UPSC Drug Inspector study materials
UPSC Drug Inspector study resources

UPSC Drug Inspector cheat sheet

UPSC Drug Inspector · Keep the key ideas within reach.

Quick reference

Pharmaceutical Chemistry

  • Aryl acetic acid NSAIDs (diclofenac, ibuprofen) act by reversible, non-selective inhibition of COX-1 and COX-2; celecoxib is a selective COX-2 inhibitor with a sulfonamide group.

  • Penicillin core is 6-aminopenicillanic acid (6-APA); cephalosporin core is 7-aminocephalosporanic acid (7-ACA); beta-lactam ring integrity is required for antibacterial activity.

  • Prodrugs: enalapril is hydrolysed to enalaprilat; sulfasalazine is cleaved by colonic azoreductase to 5-aminosalicylic acid; levodopa is decarboxylated to dopamine centrally.

  • Stereochemistry matters: S-(-)-propranolol is far more potent than R-(+); (S)-omeprazole (esomeprazole) is the active enantiomer; thalidomide enantiomers differ in teratogenicity.

  • Henderson-Hasselbalch: for weak acids pH = pKa + log([A-]/[HA]); for weak bases pH = pKa + log([B]/[BH+]); a drug crosses membranes best in its un-ionised form.

  • Bioisosterism examples: -OH/-NH2, -F/-H, -S-/-O-, carboxyl/tetrazole replacement (as in losartan) preserves acidity while improving pharmacokinetics.

  • Phase I reactions are oxidation, reduction and hydrolysis (CYP450); Phase II are conjugations (glucuronidation, sulfation, acetylation, methylation, glutathione).

  • Hard/soft acid-base (HSAB) and pKa principles predict salt formation: acidic drugs are formulated as sodium/potassium salts, basic drugs as hydrochloride/sulfate salts.

Quick reference

Pharmaceutics and Dosage Form Design

  • Noyes-Whitney: dissolution rate dC/dt = k·A·(Cs − C)/h; increase surface area A or solubility Cs to raise dissolution.

  • Stokes' law: v = d²(ρp − ρm)g/18η; smaller particle diameter d and higher viscosity η slow sedimentation in suspensions.

  • First-order drug release: ln(C) = ln(C0) − kt, t1/2 = 0.693/k; zero-order release gives constant rate independent of concentration (ideal for controlled release).

  • Higuchi model for matrix diffusion: Q = kH·t^0.5; Korsmeyer-Peppas Q = ktn where n ≈ 0.5 indicates Fickian diffusion, n ≈ 1 indicates Case II (zero-order) transport.

  • HLB scale: 3–6 for w/o emulsifiers, 8–18 for o/w emulsifiers; sodium lauryl sulfate ≈ 40, sorbitan esters (Spans) 1.8–8.6, polysorbates (Tweens) 9.6–16.7.

  • Tablet defects: capping (upper/lower separation), lamination (layers), picking/sticking (adhesion to punches), mottling (uneven colour) - each traced to moisture, compression force or granule properties.

  • Caking in suspensions is prevented by flocculation (controlled, loosely bound aggregates) rather than deflocculation, which causes hard irreversible sediment.

  • Sterility assurance level (SAL) for terminally sterilised products is 10^-6; F0 of 12 minutes at 121 °C is the reference for moist heat sterilisation.

Quick reference

Pharmacology and Toxicology

  • Competitive antagonists shift the dose-response curve right without lowering Emax (e.g. atropine, propranolol); non-competitive antagonists reduce Emax.

  • Receptor families: ligand-gated ion channels (nicotinic), G-protein coupled (beta-adrenergic), kinase-linked (insulin), nuclear (steroid, thyroid).

  • Organophosphate poisoning: acetylcholinesterase inhibition; treat with atropine (muscarinic effects) plus pralidoxime (reactivates enzyme before ageing).

  • Paracetamol overdose: NAPQI accumulates after glutathione depletion; antidote N-acetylcysteine, most effective within 8–10 hours.

  • Methanol/ethylene glycol poisoning: alcohol dehydrogenase converts them to toxic acids; treat with fomepizole or ethanol plus haemodialysis.

  • Cyanide poisoning: inhibits cytochrome c oxidase; antidotes are sodium nitrite plus sodium thiosulphate, or hydroxocobalamin.

  • Warfarin acts by inhibiting vitamin K epoxide reductase (VKORC1); overdose reversed with vitamin K1 (phytomenadione) and fresh frozen plasma.

  • Therapeutic index = TD50/ED50; drugs with narrow TI (digoxin, lithium, phenytoin, warfarin) require therapeutic drug monitoring.

Quick reference

Pharmacognosy and Phytochemistry

  • Alkaloid-bearing drugs: belladonna and Datura (tropane alkaloids atropine, hyoscine), Cinchona (quinine), Rauwolfia (reserpine), Papaver (morphine), Ephedra (ephedrine).

  • Glycoside-bearing drugs: Digitalis purpurea gives digitoxin and gitoxin; Digitalis lanata gives digoxin; cardiac glycosides are steroidal aglycone plus sugar.

  • Senna and Aloe contain anthraquinone glycosides (sennosides A and B, aloin); they act as stimulant purgatives via the colon.

  • Volatile oil drugs: clove (eugenol), peppermint (menthol), eucalyptus (cineole), cinnamon (cinnamaldehyde); extracted by hydrodistillation or steam distillation.

  • Resins and oleoresins: asafoetida (ferulic acid esters), ginger (gingerol), capsicum (capsaicin), Cannabis (tetrahydrocannabinol).

  • Chemical tests: Dragendorff and Mayer reagents for alkaloids; Keller-Kiliani for cardiac glycosides; Borntrager for anthraquinones; Molisch for carbohydrates.

  • Guggul, turmeric (curcuminoids) and Boswellia are resinous drugs; curcumin is a diarylheptanoid with reported anti-inflammatory activity.

  • Pharmacognostic evaluation uses organoleptic, macroscopic, microscopic (stomata, trichomes, calcium oxalate crystals), physical and chemical parameters plus ash values.

Quick reference

Pharmaceutical Analysis and Quality Control

  • Beer-Lambert law: A = εbc, where A is absorbance, ε molar absorptivity, b path length and c concentration; linear range must be demonstrated for a calibration curve.

  • Chromatographic system suitability parameters: resolution R ≥ 2, tailing factor ≤ 2.0, theoretical plates (N) and RSD of replicate injections typically ≤ 2.0%.

  • HPLC retention factor k = (tR − t0)/t0; selectivity α = k2/k1; resolution R = 2(tR2 − tR1)/(w1 + w2).

  • Validation parameters per ICH Q2(R1): accuracy, precision, specificity, detection limit, quantitation limit, linearity and range.

  • Limit of detection (LOD) = 3.3σ/S and limit of quantitation (LOQ) = 10σ/S, where σ is the SD of the response and S the slope.

  • Karl Fischer titration measures water content; iodometric and cerimetric titrations are common for assay of drugs such as ascorbic acid and hydrogen peroxide.

  • Potentiometric titration and conductometry suit coloured or turbid solutions; non-aqueous titration with perchloric acid in glacial acetic acid assays weak bases.

  • IR spectroscopy identifies functional groups: O-H broad 3200–3600 cm-1, C=O 1700–1750 cm-1, C-H stretch 2850–2960 cm-1; fingerprint region below 1500 cm-1.

Quick reference

Drug Regulatory Affairs and Legislation (Drugs and Cosmetics Act and Rules)

  • Drugs and Cosmetics Act, 1940; Drugs and Cosmetics Rules, 1945; definitions of drug, cosmetic, misbranded, adulterated and spurious drugs appear in Sections 3 and 17-17B.

  • Drug Technical Advisory Board (DTAB) advises the Central Government; Drug Consultative Committee (DCC) coordinates Centre and States; Central Drugs Laboratory (CDL) at Kolkata is the statutory appellate laboratory.

  • Licensing: Form 25/25A for manufacture of drugs, Form 28 for manufacture of cosmetics; Form 20/20A/21 retail sale licences; Forms 19/19A for wholesale.

  • Schedules: Schedule H lists prescription drugs; Schedule H1 includes antibiotics and drugs needing separate register with retention; Schedule X covers narcotic and psychotropic drugs requiring special licences.

  • Schedule M prescribes Good Manufacturing Practices and requirements of premises and plant; Schedule L-1 gives GLP requirements for testing laboratories.

  • Clinical trials are governed by the New Drugs and Clinical Trials Rules, 2019; approval from the Central Licensing Authority with Ethics Committee oversight and informed consent.

  • Inspectors are appointed under Section 21; powers of entry, search and seizure under Section 22; offences and penalties are in Chapter IV (Sections 27-32B).

  • Ayurvedic, Siddha and Unani drugs fall under Chapter IVA and Schedule T (GMP for ASU drugs); medical devices are regulated as drugs under the Medical Devices Rules, 2017.

Quick reference

Pharmaceutical Microbiology and Sterility Assurance

  • Sterilisation methods: moist heat (autoclave 121 °C, 15 psi, 15–20 min), dry heat (160 °C for 2 h or 170 °C for 1 h), ethylene oxide, gamma irradiation (25 kGy), and membrane filtration (0.22 µm).

  • D-value is the time to reduce a microbial population by 90% (one log); z-value is the temperature change giving a tenfold change in D-value.

  • F0 = Σ 10^((T−121)/z) · Δt; an F0 of ≥ 12 min at 121 °C is required for terminally sterilised products.

  • Biological indicators: Geobacillus stearothermophilus for moist heat and hydrogen peroxide; Bacillus atrophaeus for dry heat and ethylene oxide.

  • Sterility test methods are direct inoculation and membrane filtration (0.45 µm for sterility testing); media used are soyabean casein digest and fluid thioglycollate.

  • Microbial limit tests: total aerobic microbial count (TAMC), total yeast and mould count (TYMC), and absence of specified organisms such as E. coli, Salmonella and S. aureus.

  • Bacterial endotoxin testing (LAL) is a pyrogen test; endotoxin limit for parenterals is K/M, where K = 5 EU/kg/h and M is maximum human dose per kg per hour.

  • Antimicrobial effectiveness testing (AET) verifies preservative efficacy against S. aureus, P. aeruginosa, E. coli, C. albicans and A. brasiliensis.

Quick reference

Biochemistry and Clinical Pharmacy

  • Glycolysis yields 2 ATP and 2 NADH per glucose; complete oxidation yields about 30–32 ATP including the TCA cycle and oxidative phosphorylation.

  • Enzyme kinetics: Michaelis-Menten v = Vmax[S]/(Km + [S]); Km is the substrate concentration at half Vmax; Lineweaver-Burk plot gives 1/v versus 1/[S].

  • Competitive inhibitors raise Km without changing Vmax; non-competitive inhibitors lower Vmax without changing Km; uncompetitive inhibitors lower both.

  • HPLC and immunoassay are used for therapeutic drug monitoring; common targets include digoxin, lithium, phenytoin, valproate, cyclosporine and vancomycin.

  • Clinical pharmacy: aminoglycosides require peak and trough monitoring; vancomycin trough 10–20 µg/mL for serious infections; digoxin therapeutic range 0.5–2 ng/mL.

  • Blood glucose reference: fasting 70–100 mg/dL, HbA1c < 5.7% normal; diabetes diagnosed at fasting ≥ 126 mg/dL or HbA1c ≥ 6.5%.

  • Liver function and renal clearance: creatinine clearance by Cockcroft-Gault CrCl = (140 − age) × weight/(72 × SCr), ×0.85 for females.

  • Adverse drug reaction reporting uses the suspected ADR form under the Pharmacovigilance Programme of India; causality assessed by WHO-UMC or Naranjo scale.

Quick reference

Pharmaceutical Biotechnology and Novel Drug Delivery

  • Recombinant DNA products include human insulin, growth hormone, erythropoietin, interferon alfa and hepatitis B vaccine; expressed in E. coli, yeast or CHO cells.

  • Monoclonal antibodies are named with -mab; humanised antibodies end -zumab, chimeric -ximab, fully human -mumab (e.g. trastuzumab, rituximab).

  • Liposomes are phospholipid bilayer vesicles; stealth liposomes are PEGylated to evade reticuloendothelial clearance; niosomes use non-ionic surfactants.

  • Nanoparticles, solid lipid nanoparticles and polymeric micelles improve solubility and targeted delivery; size below 200 nm favours passive tumour targeting (EPR effect).

  • Transdermal systems deliver drug through skin; permeation enhancers include ethanol, propylene glycol, oleic acid and terpenes; iontophoresis uses a small electric current.

  • Osmotic pumps (OROS) give zero-order release driven by osmotic pressure; elementary osmotic pump uses a semipermeable membrane with a laser-drilled orifice.

  • Gene therapy vectors: viral (adenovirus, AAV, lentivirus) and non-viral (lipoplexes, polyplexes, naked DNA); AAV is favoured for long-term expression with low immunogenicity.

  • Biosimilars are follow-on biologics approved after patent expiry; they require comparability exercises, not full clinical trials, but are not identical to the innovator.

Quick reference

General Science and Current Affairs and Administrative Aptitude

  • SI base units: length metre, mass kilogram, time second, amount of substance mole, temperature kelvin, electric current ampere, luminous intensity candela.

  • Avogadro's number 6.022 × 10^23 per mole; molarity = moles of solute/litre of solution; normality = gram equivalents/litre.

  • Periodic trends: atomic radius decreases across a period and increases down a group; electronegativity increases across a period and decreases down a group.

  • Indian regulatory bodies: CDSCO under DGCI, NPPA for drug pricing under the National Pharmaceutical Pricing Authority, and NABL for laboratory accreditation.

  • National Health Policy 2017 and Ayushman Bharat (PM-JAY) are key Indian health initiatives; the National Medical Commission Act, 2019 replaced the Medical Council of India.

  • Administrative aptitude: RTI Act 2005 gives citizens the right to information within 30 days; the Central Vigilance Commission oversees vigilance in public administration.

  • Current affairs in pharma: Schedule M revision, the Jan Vishwas Act amendments to the Drugs and Cosmetics Act, and the Drugs, Medical Devices and Cosmetics Bill proposals are recurring exam themes.

Quick reference

Pharmaceutical Chemistry

  • Aryl acetic acid NSAIDs (diclofenac, ibuprofen) act by reversible, non-selective inhibition of COX-1 and COX-2; celecoxib is a selective COX-2 inhibitor with a sulfonamide group.

  • Penicillin core is 6-aminopenicillanic acid (6-APA); cephalosporin core is 7-aminocephalosporanic acid (7-ACA); beta-lactam ring integrity is required for antibacterial activity.

  • Prodrugs: enalapril is hydrolysed to enalaprilat; sulfasalazine is cleaved by colonic azoreductase to 5-aminosalicylic acid; levodopa is decarboxylated to dopamine centrally.

  • Stereochemistry matters: S-(-)-propranolol is far more potent than R-(+); (S)-omeprazole (esomeprazole) is the active enantiomer; thalidomide enantiomers differ in teratogenicity.

  • Henderson-Hasselbalch: for weak acids pH = pKa + log([A-]/[HA]); for weak bases pH = pKa + log([B]/[BH+]); a drug crosses membranes best in its un-ionised form.

  • Bioisosterism examples: -OH/-NH2, -F/-H, -S-/-O-, carboxyl/tetrazole replacement (as in losartan) preserves acidity while improving pharmacokinetics.

  • Phase I reactions are oxidation, reduction and hydrolysis (CYP450); Phase II are conjugations (glucuronidation, sulfation, acetylation, methylation, glutathione).

  • Hard/soft acid-base (HSAB) and pKa principles predict salt formation: acidic drugs are formulated as sodium/potassium salts, basic drugs as hydrochloride/sulfate salts.

Quick reference

Pharmaceutics and Dosage Form Design

  • Noyes-Whitney: dissolution rate dC/dt = k·A·(Cs − C)/h; increase surface area A or solubility Cs to raise dissolution.

  • Stokes' law: v = d²(ρp − ρm)g/18η; smaller particle diameter d and higher viscosity η slow sedimentation in suspensions.

  • First-order drug release: ln(C) = ln(C0) − kt, t1/2 = 0.693/k; zero-order release gives constant rate independent of concentration (ideal for controlled release).

  • Higuchi model for matrix diffusion: Q = kH·t^0.5; Korsmeyer-Peppas Q = ktn where n ≈ 0.5 indicates Fickian diffusion, n ≈ 1 indicates Case II (zero-order) transport.

  • HLB scale: 3–6 for w/o emulsifiers, 8–18 for o/w emulsifiers; sodium lauryl sulfate ≈ 40, sorbitan esters (Spans) 1.8–8.6, polysorbates (Tweens) 9.6–16.7.

  • Tablet defects: capping (upper/lower separation), lamination (layers), picking/sticking (adhesion to punches), mottling (uneven colour) - each traced to moisture, compression force or granule properties.

  • Caking in suspensions is prevented by flocculation (controlled, loosely bound aggregates) rather than deflocculation, which causes hard irreversible sediment.

  • Sterility assurance level (SAL) for terminally sterilised products is 10^-6; F0 of 12 minutes at 121 °C is the reference for moist heat sterilisation.

Quick reference

Pharmacology and Toxicology

  • Competitive antagonists shift the dose-response curve right without lowering Emax (e.g. atropine, propranolol); non-competitive antagonists reduce Emax.

  • Receptor families: ligand-gated ion channels (nicotinic), G-protein coupled (beta-adrenergic), kinase-linked (insulin), nuclear (steroid, thyroid).

  • Organophosphate poisoning: acetylcholinesterase inhibition; treat with atropine (muscarinic effects) plus pralidoxime (reactivates enzyme before ageing).

  • Paracetamol overdose: NAPQI accumulates after glutathione depletion; antidote N-acetylcysteine, most effective within 8–10 hours.

  • Methanol/ethylene glycol poisoning: alcohol dehydrogenase converts them to toxic acids; treat with fomepizole or ethanol plus haemodialysis.

  • Cyanide poisoning: inhibits cytochrome c oxidase; antidotes are sodium nitrite plus sodium thiosulphate, or hydroxocobalamin.

  • Warfarin acts by inhibiting vitamin K epoxide reductase (VKORC1); overdose reversed with vitamin K1 (phytomenadione) and fresh frozen plasma.

  • Therapeutic index = TD50/ED50; drugs with narrow TI (digoxin, lithium, phenytoin, warfarin) require therapeutic drug monitoring.

Quick reference

Pharmacognosy and Phytochemistry

  • Alkaloid-bearing drugs: belladonna and Datura (tropane alkaloids atropine, hyoscine), Cinchona (quinine), Rauwolfia (reserpine), Papaver (morphine), Ephedra (ephedrine).

  • Glycoside-bearing drugs: Digitalis purpurea gives digitoxin and gitoxin; Digitalis lanata gives digoxin; cardiac glycosides are steroidal aglycone plus sugar.

  • Senna and Aloe contain anthraquinone glycosides (sennosides A and B, aloin); they act as stimulant purgatives via the colon.

  • Volatile oil drugs: clove (eugenol), peppermint (menthol), eucalyptus (cineole), cinnamon (cinnamaldehyde); extracted by hydrodistillation or steam distillation.

  • Resins and oleoresins: asafoetida (ferulic acid esters), ginger (gingerol), capsicum (capsaicin), Cannabis (tetrahydrocannabinol).

  • Chemical tests: Dragendorff and Mayer reagents for alkaloids; Keller-Kiliani for cardiac glycosides; Borntrager for anthraquinones; Molisch for carbohydrates.

  • Guggul, turmeric (curcuminoids) and Boswellia are resinous drugs; curcumin is a diarylheptanoid with reported anti-inflammatory activity.

  • Pharmacognostic evaluation uses organoleptic, macroscopic, microscopic (stomata, trichomes, calcium oxalate crystals), physical and chemical parameters plus ash values.

Quick reference

Pharmaceutical Analysis and Quality Control

  • Beer-Lambert law: A = εbc, where A is absorbance, ε molar absorptivity, b path length and c concentration; linear range must be demonstrated for a calibration curve.

  • Chromatographic system suitability parameters: resolution R ≥ 2, tailing factor ≤ 2.0, theoretical plates (N) and RSD of replicate injections typically ≤ 2.0%.

  • HPLC retention factor k = (tR − t0)/t0; selectivity α = k2/k1; resolution R = 2(tR2 − tR1)/(w1 + w2).

  • Validation parameters per ICH Q2(R1): accuracy, precision, specificity, detection limit, quantitation limit, linearity and range.

  • Limit of detection (LOD) = 3.3σ/S and limit of quantitation (LOQ) = 10σ/S, where σ is the SD of the response and S the slope.

  • Karl Fischer titration measures water content; iodometric and cerimetric titrations are common for assay of drugs such as ascorbic acid and hydrogen peroxide.

  • Potentiometric titration and conductometry suit coloured or turbid solutions; non-aqueous titration with perchloric acid in glacial acetic acid assays weak bases.

  • IR spectroscopy identifies functional groups: O-H broad 3200–3600 cm-1, C=O 1700–1750 cm-1, C-H stretch 2850–2960 cm-1; fingerprint region below 1500 cm-1.

Quick reference

Drug Regulatory Affairs and Legislation (Drugs and Cosmetics Act and Rules)

  • Drugs and Cosmetics Act, 1940; Drugs and Cosmetics Rules, 1945; definitions of drug, cosmetic, misbranded, adulterated and spurious drugs appear in Sections 3 and 17-17B.

  • Drug Technical Advisory Board (DTAB) advises the Central Government; Drug Consultative Committee (DCC) coordinates Centre and States; Central Drugs Laboratory (CDL) at Kolkata is the statutory appellate laboratory.

  • Licensing: Form 25/25A for manufacture of drugs, Form 28 for manufacture of cosmetics; Form 20/20A/21 retail sale licences; Forms 19/19A for wholesale.

  • Schedules: Schedule H lists prescription drugs; Schedule H1 includes antibiotics and drugs needing separate register with retention; Schedule X covers narcotic and psychotropic drugs requiring special licences.

  • Schedule M prescribes Good Manufacturing Practices and requirements of premises and plant; Schedule L-1 gives GLP requirements for testing laboratories.

  • Clinical trials are governed by the New Drugs and Clinical Trials Rules, 2019; approval from the Central Licensing Authority with Ethics Committee oversight and informed consent.

  • Inspectors are appointed under Section 21; powers of entry, search and seizure under Section 22; offences and penalties are in Chapter IV (Sections 27-32B).

  • Ayurvedic, Siddha and Unani drugs fall under Chapter IVA and Schedule T (GMP for ASU drugs); medical devices are regulated as drugs under the Medical Devices Rules, 2017.

Quick reference

Pharmaceutical Microbiology and Sterility Assurance

  • Sterilisation methods: moist heat (autoclave 121 °C, 15 psi, 15–20 min), dry heat (160 °C for 2 h or 170 °C for 1 h), ethylene oxide, gamma irradiation (25 kGy), and membrane filtration (0.22 µm).

  • D-value is the time to reduce a microbial population by 90% (one log); z-value is the temperature change giving a tenfold change in D-value.

  • F0 = Σ 10^((T−121)/z) · Δt; an F0 of ≥ 12 min at 121 °C is required for terminally sterilised products.

  • Biological indicators: Geobacillus stearothermophilus for moist heat and hydrogen peroxide; Bacillus atrophaeus for dry heat and ethylene oxide.

  • Sterility test methods are direct inoculation and membrane filtration (0.45 µm for sterility testing); media used are soyabean casein digest and fluid thioglycollate.

  • Microbial limit tests: total aerobic microbial count (TAMC), total yeast and mould count (TYMC), and absence of specified organisms such as E. coli, Salmonella and S. aureus.

  • Bacterial endotoxin testing (LAL) is a pyrogen test; endotoxin limit for parenterals is K/M, where K = 5 EU/kg/h and M is maximum human dose per kg per hour.

  • Antimicrobial effectiveness testing (AET) verifies preservative efficacy against S. aureus, P. aeruginosa, E. coli, C. albicans and A. brasiliensis.

Quick reference

Biochemistry and Clinical Pharmacy

  • Glycolysis yields 2 ATP and 2 NADH per glucose; complete oxidation yields about 30–32 ATP including the TCA cycle and oxidative phosphorylation.

  • Enzyme kinetics: Michaelis-Menten v = Vmax[S]/(Km + [S]); Km is the substrate concentration at half Vmax; Lineweaver-Burk plot gives 1/v versus 1/[S].

  • Competitive inhibitors raise Km without changing Vmax; non-competitive inhibitors lower Vmax without changing Km; uncompetitive inhibitors lower both.

  • HPLC and immunoassay are used for therapeutic drug monitoring; common targets include digoxin, lithium, phenytoin, valproate, cyclosporine and vancomycin.

  • Clinical pharmacy: aminoglycosides require peak and trough monitoring; vancomycin trough 10–20 µg/mL for serious infections; digoxin therapeutic range 0.5–2 ng/mL.

  • Blood glucose reference: fasting 70–100 mg/dL, HbA1c < 5.7% normal; diabetes diagnosed at fasting ≥ 126 mg/dL or HbA1c ≥ 6.5%.

  • Liver function and renal clearance: creatinine clearance by Cockcroft-Gault CrCl = (140 − age) × weight/(72 × SCr), ×0.85 for females.

  • Adverse drug reaction reporting uses the suspected ADR form under the Pharmacovigilance Programme of India; causality assessed by WHO-UMC or Naranjo scale.

Quick reference

Pharmaceutical Biotechnology and Novel Drug Delivery

  • Recombinant DNA products include human insulin, growth hormone, erythropoietin, interferon alfa and hepatitis B vaccine; expressed in E. coli, yeast or CHO cells.

  • Monoclonal antibodies are named with -mab; humanised antibodies end -zumab, chimeric -ximab, fully human -mumab (e.g. trastuzumab, rituximab).

  • Liposomes are phospholipid bilayer vesicles; stealth liposomes are PEGylated to evade reticuloendothelial clearance; niosomes use non-ionic surfactants.

  • Nanoparticles, solid lipid nanoparticles and polymeric micelles improve solubility and targeted delivery; size below 200 nm favours passive tumour targeting (EPR effect).

  • Transdermal systems deliver drug through skin; permeation enhancers include ethanol, propylene glycol, oleic acid and terpenes; iontophoresis uses a small electric current.

  • Osmotic pumps (OROS) give zero-order release driven by osmotic pressure; elementary osmotic pump uses a semipermeable membrane with a laser-drilled orifice.

  • Gene therapy vectors: viral (adenovirus, AAV, lentivirus) and non-viral (lipoplexes, polyplexes, naked DNA); AAV is favoured for long-term expression with low immunogenicity.

  • Biosimilars are follow-on biologics approved after patent expiry; they require comparability exercises, not full clinical trials, but are not identical to the innovator.

Quick reference

General Science and Current Affairs and Administrative Aptitude

  • SI base units: length metre, mass kilogram, time second, amount of substance mole, temperature kelvin, electric current ampere, luminous intensity candela.

  • Avogadro's number 6.022 × 10^23 per mole; molarity = moles of solute/litre of solution; normality = gram equivalents/litre.

  • Periodic trends: atomic radius decreases across a period and increases down a group; electronegativity increases across a period and decreases down a group.

  • Indian regulatory bodies: CDSCO under DGCI, NPPA for drug pricing under the National Pharmaceutical Pricing Authority, and NABL for laboratory accreditation.

  • National Health Policy 2017 and Ayushman Bharat (PM-JAY) are key Indian health initiatives; the National Medical Commission Act, 2019 replaced the Medical Council of India.

  • Administrative aptitude: RTI Act 2005 gives citizens the right to information within 30 days; the Central Vigilance Commission oversees vigilance in public administration.

  • Current affairs in pharma: Schedule M revision, the Jan Vishwas Act amendments to the Drugs and Cosmetics Act, and the Drugs, Medical Devices and Cosmetics Bill proposals are recurring exam themes.