🔥 DRUG INSPECTOR

✅ 1. SCHEDULES – MASTER MNEMONICS

**“A B C – Forms, Standards, Biologics

D E F – Import, Poisons, Biological rules
G H X – Prescription & Narcotics
M – Manufacturing
N P Y – Pharmacy, Expiry, Clinical Trials
Q S T – Colours, Cosmetics, Ayurveda
U V W Z – Records, Claims, Essential, PVG”**

Schedule	Content	Mnemonic
A	Forms	A = Application forms
B	Test standards	B = Bench standards
C	Biologicals	C = Cold-chain drugs
C1	Additional biologicals	C+More
D	Import rules	D = Door entry rules
E1	Poisons	E = Emergency poisons
F	Biological specs	F = Formulations
G	Hormones	G = Go with caution
H	Rx drugs	H = Hospital-only
H1	Antibiotics	H1 = Highly controlled
X	Narcotics	X = Extra security
M	GMP	M = Manufacturing
N	Pharmacy requirements	N = Needs
P	Shelf-life	P = Period of validity
Y	Clinical trials	Y = Yes for trials
Q	Colours	Q = Quality colours
S	Cosmetic standards	S = Standard cosmetics
T	Ayurveda GMP	T = Traditional
U	Records	U = Used records
V	Product claims	V = Valid claims
W	Essential drugs	W = Within essentials
Z	Pharmacovigilance	Z = Zero ADRs

✅ 2. MISBRANDED vs ADULTERATED vs SPURIOUS

ONE-LINE SUPER MNEMONIC →

**“Misbranded = Fake LABEL

Adulterated = Fake QUALITY
Spurious = Fake IDENTITY”**

Mnemonic Chart:

Type	Mnemonic	Meaning
MISBRANDED	“MIS = Misleading Label”	Fake label, wrong colour, deceptive look
ADULTERATED	“A = Added Dirt/Atrocious Quality”	Contaminated, filthy, unsanitary
SPURIOUS	“S = Stolen Identity”	Fake brand, fake manufacturer

✅ 3. CENTRAL DRUG LAB / GMP / LICENSING

CDL Mnemonic: “4 T’s”

Testing of drugs
Testing of cosmetics
Trial samples (import)
Technical report to Govt

GMP (Schedule M) Mnemonic → “BIG BOSS”

Building
Inspection
Good hygiene
Batch records
Operation control
Sanitation
Storage

Manufacturing Licence Forms (Mnemonic: “28 = Permit, 25 = Permit to Sell”)

Form 25 → Licence to manufacture non-sterile
Form 28 → Licence to manufacture sterile

✅ 4. LABELS & PACKS – MNEMONICS

“G H X – Three Warning Labels”

G → “Caution: To be taken under medical supervision.”
H → “Rx only”
X → “Schedule X drug – Dangerous – Keep locked”

✅ 5. DEFINITIONS (Super Easy Tricks)

Drug → “4D Formula: Diagnose – Treat – Mitigate – Prevent”

Cosmetic → “Body Beauty Booster”

(rubbed, poured, sprinkled)

Manufacture → “PPLF”

Packing
Processing
Labelling
Finishing
(Does NOT include compounding by doctor)

✅ 6. PENALTIES – Mnemonic: “F-A-S-T”

F → Fake drug (Spurious)

→ Highest punishment (up to life imprisonment)

A → Adulterated

→ High penalty

S → Substandard / Not of standard quality

→ Moderate penalty

T → Technical offences (labelling etc.)

→ Minor penalty

✅ 7. SCHEDULE M (GMP) – Mini Mnemonic Chart

“RAW-MAN-PROD-QUAL”

RAW → Raw materials
MAN → Manpower
PROD → Production area
QUAL → Quality control area

⭐ SCHEDULE A — FORMS & FEES (DETAILED NOTES)

📌 What is Schedule A?

Schedule A provides all the official forms and fee details required under the Drugs & Cosmetics Rules, 1945 for:

Licensing
Registration
Application
Testing certificates
Appeals
Renewals

👉 Easy Way to Remember:

“A = Application Forms”

📘 CONTENTS OF SCHEDULE A

Schedule A contains 23+ standard forms used in the drug regulatory process. Important ones:

✅ 1. Forms related to Manufacturing Licenses

🔹 Form 24

→ Application for manufacturing non-sterile drugs (not under Schedule C, C1, X)

🔹 Form 25

→ Licence to manufacture non-sterile drugs

🔹 Form 27

→ Application to manufacture Schedule C & C1 drugs (biologicals)

🔹 Form 28

→ Licence to manufacture Schedule C & C1 (sterile) drugs
👉 Includes: vaccines, sera, injectables

🔹 Form 28D

→ Licence for manufacture of diagnostic kits

✅ 2. Forms for Schedule X (Psychotropic/Narcotics)

🔹 Form 24-X

→ Application for manufacture of Schedule X drugs

🔹 Form 25-X

→ Licence to manufacture Schedule X drugs

✅ 3. Forms for Loan Licences

🔹 Form 24-A

→ Application for loan licence

🔹 Form 25-A

→ Loan licence for non-sterile drugs

🔹 Form 28-A

→ Loan licence for Schedule C & C1 drugs

✅ 4. Forms for Retail / Wholesale Selling

🔹 Form 19

→ Application for retail/wholesale licence

🔹 Form 20

→ Retail licence for Schedule C, C1 exempted drugs

🔹 Form 21

→ Retail licence for Schedule C, C1 drugs

🔹 Form 20-B

→ Wholesale licence (non-Schedule X)

🔹 Form 21-B

→ Wholesale licence (Schedule C, C1)

🔹 Form 20-F / 21-F

→ Retail/Wholesale licences for Schedule X

✅ 5. Forms for Testing Laboratories

🔹 Form 36

→ Application for approval of a drug testing lab

🔹 Form 37

→ Certificate of approval of drug testing lab

✅ 6. Fee Structure

Fee is attached with the forms in Schedule A
Example:

₹2500 for new manufacturing licence
₹1000 per item of drug for testing
₹250 for licence renewal (varies)

(Exact numbers vary by amendments; exam focuses on forms, not fee amount.)

🧠 Mnemonic for Schedule A Major Forms

"20–21 SELL, 24–25 MAKE, 28 = INJECT"

20/21 → Sell
24/25 → Manufacture
28 → Schedule C & C1 (Injectables)

⭐ SCHEDULE B — STANDARDS FOR TESTS & ANALYSIS (DETAILED NOTES)

📌 What is Schedule B?

Schedule B lists the reference test standards and testing procedures that must be followed while conducting:

Quality control
Assay
Chemical / biological analysis

It specifies the Official Pharmacopoeias to be used in India.