Saturday, November 29, 2025

schedule c and C1

SCHEDULE C – BIOLOGICAL & SPECIAL PRODUCTS

Mnemonic → “C = Cold-chain / Critical Biologicals”

Schedule C contains biological, sterile, injectable, and heat-sensitive drugs that require:

  • Aseptic manufacturing
  • Special storage conditions
  • Strict quality control

LIST OF DRUGS IN SCHEDULE C

(Exam asks: “Which of the following belong to Schedule C?”)

1. Sera

  • Antisera
  • Antitoxins

2. Vaccines

  • Bacterial vaccines
  • Viral vaccines
  • Toxoids

3. Injectable preparations

  • Insulin
  • Heparin
  • Injectable antibiotics
  • Parenteral solutions (IV fluids)

4. Blood & Blood Products

  • Whole blood
  • Packed cells
  • Plasma
  • Plasma expanders
  • Factor VIII/IX

5. Ophthalmic preparations

  • Eye drops
  • Eye ointments (sterile)

6. Surgical ligatures & sutures

  • Catgut sutures
  • Absorbable sutures
  • Non-absorbable sutures

7. BCG Vaccine & Tuberculin

8. Ergometrine & Oxytocin injections

9. Penicillin & other Antibiotic injectables

All products in Schedule C require sterile conditions.

🧠 Mnemonic to remember Schedule C items → “SVIBOS PLET”

S V I B O S – P L E T

  • Sera
  • Vaccines
  • Injectables
  • Blood products
  • Ophthalmics
  • Sutures
  • Penicillin
  • Ligatures
  • Ergometrine/Oxytocin
  • Tuberculin/BCG

Regulatory Requirements for Schedule C drugs

🔹 1. Manufacturing license – Form 27

🔹 2. License issued – Form 28

🔹 3. Must follow GMP rules (Schedule M)

🔹 4. Must maintain cold chain where required

🔹 5. Batch sterilization, pyrogen-free, endotoxin-free

🔹 6. Strict testing by Central Drugs Laboratory

SCHEDULE C1 – ADDITIONAL BIOLOGICAL PRODUCTS

Mnemonic → “C1 = C + One more special group”

Schedule C1 includes biological products BUT
👉 They are NOT required to be sterile (unlike Schedule C).

LIST OF DRUGS IN SCHEDULE C1

Category

Examples

1. Biological antigens

Bacterial/viral antigens, toxoids

2. Diagnostic agents

Diagnostic reagents (e.g., pregnancy kits, viral antigens)

3. Toxins

Diphtheria toxin, tetanus toxin

4. Antigens used for diagnosis

e.g., Widal antigen

5. Immunological products (Non-injectable)

Extracts & allergens (e.g., pollen extracts)

🔥 Easiest Way to Remember C1

Schedule C1 = Non-sterile biologicals (diagnostic/reagents)

Mnemonic → “C1 = Cards, Kits, Toxins, Antigens”

Examples:

  • Widal antigen
  • Typhoid O & H antigen
  • Rapid test kits
  • Diagnostic reagents
  • Toxoids (non-injectable)

Major Differences (MOST IMPORTANT for DI Exam)

Feature

Schedule C

Schedule C1

Sterility

Must be sterile

Not required to be sterile

Products

Vaccines, Sera, Injectables, Sutures, Blood

Reagents, Antigens, Toxins

Examples

Vaccines, insulin, IV fluids

Widal antigen, diagnostic kits

Licence

Form 27 → 28

Form 27 → 28A / 28D

Storage

Mostly cold-chain

Not always

Who tests

Central Drug Laboratory

Govt approved labs

🔥 Exam Q:
“Which schedule contains Widal antigen?” → Schedule C1

🔥 Exam Q:
“Vaccines belong to which schedule?” → Schedule C

🧠 SUPER SHORT MEMORY TRICK

Schedule C = Critical sterile biologicals

Schedule C1 = Clinical kits & antigens (non-sterile)

 

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