UPSC Drug Inspector cheat sheet
UPSC Drug Inspector · Keep the key ideas within reach.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.