Pharmacy Evolution in India: History and Practice

History and Development of Pharmacy in India

1. Ancient Period (Before 1000 AD)

The origin of pharmacy in India traces back to the Vedic period. Medicines were primarily prepared from plants, minerals, and animal products.

Ayurvedic System

Ayurveda is India’s oldest medical system.

  • Drugs were prepared in forms such as churna (powders), kwatha (decoctions), asava–arishta (fermented preparations), taila (oils), and ghrita (ghee-based medicines).

Important Classical Texts:

  • Charaka Samhita – Focuses mainly on medicine and drug preparation.
  • Sushruta Samhita – Describes surgical instruments and medicinal preparations.

Initially, the pharmacist and physician were often the same person, and medicines were prepared freshly.

2. Medieval Period (1000–1700 AD)

During this era, the Unani system of medicine was introduced to India by Arab and Persian scholars.

Unani Pharmacy

  • Based on Greek principles but developed within India.
  • Medicines included syrups, pills, ointments, and distillates.
  • Drug preparation techniques became more organized.
  • Large hospitals (Dar-us-Shifa) featured separate drug preparation units.

3. Colonial / British Period (1700–1947)

This period marked the commencement of modern pharmacy in India with the introduction of Western medicine by the British.

  • Medicines were largely imported from England.
  • The first pharmaceutical industries began operating on a small scale.

Important Developments:

  • Establishment of medical stores and dispensaries.
  • Introduction of allopathic drugs.
  • In 1901, Bengal Chemical & Pharmaceutical Works was established, becoming the first Indian-owned pharmaceutical company.

4. Post-Independence Period (After 1947)

Following independence, India prioritized self-reliance in medicine production.

Key Developments:

  • Establishment of the Pharmacy Council of India (PCI) under the Pharmacy Act, 1948.
  • Standardization of pharmacy education (D.Pharm, B.Pharm, M.Pharm).
  • Growth of public sector companies like Hindustan Antibiotics Ltd. and IDPL.
  • Development of crucial drug laws, such as the Drugs and Cosmetics Act, 1940.

5. Modern Era (Present Day)

Today, India is recognized globally as the “Pharmacy of the World.”

India is a leading producer of:

  • Generic medicines
  • Vaccines
  • Active Pharmaceutical Ingredients (APIs)

Advanced areas include:

  • Clinical pharmacy
  • Hospital pharmacy
  • Industrial pharmacy
  • Regulatory affairs

India currently exports medicines to over 200 countries.

Origin, Development, and Scope of Pharmacy

Origin of Pharmacy

Pharmacy originated with preparing medicines from natural sources (plants, minerals, animals). In antiquity, the physician and pharmacist roles were often combined. Classical texts like the Charaka Samhita and Sushruta Samhita detailed drug preparation methods.

Development of Pharmacy

Pharmacy evolved into a distinct profession with scientific advancements. The medieval period saw improved formulations (syrups, pills). Post-independence in India, pharmacy education and practice were standardized under the PCI, establishing pharmacy as a science-based healthcare profession.

Scope of Pharmacy

Pharmacy offers diverse career paths, including community and hospital pharmacy, pharmaceutical industry (manufacturing, quality control), clinical pharmacy, research and development, regulatory affairs, academics, and pharmaceutical marketing. Pharmacy has transformed from the art of medicine preparation into a vital scientific profession supporting healthcare and patient safety.

Prescriptions: Definition and Handling

Definition of a Prescription

A prescription is a written or electronic order issued by a registered medical practitioner to a pharmacist, directing the preparation and dispensing of medicines to a patient.

Parts of a Prescription

  1. Date: When the prescription was written.
  2. Patient Details: Name, age, sex, and address.
  3. Superscription: Symbol ℞, meaning “take thou.”
  4. Inscription: Name of the drug(s), strength, and dosage form.
  5. Subscription: Directions to the pharmacist regarding dispensing and quantity.
  6. Signa (Signature): Instructions to the patient (dose, route, frequency, duration).
  7. Refill Instructions: Information on whether refilling is permitted.
  8. Prescriber’s Details: Doctor’s name, address, registration number, and signature.

Handling of Prescription (Procedure)

  • Receiving: Check for completeness, legality, and authenticity.
  • Reading and Understanding: Carefully review drug name, dose, form, and directions.
  • Checking for Errors: Verify dose, interactions, duplications, and patient details.
  • Dispensing the Medicine: Select the correct drug, strength, and quantity.
  • Labeling: Label clearly with patient name, drug name, directions, and warnings.
  • Patient Counseling: Explain administration methods, precautions, and duration.
  • Recording and Filing: Maintain records according to legal requirements.

Posology: Definition and Influencing Factors

Definition of Posology

Posology is the branch of pharmacology dedicated to studying drug doses—the amount required to achieve the desired therapeutic effect without inducing toxicity.

Factors Affecting Posology

  • Age: Children and the elderly often need lower doses due to immature or reduced organ function.
  • Body Weight & Body Surface Area: Dose calculation frequently relies on weight (mg/kg) or surface area, especially in pediatric patients.
  • Sex: Hormonal differences and body composition can affect drug response.
  • Route of Administration: Oral, intravenous, intramuscular, or topical routes influence dose based on absorption rates.
  • Time of Administration: Some drugs are most effective when taken at specific times (e.g., before meals).
  • Pathological Condition: Liver or kidney diseases necessitate dose adjustments.
  • Tolerance: Repeated use can decrease drug effect, requiring higher doses.
  • Idiosyncrasy & Allergy: Unusual or hypersensitive reactions may occur even at normal doses.
  • Drug Interactions: Other medications can potentiate or diminish a drug’s effect.
  • Genetic Factors: Genetic variations influence drug metabolism and response.

Classification of Dosage Forms with Examples

Dosage forms are categorized based on their physical state and intended route of administration.

1. Solid Dosage Forms

  • Tablets: Paracetamol tablet
  • Capsules: Amoxicillin capsule
  • Powders: ORS powder
  • Lozenges: Throat lozenges

2. Liquid Dosage Forms

  • Solutions: Cough syrup
  • Suspensions: Antacid suspension
  • Emulsions: Cod liver oil emulsion
  • Elixirs: Vitamin elixir

3. Semi-Solid Dosage Forms

  • Ointments: Antibiotic ointment
  • Creams: Antifungal cream
  • Gels: Diclofenac gel
  • Pastes: Zinc oxide paste

4. Gaseous / Aerosol Dosage Forms

  • Inhalations: Salbutamol inhaler
  • Aerosols: Nasal spray

5. Parenteral Dosage Forms

  • Injections: Insulin injection
  • Infusions: IV fluids (Normal saline)

6. Novel / Modified Dosage Forms

  • Sustained Release Tablets: SR Metformin
  • Transdermal Patches: Nicotine patch
  • Implants: Hormonal implants

Conclusion: Dosage forms are engineered to ensure accurate dosing, patient convenience, and maximum therapeutic effect. Selection depends on the drug, patient condition, and route of administration.

The Indian Pharmacopoeia and Pharmaceutical Powders

Indian Pharmacopoeia (IP)

The Indian Pharmacopoeia is the official book of drug standards in India. It details the identity, purity, strength, quality, testing procedures, and storage requirements for drugs and pharmaceutical preparations.

Objectives of Indian Pharmacopoeia

  • To guarantee the quality and safety of drugs.
  • To maintain uniform standards for medicines across India.
  • To safeguard public health.

The Indian Pharmacopoeia Commission (IPC) is responsible for publishing and regularly updating the IP. It contains monographs of drugs, chemical tests, assays, general notices, appendices, and storage/labeling guidelines.

Pharmaceutical Powders

Powders are solid dosage forms comprising finely divided drugs, potentially with excipients.

1. Simple Powder

  • Contains only one drug.
  • Prepared via size reduction and mixing.
  • Examples: Aspirin powder, Paracetamol powder.
  • Used internally or externally.

2. Compound Powder

  • Contains two or more drugs mixed in specific proportions.
  • Example: Compound chalk powder, Compound sodium bicarbonate powder.
  • Used to achieve combined therapeutic effects.

3. Efflorescent Powder

  • Contains water of crystallization.
  • Loses this water upon exposure to air, becoming dry.
  • Example: Ferrous sulfate, Sodium carbonate.
  • Must be stored in airtight containers.

4. Hygroscopic Powder

  • Absorbs moisture from the atmosphere, becoming damp or sticky.
  • Example: Zinc chloride, Potassium hydroxide.
  • Requires airtight and moisture-proof containers.

5. Dusting Powder

  • Finely divided powder intended for external use on the skin.
  • Must be free-flowing and non-irritant.
  • Example: Talc, Zinc oxide dusting powder.
  • Used to protect skin and absorb moisture.

6. Diuretic Mixture

A liquid preparation designed to increase urine output, used for conditions like edema and hypertension. Example ingredients include Potassium citrate and Ammonium chloride. Administered orally.

7. Effervescent Powder

  • Contains an acid (citric/tartaric acid) and sodium bicarbonate.
  • Produces carbon dioxide gas when dissolved in water.
  • This effervescence makes the medicine more palatable.
  • Example: Eno-type antacid powders.
  • Stored in dry, airtight containers.

Solubility Enhancement Techniques

Solubility enhancement techniques are methods used to increase the solubility of poorly soluble drugs in a solvent (usually water) to improve their absorption, bioavailability, and therapeutic efficacy. These techniques help drugs that dissolve poorly to dissolve faster or more completely.

Examples (Names Only):

  • Particle size reduction
  • Salt formation
  • Use of co-solvents
  • Solid dispersion
  • Complexation

Excipients in Liquid Dosage Forms

Excipients are inactive substances added to liquid dosage forms to enhance stability, palatability, appearance, and formulation effectiveness. They support the drug without providing therapeutic action.

  1. Solvents / Vehicles: Dissolve or disperse the drug. (e.g., Purified water, Alcohol, Glycerin, Propylene glycol)
  2. Sweetening Agents: Improve taste. (e.g., Sucrose, Sorbitol, Saccharin sodium, Aspartame)
  3. Preservatives: Prevent microbial growth. (e.g., Methyl paraben, Sodium benzoate, Benzalkonium chloride)
  4. Flavouring Agents: Mask unpleasant taste. (e.g., Peppermint oil, Orange flavour, Vanilla)
  5. Colouring Agents: Improve appearance and identification. (e.g., Amaranth, Tartrazine, Caramel)
  6. Viscosity Enhancers / Suspending Agents: Maintain uniform drug distribution. (e.g., CMC, Tragacanth, Xanthan gum)
  7. Buffers: Maintain optimal pH for stability and solubility. (e.g., Citrate buffer, Phosphate buffer)
  8. Antioxidants: Prevent drug oxidation. (e.g., Ascorbic acid, BHT)

Syrups, Elixirs, and Preparation Methods

Syrups

Syrups are concentrated, viscous, aqueous oral liquid preparations containing a high concentration of sugar (usually sucrose), optionally with medicinal substances.

Types of Syrups

  • Simple Syrup: Contains only sucrose and purified water.
  • Medicated Syrup: Contains one or more drugs.
  • Flavoured Syrup: Used as a vehicle or sweetening agent.

Advantages and Disadvantages

  • Advantages: Pleasant taste, good patient compliance, sugar acts as a preservative.
  • Disadvantages: Not suitable for diabetic patients; sugar may crystallize if prepared improperly.

Methods of Preparation of Syrups

  1. Solution with Heat: Sucrose is dissolved by heating; used for heat-stable ingredients.
  2. Solution without Heat (Agitation): Sucrose is dissolved by continuous stirring; used for heat-sensitive ingredients.
  3. Addition of Medicated Liquid to Syrup: Drug is dissolved separately and added to simple syrup.
  4. Percolation Method: Drug is extracted with water and then mixed with sugar; used for herbal products.

Elixirs

Definition: Elixirs are clear, sweetened, flavored hydroalcoholic oral liquid preparations containing one or more medicinal substances.

Characteristics

  • Less viscous than syrups.
  • Contain alcohol, which acts as a solvent.
  • Suitable for drugs that are insoluble in water alone.
  • Advantages include good solubility for many drugs and clarity.
  • Disadvantages include alcohol content limiting use in children and alcohol-sensitive patients.

Methods of Preparation of Elixirs

  1. Simple Solution Method: Drug is dissolved in alcohol; other ingredients are dissolved in water. The alcoholic solution is slowly added to the aqueous solution with stirring.
  2. By Admixture: Alcoholic and aqueous solutions are prepared separately and mixed carefully to prevent precipitation. Flavors and colors are added last.

Evaluation and Excipients in Semi-Solid Dosage Forms

Semi-solid dosage forms (ointments, creams, gels, pastes) are primarily for topical application. Evaluation ensures quality, stability, safety, and effectiveness, while excipients provide consistency and acceptability.

Evaluation Tests for Semi-Solid Dosage Forms

  • Physical Appearance and Homogeneity: Check for color, odor, smoothness; must be free from grittiness or lumps.
  • pH Determination: Measured for skin compatibility and drug stability (ideally close to skin pH 5.5–7).
  • Viscosity / Rheological Studies: Determines flow properties, affecting spreadability and drug release.
  • Spreadability Test: Indicates ease of application on the skin for uniform dosing.
  • Drug Content Uniformity: Ensures uniform drug distribution throughout the base.
  • Extrudability Test: Measures the force needed to push the product out of a tube, ensuring ease of patient use.
  • In-Vitro Drug Release Test: Determines the rate and extent of drug release using diffusion methods.
  • Stability Studies: Monitors changes in appearance, pH, viscosity, and drug content during storage.

Excipients Used in Semi-Solid Dosage Forms

  • Bases: Provide the main structure. (e.g., Hydrocarbon bases like petrolatum; Absorption bases like lanolin; Water-soluble bases like PEG).
  • Emulsifying Agents: Stabilize emulsions in creams. (e.g., Beeswax, Cetostearyl alcohol).
  • Preservatives: Prevent microbial growth in water-containing preparations. (e.g., Methyl paraben, Benzyl alcohol).
  • Humectants: Retain moisture and prevent drying. (e.g., Glycerin, Propylene glycol).
  • Antioxidants: Prevent oxidation of drugs and bases. (e.g., BHT, Ascorbic acid).
  • Gelling Agents: Provide structure and viscosity in gels. (e.g., Carbopol, Xanthan gum).
  • Perfumes and Colors: Improve aesthetic appeal.

Mechanism and Factors Affecting Chemical Penetration of Drugs

Chemical (drug) penetration is the movement of a drug from the application site (skin/mucous membrane) into deeper tissues or systemic circulation, crucial for topical and transdermal delivery.

Mechanism of Drug Penetration

Penetration through the skin primarily occurs via passive diffusion along a concentration gradient. The stratum corneum is the main barrier.

Routes of Penetration

  • Transcellular Route: Drug passes directly through the cells of the stratum corneum.
  • Intercellular Route: Drug passes between the cells through the lipid matrix; the most common route for lipophilic drugs.
  • Appendageal Route: Drug penetrates via hair follicles, sweat glands, and sebaceous glands (important for ions/large molecules).

Factors Affecting Chemical Penetration of Drugs

1. Drug-Related Factors

  • Molecular Size: Smaller molecules penetrate more easily.
  • Partition Coefficient (Lipophilicity): Balanced lipophilic/hydrophilic nature favors penetration.
  • Drug Concentration: Higher concentration increases the penetration rate.
  • Ionization: The unionized form of the drug penetrates the skin better.

2. Formulation-Related Factors

  • Dosage Form: Ointments generally enhance penetration more than creams or gels.
  • Penetration Enhancers: Chemicals like alcohol or DMSO increase skin permeability.
  • pH of Formulation: Affects drug ionization and subsequent penetration.
  • Vehicle Used: Influences drug release kinetics.

3. Skin-Related Factors

  • Condition of Skin: Diseased, damaged, or inflamed skin allows greater penetration.
  • Hydration of Skin: Hydrated skin increases drug penetration.
  • Thickness of Skin: Penetration varies by site (thinner skin penetrates better).
  • Age: Infants and the elderly show higher penetration due to thinner skin layers.

4. Environmental Factors

  • Temperature: Increased temperature enhances blood flow and penetration.
  • Occlusion: Occlusive dressings increase skin hydration and drug absorption.

Preparation of Creams, Ointments, Gels, and Pastes

Semi-solid dosage forms are prepared using simple mixing, fusion, or emulsification, depending on the base and ingredients.

1. Preparation of Ointments

Methods:

  • Incorporation Method: Powder the drug, mix with a small amount of base (or levigating agent), and gradually incorporate into the remaining base using spatulation. Used for heat-sensitive drugs.
  • Fusion Method: Melt base ingredients in order of increasing melting point. Cool slightly, add the drug with stirring, pour into the container, and allow to set. Used when bases contain waxes/fats.

2. Preparation of Creams

Creams are emulsions (Oil-in-Water or Water-in-Oil).

Method (Emulsification):

  1. Prepare the oil phase (oils, waxes, oil-soluble drugs) and the aqueous phase (water, water-soluble drugs, preservatives) separately.
  2. Heat both phases to the same temperature (approx. 70°C).
  3. Add the aqueous phase to the oil phase (for W/O) or oil phase to the aqueous phase (for O/W) while stirring.
  4. Cool with continuous stirring; add perfume/color last.

3. Preparation of Gels

Method:

  1. Disperse the gelling agent (e.g., Carbopol) in purified water with stirring.
  2. Allow proper hydration and swelling.
  3. Dissolve the drug separately and add it to the gel base.
  4. Adjust pH if necessary to achieve a clear gel.
  5. Mix gently to prevent air entrapment.

4. Preparation of Pastes

Pastes contain a high percentage of solid material.

Method (Incorporation):

  1. Finely powder the solid ingredients.
  2. Levigate the powder with a suitable levigating agent.
  3. Gradually incorporate the mixture into the base using spatulation.
  4. Ensure uniform distribution and a smooth consistency.