IN FORCE

176 Merit List based on the written examination held on 09.04.2017 at NIB Noida for WHO Roational Fellowhip Selection 2017-Apr-10 3,500kb

Reliability

In force — no superseding record on file.

Document text

F. No. 230026/02/2017-D Directorate Government of India Central General of Health Services Drugs Standard Control Organisation

New Delhi, dated the 10!" April, 2017

NIB, Merit List based on the written €xamination held on 09.04.2017 at NOIDA for WHO Rotational Fellowship Selection is as under. Marks obtained by the Candidates have been mailed to them. rr Ne Desnalan arg 2. gee Bose Doc 5g 82 Pe far ats Aegan DT 139g far a Sle ADC) 1 Sey Rama ADC a a far yam Pap Singh ADT) | 29g of ge Suma Gupta, DE 3g 0 eg Sekar, OF feat Sasi, DI 1g; ee "apap geet Chawla, O15 rar peat Sharma, ADSI) 33g a a "8a ease Kua Vera I~} 597. Trt ley Kumar Agana, OT 1357 rat gr gent Kumar aD) 1 5tg Ce 2 —| gy gay Kumar aoc) {5g 21 — fhe ena Sahel Matta} 22 — |e erat ADC 21 Sh Indes Singh Hara, ABC) ——} 345 Officers from S.Nos. 1 to 4 have been Selected for the keptPropo a s edreserve. WHO Rotational Fellowship. Officer at S.No. 5 have been This examination is going to be a continuous process for Selecting Officers for these Fellowships, Examination for Selecting next batch of

Officers for these Fellowships will be held in the coming months. The examination will be of two hours duration and in 3 Parts. Sample Question Papers of all the three parts are also attached for the benefit of officers appearing in the next examination to enable them to prepare for the examination. It is also Proposed to make this examination compulsory for all DDC(I)s & ADC(I)s, while it will be optional for Drug Inspectors with requisite experience/age.

(Arun —. ) Director(A)

examination. It is also Proposed to make this examination compulsory for all DDC(I)s & ADC(I)s, while it will be optional for Drug Inspectors with requisite experience/age.

(Arun —. ) Director(A)

IT Cell, CDCO (HQ) — for placing on the website of CDSCO.

}

“cas”. Central Drugs Standard Control Organization

Part I

[Maximum Mark 30] [Time permitted 490 Minutes]

Q. i Write an essay not exceeding 250 words on how to Leverage comparative cost advantage and quality for increasing the export of pharmaceutical products from India and generating white colar jobs. fi5j
Q.2 Read the following Passage and answer the questions given at the end of the passage:

People talk of memoriais to him in statues of bronze or marble or Dinars and thus they mock him and belie his message, What tribute shall to live and the way to die and if we Mave mot unaerstocd tnat 1essor, it would be better that we raised no memoria! to him, for the only fit memorial is to follow reverently in the path he showed us and to do our duty in life and in death.

He was a Hindu and an Indian, the greatest in many generations, and he was proud of being a Hindu and an Indian. To him India was dear, because she had represented through the ages certain immutable truths. But though he was intensely religious and came to be called the Father of the Nation which he had liberated. Yet no narrow religious or national bonds confined his spirit. And so he became the great internationalist, believing in the essentia! unity of man, the underiying unity of all religions, and the needs of humanity and more specially devoting himself to the service of the poor, the distressed and the oppressed millions everywhere.

Page

of man, the underiying unity of all religions, and the needs of humanity and more specially devoting himself to the service of the poor, the distressed and the oppressed millions everywhere.

Page

His death, brought more tributes than have been paid at the passing of any other human being in history. Perhaps what would have pleased him best was the spontaneous tributes that came from the people of Pakistan. On the morrow of the tragedy, ail of us forgot for a while the bitterness that had crept in, the estrangement and conflict of these past months and Gandhiji stood out as the beloved champion and leader of the people of India, of India as it was before partition cut up this living nation.

What was his great power over the mind and heart of man due to? Even we realise, that his dominating passion was truth. That truth led him to proclaim without ceasing that good ends can never be attained by evil methods, that the end itself is distorted if the method pursued is bad. The truth led him to confess publicly whenever he thought he had made a mistake - Himalayan errors he called some of his own mistakes. That truth led him to fight evil and untruth wherever he found them, regardless of the consequences. That truth made the service of the poor and the dispossessed the passion of his life, for where there is inequality and discrimination and suppression there is injustice and evil and untruth. And thus he became the beloved of all those who nave suffered from social ana Because of that truth in him wherever he sat, became a temple and where he trod was hallowed ground.

nd evil and untruth. And thus he became the beloved of all those who nave suffered from social ana Because of that truth in him wherever he sat, became a temple and where he trod was hallowed ground. - Jawahar Lai Nenru

Question

|1.|Aboutwhom is the passage written?|||[1]|
|---|---|---|---|---|
|os|Why does Nehru make the difference about being a “Hindu” and||||
||an<br>“Indian”?<br>Is<br>there|any|difference|really?|
||[Not more than three sentence ||||[2]|
|Es|What great iesson did this great man show||us for life?||
||[Two sentences]|||[2]|

Page2

4, Mention some of the virtues of ‘the great internationalist’? [Not more than three sentence] [2]
1. Nehru seems to suggest that his hero was ‘the beloved champion and leader of the people of India’ only before the Partition of Pakistan and India. Do you agree with that? Explain
[In Three sentences] [2]
6: What did ‘truth’ mean to this great man? [1]
7 Give the meaning of the following in the context of the passage: memorials, immutable, essential, estrangement, spontaneous, discrimination, dominating, Himalayan. [4]
1. What could, according to Nehru be the best tribute to the great man after his death? [1]

Page3

cee oxo Central Drugs Standard Control Organization

PART - II

Time: 40 Min [Marks: 40]

Arrange the following drug discovery process in the order of concept to product life cycle. [1] a) Compound screening or lead optimization b) Human Pharmacology trials C) Preclinical Pharmacology .

d) Therapeutic exploratory Trials €) Post Marketing Surveillance Study f) Therapeutic Confirmatory Trials

Identify the correct order/sequence given beiow: i) a,c, b,d,f,e — ii) a,b, e, d, f,c ii) by @, a, d,f, ¢ iv) a, b, &, c, f, d

The study of the use and effects/side-effects of drugs in large number of people with the objective of supporting rational and cost-effective use of drugs in the Population and thereby improving health outcomes, is called '

[1]

What is the frequency of PSUR submission to Licensing Authority after New Drugs approval as per Schedule Y of Drugs and Cosmetics Rule 1945?

[1]

Page 4

Reverse Osmosis is the phenomenon of diffusion of solvent through semi-permeable membrane from lower concentration gradient to higher concentration gradient under the influence of high pressure. [True/False] [1]
Match the correct method of sterilisation for following below mentioned materials: [2]

Table I Table II Materials Method of Sterilisation i) Glass Vial a) Steam sterilization ii) Aqueous thermo labile solutions b) Dry Heat sterilization iii) .Aqueous thermo stable solutions c) Exposure to ionizing Radiation iv) Orthopaedic implants d) Filtration

Write the roman no. and alphabet in respect of table I and table II respectively -

n iii) .Aqueous thermo stable solutions c) Exposure to ionizing Radiation iv) Orthopaedic implants d) Filtration

Write the roman no. and alphabet in respect of table I and table II respectively -

Define the periodicity of the environmental parameters monitoring for sterile manufacturing area as per Schedule M of Drugs & Cosmetics Rules, 1945. [3]

a) Particulate monitoring in air

ere

b) HEPA filter integrity testing (smoke testing)

Page5

c) Air pressure differentials

e) Temperature and Humidity

  - f) Microbiological monitoring by settle in aseptic area

Write the name of four degradation studies performed during analytical method validation. [3]
Match the bio indicators used and sterilization techniques: [4]
- | Method of Sterilisation | Bio indicator strain proposed for [_ validation of the sterilization process a. Steam sterilization L, spores of Bacillus subtilis
- | b. Filtration li, spores of Bacillus

==> picture [1 x 16] intentionally omitted <==

----- Start of picture text ----- | ----- End of picture text -----

Page 6

==> picture [388 x 112] intentionally omitted <==

----- Start of picture text ----- C Exposure to ionizing “iii. microbiological challenge of Radiation 107 CFU of Brevundimonasdiminuta per __cm? of the filter surface d. Dry Heat iv. spores of Bacillus pumilus or sterilization spores of Bacillus cereus ee __or Bacillus sphaericus ----- End of picture text -----

Write alphabet for method and roman numeral for bio indicator.

==> picture [378 x 15] intentionally omitted <==

----- Start of picture text ----- eee b venee c yexeaws d ee TT ----- End of picture text -----

Which of the following is a polysaccharide vaccine: [1]
- a) Anthrax vaccine
- b) Rabies vaccine
- c) Hepatitis A
- d) Hib vaccine
Current WHO guidelines recommending the dead leg of continuous water circulation loop should be less than. [1]

a) 5D b) 8D c) 6D d) 3D

es vaccine

c) Hepatitis A
d) Hib vaccine

Current WHO guidelines recommending the dead leg of continuous water circulation loop should be less than. [1]

a) 5D b) 8D c) 6D d) 3D

What does Sensitivity mean in validation of an analytical procedure? [1]

a) The ability to measure an analyte free of interference from other components

Page 7

b) The degree of agreement among the test results
c) The closeness of the results to the true value.
d) The ability to produce results directly proportional to the analyte concentration.
€) The capacity to record small variations in concentration.

The high-level document that summarizes the manufacturer’s overall philosophy, intentions and approach, to be used for establishing performance adequacy is called RS rene eennrmnananznnsncnnamsenmaa [1]
The document which defines what the system is intended to do i.e. basic needs or functionality of the system from the end user’s perspective and also describe the capacity, safety and control requirements is called pertain ee ts [1]
The test to verify the proper functioning of an operating system, i.e., the electronics, the equipment, the specimens and the analytical operations is called a epee —snenoento Bgtat [1]

==> picture [2 x 12] intentionally omitted <==

----- Start of picture text ----- : ----- End of picture text -----

Page 8

Write at least three parameters which should be validated during analytical method in case of the cleaning validation. [3]

xt ----- : ----- End of picture text -----**

Page 8

Write at least three parameters which should be validated during analytical method in case of the cleaning validation. [3]

16.	Which type of tablets are exempted from Disintegration<br>testing?<br>[1]
17.	Air re-circulation:<br>[1]
a) <br>b) <br>c) <br>d)	Is allowed if there is no danger of cross-contamination.<br> Is always the preferred setup for air handling systems.<br> Is allowed only if terminal HEPA filters are installed.<br> Is allowed provided that the make-up fresh air is more than 15%.
	Indicate the correct options-
18.	Air diffusers should be ofthe low induction type so that:<br>[1]

a) Laminar (uni-directional) flow can be maintained in clean rooms. b) Circulation of dust in the room is minimized. c) So that drafts are not created. d) Proper room flushing is ensured.

Page9

[1]

are the examples of live attenuated

vaccines.

a) Oral polio vaccine and Varicella-Zoster virus vaccine (VZV)
b) Pertussis vaccine, Inactivated Polio Vaccine (IPV)
Cc) Haemophilusinfluenzae PRP conjugate vaccine and Pneumococcal conjugate vaccine
d) Tetanus toxoid and Diphtheria toxoid .

b)OOS

Cc) OOT a

==> picture [398 x 6] intentionally omitted <==

----- Start of picture text ----- ee ----- End of picture text -----

d)TRS ee

e) CPCSEA:

f)RCGM_

Page 10

Zz, % fall of assay value of any product with respect to initial value is considered as the significant change during conduct of stability studies. [i]

a) 0.5%

b) 5%

c) 5.5%

d) None of the above

22. Match the following:

[4]

==> picture [395 x 108] intentionally omitted <==

BI) encexmnennnnnieiabeht EDTE I

aoe Swasthya Adhikar Manch V/s Union of India is a case filed in tHe ecceceseceesesseetesessecsestrsssseeeeeeees COurt and relates to

Page 11

Section of the Drugs and Cosmetics Act, 1940 provides power to the Central Government to regulate, restrict manufacture, etc., of drug and cosmetic in pubtic interest. [i]
The science and activities relating to detection, assessment, understanding and prevention of adverse effects or any other drug-related problem is called as ; [ij

arei Central Drugs Standard Control Organization Part ITI

[Maximum Marks - 40] [Time 40 Minutes
Q.1 ] Fillin the Blanks: [11]
(I) Placebo is a Latin name which MEANS... ceccecccceccees. (II) Anticoagulant interacts with food high — in
(III) Digoxin interacts with Food item called
, (IV) Paracentesis is the insertion of a needle into... sorte FOF FEMOVAl Of...
(V) Shigella is a micro-organism that Causes
(VI) gastroenteritis tHrOUGH... eco Uiienitenwmae Repeated use of excessive doses of drugs belonging
to the DTOUP svsisssercensvonsesassstisansneanasetstasetttlaecessveseseessecs causes kidney damage.
(VII) Thyroids hormone regulates the rate 0)eee
(VIII) Growth hormones is produced in ww. gland and it controls growth OP reerernsessesennesemnntactnstuntenaseenetssstiesteseueeessesss Production.
(IX) Renin hormone is Produced in uw... and CONEPOIS. eects teeeeseeeeeececn.

Page 13

(X) Leptin in a hormone which is produced in cccceseevssesecsecsseveeeesee ANG CONEIOIS ooo. eee certs

(XI) Dyspepsia refer to Pail in...eesti

Q.2 Write the route through which the following drugs are taken: [10]

||are taken:|are taken:|[10]|||
|---|---|---|---|---|---|
||Drug.<br>| Route |||SideEffect|||
||||[Maximum Two]|||
|||—_|OO|||
||Isonized|||||
||||a|||
||"Rifampin|a||||
||||||||
||Pyrazinamide|||||
||Ethambutol|||||
||‘Streptomycin|OO a|||||
|**e**||Ceeeee||||

Page 14

Q.3 Match the infection in table A with Host in table B

==> picture [456 x 213] intentionally omitted <==

Q.4 Explain in one sentence or phrase the following terms [5]

(i) Paracoccidioidomycosis-

Page 15

(v) Actinomycosis-

Page 16

==> picture [466 x 344] intentionally omitted <==

----- Start of picture text ----- Q.5 Write generic names of the following: [9] h N-(4-hydroxyphenyl) acetamide + Fehioro-l,| avd ro-1-methyl-5-phenyi-a / | | 2rel, | | |4-benzodiazepin-2-one | | | [-4’-fluorobutyrophenone] 4-[4-(p-chlorophenyl)-4-hydroxypiperidino] fo| || 5-thia-1-azabicyclo[4.2.0]-oct-2-ene-2 | | carboxylic acid, 7- | | se as | ‘oxo, monohydrate | | ‘di-threo-2-(methylamino)-1-phenylpropan- ----- End of picture text -----

Verbatim extracted text (OCR/PDF). Older scans and tables may show extraction artifacts — verify against the original for anything you act on.

Analysis

No analysis generated for this document yet (analysis runs over brief docs + on-demand). Run build_analysis.py --ids 24399 --apply.