Schedule G and H and H1

 

📘 SCHEDULE G – DETAILED NOTES

Definition

Schedule G lists “Drugs to be used only under medical supervision”.
They may produce serious side effects and require continuous monitoring.

Key Legal Requirement (Rule 97)

Each container must carry the caution:

“Caution: It is dangerous to take this preparation except under medical supervision.”

Purpose

● To prevent self-medication
● To ensure safe use under supervision of a Registered Medical Practitioner (RMP)
● Mostly includes:
— Hormones
— Psychotropic agents
— Cytotoxic/anti-cancer drugs
— Some fertility drugs
— High-risk chronic drugs

📌 Examples of Schedule G Drugs (N.K. Jain + standard lists)

Hormones

• Thyroxine, Carbimazole
• Testosterone, Estrogens
• Corticosteroids (Prednisolone, Dexamethasone)

Psychotropic / CNS Drugs

• Phenobarbitone
• Chlorpromazine
• Haloperidol
• Lithium carbonate
• Alprazolam / Diazepam (also in H)

Anticancer Drugs

• Cyclophosphamide
• Methotrexate
• 5-FU
• Vincristine, Vinblastine

Fertility / Gynecological Drugs

• Clomiphene
• HMG / hCG injections
• Mifepristone

Others

• Sulphonylureas (Glibenclamide)
• Anti-thyroid (Propylthiouracil)

🎯 MNEMONIC FOR SCHEDULE G DRUGS

**“G FOR GUIDED drugs” → GUIDE ME HOTLY”

G U I D E – M E – H O T L Y

Letter	Represents
G	Gonadal hormones – Estrogen, Testosterone
U	Uterine drugs – Clomiphene, HMG, hCG
I	Insane (psychotropic) drugs – Lithium, Antipsychotics
D	Diabetic drugs – Sulfonylureas
E	Endocrine drugs – Thyroxine, PTU
M	Malignancy drugs – Methotrexate, Cyclophosphamide
E	Emergency steroids – Prednisolone, Dexamethasone
H	High-risk sedatives – Barbiturates
O	Oncology drugs – Vinca alkaloids
T	Thyroid drugs – Thyroxine
L	Lithium
Y	Y-axis hormones (pituitary) – Growth hormone, ACTH

📘 SCHEDULE H – DETAILED NOTES

Definition

Schedule H contains “Prescription drugs” –
Drugs that cannot be sold without the prescription of a Registered Medical Practitioner (RMP).

Legal Requirements (Rule 65)

1. Label must bear:
   “Rx” symbol (red).
2. Label must bear:
   “Schedule H drug – Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.”
3. Record-keeping mandatory (for some drugs).
4. No advertisement allowed for Schedule H drugs.

Purpose

● To control misuse / resistance
● To ensure proper diagnosis
● Prevent OTC sale of dangerous drugs

📌 Categories of Schedule H Drugs

(Standard list – N.K. Jain + Drug & Cosmetic Rules updated lists)

1. Anti-infectives

• Penicillins
• Cephalosporins
• Fluoroquinolones
• Macrolides
• Antitubercular drugs
• Antivirals (Acyclovir)

2. Cardiovascular Drugs

• Beta-blockers
• ACE inhibitors
• Nitrates
• Calcium channel blockers

3. CNS Drugs

• Antidepressants
• Antipsychotics
• Anti-epileptics
• Benzodiazepines
• Morphine & opioids

4. Endocrine Drugs

• Insulins
• Oral antidiabetics
• Thyroid drugs
• Corticosteroids

5. Anti-cancer Drugs

(Shared with G/H)

6. Others

• Anti-histamines (2nd generation)
• Anti-ulcer H2 blockers
• Anti-emetics
• Immunosuppressants – Cyclosporine
• Vaccines

🎯 MNEMONIC FOR SCHEDULE H DRUGS

“H = Highly Controlled Prescription Drugs” → “H-CONTROL MAPS”

Letter	Represents
H	Hormones (Insulin, Steroids)
C	Cardiac drugs (Beta blockers, ACEIs)
O	Opioids (Morphine, Codeine)
N	Neuro drugs (Antipsychotics, Antidepressants, AEDs)
T	TB drugs (INH, Rifampicin)
R	Respiratory (Theophylline, Montelukast)
O	Oral antidiabetics
L	Life-saving antibiotics
M	Macrolides / Metronidazole
A	Antivirals / Anticancer
P	Proton-pump inhibitors / H2 Blockers
S	Sedatives / Benzodiazepines

📘 Difference Between Schedule G and H (Exam Favourite)

Feature	Schedule G	Schedule H
Meaning	Drugs to be used ONLY under medical supervision	Prescription-only drugs requiring an RMP prescription
Label	“Caution: Dangerous to take except under medical supervision”	“Rx” + “To be sold on prescription only”
Sale restriction	No prescription needed legally, but supervision required	Must have a prescription
Examples	Hormones, Psychotropics, Anticancer	Antibiotics, CV drugs, Insulin, Antidepressants
Control level	Moderate	High (Rx only)

⭐ SUPER MNEMONIC TO REMEMBER DIFFERENCE

“G = Guidance drugs, H = Handwritten Rx drugs”

• G → needs Guidance but NOT a prescription
• H → needs a Handwritten prescription

📘 SCHEDULE H1 – DETAILED NOTES

(Inserted under Drugs & Cosmetics Rules, 2013)

✅ Purpose

Schedule H1 contains drugs that carry a high risk of antimicrobial resistance (AMR) or dependence, therefore require strict control.
These drugs are:

• Potent antibiotics
• Anti-tubercular drugs
• Some habit-forming / dependence-prone medicines (not in NDPS)

Schedule H1 was created to prevent:
● Misuse
● Over-the-counter purchase
● Resistance (especially TB, MRSA, ESBL)
● Irrational prescribing

📌 LEGAL REQUIREMENTS OF SCHEDULE H1 (VERY IMPORTANT)

1. Prescription requirement

Cannot be sold without a valid prescription of a Registered Medical Practitioner.

2. Record keeping – 3 years

Pharmacist must maintain a separate register:

• Patient name
• Prescriber name
• Drug name, quantity
• Date of supply
  Record retained for 3 years.

3. Label requirement (Rule 96)

Red-colored box with this warning printed:

“Schedule H1 Drug — Warning: It is dangerous to take this preparation except in accordance with the medical advice.
Not to be sold by retail without the prescription of a Registered Medical Practitioner.”

Label must also show:
✔ Red box
✔ Rx symbol
✔ Drug schedule name in black font inside red border

4. No advertisement allowed

📘 LIST OF DRUGS IN SCHEDULE H1

A. 3rd & 4th Generation Cephalosporins

• Cefixime
• Cefpodoxime
• Ceftriaxone
• Cefepime

B. Fluoroquinolones

• Levofloxacin
• Moxifloxacin
• Ciprofloxacin

C. Carbapenems

• Meropenem
• Imipenem
• Faropenem

D. Anti-Tubercular Drugs (All First-Line)

• Isoniazid
• Rifampicin
• Pyrazinamide
• Ethambutol
• Streptomycin

E. Other High-risk Antibiotics

• Colistin
• Amikacin
• Linezolid
• Piperacillin–Tazobactam
• Vancomycin

F. Anti-anxiety / Psychiatric drugs (Few)

(Not all benzos; mostly habit forming)

• Alprazolam
• Zolpidem

🎯 MNEMONICS FOR SCHEDULE H1

⭐ MASTER MNEMONIC:

“H1 = HIGH-1 RISK ANTI-TB AND ANTIBIOTICS” → “TUBERCULOSIS & SUPERBUGS LIST”

🧠 MNEMONIC 1: For entire Schedule H1 list

“H1 = ‘C-F-C-A-T-V-Z’ → ‘SUPERBUGS CF CAT VZ’”

Breakdown:

Code	Drugs
C	Cephalosporins (Cefixime, Ceftriaxone, Cefpodoxime)
F	Fluoroquinolones (Levo, Moxi, Cipro)
C	Carbapenems (Imipenem, Meropenem)
A	Aminoglycosides (Amikacin, Streptomycin)
T	TB Drugs (HRZE + S)
V	Vancomycin
Z	Z-drugs (Zolpidem, Alprazolam—habit forming)**

This helps recall entire groups in one shot.

🧠 MNEMONIC 2: For Anti-TB Drugs (“HRZE-S”)

“H1 Loves TB — HRZE + S”

• H = Isoniazid
• R = Rifampicin
• Z = Pyrazinamide
• E = Ethambutol
• S = Streptomycin

🧠 MNEMONIC 3: For resistant antibiotics in H1

“SUPER V-CALM” = extremely powerful & restricted

Letter	Drugs
S	Streptomycin
U	(—)
P	Piperacillin–Tazobactam
E	Ethambutol
R	Rifampicin
V	Vancomycin
C	Carbapenems
A	Amikacin
L	Linezolid
M	Meropenem / Moxifloxacin

🧠 MNEMONIC 4: For Cephalosporins

“FIX, POD, TRI, PIME”

• Cefixime
• Cefpodoxime
• Ceftriaxone
• Cefepime

🧠 MNEMONIC 5: For Fluoroquinolones

“CIP-LE-MO”

• CIProfloxacin
• LEvofloxacin
• MOxifloxacin

Exam-Focused Table (VERY IMPORTANT FOR CDI)

Feature	Schedule H	Schedule H1
Type	Prescription drugs	Highly restricted antibiotics & anti-TB drugs
Label	Rx	Red box + Rx
Warning	“Sold by retail on prescription only”	“Dangerous without medical advice” + no OTC
Record keeping	Not mandatory	Mandatory 3 years
Main focus	All Rx drugs	AMR control & TB control
Examples	Insulin, antihypertensives	Cephalosporins, FQs, Carbapenems, HRZE

⭐ SUPER-REVISION MNEMONIC FOR EXAM

“H1 = H (High-risk) + 1 (1st line TB) + strongest antibiotics”

So recall:

✔ High-risk antibiotics (C-F-C-V-A-L)
✔ 1st-line TB (H-R-Z-E-S)
✔ Few habit-forming Z-drugs

📚 References Used (Standard Books)

• N.K. Jain – Textbook of Forensic Pharmacy
• N.K. Jain – Pharmaceutical Regulatory Affairs
• Drugs & Cosmetics Rules (GSR 588(E), 2013)
• Rajesh K. Gupta – Drug Inspector Manual
• Remington Pharmacy Practice (Schedules appendix)