DTAB, PCI, CDL

1. LNBC INSTITUTE OF PHARMACY, RAIGAON, SATARA
FINAL YEAR B.PHARMACY
SEM-VIIIth
ASSINGMENT WORK (ANSWERS)
DATE: - 20th
April to 22th
April 2020
Q.No.1 Attempt all the Questions (20 Questions)
i. Import of cosmetics intended for use on eyebrows & eyelash
containing coaltar is
a. Both A&B B. Permitted C. Prohibited D. None of this
ii. Every year the state pharmacy counsel registers are printed on
a. 31st
march b. 20th
February c. 31st
December d. 1st
april
iii. Major amendments in drug & cosmetics act was made in
a. 1986 b. 1985 c. 1984 d. 1982
iv. Persons from teaching profession are nominated in pci by?
a. central government b. state government c. PCI d. none of this
v. Drug for examination, test or analysis can be imported under the
license in form?
a. 11 b. 20 c. 21 d. both a & c
vi. Dangerous drug act & rules related to the year
a. 1948 b.1930 c. 1945 d. 1947
vii. List of aliments & disease that drug should not claim to cure is given
in schedule?
a. schedule r b. schedule r c. schedule o d. schedule j
viii. The tablets or capsule drug specified in schedule ‘x’ can be marketed
in packing not exceeding?
a. 200 unit dose b. 100 unit dose c. 20 unit dose d. none of this
ix. Standards for patent are laid down in schedule:
a. Schedule X b. Schedule N c. Schedule V d. Schedule F
x. Drug retail sale licenses are issued by?
a. drug controller authority of the state
b. drug controller of INDIA

2. c. both a & b
d. none of this
xi. The pharmacy counsel of INDIA is also known as?
a. joint pharmacy counsel
b. central druggist association
c. central pharmacy counsel
d. none of this
xii. Chloramphenicol comes under schedule?
a. schedule C1
b. schedule M(II)
c. schedule H
d. schedule K
xiii. The Pharmacy Act was passed in:
a. 1960 b. 1948 c. 1962 d. 1965
xiv. Standards for medical contraceptives are given in schedule
a. schedule R b. schedule P c. schedule Q d. schedule S
xv. List of drugs which can be marketed under generic names only is
given in schedule
a. schedule W b. schedule U c. schedule T d. schedule X
xvi. The secretary of PCI may also act as its?
a. vice-president b. register c. treasurer d. Both b & c
xvii. The term of patent for ordinary invention from the date of patent is?
a. 10 years b. 11 years c. 14 years d. both a & c
xviii. Schedule M & Y were introduced in D & C act in?
a. 1986 b. 1987 c. 1988 d. 1989
xix. The left hand top corner of the label of schedule ‘X’ drugs contain
symbol?
a. Rx b. NRx c. RMP d. TDS
xx. List of minimum requirements for retail pharmacy is given in
schedule
a. schedule M b. schedule C c. schedule R d. schedule N
Q.No.2 Attempt all the questions (5 Questions)

3. i. Give the constitution of d.t.a.b
ANS: 1.Ex-Officio:
(i) Director General of Health Services (Chairman)
(ii) Drugs Controller, India
(iii) Directorof the Central Drugs Laboratory, Calcutta
(iv) Director of the Central Research Institute, Kasauli
(v) Director of Indian Veterinary Research Institute, Izatnagar
(vi) President of Medical Council of India
(vii) President of the Pharmacy Council of India
(viii) Directorof Central Drug Research Institute, Lucknow.
2. Nominated:
(i) Two persons by the Central Government.
(ii) One person by the Central Government from the pharmaceutical
industry
(iii) Two persons holding the appointment of Government Analyst under
this Act.
3. Elected:
(i) One person, to be elected by the Executive Committee of the Pharmacy
Council of India
(ii) One person, to be elected by the Executive Committee of the Medical
Council of India
(iii) One pharmacologist to be elected by the Governing Body of the
Indian Council of Medical Research
(iv) One person to be elected by the Central Council of the Indian Medical
Association
(v) One person to be elected by the Council of the Indian Pharmaceutical
Association
ii. State the classes of prohibited advertisements as per drug & magic
remedies act 1954
ANS:

4. 1. Prohibition of Advertisement of Certain Drugs for Treatment of Certain
Diseases and Disorders.
a) For 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 schedule, or in rules made under this Act:
2. 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
nature or character of the drug; or
b) Makes a false claim for the drug; or
c) Is otherwise false or misleading in any material particular are
prohibited.
3. Prohibition of Advertisement of Magic Remedies for Treatment of
Certain Diseases and Disorders.
A) No person carrying on or purporting to carry on the profession of
administering magic remedies shall take any part in the publication of
any advertisement referring to any magic remedy which directly or
indirectly claims to be efficacious for any of the purposes specified in
section 3.
4. Prohibition of Import into, and Export from, India of Certain
Advertisements.
A) No person shall import into, or export from, the territories to which
this Act extends any document containing an advertisement of the nature
referred to in 2,3 above.
iii. Give the offences & penalties under NDPS act 1985
ANS:
 OFFFENCE : Cultivation of opium, cannabis or coca plants without
license

5. PENALTIES: imprisonment up to 10 years + fine up to Rs.1 lakh
 OFFFENCE : Embezzlement (theft or misappropriation) of opium
by licensed farmer
PENALTIES: imprisonment - 10 to 20 years + fine Rs. 1 to 2 lakhs
 OFFFENCE : Production, manufacture, possession, sale, purchase,
transport, import inter- state, export inter-state or use of narcotic
drugs and psychotropic substances
PENALTIES: Small quantity - Rigorous imprisonment up to 6
months or fine up to Rs. 10,000 or both. Rigorous imprisonment.
up to 10 years + fine up to Rs. 1 Lakhs.
Commercial quantity - Rigorous imprisonment 10 to 20
years + fine Rs. 1 to 2 Lakhs
 OFFFENCE : External dealings in NDPSi.e. engaging in or
controlling trade whereby drugs are obtained from outside India
and supplied to a person outside India
PENALTIES: imprisonment 10 to 20 years + fine of Rs. 1 to 2 lakhs
(Regardless of the quantity)
 OFFFENCE : Knowingly allowing one's premises to be used for
committing an offence
PENALTIES: imprisonment 10 to 20 years + fine of Rs. 1 to 2 lakhs
 OFFFENCE : Violations pertaining to controlled substances
(precursors)
PENALTIES:imprisonment up to 10 years + fine Rs. 1 to 2 lakhs
 OFFFENCE : Financing traffic and harboring offenders
PENALTIES:imprisonment 10 to 20 years + fine Rs. 1 to 2 lakhs
 OFFFENCE : Attempts, abetment and criminal conspiracy
PENALTIES:imprisonment 10 to 20 years + fine Rs. 1 to 2 lakhs
 OFFFENCE : Import, export or transhipment of NDPS

6. PENALTIES: Small quantity - imprisonment up to 6 months or fine
up to Rs. 10,000 or both. Rigorous imprisonment. up to 10 years +
fine up to Rs. 1 Lakhs
Commercial quantity - imprisonment 10 to 20 years +
fine Rs. 1 to 2 Lakhs
iv. Explain in short the procedure followed by inspector for taking
samples of drug for analysis
ANS:
 Where an Inspector takes any sample of a drug or cosmetic under
this Chapter, he shall tender the fair price thereof and may require
a written acknowledgement there for.
 Where the price tendered under sub-section (1) is refused, or
where the Inspector seizes the stock of any drug or cosmetic under
clause (c) of section 22, he shall tender a receipt there for in the
prescribed form.
 Where an Inspector takes a sample of a drug or cosmetic for the
purpose of test or analysis, he shall intimate such purpose in
writing in the prescribed form to the person from whom he takes it
and, in the presence of such person unless he willfully absents
himself, shall divide the sample into four portions and effectively
seal and suitably mark the same and permit such person to add his
own seal and mark to all or any of the- portions so sealed and
marked:
 Provided that where the sample is taken from premises
whereon the drug or cosmetic is being manufactured, it shall be
necessary to divide the sample into three portions only :
 Provided further that where the drug or cosmetic is made up in
containers of small volume, instead of dividing a sample as
aforesaid, the Inspector may, and if the drug or cosmetic be
such that it is likely to deteriorate or be otherwise damaged by
exposure shall, take three or four, as the case may be, of the
said containers after suitably marking the same and, where
necessary sealing them.
 The Inspector shall restore one portion or a sample so divided or one
container, as the case may be, to the person from whom he takes it,
and shall retain the remainder and dispose of the same as follows : -
 one portion or container he shall forthwith send to the
Government Analyst for test or analysis;
 the second he shall produce to the Court before which
proceedings, if any, are instituted in respect of the drug or
cosmetic and

7.  the third, where taken, he shall send to the person, if any,
whose name, address and other particulars have been disclosed
under section 18A.
 Where an Inspector takes any action under clause (c) of section 22,-
 he shall use all dispatch in ascertaining whether or not the
drug or cosmetic contravenes any of the provisions of section
18 and, if it is ascertained that the drug or cosmetic does not
so contravene, forthwith revoke the order passed under the
said clause or, as the case may be, take such action as may be
necessary for the return of the stock seized;
 if he seizes the stock of the drug or cosmetic, he shall as soon
as may be inform a Judicial Magistrate and take his orders as
to the custody thereof;
 without prejudice to the institution of any prosecution, if the
alleged contravention be such that the defect may be remedied
by the possessor of the drug or cosmetic, he shall, on being
satisfied that the defect has been so remedied, forthwith
revoke his order under the said clause.
 Where an Inspector seizes any record, register, document or any
other material object under clause (cc) of sub-section (1) of section
22, he shall, as soon as may be, inform a Judicial Magistrate and take
his orders as to the custody thereof
v. Write the functions of CPCSEA
ANS:
 Registration of establishment conducting animal
experimentation or breeding of animals for this purpose.
 Selection & appointment of nominees in the Institutional
Animal Ethics Committees of registered establishments.
 Approvals of Animal House Facilities on the basis of reports of
inspection conducted by CPCSEA.
 Permission for conducting experiments involving use of
animals.
 Recommendation for Import of animals for use in experiments.
 Action against establishments in case of violation of any legal
norms or stipulation.
Q.No.3 Attempt all the questions (2 Questions)

8. i. Give the conditions for grant of license for retail, wholesale of
schedule c & c1 drugs &to sell, stock, or exhibit for sale or distribute
by retail the drugs specified in schedule x
ANS:
Category Type Sale
Application
Form
Licence
Form
Fees for
Grant
/Renewal
Renewal
Certificate
Form No.
Fee+
Penalty after expiry
but within
six months
Fees for
duplicate
copy of Org.
Lic
Drugs other
than those
specified in
Schedule C&C
(1)&X
Whole Sale 19 20-B
Rs.1500 21 –C
Rs.1500+Rs.500 p.m. or part there
of
Rs.150
Retail Sale 19 20
Restricted
(Gen.Store)
19-A 20-A
Drugs
specified in
Schedule C&C
(1) but
excluding
those specified
in Schedule
‘X’
Whole Sale 19 21-B
Rs.1500 21 –C
Rs.1500+Rs.500 p.m. or part there
of
Rs.150
Retail Sale 19 21
Restricted
(Gen.Store)
19-A 21-A
Drugs
specified in
Schedule ‘X
Whole Sale 19-C 20-G
Rs.500 21-C Rs.500+Rs.250 p.m. or part thereof Rs.150
Retail Sale 19-C 20-F
Sale of Drugs
from motor
vehicles:
(1) Drugs
other than
those specified
in Schedule
C&C (1)
Whole Sale 19-AA 20-BB
Rs.500 21-CC Rs.500+Rs.250 p.m. or part thereof Rs.150
(2) Drugs
specified in
Schedule C&C
(1)
Whole Sale 19-AA 21-BB
In short conditions:
Wholesale Of Biological (C/C1 )
 Adequate premises, with greater than 10 M2
area, with proper
storage facility
 Drugs sold only to retailer having license

9.  Premises should be in charge of competent person who is Reg.
Pharmacist.
 Records of purchase & sale
 Records preserved for 3years from date of sale
 License should displayed on premises

Wholesale Of Other Than Those Specified In C/C1 And X
 All the conditions as discussed in for biological.
 Compounding is made by or under the direct and personal
supervision of a qualified person.
Retail sale for retail sale, two types of licenses are issued:
 General licenses
 Restricted licenses: Granted to those dealers who do not engage
the services of a qualified person and only deal with such classes
of drugs whose sales can be effected without qualified person
and vendors who do not have fixed premises.
ii. A. Write about central drug laboratories
ANS:
The Central Drugs Laboratory, Kolkata is the national statutory
laboratory of the Government of India for quality control of Drug and
Cosmetics and is established under the Indian Drug & Cosmetics Act,
1940. It is the oldest quality control laboratory of the Drug Control
Authorities in India. It functions under the administrative control of
the Director-General of Health Services in the Ministry of Health and
Family Welfare.
FUNCTIONS:
 Analytical quality control of majority of the imported Drug available in Indian
market.
 Analytical quality control of drug and cosmetics manufactured within the
country on behalf of the Central and State Drug Controller Administrations.
 Acting as an Appellate authority in matters of disputes relating to quality of
Drug. II. Other Funtions:
 Collection, storage and distribution of International Standard International
Reference Preparations of Drug and Pharmaceutical Substances.
 Preparation of National Reference Standards and maintenance of such
Standards. Maintenance of microbial cultures useful in drug analysis
Distribution of Standards and cultures to State Quality Control Laboratories
and drug manufacturing establishments.

10.  Training of Drug Analysts deputed by State Drug Control Laboratories and
other Institutions.
 Training of World Health Organisation Fellows from abroad on modern
methods of Drug Analysis.
 To advise the Central Drug Control Administration in respect of quality and
toxicity of drug awaiting licence.
 To work out analytical specifications for preparation of Monographs for the
Indian Pharmacopoeia and the Homoeopathic Pharmacopoeia of India.
 To undertake analytical research on standardisation and methodology of Drug
and cosmetics.
 Quick analysis of life saving Drug on an All-India basis received under
National Survey of Quality of Essential Drug Programme from Zonal Offices
of Central Drug Standard Control Organisation. In addition to the above
functions the Central Drug Laboratory also actively collaborates with the
World Health Organisation in the preparation of International Standards and
Specifications for International Pharmacopoeia. It also undertakes
collaborative study on behalf of the Indian Pharmacopoeia Committee. The
senior Officers of the Laboratory have been appointed as Government
Analysts on behalf of most of the States of the Union for analysis of drug
samples.
 Analysis of Cosmetics received as survey samples from Central Drug
Standard Control Organisation.
B. Write the qualification & duties of public analyst
ANS:
Public Analyst appointed by central or state government
QUALIFICATION:
 A person who holds degree in science with chemistry/ food
technology/ food and drugs/biochemistry or equivalent
examination.
 And not less than 5 years practical experience after graduation
in analysis of food articles or holds masters degree in
chemistry/food technology/biochemistry/food and
drugs/microbiology.
 or Associate ship of Institution of Chemists (analysis of food) or
any other equivalent qualification with a minimum of 3 years
practical experience after post graduation in analysis of food.
 The person should have been declared qualified for
appointment by the Board appointed by Government.
DUITES:
 On receipt of sample public analyst confirms the authenticity
of the sample sent by comparing the seal on it.

11.  He keeps the sample in safe custody before, during and after
analysis and preserves it for submission into court, as and
when required.
 He carries out the analysis using approved methods, records
the findings in specified manner and inform the food Inspector
about the analysis.
 The public analyst should also be in touch with the Central
Food Laboratories for the purpose of consultation and
dissemination of knowledge.
c. write the qualification & duties of food inspector
ANS:
Food Inspector appointed by central or state government
QUALIFICATION:
 A medical officer incharge of Health Administration of Local
Area or
 A graduate in medicine with a minimum of one month training
in inspection of food sampling work in an institution approved
by Central Government or State Government or
 A graduate in science with chemistry/agriculture/pharmacy/
veterinary science/food technology/dairy technology/public
health/diploma holder in food or dairy technology or equivalent
qualification and a minimum of 3 months satisfactory practical
training in inspection of food and training approved by Central
Government or State Government.
DUITES:
 To inspect establishment for license for manufacture,
storage or sale of food article and satisfy that the conditions
and provisions of the Act are complied with
 To make enquiries on receipt of complaints about the quality
of food and conduct inspection accordingly
 To procure the sample of food and send to public analyst as
and when required.
 To investigate into matters of specific complaints given in
writing.
 To maintain the records of inspection properly and keep
inform higher authorities about inspection.
-------------------------------------------------THANKYOU---------------------------------------------------------------------
Mr. R.R.Patil