Pharmacognosy and herbal drugs

Pharmacy (B.Pharm) · Pharmacognosy · free study notes for exams, placements and interviews

In short

Pharmacognosy is the study of drugs of natural origin — their source, cultivation, collection, identification, chemistry, standardisation, adulteration and therapeutic use. It links botany and chemistry to pharmacy: a leaf, bark or root becomes a legally saleable "crude drug" only after it is identified and shown to meet pharmacopoeial limits. In B.Pharm it is examined in Pharmacognosy and Phytochemistry I and II (PCI syllabus) and in GATE-PH / NIPER / GPAT; practically it is the core skill in quality control at AYUSH and herbal/nutraceutical manufacturers (Dabur, Himalaya, Zandu-Emami, Patanjali, Charak, Hamdard, Baidyanath, Natural Remedies, Arjuna Natural, Sami-Sabinsa) and in phytochemical and raw-material testing laboratories. Indian practice is governed by the Drugs and Cosmetics Act, 1940 and Rules, 1945 (ASU chapter and Schedule T GMP), with the Ayurvedic/Siddha/Unani Pharmacopoeias of India as the standards books.

Explained

Definitions, scope and history

Pharmacognosy (Greek *pharmakon* = drug, *gnosis* = knowledge): the science of crude drugs of plant, animal, mineral and microbial origin — coined by C. A. Seydler (1815); Indian texts also credit J. A. Schmidt (1811).
Crude drug: a natural substance that has undergone no processing beyond collection and drying (e.g. senna leaflets, ginger rhizome, gum acacia).
Scope: identification (pharmacobotany), chemistry of actives (phytochemistry), biosynthesis, cultivation and conservation, standardisation and quality control, ethnopharmacology, drug discovery from plants, marine and plant tissue culture.
Herbal drug / phytomedicine: a plant, plant part or its extract used therapeutically; in India also classified as an ASU drug, a nutraceutical/food supplement (FSS Act, 2006 and the 2016 Nutraceutical Regulations, amended since) or a cosmetic, depending on claim — the claim decides the law that applies.
Allied terms: *official* drug (in a pharmacopoeia), *unofficial*, *indigenous*, *drug of natural origin vs. semi-synthetic* (e.g. digoxin natural, dihydroergotamine semi-synthetic).

Classification of crude drugs

Alphabetical — by Latin or English name (e.g. in the API, IP). Easy to locate, no scientific grouping.
Morphological (organised/unorganised) — organised: leaves (senna, digitalis, vasaka), flowers (clove, saffron), fruits (fennel, ajwain), seeds (nux vomica, isabgol), barks (cinchona, cinnamon), woods (sandalwood), roots and rhizomes (rauwolfia, ginger, turmeric); unorganised: gums (acacia), resins (asafoetida), latex, dried juices (aloe, opium), fixed oils and fats, waxes, volatile oils.
Taxonomic — by family/genus (Solanaceae: belladonna, datura, stramonium). Groups related chemistry but mixes unrelated uses.
Chemical — by major constituent: alkaloids, glycosides, volatile oils, tannins, resins, carbohydrates, lipids, proteins, vitamins. Best for a phytochemist; the same plant can appear twice.
Pharmacological/therapeutic — by action: laxatives (senna, isabgol), cardiotonics (digitalis), antihypertensives (rauwolfia), bitters (gentian), antitussives (vasaka). Best for a prescriber; one drug may have several actions.
Chemotaxonomic — uses chemical markers (chemical "fingerprints", chemo-races) to settle taxonomy; e.g. *Cinchona* species distinguished by alkaloid pattern, *Mentha* and *Ocimum* chemotypes by oil composition.

Cultivation, collection, processing and storage

Why cultivate rather than collect wild: uniform quality and yield, correct species, scope for selection and plant improvement, protection of threatened species (conservation is also a legal duty under the Biological Diversity Act, 2002, as amended in 2023, with NBA/State Boards and access-and-benefit-sharing for commercial use).
Factors affecting growth and constituents: altitude, temperature, rainfall, day length, soil type and pH, fertilisers (N for alkaloids, P/K for glycosides broadly), irrigation, pest and weed control.
Plant propagation: sexual (seeds) and asexual (cuttings, layering, grafting, bulbs, rhizomes, tissue culture/micropropagation for uniform clones).
Plant growth regulators: auxins, gibberellins, cytokinins, ethylene, abscisic acid — used for rooting, dwarfing, flowering and fruit set.
Collection at the stage of maximum active constituent: leaves just before/at flowering, flowers at or before full bloom (clove as unopened buds), barks in the rainy season or spring, rhizomes/roots when aerial parts die down, seeds and fruits at maturity.
Processing steps: garbling (removal of foreign and unwanted parts) → drying → grading → packing → storage.
Drying: natural (sun, shade) or artificial (tray, tunnel, vacuum, spray and freeze drying for thermolabile actives). Drying arrests enzymatic change, prevents mould and makes powdering possible.
Enzymatic treatment is deliberate in some drugs — fermentation of vanilla, gentian, cascara (to mellow anthrones); enzymes are destroyed (blanching with steam/alcohol vapour, or rapid drying below about 60 °C) in digitalis, where the primary glycosides must be preserved.
Storage: well-closed containers, cool and dry, protected from light, moisture (preferably below about 10% moisture for most dried herbs, as per the monograph), insects and rodents; deterioration shows as loss of volatile oil, oxidation of resins, racemisation, mould and aflatoxin.
Good Agricultural and Collection Practices (GACP) — WHO guidelines and Indian GACP/Good Field Collection Practices issued through the Ministry of Ayush/NMPB; cover seed source, site, agrochemical records, hygiene, post-harvest handling and documentation.

Adulteration and substitution

Adulteration: a drug that does not meet the pharmacopoeial standard — intentional or unintentional.
Types: (a) substitution with inferior/exhausted drug (exhausted ginger, clove from which oil has been distilled); (b) substitution with a superficially similar but different species (Indian for Alexandrian senna; *Strophanthus* seeds); (c) admixture of worthless matter (sand, stones, chalk, lead shot in opium, iron filings); (d) artificially manufactured substitutes (coloured paraffin for beeswax); (e) presence of foreign matter — insects, excreta, moulds; (f) unintentional: wrong collection, faulty drying, careless storage, mix-up of vernacular names, confusion of *Brahmi* (*Bacopa monnieri* vs *Centella asiatica*).
Detection: systematic evaluation (below), plus determination of foreign organic matter (NMT 2% for most monographs — check each), moisture, ash and specific chemical assay.

Evaluation (standardisation) of crude drugs — the five classical methods

Organoleptic (morphological): colour, odour, taste, size, shape, fracture, surface, texture. Fast, needs no equipment, needs an experienced analyst; e.g. cinnamon's compound quill (several thin quills packed one inside another) and sweet aromatic taste versus cassia's single, thicker quill and mucilaginous taste.
Microscopic: identity from cell and tissue characters — stomata type (anomocytic in digitalis, paracytic in senna, anisocytic in datura), trichomes, calcium oxalate crystals, starch grains, lignified fibres, stone cells, sclereids. Includes quantitative microscopy on powders: leaf constants, lycopodium spore method for percentage composition of a powder.
Physical: moisture content (loss on drying), ash values, extractive values, volatile oil content, swelling index, foaming index, specific gravity, refractive index, optical rotation, melting point, viscosity, solubility, ultraviolet fluorescence.
Chemical: limit tests, identification colour and precipitation tests, assay of actives by titrimetry, gravimetry, UV-visible spectrophotometry, HPLC/HPTLC fingerprinting, GC for volatile oils, and marker-based standardisation (e.g. sennosides in senna, curcuminoids in turmeric, reserpine in rauwolfia, withanolides in ashwagandha, andrographolide in kalmegh).
Biological: bioassays where chemistry cannot measure potency — digitalis potency on guinea-pig/pigeon heart against the international standard, hemolytic index for saponins, antibacterial activity, insecticidal assay. Costlier and more variable; now minimised in favour of chromatographic methods.
Modern additions required by WHO/API quality profiles: heavy metals (lead, cadmium, mercury, arsenic), pesticide residues, aflatoxins, microbial load, radioactive contamination, and TLC/HPTLC fingerprint as the identity criterion for an extract.

Phytochemistry in brief — classes, tests and example drugs

Alkaloids — basic N-containing; tests: Dragendorff's (orange-red), Mayer's (cream), Wagner's, Hager's. Examples: atropine (belladonna), morphine (opium), quinine (cinchona), reserpine (rauwolfia), vinca alkaloids (*Catharanthus*), caffeine (tea, coffee).
Glycosides — sugar + aglycone; cardiac (digitalis — Keller–Kiliani for deoxy-sugar, Baljet, Legal's), anthraquinone (senna, cascara, rhubarb — Borntrager's test), saponin (liquorice, shatavari — froth and hemolysis), cyanogenetic (bitter almond — sodium picrate paper), isothiocyanate (mustard), bitter (gentian, quassia), flavonoid (rutin — Shinoda test), coumarin.
Volatile (essential) oils — steam-distilled, odorous, leave no permanent grease stain; clove, peppermint, eucalyptus, lemongrass, ajwain; estimated by Clevenger apparatus.
Tannins — polyphenols, astringent; hydrolysable (gallotannins, myrobalan) and condensed (catechin); ferric chloride, gelatin and goldbeater's-skin tests.
Resins and oleo-gum-resins — asafoetida, guggul, myrrh, benzoin, colophony.
Carbohydrates and derived products — acacia, tragacanth, guar gum, isabgol, agar, starch, honey.
Lipids — castor, arachis, sesame, coconut oil; characterised by acid, saponification, iodine and peroxide values.
Primary metabolites vs secondary metabolites: the latter are the therapeutic constituents, formed by the shikimic acid (phenolics), acetate–mevalonate (terpenoids, steroids), acetate–malonate (fatty acids, anthraquinones) and amino-acid-derived (alkaloids) pathways.

Herbal formulations and Indian regulation

Dosage forms: churna (powder), kwatha/decoction, asava-arishta (fermented), taila and ghrita (oil/ghee), bhasma (calcined mineral), vati/gutika (tablet), capsules of standardised extracts, syrups, lehya, and modern phytosomes, herbal cosmetics and nutraceuticals.
Extracts: maceration, percolation, Soxhlet (continuous hot), infusion, decoction, digestion; modern — supercritical CO₂, microwave- and ultrasound-assisted extraction. Products: tinctures, fluid extracts, soft and dry extracts (spray-dried), standardised to a marker.
Law and standards in India (Drugs and Cosmetics Act, 1940 and Rules, 1945): ASU drugs are defined in section 3(a) and regulated under Chapter IV-A; Schedule T prescribes GMP for Ayurveda, Siddha and Unani manufacture; licensing of ASU manufacture is under Rule 158B (which also sets proof-of-effect and safety requirements for classical, patent/proprietary and new ASU drugs); Rule 161 and related rules govern labelling; Schedule E(1) lists poisonous ASU substances requiring a caution. A consolidated replacement Bill for the 1940 Act has been under consideration in recent years — the 1940 Act and 1945 Rules remain the operative law.
Standards books: Ayurvedic Pharmacopoeia of India (API), Siddha, Unani and Homoeopathic Pharmacopoeias, Ayurvedic Formulary of India; Indian Pharmacopoeia (IP) for herbal monographs of allopathic relevance; WHO monographs on selected medicinal plants.
Institutions: Ministry of Ayush; PLIM (Pharmacopoeial Laboratory for Indian Medicine, Ghaziabad) and the Pharmacopoeia Commission for Indian Medicine & Homoeopathy; NMPB (National Medicinal Plants Board) for cultivation and GACP; CDSCO for allopathic herbal products; AYUSH Standard Mark / AYUSH Premium Mark certification by the Quality Council of India for export-grade products.
Other applicable laws: Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 (no claims for listed diseases); Biological Diversity Act, 2002 (as amended 2023) for access and benefit sharing; CITES and the Wild Life (Protection) Act for endangered species; FSS Act, 2006 for nutraceuticals; Legal Metrology for pack declarations; GST on medicines is levied at the notified rate (GST slabs are 5%, 18% and 40% since 22 September 2025 — most medicaments, including Ayurvedic ones, sit in the lowest slab; verify the current HSN notification).

Key points

Pharmacognosy — science of crude drugs of natural origin: source, chemistry, identification, standardisation, use.
Crude drug — natural material processed no further than collection, drying and garbling.
Six classification systems — alphabetical, morphological, taxonomic, chemical, pharmacological, chemotaxonomic; chemical and pharmacological are the most used in practice.
Organised vs unorganised — organised drugs have cellular structure (leaf, bark, root); unorganised are exudates and extractives (gums, resins, aloe).
Collection stage decides potency — leaves before flowering, barks in spring/rains, roots when the plant is dormant.
Drying stops enzyme action and microbial growth; blanching destroys enzymes where glycosides must survive (digitalis), while fermentation is deliberate in vanilla and cascara.
Garbling — removal of foreign organic matter and unwanted plant parts before packing.
Adulteration — failure to meet standard: exhausted drug, inferior species, worthless admixture, artificial substitute, foreign matter.
Five evaluation methods — organoleptic, microscopic, physical, chemical, biological; identity + purity + strength together make standardisation.
Leaf constants — stomatal number and index, palisade ratio, vein-islet number, veinlet termination number, trichome number — used on powdered leaf drugs where morphology is lost.
Ash values — total ash (all inorganic), acid-insoluble ash (mainly silica — detects earthy adulteration), water-soluble ash (obtained by difference: total ash minus water-insoluble ash).
Extractive values — amount dissolved by water, alcohol or ether; a low value suggests an exhausted or adulterated drug.
Swelling index — mL occupied by 1 g of swollen drug; the key test for mucilage drugs (isabgol, linseed).
Foaming index and hemolytic index — measures of saponin content.
Bitterness value — expressed in units relative to quinine hydrochloride; applied to gentian, quassia, chirata.
Biological assay is used only where chemical assay cannot measure potency, e.g. digitalis against the international standard.
Markers — sennosides (senna), curcuminoids (turmeric), reserpine (rauwolfia), withanolides (ashwagandha), andrographolide (kalmegh); HPTLC fingerprint is the modern identity test.
Indian framework — D&C Act 1940 with Schedule T GMP and Rule 158B licensing; API/AFI as standards; Ministry of Ayush, PLIM, NMPB; Biological Diversity Act for ABS.

Formulas and examples

Stomatal index SI = [S / (S + E)] × 100 — S = number of stomata per unit area, E = number of ordinary epidermal cells in the same area (each guard-cell pair counts as one stoma); dimensionless.

Stomatal number = average number of stomata per square millimetre of epidermis (mm⁻²).

Palisade ratio = average number of palisade cells beneath one upper-epidermal cell — count palisade cells under a group of four epidermal cells and divide by 4; dimensionless.

Vein-islet number = number of vein islets (areas of mesophyll enclosed by veinlets) per mm² of leaf between the midrib and the margin; mm⁻².

Veinlet termination number = number of free veinlet endings per mm² of the same area; mm⁻².

Total ash % w/w = (weight of ash / weight of air-dried drug taken) × 100; acid-insoluble and water-insoluble ash computed the same way on the residue obtained.

Extractive value % w/w = (weight of dried residue × total volume of menstruum) / (volume of filtrate evaporated × weight of drug) × 100.

Loss on drying (moisture) % w/w = (loss in weight / initial weight of sample) × 100, dried at the temperature stated in the monograph (commonly 105 °C) to constant weight.

Swelling index = volume in mL occupied by 1 g of drug, including any adhering mucilage, after swelling in water (or the stated liquid) for 4 h (24 h for some monographs).

Foaming index = 1000 / a — a = volume (mL) of the 1% decoction in the tube (series of 1–10 mL made up to 10 mL) that shows a persistent froth 1 cm high after shaking and standing 15 min. Reported as "less than 100" if no tube in the series froths (not even the 10 mL tube), and "more than 1000" if the first tube, holding 1 mL, already froths.

Bitterness value (units per g) = (2000 × c) / (a × b) — a = concentration of the drug stock solution (mg/mL), b = volume (mL) of that stock in the tube at the threshold of bitterness made up to 10 mL, c = quantity of quinine hydrochloride (mg) in the quinine tube at its threshold; 1 unit = bitterness of a solution of 1 g quinine HCl in 2000 mL.

Hemolytic index = 1000 × a / b — a = weight (g) of standard saponin producing complete hemolysis, b = weight (g) of the drug producing complete hemolysis under identical conditions; standard saponin taken as 1000 units.

Example 1 — stomatal index. A leaf-surface preparation under a camera lucida shows 18 stomata and 42 epidermal cells in the field.

SI = 18 / (18 + 42) × 100 = 18/60 × 100 = 30.
Stomatal index is nearly constant for a species and almost independent of leaf age, which is why it is preferred over stomatal number (which varies with leaf age and growing conditions, generally falling per mm² as the epidermal cells enlarge). Different values on the two surfaces mean the leaf is dorsiventral.

Example 2 — ash values of a powdered rhizome. Empty silica crucible = 22.4500 g; crucible + 2.0000 g drug incinerated at 450 °C to constant weight = 22.5620 g. The ash is boiled with dilute HCl and the insoluble residue weighs 0.0280 g.

Ash = 22.5620 − 22.4500 = 0.1120 g → total ash = 0.1120/2.0000 × 100 = 5.6% w/w.
Acid-insoluble ash = 0.0280/2.0000 × 100 = 1.4% w/w.
Ginger's monograph limit for acid-insoluble ash is NMT 2% — this sample passes; a figure of, say, 6% would indicate sand or earth. Always read the limit from the current monograph, as limits differ for every drug.

Example 3 — alcohol-soluble extractive. 5.00 g of coarsely powdered drug is macerated with 100 mL of 90% ethanol for 24 h, filtered, and 25 mL of filtrate evaporated in a tared dish; residue dried at 105 °C = 0.0850 g.

25 mL of filtrate corresponds to 5.00 × 25/100 = 1.25 g of drug.
Extractive value = 0.0850/1.25 × 100 = 6.8% w/w.
If the monograph requires not less than 10%, the batch fails — a classic signature of an exhausted drug from which the actives have already been extracted.

Example 4 — moisture, foaming index and swelling index.

2.0000 g of leaf powder dried at 105 °C weighs 1.8260 g → loss = 0.1740 g → LOD = 8.7% w/w, acceptable where the limit is NMT 10%.
In the foaming-index series, a persistent 1 cm froth first appears in the tube containing 8 mL of the 1% decoction → foaming index = 1000/8 = 125.
1.0 g of ispaghula husk in a graduated cylinder with water occupies 45 mL after 24 h → swelling index = 45, meeting a specification of not less than 40.

Example 5 — bitterness value. Threshold bitterness is reached in the tube holding 3.0 mL of a drug stock of 1.0 mg/mL (made to 10 mL); the quinine HCl threshold tube contains 0.0580 mg of quinine HCl.

Bitterness value = (2000 × 0.0580) / (1.0 × 3.0) = 116/3 = 38.7 units per g.
Reported against the monograph minimum (gentian, for instance, is required to be strongly bitter); a low value suggests dilution with an inert powder.

Evaluation method	What it answers	Tools	Limitation
Organoleptic	Is this the right drug, broadly?	Senses	Subjective; powders defeat it
Microscopic	Identity and admixture in powders	Microscope, reagents, leaf constants	Needs trained eye, authentic slides
Physical	Purity, moisture, inorganic load	Oven, muffle furnace, cylinders	Does not identify the active
Chemical	Strength of the active/marker	Titrimetry, UV, HPLC, HPTLC, GC	Costly; marker may not equal activity
Biological	Potency when chemistry fails	Animal/tissue/microbial assay	Variable, expensive, ethically restricted

Parameter	Senna (leaf)	Isabgol (seed husk)	Turmeric (rhizome)
Part used	Dried leaflets of Cassia angustifolia	Husk of Plantago ovata seeds	Rhizome of Curcuma longa
Active class	Anthraquinone glycosides	Mucilage (polysaccharide)	Curcuminoids, volatile oil
Key test	Borntrager's; sennoside assay	Swelling index	Curcuminoid assay, HPTLC
Use	Stimulant laxative	Bulk laxative	Anti-inflammatory, colouring

Where it is used

Herbal and ASU manufacturing QC: raw-material identification, leaf constants, ash and extractive values, HPTLC fingerprints and heavy-metal/pesticide/aflatoxin limits under Schedule T GMP at Dabur, Himalaya, Baidyanath, Charak, Hamdard, Emami and Patanjali plants.
Phytochemical and extract industry: standardised extracts for export (Sami-Sabinsa, Arjuna Natural, Natural Remedies, Olene, Plant Lipids) with marker assays — roles as QC analyst, R&D phytochemist, HPLC/HPTLC chemist.
Nutraceuticals and herbal cosmetics: ashwagandha, moringa, amla, tulsi and neem products under the FSS Act and the Cosmetics Rules; label claims must satisfy the Drugs and Magic Remedies Act, 1954.
Cultivation and supply chain: NMPB-supported medicinal-plant farming of ashwagandha, isabgol (Gujarat/Rajasthan), senna (Tamil Nadu), mint (UP) with GACP documentation; roles in procurement and vendor audit.
Regulatory and testing laboratories: PLIM Ghaziabad, state drug testing laboratories, NABL-accredited private labs; dossier work for ASU licences, export COAs and ABS clearances.
Research and academia: CSIR-CIMAP, CSIR-NBRI, CDRI, NIPERs, Ayush research councils (CCRAS, CCRUM) — isolation, pharmacological screening and new-drug leads; plant tissue culture for scarce species.

Interview questions

Q: What is the difference between adulteration and substitution? A: Adulteration is any failure of the drug to meet the prescribed standard, including accidental deterioration; substitution is the deliberate replacement of the genuine drug by another material, which is one kind of adulteration.
Q: Why is stomatal index preferred to stomatal number? A: Stomatal number per mm² changes with leaf age and growing conditions, whereas the ratio of stomata to epidermal cells stays almost constant for a species.
Q: What does a high acid-insoluble ash indicate? A: Contamination with sand, soil or siliceous earthy matter, since the physiological ash dissolves in acid and the silica does not.
Q: A sample has normal appearance but a low alcohol-soluble extractive. What do you suspect? A: An exhausted drug — the actives have already been extracted — or dilution with an inert powder; confirm by assay of the marker constituent.
Q: Why are digitalis leaves dried quickly below about 60 °C and sometimes blanched? A: To destroy or inactivate the hydrolysing enzymes so the primary cardiac glycosides are not converted or lost.
Q: Which crude drugs are deliberately fermented, and why? A: Vanilla, cascara and gentian — enzymatic/microbial change develops the aroma or mellows harsh anthrone constituents.
Q: Where is biological assay still justified? A: Where potency cannot be captured chemically — classically digitalis against the international standard, hemolytic index for saponins, and antimicrobial screening.
Q: What standards does an Indian manufacturer follow for an Ayurvedic tablet? A: The Ayurvedic Pharmacopoeia of India and Ayurvedic Formulary of India monographs, with manufacture under Schedule T GMP and a licence under the ASU rules of the Drugs and Cosmetics Rules, 1945.
Q: How is a herbal extract standardised? A: By fixing the drug–extract ratio, the extraction solvent and conditions, a quantified marker or active content, an HPTLC/HPLC fingerprint, and limits for moisture, heavy metals, pesticides, aflatoxins and microbial load.
Q: Keller–Kiliani test — what does it detect and in which drug? A: Deoxy sugars of cardiac glycosides; a reddish-brown ring at the junction with the acetic acid/ferric chloride and sulphuric acid layers, used for digitalis.
Q: What is the chemotaxonomic classification and give an example? A: Classification based on chemical constituents used as taxonomic markers — *Cinchona* species separated by their alkaloid profiles, and *Mentha*/*Ocimum* chemotypes by volatile-oil composition.
Q: Why does the Biological Diversity Act matter to a herbal company? A: Commercial use of Indian biological resources requires approval and benefit-sharing with the National Biodiversity Authority or State Board; the 2023 amendment eased obligations for registered AYUSH practitioners and cultivated medicinal plants.

Common mistakes

Counting each guard cell as a separate stoma, or including stomata in the epidermal-cell count, when calculating stomatal index.
Reporting palisade ratio from one epidermal cell instead of averaging over a group of four, and not stating the surface (upper) used.
Confusing total ash with acid-insoluble ash, or quoting one monograph's ash limit as a universal value.
Forgetting the dilution factor in extractive-value calculations — the residue must be referred to the weight of drug represented by the aliquot evaporated, not the whole sample.
Treating a positive colour test as an assay: Dragendorff's or Borntrager's confirms a class, it does not quantify the constituent.
Assuming a standardised marker equals therapeutic activity, and omitting heavy metals, pesticides, aflatoxin and microbial limits from a "standardisation" answer.
Writing "herbal is safe, so unregulated" — ASU drugs are licensed drugs under the Drugs and Cosmetics Act with Schedule T GMP, Schedule E(1) cautions and advertising restrictions under the 1954 Act.