanying
the drug bears any statement, design or device which makes any false claim for the drug or which is
false or misleading in any particular
Adulterated drugs
if it consists, in whole or in part, of any filthy, putrid or decomposed substance; or 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 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
if it bears or contains, for purposes of colouring only, a colour other than one which is prescribed;
or if it contains any harmful or toxic substance which may render it injurious to health; or
if any substance has been mixed therewith so as to reduce its quality or strength.

15. What are loan license and repacking license as per D &C act.. Explain their licensing
conditions.
LOAN LICENCES
The D&C Act provides for the grant of licenses for the manufacture of drugs other than those
specified in Schedule X to persons who do not have their own facilities for the manufacture of
drugs, but who wish to avail of the facilities existing with another person licensed to manufacture
drugs. Such licences are known as loan licenses and their holders must satisfy conditions relating to
licences issued under the Act, except that they may not have their own facilities for the manufacture
and testing of drugs.
Applications for grant of loan licenses should be supported by documentary consent of the licensee
whose facilities are to be availed of for the manufacture. Before the grant of a loan license, the
licensing authority may satisfy himself that the person, whose facilities the applicant wishes to avail
of, possesses the necessary staff, space and equipment for manufacture of drugs. In case the license
of a person whose manufacturing facilities where being availed of by the licensee is suspended or
cancelled, the loan license will also be deemed to be suspended or cancelled.
REPACKING LICENCES
A licence is required for the ‘repacking’ of drugs other than those specified in Schedules C &C1.
License for repacking of drugs can be had on application to the licensing authority just like other
manufacturing licenses. Persons licensed to repack drugs should observe the following conditions.
 Adequate space and equipment should be provided for the repacking operating operations
which must be carried out under hygienic conditions and under the supervision of at least
one person, who has been approved as a ’competent person’ by the licensing authority.
Persons who either hold Diploma in Pharmacy or are registered pharmacists under the
Pharmacy Act 1948 or have passed the intermediate examination with chemistry as
principal subjects or have passed the matriculation examination and have had not less than
4 years’ experience in the manufacture, dispensing or repacking of drugs shall be deemed
to be competent persons for the repacking of drugs.
 The licensee should maintain adequate arrangements for the analysis and testing of batch of
raw materials and repacked drugs or have the same analysed and tested by an approved
institution. He should also maintain records in respect of such tests for at least a period of 3
years from the date of manufacture and in case of drugs with expiry date at least for 3
months from such date.
 The licensee should make adequate arrangements for the storage of drugs and should allow
an authorised inspector to inspect the premises and records and samples of drugs.
 The licensee should maintain detailed records for the repacking of drugs and should allow
an inspector to check the same.
 The licensee should be kept on the licensed premises and should be produced before an
authorised inspector on demand.
 Any change in the component staff name in the license should forthwith notified to the
licensing authority.
 The drugs repacked should, in addition to other particulars, bear the number of the license
preceded by the words ‘Rpg. Lic.No.” on their label.
 The licensee should comply with the provisions of the Act and the rules and with such
further requirements of which he has been given not less than 4 months’ notice by the
licensing authority

2 marks questions
1. Define Schedule J. Give two examples.
Schedule J includes diseases and ailments (by whatever name described) which a drug may not
purport to prevent or cure or make claims to prevent or cure.
Example: AIDS
Angina Pectoris
Blindness
Baldness
 2. Define Loan licenses.
Loan license may be issued to a person who does not have his own premises and facilities
for the manufacture of drugs but who intends to have his drugs manufactured at the
premises of another person or party licensed to manufacture drugs under the Act. Loan
licence can be granted only for drugs other than those specified in Schedule X.
3. Define Schedule FF. Give two examples.
Standards for ophthalmic preparations.
Part-A. Ophthalmic Solutions and suspensions.
Ophthalmic Solutions and Suspensions shall-
(a) be sterile when dispensed or when sold in the unopened container of the
manufacturer, except in case of those ophthalmic solutions and suspensions which are
not specifically required to comply with the test for ‘Sterility’ in the Pharmacopoeia.
(b) contain one or more of the following suitable substances to prevent the growth of
micro -organisms.
(i) Benzalkonium Chloride, 0.01 per cent (This should not be used in solutions of
nitrates or salicylates).
(ii) Phenyl mercuric nitrate, 0.001 per cent.
(iii) Chlorbutanol 0.5 per cent.
(iv)Phenyl ethyl alcohol 0.5 per cent.
*for labelling refer Q1 (5marks)
4. Give labelling requirements for schedule H drugs.
(i) “Schedule H Drug. Warning: To be sold on the prescription of a Registered Medical Practitioner
only.”
(ii) symbol Rx prominently on the left hand top corner of the label.
(iii) Symbol NRx prominently on the left hand top corner if drug is covered under Narcotic Drugs
and Psychotropic Substances Act
5. Define Schedule P. Give two examples.
Schedule P included the life period of drugs
Period in months (unless conditions of storage otherwise specified) between the date of
manufacture and date of expiry which the labelled potency period of the drug shall not exceed
under the conditions of storage
e.g.: cephalexin can be stored in a cool place for 24 months
Ampicillin injection can be stored for 24 months
6. Give labelling requirements for schedule G drugs.
Schedule G drugs: “caution: it is dangerous to take this preparation except under medical
supervision.”
7. Define Schedule X. Give two examples.
Schedule X is a class of prescription drugs which cannot be purchased over the counter without the
prescription of a qualified prescriber. It includes narcotic and psychotropic drugs so the pharmacist
should keep a copy of the prescription for a period of 2 years
E.g. cyclobarbital
Methylphenidate
Amobarbital
8. Define Repacking licenses.
Repacking licences are granted for the purpose of breaking up any drug, other than those
specified in Schedules C and C1, from a bulk container into small packages with a view to
its sale and distribution.
9. Define Schedule J. Give two examples.
Schedule J includes diseases and ailments (by whatever name described) which a drug may not
purport to prevent or cure or make claims to prevent or cure.
Example: AIDS
Angina Pectoris
Blindness
Baldness
10. Define Loan licenses.
*refer Q2 (10 marks)
11. Define Schedule U& V.
Schedule U: Particulars to be shown in the manufacturing records of the drugs.
Schedule U-1: particulars to be shown in the manufacturing records of cosmetics
Schedule V: Standards for patent or proprietary medicines
12. Give labeling requirements for Schedule H drugs.
*refer Q4 (2mark)
13. Define Schedule P& Jas per D &C act.
Schedule P included the life period of drugs
Period in months(unless conditions of storage otherwise specified) between the date of manufacture
and date of expiry which the labelled potency period of the drug shall not exceed under the
conditions of storage
e.g: cephalexin can be stored in a cool place for 24 months
*for schedule J refer Q9(2marks)
14. Give two examples of permitted colours as per D &C act.
Amaranth Red colour index number- 16185
naphthol Blue Colour index number- 20470
15. Write specimen label of Schedule H drug for parenteral administration.
Rx 2ml – For IM/IV use
GENTAMICIN INJECTION IP
Each ml contains Gentamicin 40mg
As Gentamicin Sulphate I P
Methyl Paraben I P 1.8 mg
Propyl Paraben I P 0.2 mg
Store in a Cool place
Schedule H Drug
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only
Mfg. Lic. No Retail price not to exceed Rs.
Batch No. Local taxes extra
Mfg Date
Exp. Date
Made in India by
Bharath Pharma
Madras 600 004

16. Define cosmetics under D&C Act

Articles meant to be rubbed, poured, sprinkled or sprayed on any part of the human body for
cleansing, beautifying, promoting attractiveness or altering appearance.
17. Define ‘patent and proprietary medicines’ as per D&C act.
In relation to Ayurvedic, Siddha or Unani systems of medicine all formulations containing only
such ingredients mentioned in the formulae described in the authoritative books of Ayurveda,
Siddha or Unani Tibb systems of medicine specified in the First Schedule, but does not include a
medicine which is administered by parenteral route and also a formulation included in the
authoritative books as specified in clause (a);
(ii) in relation to any other systems of medicine, a drug which is a remedy or prescription presented
in a form ready for internal or external administration of human beings or animals and which is not
included in the edition of Indian Pharmacopoeia for the time being or any other Pharmacopoeia
authorized in this behalf by Central Government after consultation with the Drugs Technical
Advisory Board constituted under section 5
18. Give the functions of Drug Consultative Committee.
The central government Constitutes the Drug Consultative Committee, to advice both Central and
State Governments and the Drug Technical Advisory Board on matter trending to secure uniformity
throughout India in the administration of this act.
It consists of 2 representatives nominated by central government and one representative nominated
by each state government.
19. Give labelling requirements of patent and proprietary medicines as per D&C Act.
The label should contain the following:
1. quantities of active ingredients
2. name and address of the manufacturer

20. Define Schedule Y as per D&C act.

Schedule Y includes requirements and guidelines on clinical trials for import and manufacture of
new drugs
Chapter 4- Pharmacy Act
10 marks questions
1. Describe in detail the constitution of Pharmacy Council of India. Discuss in detail education
regulation.
*refer Q4 for constitution
*refer Q2 for educational regulation
2. Write in detail about the constitution and functions of the state and joint state pharmacy council.
Refer page 22 to 27 in B.M mithal
CONSTITUTION
STATE PHARMACY COUNCIL
  registered pharmacist in the state – to be elected by all the registered pharmacist. Election to
be conducted by the state pharmacy council.
 5 nominees of the state govt. – at least 3 should have degree or diploma in pharmacy or
pharmaceutical chemistry.
 1 representative of the state medical council – to be elected by the state medical council.
 1 govt. analyst appointed under the drugs and cosmetic act. – to be nominated by the state
govt.
 1 govt. analyst appointed under the drugs and cosmetics act - to be nominated by the state
govt.
 Chief of the drug control department of the state – ex-official
 Chief administrator of the state medical services – ex-official
When 2 or more states enter into an agreement, whereby the state pharmacy council of one
state is to serve the needs of the other state or states, the membership of the state pharmacy
council may be augmented by not more than 2 persons, nominated by each of the state
governments. The states, while entering into an agreement, where by joint pharmacy
councils are constituted or the council of one state agrees to serve the needs of other states,
may also determine as to which of the participating governments shall exercise various
functions of the state government under the act, the amount of the expenditure to be shared
between the states and may make other incidental and ancillary provisions for giving effect
to the agreement.
JOINT STATE PHARMACY COUNCIL
 Registered pharmacist: 3 – 5 from each state instead of 6 in the single state council.
 Govt. nominees: 2 -4 from each state instead of 5
 Medical council nominees: 1 from each state
 Chief administrative medical officer, govt. analyst and officer in charge, drug control – ex
officio from each state.
FUNCTIONS
 Maintenance of registers
It may be recalled that the very first register of pharmacists in the states was prepared by
the state governments through a tribunal. For entry of names on the 1st register qualifications
were slightly different and provided for entry of names of persons, who had passed
compounders or dispensers examinations approved by the state or had any degree and 3
years experience of dispensing or just 5 year’s experience in dispensing the prescriptions of
doctors. This process went on for nearly 3 decades. When it did not seem to end, the
amendment to the act in 1976 provided that the 1st registers will be handed over by the state
governments to the state councils. The state councils were constituted soon after the
preparation of the 1st register and once the state council has been constituted, the registers to
be handed over to them. The state council will then be responsible for the maintenance of the
registers.
 Entry and removal of names
 After an appointed date, all application for registration should be addressed to the
registrar of the state pharmacy council. If upon receipt of the application, the registrar is of
the opinion that the applicant has requisite qualifications for registration, he may direct his or
her name to be entered in the register. Persons whose name have been removed from the
registers of other states shall not be entitled to registration unless the state council gives its
consent there to. Any person, whose application for registration has been rejected by the
registrar, may appeal to the state council, within 3 months of the rejection of application. The
decision of the state council shall be final.
Upon entry of the name of a person in the registrar, the registrar is required to issue to
him a certificate of registration in the prescribed form. The retention of the name on the
register shall be subjected to payment of prescribed fee annually to the state council by due
date, as specified in this behalf. If the renewal fee is not paid by the due date, the registrar
shall remove the name of the defaulter from the register. The name so removed may,
however, be restored to the register on the prescribed condition being satisfied. On payment
of the fees, the registrar is required to issue a receipt thereof and such receipts are deemed to
be proofs of renewal of registration. A registered pharmacist is entitled to have any further
professional qualifications entered against his name in the register, subject to the payment of
fees prescribed on that behalf.
 Removal of names from the register
The name of the pharmacist may be removed from the register on following counts
i. If his name has been entered in the register due to error, misrepresentation or
suppression of facts
ii. If he has been convicted of an offence in any professional respect, which in the
opinion of the executive committee, renders him unfit to be on the register of
pharmacists
iii. If a 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,
such that if he was a registered pharmacist himself, his name would have been
removed from the register. Action against the pharmacist can be taken only if it is
proved that:
a) The objectionable conduct was instigated or connived at by the pharmacist
himself
b) The registered pharmacist, during the period of 12 months preceding the
offence, has been guilty of a similar offence or conduct
c) Any person, employed by the pharmacist for purpose of business of
pharmacy, has been guilty of similar offence during the preceding 12 months
and the pharmacist had the knowledge of the offence
d) The offence or conduct had continued over a long period and the pharmacist
had or should have had the knowledge of the continuing offence.
e) The act is an offence under the drugs and cosmetics act, 1940 and the
pharmacist did not use his intelligence to see that the provisions of this act
were being observed at his place of business by persons under his control.
 Names can be removed only by an order of the executive committee of the state
pharmacy council, after it has made due enquiries and given opportunity to the
person concerned to explain his conduct. The removal of names from the register
may either be permanent or foe a specific period of time. The order of executive
committee directing removal of a name from the register should be confirmed by
the state pharmacy council and it takes effect only after 3 months of the date of
the order. This rule implies that any pharmacist, who is held guilty and whose
name has been removed from the register, shall continue to remain a registered
pharmacist for the next 3 months and only after the expiry of that period he shall
cease to be a registered pharmacist. This period of grace is probably given to a
person to find another means of livelihood. A person aggrieved by the order
directing the removal of his name, may appeal to the state government within 80
days whose decision shall be final. A person whose name has been removed from
the register is required to surrender his certificate of registration to the registrar of
pharmacy council of concern. The state pharmacy council may at any time for
reasons appearing sufficient to it, order that the name of a person shall be restored
to the register. When an appeal against the removal was made and rejected by the
state government, the name cannot be restored, unless confirmed by the state
government.
 Printing of registers
The registrars of the state pharmacy councils were required to publish the registrars on
st
the 1 April following the commencement of the pharmacy act, 1959 as they stood on that
date. Later on, each year after the 1st of April, they were to publish supplements to the
registers showing all additions or amendments. All registers should be brought up to date 3
months before ordinary elections to the state pharmacy council and printed. Copies of printed
registers and all supplements to them, should be supplied to persons applying for them, on
payment of the prescribed costs. These registers and supplements are deemed to be proofs
that the persons, whose names are contained therein, are registered pharmacist.
 Inspection by state councils
The state pharmacy councils have been empowered to appoint suitable number of
inspectors having prescribed qualifications to inspect premises where drugs are dispensed or
compounded, to investigate complaints in respect of contravention of the act and to institute
prosecutions when directed to do so by the executive committees of the state councils. The
inspectors may also exercise such other powers as are necessary to give effect to some
provisions of the act. The inspectors of the council shall be deemed to be public servants
within the meaning of section 21 of the Indian penal code.

3. Describe the constitution and functions of Pharmacy council of India.

Refer page 18 to 22 in B.M mithal
CONSTITUTION
  Six teachers: Elected by the university grant commission from amongst the staff of
universities/ colleges conducting pharmacy/degree/diploma programmes. Out of these there
should be at least one from the specialities of pharmacy pharmacology, pharmaceutical
chemistry and pharmacognosy.
 One nominee of each pharmacy council: should be a registered pharmacist
 One nominee of each state government: Should be a registered pharmacist
 6 nominees of govt. of India: at least 4 should hold degree/ diploma in pharmacy and be
engaged in the pharmacy practice/ pharmaceutical chemistry.
 A nominee of medical council of India: Should be elected by members if the council.
 A representative of the university grants commission: No specific background provided for
 A representative of the all India council of technical education: No specific background
provided for
 Director of central drugs laboratory established under drugs and cosmetics act: Ex-officio
 Director general of health services of the govt. of India who is incharge of all health matters
across the nation: Ex-officio
 Drugs controller of India having administrative control over matters related to drugs: Ex-
officio
The council is deemed to be a corporate body, having a perpetual succession and a common
seal with power to acquire and hold movable or immovable property.
FUNCTIONS
I. Design of the educational pattern
One of the primary tasks of the pharmacy council of India is to frame an educational
structure for the would be pharmacist and to keep it turned to the changing needs with
passage of time. The standards of education for pharmacists framed by the council are
known as the education regulations and amongst other things prescribed.
i. Minimum qualification for the admission of the course
ii. Duration of the training and the course of study to be covered.
iii. Nature and period of practical training to be undertaken after the completion of the
regular course.
iv. The subjects of examinations and the standards to be attained therein for
qualifications
v. Equipment and facilities to be provided by the institution running approved courses
of study
vi. Conditions to be fulfilled by institutions giving practical training.
vii. Conditions to be fulfilled by the authorities holding approved examinations.
The education regulations have to be framed with the approval of the govt. of India and
after circulating the draft to each state govt. and taking into consideration their considerations of
their comments, if any. The executive committee of the council has to monitor the effectiveness of
the regulations from time to time and may recommendations to the council amendments considered
essential. Whenever any amendment is sought to be done in the regulations the council has to
follow the procedure presented for their initial drafting namely circulation to the state govt. and
approval of the central govt.
II. Approval of institutions/ withdrawal of approvals
An institution or authority, which conducts a course or holds an examination for the
pharmacists, has to apply to the pharmacy council of India for approval of the course or the
examination. Whenever any institution or authority applies to the pharmacy council seeking
approval of the course conducted or examination held by it, the council may depute its
inspectors to visit the institution to check whether the prescribed facilities for imparting
training or holding examinations are in accordance with the education regulations or not. It
may also require inspectors to attend any examination, to judge its standards without
interfering with its conduct. The inspectors then report to the council on the sufficiency or
otherwise of the facilities available in the institution and on the conduct and standards of the
examinations held.
III. Recognition of foreign qualifications
The council may recognise any qualification, granted by an authority outside India,
which affords guarantee of requisite skill and knowledge to be a sufficient qualification for
registration as a pharmacist under the act. The council may further specify that such
qualifications shall be deemed to be sufficient, only when granted before or after a particular
date subjected to such additional conditions as may be specified by the council. Normally
only citizens of India possessing such qualifications shall be eligible for registration.
Citizens of other countries holding qualifications granted there shall be registrable in this
country when an Indian national, holding the same qualification, is by law allowed to enter
and practice the profession of pharmacy in that country
IV. Maintenance of central register of pharmacists
Under the provisions of the pharmacy act 1976, the pharmacy council of India is required
to maintain a register containing names of all persons registered as pharmacists in different
states. This register has to be maintained by the registrar of the council in accordance with
the direction of the pharmacy council of India and has to be revised suitably from time to
time and publishes in the gazette of India. This register would be deemed to be a public
document within the meaning of the Indian evidence act 1872.
The state pharmacy councils are required to supply to the pharmacy council of India five
copies of their registers as soon as possible, after 1st April each year and inform it about any
amendments made in the registers from time to time.
4. Describe the constitution of State pharmacy council. Explain preparation of ‘first register and
‘subsequent register’
*refer Q1 5 mark for preparation of register
*refer Q2 of 10 marks for constitution

5. Explain Registration of pharmacist detailing about first register, qualifications for entry into first
register, subsequent register and removal of name from the register as per Pharmacy Act.
*refer Q1(5mark) for registration
*refer Q 2 (10 marks) for the rest.

5 marks questions
1. Define the terms first register and subsequent registers. How first register is prepared?
Preparation of first register.-
( I) For the purpose of preparing the first register, the State Government shall by notification
in the Official Gazette constitute a Registration Tribunal consisting of three persons, and
shall also appoint a Registrar who shall act as Secretary of the Registration Tribunal.
(2) The State Government shall, by the same or a like notification, appoint a date on or
before which applications for registration, which shall be accompanied by the prescribed
fee, shall be made to the Registration Tribunal.
(3) The Registration Tribunal shall examine every application received on or before the
appointed date, and if it is satisfied that the applicant is qualified for registration under
section 31, shall direct the entry of the name of the applicant on the register.
(4) The first register so prepared shall thereafter be published in such manner as the State
Government may direct, and any person aggrieved by a decision of the Registration
Tribunal expressed or implied in the register as so published may, within sixty days from
the date of such publication, appeal to an authority appointed by the State Government in
this behalf by notification in the Official Gazette.
(5) The Registrar shall amend the register in accordance with the decisions of the authority
appointed under sub-section (4) and shall thereupon issue to every person whose name is
entered in the register a certificate of registration in the prescribed form.

(6) Upon the constitution of the State Council, the register shall be given into its custody,
and the State Government may direct that all or any specified part of the application fees for
registration in the first register shall be paid to the credit of the State Council.
Qualifications for entry on first register.-
[A person who has attained the age of eighteen years shall be entitled] on payment of the
prescribed fee to have his name entered in the first register if he resides. or carries on the
business or profession of pharmacy, in the State and if he (a) holds a degree or diploma in
pharmacy or pharmaceutical chemistry or a chemist and druggist diploma of an Indian
University or a State Government as the case may be. or a prescribed qualification granted
by an authority outside [***] India, or(b) holds a degree of an Indian University other than a
degree in pharmacy or pharmaceutical chemistry. and has been engaged in the.
compounding of drugs in a hospital or dispensary or other place in which drugs are
regularly dispensed on prescriptions of medical practitioners for atotal period of not less
than three years, or (c) has passed an. examination recognized as adequate by the State
Government for commoners or dispensers, or (d) has been engaged in the compounding of
drugs in a hospital or dispensary or other place in which drugs are regularly dispensed on
 prescriptions of medical practitioners for a total period of not lessthan five years prior to the
date notified under subsection (2) of section 30.

Qualifications for subsequent registration. –

(l) After the date appointed under sub-section (2) of section 30 and before the Education
Regulations have, by or under section II, taken effect in the State, 3[a person who has
attained the age of eighteen years shall on payment of the prescribed fee] be entitled to have
his name entered in the register if he resides or carries on the business or profession of
pharmacy in the State and if he—
(a) satisfies the conditions prescribed with the prior approval of the Central Council,or
where no conditions have been prescribed, the conditions entitling a person to have his
name entered on the first register as set out in section 31, or
(b) is a registered pharmacist in another State, or
(c) possesses a qualification approved under section 14:Provided that no person shall be
entitled '[under clause (a) or clause (c)] to have his name entered on the register unless he
has passed a matriculation examination or an examination prescribed as being equivalent to
a matriculation examination.
(2) After the Education Regulations have by or under section 11 taken effect in the State, a
person shall on payment of the prescribed fee be entitled to have his name entered on the
register if he has attained the age of 2[eighteen years], if he resides, or carries on the
business or profession of pharmacy, in the State and if he has passed an approved
examination or possesses a qualification approved under section 14 '[or is a registered
pharmacist in another State.]
2. What are the education regulations and how they are implemented as per Pharmacy Act?

Educational Regulations:-
(l) Subject to the provisions of this section, the Central Council may, subject to the approval of the
Central Government, make regulations, to be called the Education Regulations, prescribing the
minimum standard of education required for qualification as a pharmacist.
(2) In particular and without prejudice to the generality of the foregoing power, the Education
Regulations may prescribe
(a) the nature and period of study and of practical training to be undertaken before admission to an
examination;
(b) the equipment and facilities to be provided for students undergoing approved courses of study;
(c) the subjects of examination and the standards therein to be attained;
(d) any other conditions of admission to examinations.
(3) Copies of the draft of the Education Regulations and of all subsequent amendments thereof shall
be furnished by the Central Council to all State Governments, .and the Central Council shall before
submitting the Education Regulations or any amendment thereof, as the case may be, to the Central
Government for approval under subsection (1) take into consideration the comments of any State
Government received within three months from the furnishing of the copies as aforesaid.
(4) The Education Regulations shall be published in the Official Gazette and in such other manner
as the Central Council may direct.
(5) The Executive Committee shall from time to time report to the Central Council on the efficacy
of the Education Regulations and may recommend to the Central Council such amendments thereof
as it may think f i t .
3. Write the constitution of Joint State Pharmacy Council. Enumerate its functions
A Joint State Council consists of the following:
(i) not less than three and not more than five members elected amongst themselves by the registered
pharmacists of each of the participating States,
(ii) not less than three but not more than four members nominated by each participating State
Government
(iii) one member elected from amongst themselves by the members of each Medical Council or the
Council of Medical Registration of each participating State,
(iv) the chief administrative medical officer of each participating State or his authorised person,
(v) the officer in-charge of drugs control organisation of each participating State or his authorised
person.
(vi) the Government Analyst of each participating State.
Functions:
I. Maintenance of registers
II. Entry and removal of names
III. Removal of names from the register
IV. Printing of registers
V. Inspection by state council

4. Give constitution of Pharmacy Council of India as per Pharmacy Act.

The Pharmacy Council of India consists of the following:
(i) Six members, among whom at least one teacher of pharmaceutical chemistry, pharmacy.
Pharmacology and pharmacology elected by the University Grants Commission.
(ii) Six members, four of whom are persons possessing a degree or diploma in and
practicing pharmacy or pharmaceutical chemistry, nominated by the Central Government .
(iii) One member elected from amongst themselves by the members of the Medical Council
of India.
(iv) the Director General of Health Services or an authorized person by him.
(v) the Drugs Controller of India or an authorized person by him,
 (vi) the Director of Central Drugs Laboratory,

(vii) a representative of the University Grants Commission,

(viii) a representative of the All India Council for Technical Education.
(ix) One member to represent each state elected from each state council and who is a
registered pharmacist,
(x) One member to represent each state nominated by the State Government who is a
registered pharmacist.’
(xi) One member to represent each Union territory, nominated by the Union territory
Council, being eligible for
registration under section 31 of the Act,
The Executive Committee.-(l) The Central Council shall, as soon as may be, constitute an
Executive Committee consisting of the President (who shall be Chairman of the Executive
Committee) and VicePresident, ex officio, and five other members elected by the Central
Council from amongst its members.
(2) A member of the Executive Committee shall hold office as such until the expiry of his
term of office as member of the Central Council, but, subject to his being a member of the
Central Council, he shall be eligible for re-elect ion.
(3) In addition to the powers and duties conferred and imposed it by this Act the Executive
Committee shall exercise and discharge such powers and duties as may be prescribed.
5. Discuss approval and withdrawal of approval of institutions providing course of study and
examination according to Pharmacy Act.
An institution or authority, which conducts a course of study or holds an examination for the
pharmacists, has to apply to the Pharmacy Council of India for approval of the course or
examination. Whenever any institution or authority applies to the Pharmacy Council seeking
approval of the course conducted or examination held by it, the Council may depute its inspectors
to visit the institution to check whether the prescribed facilities for imparting training or holding
examinations are in accordance with the educational regulations or not. It may also require
inspectors to attend any examination, to judge its standards without interfering its conduct. The
inspectors then report to the council on the sufficiency or otherwise of the facilities available in the
institution and on the conduct and standards of the examination held.
If on the report of the inspectors, the Council is satisfied that the course or the examination under
consideration is in conformity with the Education Regulations, it may accord approval to it and then
the said course or examination shall be deemed to be approved for qualifying for registration as a
pharmacist under the act. Declaration of approval should be made by a resolution passed at a
meeting of the council and should be published in official gazette.
If it comes to the notice of Pharmacy Council of India, that any approved course of study or
approved examination does not continue to be in conformity with the Education Regulations, the
Council may give notice to the institution or authority concerned of its intention to withdraw the
approval. After taking into consideration any representation that may be made by the institution or
authority(through the respective state government within 3 months of the notice), the Council may
decide whether the approval is to be withdrawn or is to be continued conditionally, subject to
fulfilment of specified conditions by the authority or the institution concerned.

2 marks questions
1. List out the Ex-Officio Members of PCI.
 Director of Central Laboratory established under the drugs & cosmetics act
 Director General of Health services of the Government of India who is in charge of
all health matters across nation
 Drug Controller of India having administrative control over matters related to drugs
2. Define “Registered Pharmacist”.
Registered pharmacists are the persons registered as pharmacists under the pharmacy Act of
1948
3. Give objectives of Pharmacy Act.
 To provide uniform education and training to the persons who are willing to enter
into the profession of pharmacy throughout India
 To maintain control over the persons entering the profession of pharmacy by
registration of pharmacists in every state and maintaining records thereof.
4. Mention the grounds on which names of registered pharmacist can be removed.
(i) his name has been entered by error or on account of misrepresentation or suppression of material
fact, or
(ii) he has been convicted of any offence or has been guilty of any infamous conduct in any
professional respect; or
(iii) a person employed by him for the purposes of his business of pharmacy or employed to work
under him in connection with any business of pharmacy has been convicted of any such of offence
or has been guilty of any such infamous conduct as would, if such person were a registered
pharmacist, render him liable to have his name removed from the register.
5. Mention the qualifications necessary for entering name into ‘first register’.

A person who has attained the age of eighteen years shall be entitled] on payment of the
prescribed fee to have his name entered in the first register if he resides. or carries on the
business or profession of pharmacy, in the State and if he:

(a) holds a degree or diploma in pharmacy or pharmaceutical chemistry or a chemist and

druggist diploma of an Indian University or a State Government as the case may be. or a
prescribed qualification granted by an authority outside india
(b) holds a degree of an Indian University other than a degree in pharmacy or
pharmaceutical chemistry. and has been engaged in the. compounding of drugs in a
hospital or dispensary or other place in which drugs are regularly dispensed on
prescriptions of medical practitioners for a total period of not less than three years, or
 (c) ) has passed an. examination recognized as adequate by the State Government for
commoners or dispensers, or
(d) has been engaged in the compounding of drugs in a hospital or dispensary or other
place in which drugs are regularly dispensed on prescriptions of medical practitioners
for a total period of not lessthan five years prior to the date notified under subsection
6. Enumerate two functions of PCI Inspector
 Inspect any premises, where drugs are compounded or dispensed and submit a
written report to the registrar
 Investigate any complaint made in writing in respect of any contravention of this Act
7. Explain approval of foreign qualification by PCI.
The council may recognise any qualification, granted by an authority outside India, which
affords guarantee of requisite skill and knowledge to be a sufficient qualification for registration
as a pharmacist under the act.
The council may further specify that such qualification shall be deemed to be sufficient, only
when granted before or after a particular date subject to such additional conditions as may be
specified by the council.
Citizens of other countries, holding qualification granted there, shall be registrable in this
country when an Indian national, holding the same qualification, is by law allowed to enter and
practice the profession of pharmacy in that country.
8. What Punishment is provided under pharmacy act for falsely claiming to be registered
pharmacist?
If any person whose name is not for the time being entered into the register of the State falsely
pretends that it is so entered or uses in connection with his name or title any words or letters
reasonably calculated to suggest that his name is so entered, he shall be punishable on first
conviction with fine which may extend to five hundred rupees and on any subsequent conviction
with imprisonment extending to six months or with fine not exceeding one thousand rupees or with
both: Provided that it shall be a defiance to show that the name of the accused is entered in the
register of another State and that at the time of the alleged offence under this section an application
for registration in the State had been made.
9. How to Restore to the register as per Pharmacy act.
A person, aggrieved by the order directing the removal of his name, may appeal to the state
government within 80 days whose decision shall be final. A person whose name has been removed
from the register, is required to surrender his certificate of registration to the registrar of the
pharmacy council concerned. The state pharmacy council may, at any time, for reasons appearing
sufficient to it, order that the name of a person shall be restored to the register.
Where an appeal against the removal was made and rejected by the state government, the name
cannot be restored, unless confirmed by the State Government.
Chapter 5- Medicinal & Toilet Preparation Act 1955
10 marks questions
1. Give the design of bonded laboratory. Discuss in detail manufacturing of alcoholic
preparations in bonded laboratory.
DESIGN AND CONSTRUCTION OF BONDED LABORATORY
A bonded laboratory should consist of the compartments as per following diagrams:

Manufacturing room Finished goods store

Raw spirit store Excise officer

Entrance
i. A spirit store (unless the laboratories attached to either a distillery or a spirit
warehouse)
ii. A room for the manufacture of medicinal preparations;
iii. One or more rooms for the storage of finished medicinal preparations
iv. If the manufacture of toilet preparations is also carried on, a separate manufacturing
room for these together with a separate room or rooms for the storage of finished
toilet goods.
v. Accommodations, with necessary furniture, for the excise officer-in-charge of the
bonded laboratory near its entrance
There should be only one entrance to the laboratory and only one door for each of
its compartments. The laboratory can be opened only in the presence of the excise
officer-in-charge and during his absence all the doors should be secured with excise
ticket locks. Every window in the bonded premises should be provided with malleable
ion rods, not less than 1.9 cm in thickness and set not more than 10 cm. apart, embodied
in brick work to a depth of at least 5 cm and covered on the inside with strong wire
netting or expanded metal of a mesh not more than 2.5 cm in diameter or length. Each
room in the laboratory should bear a board indicating its serial number and purpose. The
pipes from sinks inside the laboratory should be connected with the general drainage
system of the premises. The gas and the electric connections in the laboratory should be
so arranged that their supply can be cut off at the end of the day’s work. Permanent
vessels should be provided for the storage of alcohol and other narcotic drugs received
under bond. All vessels, intended to hold alcohol and other liquid preparations should
bear a distinctive serial number and a statement of their full capacity. Tables should be
constricted to show the contents of each vessel at 2.5 cm and at 2.5 mm. All vessels,
containing the preparations on which duty has not been paid, should be secured with
excise ticket locks.
Refer Q4 (10 mark) for manufacture
2. What is meant by “Manufacture in Bond? Discuss the conditions to be followed before and after
obtaining a license for manufacture in bond.
refer Q4 (10 mark)
3. Discuss the procedure to be followed for manufacturing medicinal preparations without bond.
MANUFACTURE OUTSIDE BOND
A. LICENSE
A license is necessary for undertaking the manufacture of medicinal and toilet
preparations without bond. Such a license may be obtained on application to such officers as
may be appointed in his behalf by the state governments. The form of application and other
conditions of the licence for the preparations of spirituous medicinal preparations outside
bond are the same as those for manufacture under bond. The following fees are required to
be paid for obtaining the licence for non-bonded manufacturing.
a) Where consumption of alcohol is 125 LP litres or less per annum – Rs. 100
b) Where consumption of alcohol per annum is more than 125, but less than 500 LP
litres per annum – Rs 25
c) For manufacture of ayurvedic or unanic preparations containing self-generated
alcohols or containing alcohol produced by distillation – Rs 25
B. DESIGN AND CONSTRUCTION OF NON BONDED LABORATORY
In the manufacture and sale in a non-bonded laboratory should be conducted between
sunrise and sunset only and on days fixed by the excise commissioner for the purpose.
There should be a spirit store and a laboratory and a finished goods store in each non-
bonded manufacturer. There should be only one entrance to the non-bonded manufacturing
and only one door to each laboratory, spirit store and finished goods store. Windows, if any,
should be covered with iron bars, etc. as specified for bonded laboratories. Pipes from sinks
and washbasins should be constricted so as to discharge effluents into general drainage
system. Electric and gas connections should be capable of being shut off at the end of day’s
work. Suitable receptacles should be provided for the storage of rectified spirit and finished
preparations.
C. MANUFACTURE IN NONBONDED LABORATORY

I. Obtaining the spirit

The spirit can be obtained from a distillery or a spirit warehouse by sending an
intend induplicate, one copy to the distiller on the warehouse keeper, and the other to
the excise officer incharge of the warehouse or the distillery. Before sending the
duplicate of the intend to the officer incharge of the distillery, the manufacturer
should be the excise duty on the quantity of spirit desired to be purchased and
enclose the treasury challan of the payment along with the intend. The excise officer
in charge of the distillery after satisfying himself that the correct amount of duty has
been deposited, shall issue the spirit together with the permit covering the issue. The
spirit so obtained by the manufacturer should be transferred to the respective spirit
store soon after its arrival and after entry in proper register.
II. Manufacture
The manufacture of preparations from duty paid spirit should be carried out only at
the license premises. Each preparation, soon after its manufacture, should be
registered and given a distinctive batch number.
 III. Storage
All finished preparations should be transferred from the laboratory to the finished
goods store and so arranged there that they can be easily checked from the stock
register. The quantities taken out from time to time should be entered in the stock
card maintained for the purpose.
IV. Sampling
The excise officer, in whose jurisdiction the non-bonded laboratory is situated shall,
without any previous notice, to the manufacturer, take samples of not less than 19%
and more than 15% of the total number of batches manufactured during the month.
All such samples should be taken personally by the officer in the presence of the
manufacturer of his authorised agent. Every sample shall be taken in duplicate and
the labels of the bottles should be signed by the officer taking the samples. The cork
after every bottle should be fixed with the seal of the officer.
If the alcoholic content of preparations reported by the chemical examiners
differ by more than tertiary proof on either side from the strength declared by the
manufacturer should be liable to pay penalty at the rate of 10 times the duty payable
on the difference subject to a maximum of Rs 2000.
V. Returns
The manufacturer should maintain up-to-date and proper accounts of the transactions
of business in his manufacturing and deliver them to proper officer on the 5th of each
month. The manufacturer should furnish a list of names of manager and assistant
manager employed by him and of other employees whose duties necessitate their
entrance into the non-bonded laboratory.

VI. Inspection
Non-bond laboratory shall be opened to inspection by excise commission and such
other excise officers as have jurisdiction over the area. It shall be inspected atleast
once every month by the proper excise officer. The state govt. may authorise
inspection of a non-bonded establishment by any officer of prohibition, land revenue
or medical and public health practices.
4. Define manufacturing in bond. Outline the procedure to be followed in obtaining a license for
manufacture in bond including the conditions that are to be fulfilled.
Refer page 53 to 56 in B.M mithal for manufacture
Refer page 50 to 51 in B M Mithal for licence
5. Explain Warehousing of alcoholic preparation as per Medicinal and Toilet preparations act. How
alcoholic goods are transported from one warehouse to another.
*refer Q5 (5marks) for ware housing of alcoholic preparations
For transportation refer page 63 to 65
5 marks questions
1. Give offenses and penalties for medicinal and toilet preparations act
Offence
1. offences with respect to manufacture of alcoholic preparations
(i) Non-compliance with
conditions of licence and
failure to pay duty.
(ii) Failure to supply information
asked or supplying false
information
(iii) Attempting or committing or
abetting commission of any
offence
(iv) Improper keeping of stock or
accounts
(v) Making false entries or
tearing pages from stock
book.
(vi) Sale of dutiable goods
otherwise than in prescribed
containers bearing the label.
(vii) Connivance of offences by
owners or occupiers of lans.
(viii) Vexatious search, seizure etc.
by excise officer.
(ix) Failure of excise officer on
duty.
(x) Failure to furnish proof of
export within special period
2. Offenses with respect to warehousing
(i) Opening any lock or door of
warehouse without prior
consent
(ii) Making an alteration in
warehouse without prior
consent.
(iii) Warehousing or removing
goods in contravention of the
rules
(iv) Privately remaining or
concealing any goods either
before or after being
concealing.
(v) Obstructing the officers and
Penalty
(i) Imprisonment upto 6 months
or fine upto Rs. 2000
(ii) Imprisonment upto 6 months
or fine upto Rs. 2000
(iii) Imprisonment upto 6 months
or fine upto Rs. 2000
(iv) Fine upto Rs. 100
(v) Fines upto Rs. 2000 and goods
liable to confiscation
(vi) Imprisonment upto 6 months
or fine up to Rs. 500 or both
(vii) Fine upto Rs. 2000 for every
offense
(viii) Fine upto Rs. 2000 for every
offense
(ix) Imprisonment upto 3 months
or fine upto 3 months pay or
both
(x) Fine upto Rs. 2000
(i) Fine upto Rs. 2000 and goals
liable to confiscation
(ii) Fine upto Rs. 2000 and goals
liable to confiscation
(iii) Fine upto Rs. 2000 and goals
liable to confiscation
(iv) Fine upto Rs. 2000 and goals
liable to confiscation
 giving false information (v) Fine upto Rs. 500
(vi) Wilfully and maliciously (vi) Imprisonment upto 2 years or
giving false information and fine upto Rs. 2000 or more
causing arrest.
(vii) Disclosure of information by (vii) Fine upto Rs. 1000
excise officers.
(viii) Breach of any rule when the (viii) Fine upto Rs. 1000 and goods
penality is provided. liable to confiscation.

2. What are the requirements of a bonded laboratory?

A bonded laboratory should make provision for the following:
(i) A spirit store, unless in laboratory is attached to a distillery or a spirit warehouse.
(ii) A separate room for manufacture of medicinal preparations and toilet preparations.
(iii) A separate room for storage of finished medicinal preparations and toilet preparations.
(iv) Accommodation with necessary furniture for the excise officer-in-charge of the bonded
laboratory near the entrance.
(v) All the windows in the bonded premises should be provided with malleable iron rods not
less than 1.9 cm in the thickness and set not more than 10cm apart embodied in a brick
work to a depth of at least 5cm and covered on the inside with strong wire netting.
(vi) Each room in the laboratory should hear a board indicates the name and a serial number.
(vii) All pipes from sinks or wash basins inside laboratory should be connected with the
general drainage system of the premises.
(viii) All gas and electrical connections in the laboratory should be so arranged that their
supply can be cut off at the end of the days work.
3. Discuss the procedure to be followed for manufacturing medicinal preparations without
bond.
The manufacture in a non-bonded laboratory should be conducted between sunrise and
sunset only and on such days and hours as fixed by the Excise Commissioner.
1. obtaining duty paid rectified spirit:
The spirit can be obtained from a distillery or a spirit warehouse by sending an
indent prepared in triplicate. The original copy is sent to the distiller or spirit
warehouse keeper.
The duplicate copy is sent to the officer in charge of the distillery or spirit
warehouse along with treasury challan from showing payment of excise duty on the
quantity to be purchased. The triplicate copy is retained by the manufacturer. The
treasury officer also sends an advice to the officer-in-charge of the distillery or the
spirit warehouse, who shall issue the spirit together with a permit covering the issue.
The spirit so obtained by the manufacturer should be transferred to the respective
spirit store soon after its arrival and after entry in proper register. The manufacturer
cannot sell or transfer the rectified spirit obtained by him
2. Manufacture of preparation:
 The manufacture of the preparations from duty paid spirit should be carried out only
at the licensed premises. Each preparation soon after its manufacturer should be
registered and batch number is given to it.
3. Storage:
All finished preparations should be transferred from the laboratory to the finished
goods store. The goods are arranged in such a way that they can be easily checked
from the stock store. The goods are arranged in such a way that they can be easily
checked from the stock store. Preparations stored in bulk should be measured in the
storage vessel nearest to 28.350 ml and sealed. The quantities taken out from time to
time should entered in stock card maintained for the purpose.
4. Sampling:
Without previous notice to the manufacturer, the excise officer shall take samples of
not less than 10% and not more than 15% of the total number of batches
manufactured during the month. The samples should be taken personally by the
excise officer in the presence of the manufacturer or his representative.
5. Return of business transactions:
The manufacturer should maintain up-to-date and proper account of his transaction
of business in his laboratory and deliver them to proper officer by 5th of each month.
6. list of employees working in the laboratory:
the manufacturer should inform the excise Commissioner; the names of the
employees whose duties require them to enter the non-bonded laboratory. Only such
persons should be allowed to enter the laboratory. Any change in such persons
should be immediately informed to the Excise Commissioner. No other person can
enter the laboratory without the special permission of the proper officer.
7. Inspection:
The non-bonded laboratory shall be open for inspection by the excise Commissioner
and such other excise duty having jurisdiction over the area.

4. Explain Export of Alcoholic preparations under bond

Those persons who have a bonded laboratory or a bonded warehouse, can export
alcoholic preparations under bond. The exporter should present an application in
triplicate, to the excise officer-in-charge of the laboratory or the warehouse for the
export of alcoholic preparations from India, stating whether the goods are to be exported
by land, sea, air or by post parcel. A separate application is to be made in respect of each
consignment.
The goods meant for export should be packed in cases or packages and should be
marked in ink or oil colour with the following particulars:
 Serial number beginning from I for each year
 Owner’s name and special marks, if any.
 Total quantity of dutiable goods with their alcoholic content in L.P litres
After verifying the particulars entered in the application the officer-in-charge should get the
following particulars noted on the body of each package:
  Name and address of the consignee
 Description of goods
 Total quantity of goods packed
 Alcoholic content of the goods in L.P litres as declared by the manufacturer.
 Gross weight of the package.

Each package is sealed by the said officer with his official seal in such a way that the
package cannot be tempered with, without breaking the seal.
All the copies of the application and then endorsed by the said ooficer, specify the
period within which goods must be exported and returns the duplicate copy of the
application to the exporter. After dispatching the goods, the exporter the exporter
should enter the number and date of R/R (Railway Receipt) or Bill of landing under
which goods have been exported on the duplicate copy and communicate these
particulars to the excise officer for entry in other copies. In case goods are exported
through post office, the exporter should present the duplicate copy of application
endorsed by the excise officer to the Post Master of the post office along with sealed
packages of goods. After the goods have been exporter, the Post Master shall
endorse the duplicate copy of the application accordingly and return it to the officer-
in-charge of his laboratory or warehouse.
5. Explain warehousing of alcoholic preparations.
The manufacturers and dealers in alcoholic preparations are allowed to establish warehouses
anywhere in India for the purpose of depositing spirituous goods on which duty has not been paid.
Those wishing to establish such a warehouse, should obtain a licence for the purpose from the
excise commissioner of the state, by making application to him with a fee of Rs. 25. The Excise
commissioner, before granting a license to any person, may require him to furnish a bond in the
prescribed form with security, in case or kind, binding him to pay duty on the issues of goods
deposited in his warehouse or for their safe transport to another warehouse.
The person may also be bound for the observance of the rule and conditions may under the act.
All goods, observance of the rule and conditions made under the act. All goods, received at the
warehouse, should be covered by valid transit permits received at the warehouse, should be covered
by valid transit permits and should, on their arrival, be produced to the Excise-officer-in-charge of
the warehouse. The goods should also be gauged and the duty chargeable calculated and only after
all particulars have been recorded in the proper register, they can be deposited in the warehouse.
No goods should be removed from the warehouse without the payment of duty, unless they are
removed for the purpose of export from India or transfer to another bonded warehouse.
No goods, other than the dutiable ones, can be deposited in a licensed warehouse.
The excise commissioner may direct as to how should a bonded warehouse be locked and secured.
2 marks questions
1. How do you procure rectified spirit as per provisions of Medicinal and Toilet Preparations Act?
Indent for getting rectified spirit from the distillery approved by the Excise commissioner shall be
made in the prescribed form in triplicate, and countersigned by the officer in charge. The original is
sent directly to the distiller along with the cost price of rectified spirit.
The duplicate is sent through the officer in charge to the distillery excise officer, who issues the
spirit in sealed containers and sent the invoice(bill) of the consignment to the officer in charge of
the bonded laboratory.
The manufacturers are allowed to obtain their requirements of spirit from sources situated in the
same state or from other state. The third copy is retained as office copy
2. How to dispose recovered alcohol as per provisions of Medicinal and Toilet Preparations
Act.
Alcohol which is recovered during the manufacture may be used for manufacture of
subsequent batches of the same preparation. A separate account should be maintained for it.
Recovered alcohol declared by the manufacturer to be unfit for consumption shall be
destroyed by him in the presence of excise officer in charge, on submission of written
application, no rebate of duty shall be allowed on recovered alcohol so destroyed.
3. Define ‘restricted preparations’ under Medicinal and Toilet Preparations Act
Medicinal and toilet preparations (both official and non-official preparations) which are
capable of being consumed as ordinary beverages are referred to as restricted preparations
under the act.
. 4Define ‘London proof spirit’ under Medicinal and Toilet Preparations Act.
It is a mixture of ethyl alcohol and distilled water and at 51-degree f, it weighs exactly 12/13tg parts
of an equal measure of distilled water at same temperature.
5. Define ‘rectified spirit’ under Medicinal and Toilet Preparations Act.
It is denatured alcohol of strength not less than 50˚ over proof.
It is also known as neutral spirit.
Chapter 6- Narcotic Drugs & Psychotropic Substances Act
5 marks questions
1. Define ‘Manufactured Drugs’ and ‘Controlled Substances’ as per NDPS Act.
Manufactured Drugs
"manufactured drug" means all coca derivatives, medicinal cannabis, opium derivatives and
poppy straw concentrate;
all preparations containing more than 0.2 per cent. of morphine or containing any
diacetylmorphine;
any other narcotic substance or preparation which the Central Government may, having
regard to the available information as to its nature or to a decision, if any, under any
International Convention, by notification in the Official Gazette, declare to be a
 manufactured drug; but does not include any narcotic substance or preparation which the
Central Government may, having regard to the available information as to its nature or to a
decision, if any, under any International Convention, by notification in the Official Gazette,
declare not to be a manufactured drug;
Controlled substances
"controlled substance" means any substance which the Central Government may, having
regard to the available information as to its possible use in the production or manufacture of
narcotic drugs or psychotropic substances or to the provisions of any International
Convention, by notification in the Official Gazette, declare to be a controlled substance
2. Write the constitution and functions of Narcotic and Psychotropic consultative committee
Constitution:
The Committee shall consist of a Chairman and such other members, not
exceeding twenty, as may be appointed by the Central Government.
The Committee shall meet when required to do so by the Central Government and shall have
power to regulate its own procedure.
The Committee may, if it deems it necessary so to do for the efficient discharge of any of
its functions constitute one or more sub-committees and may appoint to any such sub-committee,
whether generally or for the consideration of any particular matter any person (including a
nonofficial)
who is not a member of the Committee.
The term of office of, the manner of filling casual vacancies in the offices of and the
allowances, if any, payable to, the Chairman and other members of the Committee, and the
conditions and restrictions subject to which the Committee may appoint a person who is not a
member of the Committee as a member of any of its sub-committees, shall be such as may be
prescribed by rules made by the Central Government.

Functions:
 To advice central government on the matters relating to administration of act
 To supervise cultivation of opium poppy and production of opium and give effect to other
provisions of the law
 To identify the addicts and refer them to deaddiction centre
 Support in the formation of National fund for control of drug abuse
3. Define the term ‘Opium Derivatives’ and ‘Coca derivatives’ under NDPS Act
Opium Derivatives
(a)medicinal opium, that is, 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 notified in this behalf by the Central Government, whether in powder form or
granulated or otherwise or mixed with neutral materials;
(b) prepared opium, that is, any product of opium by any series of operations designed to transform
opium into an extract suitable for smoking and the dross or other residue remaining after opium is
smoked;
(c) phenanthrene alkaloids, namely, morphine, codeine, thebaine and their salts;
(d) diacetylmorphine, that is, the alkaloid also known as dia morphine or heroin and its salts; and
(e) all preparations containing more than 0.2 per cent. of morphine or containing any
diacetylmorphine;
Coca derivatives
(a)crude cocaine, that is, any extract of coca leaf which can be used, directly or indirectly, for the
manufacture of cocaine;
(b) ecgonine and all the derivatives of ecgonine from which it can be recovered;
(c) cocaine, that is, methyl ester of benzoyl-ecgonine and its salts; and
(d) all preparations containing more than 0.1 percent of cocaine;
4. Explain manufacture, Sale and export of Opium
Manufacture of opium;
Only central government can manufacture opium at its 2 factories at Ghazipur and Neemuch.
However, any opium mixture may be manufactured from lawfully possessed opium in accordance
with rules made for the purpose.
Sale of opium:
Sale of opium to State Governments or manufacturing chemists can be made only from government
opium factory, Ghazipur. The sale to manufacturing chemist is only possible under permit from
concerned State Government 3 copies of which are sent to the opium factory.
The sale price shall be as fixed by the Central Government from time to time.
Export:
Opium can be exported only on behalf of the Central Government
5. Discuss cultivation and production of opium.
Cultivation of opium:
The opium can be cultivated only on behalf of the Central Government and under a licence granted
for the purpose in such parts of the country as may be specified.
The licenses may be granted by district opium officers for cultivation in specified areas and plots.
The district opium officers may also designate one of the licensed cultivators as Lambardar who
may discharge duties specified by the Narcotics Commissioner.
The licences granted by district opium officers may be with held or cancellation by higher officers
after giving a chance to the cultivator for being heard.
If any opium is cultivated under a licence which is subsequently cancelled, the crop may be
destroyed.
Production of opium:
Cultivators during harvesting should take each day’s collection to Lambardar for weighing and
entry in records which should be jointly attested, everyday by Lambardar and cultivator. These
records may be checked by officers. In case of any discrepancies between the quantity produced
and quantity entered enquiry shall be made to determine the liability of the cultivator for
punishment.
All opium produced has to be delivered to the district opium officer who will weigh, examine and
classify the same in the prescribed manner. A cultivator dissatisfied with classification may have
the opium forwarded to government opium factory. All opium forwarded to government factory has
to be classified by its General Manager.
If the district opium officer suspects any opium delivered to him to be adulterated, he may send it
separately to government opium factory after sealing it in the presence of Lambardar and cultivator.
Adulterated opium is liable to confiscation after given a hearing to the cultivator.
2 marks questions
1 What is the punishment specified for illegal cultivation of coca plant.
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 licence
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
2 Write the constitution and functions of Narcotic and Psychotropic consultative committee
Constitution
It consists of a chairman and a maximum of 20 members, has also to be appointed by the Central
Government for advice on matters related to administration of the act.
The committee can appoint sub-committees for consideration of any particular matter
Functions:
 To advice central government on the matters relating to administration of act
 To supervise cultivation of opium poppy and production of opium and give effect to other
provisions of the law
3 Define ‘Psychotropic substances’ as per NDPS Act
*refer Q14(2mark)
4 What is the punishment specified for allowing the use of premises, vehicles etc. for commission
of an offence under NDPS act.
*refer Q11 (2mark)
5 Give four examples for psychotropic substances.
*refer Q14 (2marks)
6 What are objectives of NDPS act.
 It imposes certain restrictions on cultivation, manufacture and trade of dangerous drugs.
 To consolidate and amend the laws relating to narcotic drugs, to make stringent provisions
for the control and regulation of operation relating to narcotic drugs and psychotropic
substances and for matters connected therewith
7 Define the term coca derivatives under NDPSAct.
*refer Q3 5marks)
8 Differentiate between Poppy straw and poppy concentrate
"poppy straw" means all parts (except the seeds) of the opium poppy after harvesting whether in
their original form or cut, crushed or powdered and whether or not juice has
been extracted therefrom;
"poppy straw concentrate" means the material arising when poppy straw has entered into a
process for the concentration of its alkaloids;
9 Define Narcotic Drug as per NDPSAct.
narcotic drug" means coca leaf, cannabis (hemp), opium, poppy straw and includes all
manufactured goods;
10 Define Manufactured Drug as per NDPS Act.
*refer Q1 (5mark)
11 What is the punishment specified for allowing the use of premises, vehicles etc. for commission
of an offence under NDPS act?
. 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 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.
12 Define controlled substance
*refer Q1 (5mark)
13 What is the punishment specified for illegal cultivation of coca plant?
*refer Q1(2 mark)

14 Give four examples of Psychotropic Substances under NDPS act

"psychotropic substance" means any substance, natural or synthetic, or any natural material or any
salt or preparation of such substance or material included in the list of psychotropic substances
specified in the Schedule;
l
example: hallucinogens
benzodiazepines- alprazolam
barbiturates-pentobarbital, allobarbital
Amphetamine-type stimulants
Sedative hypnotics

15 Define illicit traffic as under NDPS Act.

"illicit traffic", in relation to narcotic drugs and psychotropic substances, means
(i) cultivating any coca plant or gathering any portion of coca plant;
(ii) cultivating the opium poppy or any cannabis plant;
(iii) engaging in the production, manufacture, possession, sale, purchase, transportation,
warehousing, concealment, use or consumption, import inter-State, export inter-State, import into
India, export from India or transhipment, of narcotic drugs or psychotropic substances;
(iv) dealing in any activities in narcotic drugs or psychotropic substances other than those
referred to in sub-clauses (i) to (iii); or
(v) handling or letting out any premises for the carrying on of any
of the activities referred to in sub-clauses (i) to (iv);
other than those permitted under this Act, or any rule or order made, or any condition of any
licence, term or authorisation issued, thereunder, and includes
(1) financing, directly or indirectly, any of the aforementioned activities;
(2) abetting or conspiring in the furtherance of or in support of doing any of the aforementioned
activities; and
(3) harbouring persons engaged in any of the aforementioned activities

Chapter 7- Drug & Magic Remedies Act

5 marks questions
1. Describe the classes of advertisements exempted conditionally under the Drugs and Magic
Remedies Act.
Magic remedy
A talisman, mantra, kavacha and any other charm of any kind which is alleged to possess
miraculous powers for or in the diagnosis, cure, mitigation, treatment or prevention of any disease
in human beings or animals or for affecting or influencing in any way the structure or any organic
function of the body of human beings or animals;

(i) in respect of any disease, disorder or condition which requires timely treatment in
consultation with a registered medical practitioner or for which there are normally no
accepted remedies, and (ii) after consultation with the Drug Technical Advisory Board
constituted under the Drugs and Cosmetics Act, 1940 (23 of 1940) and, if the Central
Government considers necessary, with such order persons having special knowledge or
practical experience in respect of Ayurvedic or Unani systems of medicines as that
Government deems fit.
(ii) any signboard or notice displayed by a registered medical practitioner on his premises
indicating that treatment for any disease, disorder or condition specified in Section 3, the
Schedule or the rules made under this Act, is undertaken in those premises; or
(iii) (b)any treatise or book dealing with any of the matters specified in Section 3 from a
bonafide scientific or social standpoint; or
(iv) (c) any advertisement relating to any drug sent confidentially in the manner prescribed
under Section 16 only to a registered medical practitioner; or
(v) any advertisement relating to a drug printed or published by the Government; or
(vi) (e) any advertisement relating to a drug printed or published by any person with the
previous sanction of the Government granted prior to the commencement of the Drugs
and Magic Remedies (Objectionable Advertisement) Amendment Act, 1963 (42 of
1963);
(vii) If in the opinion of the Central Government public interest requires that the
advertisement of any specified drug or class of drugs 1[or any specified class of
advertisements relating to drugs] should be permitted; it may, by notification in the
Official Gazzette, direct that the provisions of sections 3, 4, 5 and 6 or any one of such
provisions shall not apply or shall apply subject to such conditions as may be specified
in the notification to or in relation to the advertisement of any such drug or class of
drugs 1[or any specified class of advertisement relating to drugs].

2. Define magic remedy. Write the classes of advertisements prohibited under D&MR Act.
*refer Q1(5marks) for definition
Subject to the provisions of this Act, no person shall take any part in the publication of any
advertisement referring to any drug in terms which suggest or are calculated to lead to the use of
that drug for – (a) the procurement of miscarriage in women or prevention of conception in women;
or
(b) the maintenance or improvement of the capacity of human beings for sexual pleasure; or
(c) the correction of menstrual disorder in women; or
(d) the diagnosis, cure, mitigation, treatment or prevention of any disease, disorder or condition
specified in the Schedule, or any other disease, disorder or condition (by whatsoever name called)
which may be specified in the rules made under this Act.

Prohibition of misleading advertisements relating to drugs Subject to the provisions of this Act, no
person shall take any part in the publication of any advertisement relating to a drug if the
advertisement contains any matter which – (a) directly or indirectly gives a false impression
regarding the true character of the drug; or
(b) make a false claim for the drug; or
(c) is otherwise false or misleading in any material particular.

3. Define ‘advertisement’. Write the classes of advertisements exempted under D&MR Act.

‘Advertisement’ includes any notice, circular, label, wrapper, or other document, and any
announcement made orally or by any means of producing or transmitting light, sound or
smoke;
*refer Q1 (5marks)
4. Define ‘Drugs’, ‘Advertisements’, and ‘Magic Remedies’ as per Drugs and Magic
Remedies Act.
Drugs

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;
such substances (other than food) intended to affect the structure or any function of human
body or intended to be used for the destruction of vermin or insects which cause disease in
human beings or animals, as may be specified from time to time by the Central Government
by notification in the Official Gazette
*for advertisements refer Q1 for magic remedy
*refer Q3(5 mark) for definition of advertisement
5. What are objectives of Drugs and Magic Remedies Act. Give offences and penalties under the
act.
Objectives

1) Subject to the provisions of any rules made in this behalf, any Gazetted officer authorised by the
state Government may, within the local limits of the area for which he is so authorised –
a) enter and search at all reasonable times, with such assistants, if any, as he considers necessary,
any place in which he has reason to believe that an offence under this act has been or is being
commited;
b) seize any advertisement which he has reason to believe contravenes any of provisions of this act;

Examine any record, register, document or any other material object found in any place mentioned
in clause (a) and seize the same if he has reason to believe that it may furnish evidence of the
commission of an offence punishable under this act.
(2) Provisions of the code of criminal procedure, 1898 shall may apply to any search under this act.
(3) Where any person seizes anything under clause (b) or clause (c) of sub section (1), he shall, as
soon as may be inform a Magistrate and take his orders as to the custody thereof.
The Central Government may, by notification in the Official Gazzette, make rules for carrying out
the purposes of this Act.
(2) In particular and without prejudice to the generality of the foregoing power, such rules may-
(a) specify any [disease, disorder or condition] to which the provisions of section 3 shall apply;
(b) prescribe the manner in which advertisements of articles or things referred to in clause (c) of
section 14 may be sent confidentially.
3)Every rule made under this Act shall be laid as soon as may be after it is made, before each House
of Parliament while it is in session for a total period of thirty days which may be comprised in one
session or in two or more successive sessions and if before the expiry of session in which it is so
laid or the successive sessions aforesaid, both Houses agree in making any modification in the rule
or both Houses agree that the rule should not be made, the rule shall thereafter have effect only in
such modified form or be of no effect, as the case may be; so, however, that any such modification
or annulment shall be without prejudice to the validity of anything previously done under that rule.

Offences
(1)If the person contravening any of the provisions of this Act is a company, every person who, at
the time the offence was committed, was in charge of, and was responsible to, the company for the
conduct of the business of the company as well as the company shall be deemed to be guilty of the
contravention and shall be liable to be proceeded against and punished accordingly:
(2) Notwithstanding anything contained in sub-section (1) where an offence under this act has been
committed by a company and it is proved that the offence was committed with the consent or
connivance of, or is attributable to any neglect on the part of, any director or manager, secretary or
other officer of the company, such director manager, secretary or other officer of the company shall
also be deemed to be guilty of that offence and shall be liable to be proceeded against and punished
accordingly.

Whoever contravenes any of the provisions of this Act [or the rules made there under] shall, on
conviction, be punishable –
a) in the case of a first conviction, with imprisonment which may extend to six months or with fine,
or with both; b) in the case of a subsequent conviction, with imprisonment which may extend to one
year, or with fine, or with both.

Chapter 8 & 9- Essential commodities Act relevant to DPCO & National Drug Pol
2 marks questions
1. Define ‘ceiling price’ as per DPCO.
*refer Q7 (2marks)
2. Write objectives of National Drug Policy
 Ensuring abundant availability, at reasonable prices of essential life-saving and prophylactic
medicines of good quality.
 Strengthening the system of quality control over drug production and promoting the rational
use of drugs in the country.
 Strengthening the indigenous capability for production of drugs.
 To revise and issue a fresh Drug price control order
3. How retail price of formulation is calculated as per DPCO
R.P = ( M.C + C.C + P.M + P.C) x (1 + MAPE / 100) + E.D.
Where, R.P = Retail Price
M.C = Material Cost
C.C = Conversion Cost
P.M = Packaging Material Cost
 P.C = Packing Charges
E.D. = Excise Duty
MAPE = Maximum allowable post manufacturing expenses
4. How MAPE is calculated as per DPCO
MAPE means Maximum Allowable Post Manufacturing Expenses including trade margin and
margin of the manufacturer and shall not exceed the limit fixed.
MAPE shall not exceed 100% for indigenously manufactured scheduled formulations. In case of an
imported formulation the landed cost shall be from the basis for fixing its price along with such
margin to cover selling and distribution expenses including intrest and profit of the importer which
shall not exceed 50% of the landed cost
5. What is MAPE as described in DPCO
MAPE means maximum allowable post-manufacturing expenses including trade margin and
margin of the manufacturer and shall not exceed the limit fixed
6. How do you calculate retail price for formulations as per DPCO?
*refer Q3 (2mark)
7. What is ceiling price as per DPCO
Ceiling price means a fixed price by the Government for the formulations specified in the Category
I or Category II of the third schedule in accordance with the price calculation formula of the order
keeping in view the cost of efficiency or both of major manufacturers of such formulations.
8. Explain the term MAPE. How it is calculated.
Refer Q4 (2marks)
9. Describe facilities to be maintained for experimentation animals under CPCSEA
guidelines.
Dogs held for experimental purposes shall not be debarked. Applying any chemical
substance to the eye of an animal by way of experiment for the purpose of
absorption through the conjunctival membrane or through the cornea calculated to
only give pain, is not allowed.
No paralyzing agent shall be administered for the purpose of any experiment except
under deep anaesthesia.
10. Name the Authorities under DPCO.
 National Pharmaceutical Pricing Authority
 National List of Essential Medicines
11. Write Objectives of DPCO
The Drug Price Control Order(DPCO) is an order issued by the government under the Essential
Commodities Act which enables it to fix the prices of some essential bulk drugs and their
formulations.
Objectives:
 To ensure availability, at reasonable prices of essential and life saving and
prophylactic medicines of good quality.
 Promoting the rational use of drugs in the country to encourage cost effective
production with economic sizes.
 To regulate equal distribution
 To maintain and increase supply of bulk drugs and formulations

Chapter 10- Prevention of cruelty to animals act

5 marks questions
1. Write objectives of ‘Prevention of cruelty to animals act’. What are the parts of CPCSEA
guidelines?
The prevention of cruelty to animals Act 1960 has been enacted to prevent the infliction of
unnecessary pain or sufferings of animals and for that purpose to amend the laws relating to
the prevention of cruelty to animals
Objectives:
 Where the experiments are performed by institutions, their head shall be responsible
for furtherance of the objects of the Act and where individuals run any experiment
on animals they shall be individually responsible for avoidance of cruelty to the
animals
 The experiments, as far as possible are performed while the animal is under the
influence of an anaesthetic and if recovery of the animal involves serious suffering,
it should be destroyed while it is unconscious.
 The animals intended to be used for experiments should be properly looked after
before and after the experiments and records of experiments should be maintained.

CPCSEA Guidelines:

For the purpose of registration of establishments/breeders (including universities and colleges , the
Government of India has set up the “Committee for the Purpose of Control and Supervision of
Experiments on Animals” under the ministry of Social Justice and Empowerment, new Delhi
The committee is required to take all such measures as may be necessary to ensure that animals
used for scientific experiments are not subjected to unnecessary pain or suffering.
 Where the experiments are performed by institutions, their head shall be responsible
for furtherance of the objects of the Act and where individuals run any experiment
 on animals they shall be individually responsible for avoidance of cruelty to the
animals
 Experiments are performed with due care and humanityand s far as possible,
experiments are performed under the influence of anaesthetic , and if recovery of the
animal involves serious suffering, it should be destroyed while it is unconscious.
 The animals intended to be used for experiments should be properly looked after
before and after the experiments and records of experiments should be maintained.

 As far as possible, small laboratory animals should be used to perform experiments

to avoid large animals. Substitute the use of animals by devices such as models,
films etc.

 The experiments on animals should not be performed merely for acquiring manual
skill

 Suitable records are maintained with respect to experiments performed on animals

2. Define ‘Cruelty to animals’. Explain provisions for breeding and stocking of animals as per this
act.
The prevention of cruelty to animals Act 1960 has been enacted to prevent the infliction of
unnecessary pain or sufferings of animals and for that purpose to amend the laws relating to the
prevention of cruelty to animals
The act is required to take all such measures as may be necessary to ensure that animals used for
scientific experiments are not subjected to unnecessary pain or suffering.
*refer Q3(5marks) for breeding and stocking
3. Describe facilities to be maintained for experimentation animals under CPCSEA guidelines
The business of breeding and stocking of animals for the purpose of experiments can be done by
registered establishment. The breeder/establishment interested in carrying on the business of
breeding animals or trade of animals for the purpose of experiments shall apply for registration
within 60 days from the date of commencement of the breeding. The application for registration
shall be made in a prescribed proforma to the Member-secretory or any other authorised officer of
the committee for the purpose of control and supervision of experiments on animals.
The authorised officer of the committee may ask for information relating to premises where the
experiments are to be conducted, animal housing facilities, details of breeding of animals, other
infrastructure including trained persons in handling animals and for verification of facts mentioned
in the application for registration. The establishment or the breeder get registered shall comply with
the conditions mentioned at the time of registration.
Every registered establishment shall maintain a register as prescribed format and keep complete
details about the type of animals to be used for conducting experiments, the health of animals, the
nature of experiments to be performed and the reasons for performing of such an experiment on
particular species.
The officer authorised by the committee may examine the register and in case if he is not satisfied
irrespective of the opportunity given for improvement, he may bring this to the notice of the
committee seeking direction in this regard.
The animals shall be kept by the breeder and establishments in the prescribed manner. Animal
houses shall be located in a quite atmosphere undisturbed by traffic.
The premises should be kept neat and clean. The animals should be protected from harsh weather.
There shall be satisfactory arrangements for looking after the animals in the animal house during
off hours and on holidays
4. Give constitution and function of Institute Animal Ethics(IAE) Committee
Constitution:
Every institutional Animal ethics committee shall consist of following members:
 A biological scientist
 2 scientists from different biological disciplines.
 A veterinarian invited in the case of animals.
 A scientist from outside the institution.
 A non-scientific socially aware member
 A specialist may be co-opted while reviewing special projects using hazardous agents such
as radioactive substances and deadly microbes.
Functions:
 Transfer and acquisition of animals for experiments:
Transfer of any animal by way of sale or otherwise by a breede to an unregisterd
establishment is not permitted.
 Maintain records of animals under its control and custody:
Every establishment/ institutional animals Ethics Committee shall maintain a record of the
animals under its control and custody and furnish such information, as committee may
required in the prescribed performa from time to time
 Power to suspend or revoke registration
 Contract animal experiments:
No establishment shall contract or undertake to perform contract research or experiments on
contract basis on the behalf of any other establishments/ research on educational institution.
  Penalties:
If any person contravenes any conditions imposed by the committee is punishable with fine
which may extent to Rs. 200.
 Power to make rules

5. How are experimental animals to be handled during and after experiments as per
CPSCEA guidelines?
Experiment shall be performed with due care and humanity.
Animals intended for the performance of experiments are properly looked both before and after the
experiments.
Experiments involving operative procedure more severe than simple inoculation or superficial
venesection shall be performed under the influence of anaesthetic to prevent animal feeling pain
and it shall remain so throughout the experiment. Anaesthesia shall be administered by a veterinary
surgeon trained in methods of anaesthesia or a scientist/technician so trained for this purpose and
who shall remain present near the animal till the completion of the experiment.
The animals which, in the course of experiments under the influence of anaesthetic, are so
injured that their recovery would involve serious suffering, they should be destroyed while
still unconscious
Where there is a reason to believe that an animal is suffering abnormal or severe pain at any stage
of a continuing experiment, it shall be painlessly destroyed at that stage without proceeding with
the experiment.
The substances known as urari or curare or any paralysan shall not be used or administered for the
purpose of any experiment except in conjuction with anaesthetic or sufficient depth to produce loss
of consciousness.
Dogs held for experimental purposes shall not be debarked. Applying any chemical substance to the
eye of an animal by way of experiment for the purpose of absorption through the conjunctival
membrane or through the cornea calculated to only give pain, is not allowed.
2 marks questions
1. Under what conditions an animal for experiment is sacrificed as per CPCSEA guidelines?
The animals which, in the course of experiments under the influence of anaesthetic, are so
injured that their recovery would involve serious suffering, they should be destroyed while
still unconsious
2. Write the objectives of Prevention of Cruelty to Animals Act.
  To prevent the infliction of unnecessary pain or suffering on animals and for that purpose to
amend and for that purpose to amend the law relating to the prevention of cruelty to
animals.
 The act provides for the constitution of animal welfare board of India and a committee for
control and supervision of experiments on animals, in separate chapters in the act, giving the
constitution, and functions of these
 Cruelty to animals and performing animals are also dealt in this act, with penalty and
offenses.
3. Define CPCSEA.
For the purpose of registration of establishments/breeders (including universities and colleges , the
Government of India has set up the “Committee for the Purpose of Control and Supervision of
Experiments on Animals” under the ministry of Social Justice and Empowerment, new Delhi
The committee is required to take all such measures as may be necessary to ensure that animals
used for scientific experiments are not subjected to unnecessary pain or suffering.

4. Give the constitution of Institutional Animal Ethics Committee

Every institutional Animal ethics committee shall consist of following members:
 A biological scientist
 2 scientists from different biological disciplines.
 A veterinarian invited in the case of animals.
 A scientist from outside the institution.
 A non-scientific socially aware member
 A specialist may be co-opted while reviewing special projects using hazardous agents such
as radioactive substances and deadly microbes.

5. What are the functions of Institutional Animal Ethics Committee?

 Transfer and acquisition of animals for experiments
 Maintain records of animals under its control and custody
 Power to suspend or revoke registration
 Contract animal experiments
 Penalties
 Power to make rules
Chapter 11- Patent & design Act
10 marks
1. Name the types of patents granted under patents act. Give the procedure for obtaining the
patent.
 *refer Q4 for type of patent
*refer Q5 for procedure
2. Define Patent. List the inventions that are not patentable within the meaning of Patent Act. Give
offence and penalties under this Act.
*refer Q1 for definition and inventions that are not patentable
 Offences and Penalties
 Contraventions of secrecy provisions relating to certain invention
If any person fails to comply with any secrecy directions given for defence purposes, he shall be
punishable with imprisonment for a term up to two years or with fine or with both.
 Falsifications of entries in Register, etc.
If any person makes, or causes to be , a false entry in any register kept under this act, or
produces any such false entry as an evidence, he shall be punishable with imprisonment for a term
which may extend to two years or with fine or with both.
Unauthorised claims of patent rights
 If any person falsely represents that any article sold by him is patented in India or is the
subject of an application for a patent in India, he shall be punishable with fine which may
extend to five hundred rupees.
Wrongful use of words “ Patent office”
 If any person uses on his place of business or any document issued by him or otherwise the
words “Patent Office” or any other words which would reasonably lead to the belief that
place of business is officially connected with , the patent office , he shall be punishable with
imprisonment for a term which may extend to six months or with fine or with both.
Refusal or failure to supply information
 If any person refuses or fails to furnish to the Central Government or to the Controller, any
information which he is required to furnish, he shall be punishable with fine which extend to
one thousand rupees.

3. Explain procedure of application of patent including revocations of patents under Indian Patent
Act.
*refer Q5(5marks) for procedure

*refer Q3(5 marks) for revocaton

4. What is Patent Coopertative Treaty. Explain Patent of addition and restoration of Lapsed patents
under Patent Act.
Patent cooperative treaty
With a view to the fulfilment of a treaty, convention or arrangement with any
country outside India which affords to applicants for patents in India or to citizens of India
similar privileges as are granted to its own citizens in respect of the grant of patents and the
protection of patent rights, the Central Government may, by notification in the Official
Gazette, declare such country to be a convention country for the purposes of this Act.
*for patent of additon refer Q (5marks)

*for restroraton of lapsed patent refer Q ( marks)

5. Describe Publication and examination of application for patents.Give offences and penalties
patents act.
When the complete specification has been filed in respect of an application for
a patent, the application and the specification relating thereto shall be referred by the
Controller to an examiner for making a report to him in respect of the following matters,
namely:
(a) whether the application and the specification relating thereto are in accordance with
the requirements of this Act and of any rules made thereunder;
(b) whether there is any lawful ground of objection to the grant of the patent under this
Act in pursuance of the application;
(c) the result of investigations made under section 13; and
(d) any other matter which may be prescribed.
(2) The examiner to whom the application and the specification relating thereto are
referred under sub-section (1) shall ordinarily make the report to the Controller within a
period of eighteen months from the date of such reference.
(1) The examiner to whom an application for a patent is referred under section 12
shall make investigation for the purpose of ascertaining whether the invention so far as
claimed in any claim of the complete specification—
(a) has been anticipated by publication before the date of filing of the applicant’s
complete specification in any specification filed in pursuance of an application for a patent
made in India and dated on or after the 1st day of January, 1912;
(b) is claimed in any claim of any other complete specification published on or after the
date of filing of the applicant’s complete specification, being a specification filed in
pursuance of an application for a patent made in India and dated before or claiming the
priority date earlier than that date.
(2) The examiner shall, in addition, make such investigation as the Controller may
direct for the purpose of ascertaining whether the invention, so far as claimed in any claim of
the complete specification, has been anticipated by publication in India or elsewhere in any
document other than those mentioned in sub-section (1) before the date of filing of the
applicant’s complete specification.
Where a complete specification is amended under the provisions of this Act before
it has been accepted, the amended specification shall be examined and investigated in like
manner as the original specification.
(4) The examination and investigations required under section 12 and this section shall
not be deemed in any way to warrant the validity of any patent, and no liability shall be
incurred by the Central Government or any officer thereof by reason of, or in connection with,
any such examination or investigation or any report or other proceedings consequent thereon.
Where, in respect of an application for a patent, the report of the examiner received
by the Controller is adverse to the applicant or requires any amendment of the application or
of the specification to ensure compliance with the provisions of this Act or of the rules made
thereunder, the Controller, before proceeding to dispose of the application in accordance with
the provisions hereinafter appearing, shall communicate the gist of the objections to the
applicant and shall, if so required by the applicant within the prescribed time, give him an
opportunity of being heard.
(1) Where the Controller is satisfied that the application or any specification filed
in pursuance thereof does not comply with the requirements of this Act or of any rules made
thereunder, the Controller may either—
(a) refuse to proceed with the application; or
(b) require the application, specification or drawings to be amended to his satisfaction
before he proceeds with the application.
(2) If it appears to the Controller that the invention claimed in the specification is not
an invention within the meaning of, or is not patentable under, this Act, he shall refuse the
application.
(3) If it appears to the Controller that any invention, in respect of which an application
for a patent is made, might be used in any manner contrary to law, he may refuse the
application, unless the specification is amended by the insertion of such disclaimer in respect
of that use of the invention, or such other reference to the illegality thereof, as the Controller
thinks fit.
(1) A person who has made an application for a patent under this Act may, at any
time before the acceptance of the complete specification, if he so desires, or with a view to
remedy the objection raised by the Controller on the ground that the claims of the complete
specification relate to more than one invention, file a further application in respect of an
invention disclosed in the provisional or complete specification already filed in respect of the
first mentioned application.
(2) The further application under sub-section (1) shall be accompanied by a complete
specification, but such complete specification shall not include any matter not in substance
disclosed in the complete specification filed in pursuance of the first mentioned application.
(3) The Controller may require such amendment of the complete specification filed in
pursuance of either the original or the further application as may be necessary to ensure that neither
of the said complete specifications include a claim for any matter claimed in the other
*refer Q1 (10 marks) for offences and penslities

5 marks question
1. Define the term Patent as per Patent act. Which inventions are not patentable under the Act.
 “patent” means a patent granted under this Act and includes for the purposes of
sections 44, 49, 50, 51, 52, 54, 55, 56, 57, 58, 63, 65, 66, 68, 69, 70, 78, 134, 140, 153, 154
and 156 and Chapters XVI, XVII and XVIII, a patent granted under the Indian Patents and
Designs Act, 1911
The following are not inventions within the meaning of this Act,—
(a) an invention which is frivolous or which claims anything obviously contrary to well
established natural laws;
(b) an invention the primary or intended use of which would be contrary to law or
morality or injurious to public health;
(c) the mere discovery of a scientific principle or the formulation of an abstract theory;
(d) the mere discovery of any new property or new use for a known substance or of the
mere use of a known process, machine or apparatus unless such known process results in a
new product or employs at least one new reactant;
(e) a substance obtained by a mere admixture resulting only in the aggregation of the
properties of the components thereof or a process for producing such substance;
(f) the mere arrangement or re-arrangement or duplication of known devices each
functioning independently of one another in a known way;
(g) a method or process of testing applicable during the process of manufacture for
rendering the machine, apparatus or other equipment more efficient or for the improvement
or
restoration of the existing machine, apparatus or other equipment or for the improvement or
control of manufacture;
(h) a method of agriculture or horticulture;
(i) any process for the medicinal, surgical, curative, prophylactic or other treatment of
human beings or any process for a similar treatment of animals or plants to render them free
of disease or to increase their economic value or that of their products.
No patent shall be granted in respect of an invention relating to atomic energy falling
within sub-section (1) of section 20 of the Atomic Energy Act, 1962.
In the case of inventions—
(a) claiming substances intended for use, or capable of being used, as food or as
medicine or drug, or
(b) relating to substances prepared or produced by chemical processes (including
alloys, optical glass, semi- conductors and inter-metallic compounds),
no patent shall be granted in respect of claims for the substances themselves, but claims for
the methods or processes of manufacture shall be patentable.

2. What is the Patent of addition? What are the rights of patentees & co owners of patent.
“patent of addition” means a patent granted in accordance with Section 51, where an
application is made for a patent in respect of any improvement in or modification of an
invention described or disclosed in the complete specification filed therefor (in this Act
referred to as the “main invention”) and the applicant also applies or has applied for a patent
 for that invention or is the patentee in respect thereof, the Controller may, if the applicant so
requests, grant the patent for the improvement or modification as a patent of addition.

Rights of Patentees
Exclusive right to make, use, exercise, sell or distribute the invention in India.
• A patent granted after the commencement of this Act confers upon the patentee:
• Where the patent is for an article or substances, the exclusive right to make, use, exercise,
sell or distribute such article or substances in India.
• Where a patent is for a method or process of manufacturing an article or substances, the
exclusive right to use or exercise the method or process in India.
Right of Co Owner of Patents
Each of the co-owner shall be entitled to equal rights on the patent.
• If two or more persons are registered as grantee or proprietor of a patent, a licence under
the patent shall not be granted and share in the patent shall not be assigned by one of the
such person except with the consent of the other person(s).
• Where a patented article is sold by one or two or more persons registered as grantee or
proprietor of a patent, the purchaser shall be entitled to deal with the article in the same
manner as if the article has been sold by the sole patentee.
The rules of law applicable to the ownership band mutual rights of the trustees or legal
representatives
3. Explain the procedure for revocation of patents.
Revocation of Patent
A patent may be revoked by high court on any of the following grounds
 That the invention, so far as claimed is already granted of another patent in India.
 The patent was granted on application of a person not entitled under the provisions of this
act to apply therefore.
 That the patent was granted wrongfully in contravention of the rights of the petitioner or any
person under or through whom he claims
 That The subject of any claim of the complete specification is :
 Not an invention within the meaning of the Act.
 Is not new.
 Is obvious or does not involve in any inventive step.
 Is not useful.
 Is not patentable under this Act.
 If complete method and specification is not given.
 If the scope of any claim is not sufficiently and clearly defined or any claim of the complete
specification is not fairly based on the matter disclosed.
 If the applicant has failed to disclose to the controller the information required by him
 If the furnished information of material particular was false to his knowledge.
• If the patent was obtained on a false suggestion or representation.
• If the applicant contravened any direction for secrecy.
• If leave to amend complete specification was obtained by fraud.
 4. Enumerate the types of patents. What are the criteria for inventions to be patentable?
Types of patent Granted
An ordinary patent.
A patent of addition for improvement in modification of an invention for which a patent has
already been applied for granted.
A patent granted in respect of a convention application filled under section 135 of the act.
A part patent for a medicine or drug as provided by the patents (amendment) act 1999

Criteria for Inventions to be patentable

(1) Subject to the provisions contained in section 134, an application for a patent
for an invention may be made by any of the following persons, that is to say,—
(a) by any person claiming to be the true and first inventor of the invention;
(b) by any person being the assignee of the person claiming to be the true and first
inventor in respect of the right to make such an application;
(c) by the legal representative of any deceased person who immediately before his
death was entitled to make such an application.
(2) An application under sub-section (1) may be made by any of the persons referred to
therein either alone or jointly with any other person.
(1) Every application for a patent shall be for one invention only and shall be made
in the prescribed form and filed in the patent office.
(2) Where the application is made by virtue of an assignment of the right to apply for a
patent for the invention, there shall be furnished with the application, or within such period
as
may be prescribed after the filing of the application, proof of the right to make the
application.
3) Every application under this section shall state that the applicant is in possession of
the invention and shall name the owner claiming to be the true and first inventor; and where
the person so claiming is not the applicant or one of the applicants, the application shall
contain a declaration that the applicant believes the person so named to be the true and first
inventor.
(4) Every such application (not being a convention application) shall be accompanied
by a provisional or a complete specification.
5. Define Invention as per patent act. Enlist the steps for obtaining a patent
“invention” means any new and useful—
(i) art, process, method or manner of manufacture;
(ii) machine, apparatus or other article;
(iii) substance produced by manufacture,
and includes any new and useful improvement of any of them, and an alleged invention;
Steps for obtaining a patent
  An application for an ordinary patent including that for a product patent may be made by the
person claiming to be the 1st true inventor his legal representive, his assignee, either alone or
jointly with any other person. Addition patent application can be made if patent is pending
already granted.
 Application for every patent made in single application for and field in the patent office.
(head office at Calcutta and branch office at Chennai, Mumbai and Delhi)
 Proof of the right
 True inventor or owner inventor claiming must be mention.
 Complete application.
 Document attached following: a full description of the invention and its operation or use and
the method of performance. Statements of claim, claims defining the scope of invention for
which protection is sought.
 Disclosure of the best method of performing the invention for which protection is sought.
 When an application is accompanied by a provisional specification a completed
specification must be filed within 12 months.
 Controlled examine application
 Application is specific, complete or not
 Lawful ground or not
 Results of investigation
 Any other matter which may be prescribed
 Controller empowered to refuse also on acceptance, notify in official gazettes that is
accepted.
 Date of sealing given by controller.
 Applicant has right and privileges of patent.

2 marks questions
1. What are the rights of owner a patent under the Patent Act?
Exclusive right to make, use, exercise, sell or distribute the invention in India.
• A patent granted after the commencement of this Act confers upon the patentee:
• Where the patent is for an article or substances, the exclusive right to make, use, exercise,
sell or distribute such article or substances in India.
Where a patent is for a method or process of manufacturing an article or substances, the
exclusive right to use or exercise the method or process in India
2. How restoration of lapsed patent can be done?
 Where the patent has ceased due to failure to pay any renewal fee within the prescribed
period, an application for the restoration of the patent can be made to the controller within
one year from the date on which the patent ceased to have effect.
If the controller is satisfy that the failure to pay was unintentional and there has been no
undue delay in making of the application, he may restore the patent and any patent of
addition which is lapsed.
3. Define ‘exclusive license’ as per patent act.
 Exclusive licence:
“exclusive licence” means a licence from a patentee which confers on the licensee,
or on the licensee and persons authorised by him, to the exclusion of all other persons
(including the patentee), any right in respect of the patented invention, and “exclusive
licensee” shall be construed accordingly;
4. What are the rights of patentee as per the Patent Act.
Exclusive right to make, use, exercise, sell or distribute the invention in India.
• A patent granted after the commencement of this Act confers upon the patentee:
• Where the patent is for an article or substances, the exclusive right to make, use, exercise,
sell or distribute such article or substances in India.
Where a patent is for a method or process of manufacturing an article or substances, the exclusive
right to use or exercise the method or process in India

5. Define ‘priority date’ in filing patent.

It is the date used to establish the novelty and/or obviousness of a particular invention relative to the
art.
The priority date may be earlier than the actual filing date of an application. If an application claims
priority to an earlier parent application, then its priority date may be same as the parent.
Chapter 12- Prescription & Non-prescription products
2 marks questions
1. What are OTC products?
Non-prescription drugs or OTC drugs are drugs that are sold over the counter, which means
they are sold without a prescription from a doctor. These drugs are sold directly to the
consumers as compared to prescription drugs, which requires a prescription
Example

 Cough-Suppressants
 Anti-acne Drugs
 Non-steroidal Anti-inflammatory Drugs: Some can be bought over the counter; others are
available only with a prescription from a physician or dentist.
  Antiseptics
 Analgesics

2. Give two examples of diagnostic aids.

Diagnostic aids are the substances used to examine the body in order to detect impairment
of its normal functions.
E.g.: thermometer
Sphygmomanometer
ECG
3. Give two examples of surgical aids
These are the materials used for dressing of wounds or injured or diseased tissues to hold wound
edges closely during healing.
Example
 sutures and ligatures
 Absorbable cotton
 Medicated bandages
 Absorbable and non-absorbable catgut
4. What are prescription drugs. Give two examples
Prescription drugs are drugs that are not locally available without a physician's prescription. A
prescription drug is a licensed medicine which is obtained only by prescription. The prescription
drugs are regulated by legislation and different from over-the-counter (OTC) drugs which can be
obtained without a prescription.

1. Anti-convulsant Drugs E.g.: phenytoin

. Anti-Fungal Drugs E.g.: griseofulvin
3. Anti-Viral Drugs E.g.: Amantadine
4. Anti-Diabetic Drugs E.g.: metformin

5. What are Non-prescription drugs. Give two examples.

*refer Q1(2 marks)
6. What are diagnostic aids. Give one example.
*refer Q2 (2marks)
7. Name any four surgical accessories
*refer Q3 (2marks)
8. Distinguish between prescription and non-prescription products
*refer Q1(2marks) for non-prescription drugs
*refer Q4(2marks) for prescription drugs
9. What are OTC products. Give two examples.
*refer Q1 (2marks)
10. Give the procedure for disposal of expiry drugs.
Procedure included 4 steps:
1) Mix: mix medicines (do not crush tablets or capsules) with an unpalatable substance such as
dirt, kitty litter or used coffee grounds.
2) Place: place the mixture in a container such as a sealed plastic bag
3) Throw: throw the container in your household trash.
4) Scratch out: Scratch out all personal information on the prescription label of your empty pill
bottle or empty medicine packaging to make it unreadable, then dispose of the container.