MPSC Drug Inspector – PYQ Study Guide
(English)
Topic-wise Questions with Answers • Consolidated from Past Papers & Answer Keys
Compiled on: 18 Aug 2025
Use this guide for quick revision. Questions are paraphrased and grouped by syllabus units
frequently seen in MPSC DI exams.
Pharmaceutical Jurisprudence & Drug Laws
Q1. Which Schedule of Drugs & Cosmetics Rules, 1945 prescribes standards for
Ayurvedic, Siddha, Unani drugs?
Ans: Schedule T covers GMP for ASU drugs; pharmacopoeial standards are in the
Ayurvedic Pharmacopoeia/Unani Pharmacopoeia; for cosmetics, standards appear in
Schedule S.
Q2. Schedule H vs Schedule H1—key difference?
Ans: Schedule H drugs are prescription-only; Schedule H1 is a tighter subset requiring
special record maintenance by the pharmacist for 3 years to curb antimicrobial misuse.
Q3. Which schedule relates to list of OTC (household) remedies?
Ans: Schedule K lists certain exempted categories; classical OTC household remedies
list historically referenced as Schedule K items (e.g., some disinfectants), but OTC is not
a legal term in the Act.
Q4. What is the role of Section 18 of the Drugs and Cosmetics Act, 1940?
Ans: It prohibits manufacture, sale, distribution of misbranded, adulterated, or spurious
drugs and cosmetics, and sale without license, among others.
Q5. What is the minimum qualification for an Inspector under the Act?
Ans: Degree in Pharmacy/Pharmaceutical Sciences/Medicine with specialization in
Clinical Pharmacology or Microbiology; plus experience as prescribed by State rules.
Q6. Under which rule must pharmacies maintain Schedule H1 sale records?
Ans: Rule 65 specifies record‑keeping; entries include patient, prescriber, drug,
quantity, and date, preserved for three years.
Q7. What does Schedule M specify?
Ans: Good Manufacturing Practices (GMP) and requirements of premises, plant, and
equipment for pharmaceutical products.
Q8. Define ‘spurious drug’ under the Act in brief.
Ans: A drug falsely purporting to be another, or misrepresented manufacturer, or
imitation of another brand; identity/ source is deliberately misstated.
Q9. Time limit to report seizure of samples by Drug Inspector to the court?
Ans: Typically without undue delay; Form 15/16 handling with prompt intimation;
practical expectation is immediate forwarding as per respective state procedures.
Q10. Which form is used to send samples to Government Analyst?
Ans: Form 18 with sealed packets; analyst issues report in Form 13/13A as applicable.
Pharmaceutics (Dosage Forms, Manufacturing & QC)
Q1. Zero‑order vs first‑order release in sustained systems—distinguish.
Ans: Zero‑order releases a constant amount per unit time (dC/dt = k0); first‑order is
concentration‑dependent (dC/dt = −kC). Matrix systems often approximate first‑order;
reservoir systems can target zero‑order.
Q2. Higuchi model applies to which dosage designs?
Ans: Porous matrix systems where drug release is diffusion‑controlled: Q ∝ √t (Higuchi
square‑root law).
Q3. Why is magnesium stearate limited as a lubricant?
Ans: It is hydrophobic; excess reduces tablet hardness and increases disintegration
time, impairing dissolution.
Q4. Role of disintegrants in tablets?
Ans: Promote breakup into granules/particles via swelling, wicking, or strain recovery
(e.g., croscarmellose sodium, crospovidone).
Q5. Enteric coating polymers—give examples.
Ans: Cellulose acetate phthalate (CAP), hydroxypropyl methylcellulose phthalate
(HPMCP), methacrylic acid copolymers (Eudragit L/S).
Q6. Definition of content uniformity test (USP <905>).
Ans: Assesses dose variation by individually assaying units; acceptance value (AV) must
meet criteria based on mean and variability.
Q7. Parenteral sterility assurance—what is SAL?
Ans: Sterility Assurance Level is the probability of a non‑sterile unit post‑process;
typical SAL target is 10⁻⁶ for terminal sterilization.
Q8. Stokes’ law relevance in suspensions?
Ans: Sedimentation velocity v = 2r²(ρp−ρm)g / 9η; reduce v by decreasing particle size,
increasing viscosity, or reducing density difference.
Q9. Lyophilization stages.
Ans: Freezing → Primary drying (sublimation under vacuum) → Secondary drying
(desorption of bound water).
Q10. BU (bacterial endotoxin) test—principle briefly.
Ans: Limulus Amebocyte Lysate (LAL) reacts with endotoxin; methods: gel‑clot,
turbidimetric, chromogenic.
Pharmacology & Therapeutics
Q1. Mechanism of action of sulfonamides?
Ans: Competitive inhibition of dihydropteroate synthase, blocking folate synthesis in
bacteria.
Q2. Which anti‑TB drug causes optic neuritis?
Ans: Ethambutol (monitor visual acuity and red‑green discrimination).
Q3. Antidote for organophosphate poisoning?
Ans: Atropine (muscarinic antagonist) plus oximes like pralidoxime early; supportive
care crucial.
Q4. Name a bactericidal concentration‑dependent antibiotic class.
Ans: Aminoglycosides and fluoroquinolones show concentration‑dependent killing with
post‑antibiotic effect.
Q5. ACE inhibitors—common adverse effect and contraindication.
Ans: Dry cough; contraindicated in bilateral renal artery stenosis and pregnancy.
Q6. Warfarin–CYP interaction example increasing INR.
Ans: CYP2C9 inhibitors (e.g., fluconazole) increase INR; inducers (e.g., rifampicin)
decrease INR.
Q7. Drug for status epilepticus initial management.
Ans: IV benzodiazepines (lorazepam/diazepam), followed by antiepileptics like
phenytoin/levetiracetam.
Q8. Partial agonist at β‑receptors example.
Ans: Pindolol exhibits intrinsic sympathomimetic activity (ISA).
Q9. Opioid antagonist used for acute overdose.
Ans: Naloxone; short half‑life necessitates repeated dosing.
Q10. Teratogenic acne drug and key precaution.
Ans: Isotretinoin; strict pregnancy prevention and monitoring.
Pharmaceutical Analysis & QA
Q1. Beer–Lambert law—state it.
Ans: A = ε l c ; absorbance is proportional to path length and concentration at a given
wavelength.
Q2. Why is HPLC preferred for assay of thermolabile drugs?
Ans: Low column temperatures and rapid analysis reduce degradation; gradient control
offers selectivity.
Q3. Internal standard—purpose in chromatography?
Ans: Compensates for injection/handling variability; response ratio (analyte/IS)
improves precision.
Q4. LOD vs LOQ—difference.
Ans: LOD is the lowest detectable amount (signal/noise ~3:1); LOQ is the lowest
quantifiable (S/N ~10:1) with acceptable precision/accuracy.
Q5. Karl Fischer titration measures what?
Ans: Water content via iodine–sulfur dioxide reaction in methanol with base; volumetric
or coulometric.
Q6. Isocratic vs gradient elution.
Ans: Isocratic uses constant mobile‑phase composition; gradient changes composition
over time to elute late‑retained analytes efficiently.
Q7. Validation parameter for method robustness—example.
Ans: Deliberate variations in flow rate, pH, temperature show minimal impact on
system suitability and results.
Q8. Peak tailing—common cause and fix.
Ans: Silanol interactions or column overloading; use end‑capped columns, adjust pH,
reduce load, add amine modifiers.
Q9. Why use phosphate buffer in HPLC?
Ans: Good buffering capacity around pH 2–7, low UV absorbance; but non‑volatile (not
ideal for LC‑MS).
Q10. System suitability tests—examples.
Ans: Theoretical plates (N), tailing factor (T), resolution (Rs), %RSD of replicate
injections.
Microbiology, Sterilization & Parenterals
Q1. Decimal reduction time (D‑value) meaning.
Ans: Time at a given temperature to reduce microbial population by 90% (1 log).
Q2. Membrane filtration pore size for sterility testing?
Ans: Commonly 0.45 μm for filtration; 0.22 μm for sterilizing-grade filtration.
Q3. Zinc oxide ointment—primary function in dermatology.
Ans: Protectant and mild astringent; forms a barrier and reduces irritation.
Q4. HEPA filter efficiency rating typical in pharma cleanrooms.
Ans: 99.97% for 0.3 μm particles (most penetrating particle size).
Q5. Autoclave standard cycle for sterilization.
Ans: 121°C at ~15 psi (103 kPa) for 15–20 minutes for standard loads.
Q6. Bacillus species used as biological indicator for moist heat.
Ans: Geobacillus stearothermophilus spores.
Q7. Fumigation with hydrogen peroxide—advantage.
Ans: Effective sporicidal activity with residue‑free decomposition (H2O and O2)
post‑aeration.
Q8. Cleanroom grades—where are Grade A zones used?
Ans: Critical zones for aseptic operations (e.g., filling) with unidirectional airflow.
Q9. Endotoxin removal vs inactivation—key point.
Ans: Endotoxin is heat‑stable; remove by depyrogenation (e.g., dry heat 250°C) rather
than normal moist heat.
Q10. Preservatives unsuitable for parenterals—example.
Ans: Benzalkonium chloride is not suitable for large‑volume parenterals; use with
caution in injections.
Pharmaceutical/Medicinal Chemistry
Q1. Identify primary amine with reagent?
Ans: Hinsberg test forms sulfonamide soluble in alkali for primary amines; carbylamine
test yields isocyanide (offensive odor) for primary amines.
Q2. Iodometric vs iodimetric titration difference.
Ans: Iodometric: analyte reduces I2 to I− (indirect); Iodimetric: direct titration with
iodine as oxidant.
Q3. Limit test for arsenic principle (old IP).
Ans: Formation of arsine gas and deposition on mercuric bromide paper producing a
stained spot compared to a standard.
Q4. Chelating agent in complexometric titrations widely used.
Ans: EDTA forms stable 1:1 complexes with many metal ions.
Q5. Indicator for EDTA titration of Ca/Mg hardness.
Ans: Eriochrome Black T at pH ~10 with ammonia buffer.
Q6. Saponification value indicates what?
Ans: Milligrams of KOH required to saponify 1 g of fat/oil; higher value suggests shorter
average chain length.
Q7. Phenol coefficient—what does it express?
Ans: Disinfectant efficacy relative to phenol against a standard organism under
specified conditions.
Q8. Oxidizing agents stored how?
Ans: Away from organic materials and reducing agents; cool, dry, ventilated storage
with compatible containers.
Q9. Confirmatory test for alkaloids.
Ans: Dragendorff’s, Mayer’s, Wagner’s reagents give characteristic precipitates.
Q10. Why light‑resistant containers for nitroprusside?
Ans: Protect from photodegradation and cyanide liberation; maintain potency.
Biopharmaceutics & Pharmacokinetics
Q1. BCS class with high solubility but low permeability?
Ans: Class III; formulation focuses on permeability enhancement (e.g., permeation
enhancers).
Q2. First‑pass metabolism—example drug highly affected.
Ans: Propranolol; high hepatic extraction reduces bioavailability orally.
Q3. Flip‑flop kinetics observed when?
Ans: When absorption is slower than elimination; terminal slope reflects absorption rate
constant.
Q4. Bioavailability vs bioequivalence—difference.
Ans: Bioavailability: rate and extent entering systemic circulation; bioequivalence:
comparative bioavailability between products to show no significant difference.
Q5. Narrow therapeutic index drugs—monitoring need.
Ans: Drugs like digoxin, theophylline require TDM due to small margin between
effective and toxic levels.
Q6. Enterohepatic recycling—effect on profiles.
Ans: Secondary peaks in plasma concentration–time curve; prolongs apparent half‑life.
Q7. Sublingual route advantage.
Ans: Bypasses first‑pass metabolism; rapid onset for lipophilic, potent drugs.
Q8. Transdermal systems—rate‑limiting step.
Ans: Stratum corneum diffusion is the primary barrier; flux increases with occlusion and
permeation enhancers.
Q9. In vitro–in vivo correlation (IVIVC) useful when?
Ans: For extended‑release products to predict in vivo performance from dissolution
data.
Q10. Effect of food on absorption—general note for BCS II drugs.
Ans: High‑fat meals may increase solubilization and bioavailability; needs label‑specific
guidance.
GMP, QA/QC & Regulatory
Q1. Line clearance—define briefly.
Ans: Documented activity ensuring previous product, documents, and materials are
cleared before starting a new batch.
Q2. Deviation vs change control—difference.
Ans: Deviation: unplanned departure requiring investigation and CAPA; Change control:
planned change assessed and approved before implementation.
Q3. Retain sample purpose.
Ans: Enable future investigation of complaints/OOS; kept under labeled storage for
defined period post‑expiry.
Q4. Data integrity ALCOA stands for?
Ans: Attributable, Legible, Contemporaneous, Original, Accurate.
Q5. Qualification sequence for equipment.
Ans: DQ → IQ → OQ → PQ (Design, Installation, Operational, Performance Qualification).
Q6. Cleaning validation acceptance—what is MACO?
Ans: Maximum Allowable Carryover to next product/equipment, calculated from toxicity
or therapeutic dose and safety factors.
Q7. Primary vs secondary packaging examples.
Ans: Primary: blister, vial, ampoule; Secondary: carton, shipper.
Q8. OOS vs OOT—difference.
Ans: OOS: result outside specification; OOT: result outside historical trend but still
within spec.
Q9. Market complaint handling—timeline basics.
Ans: Triage immediately; critical complaints trigger recall decision per risk categories
(Class I–III).
Q10. Temperature mapping—why for warehouses?
Ans: Identifies hot/cold spots; ensures storage conditions within labeled limits across
seasons.
References & Sources (for further reading)
• MPSC Drug Inspector 2008 question paper & solutions (various online repositories).
• Drugs & Cosmetics Act, 1940 and Rules, 1945 (Schedules: M, H, H1, K, etc.).
• Indian Pharmacopoeia (general chapters), USP <905> Uniformity of Dosage Units.
• GMP/QA guides: WHO TRS annexes; ICH Q1–Q10 (stability, quality systems).
Note: This compact guide is intended for revision. Always verify latest MPSC notifications, syllabus,
and official answer keys.
