what are the different drugs to be maintained in schedule h1 register

what are the different drugs to be maintained in schedule h1 register in pharmacy

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Schedule H1 drugs list India pharmacy register maintenance complete list

Here is the complete, organized answer on Schedule H1 drugs and register maintenance requirements in India:

Schedule H1 Drugs - India (Drugs & Cosmetics Rules, 1945)

Schedule H1 was introduced via Gazette Notification GSR 588(E) dated 30 August 2013, effective 1 March 2014, under Rule 65(3)(h) of the Drugs and Cosmetics Rules, 1945.

Complete List of 50 Schedule H1 Drugs

Third & Fourth Generation Cephalosporins (Antibiotics)

#	Drug Name
1	Cefdinir
2	Cefditoren
3	Cefepime
4	Cefetamet
5	Cefixime
6	Cefoperazone
7	Cefotaxime
8	Cefpirome
9	Cefpodoxime
10	Ceftazidime
11	Ceftibuten
12	Ceftizoxime
13	Ceftriaxone

Carbapenem Class (Antibiotics)

#	Drug Name
14	Doripenem
15	Ertapenem
16	Faropenem
17	Imipenem
18	Meropenem

Fluoroquinolones (Antibiotics)

#	Drug Name
19	Balofloxacin
20	Gemifloxacin
21	Levofloxacin
22	Moxifloxacin
23	Prulifloxacin
24	Sparfloxacin

Anti-Tuberculosis Drugs

#	Drug Name
25	Capreomycin
26	Clofazimine
27	Cycloserine
28	Ethambutol Hydrochloride
29	Ethionamide
30	Isoniazid
31	Pyrazinamide
32	Rifabutin
33	Rifampicin
34	Sodium Para-aminosalicylate
35	Thiacetazone

Benzodiazepines / Psychotropics / Sedatives (Habit-Forming)

#	Drug Name
36	Alprazolam
37	Chlordiazepoxide
38	Diazepam
39	Midazolam
40	Nitrazepam
41	Zolpidem

Opioids / Habit-Forming Analgesics

#	Drug Name
42	Buprenorphine
43	Codeine
44	Diphenoxylate
45	Pentazocine
46	Tramadol
47	Tapentadol

Other / Later Additions

#	Drug Name
48	Oxytocin
49	Oseltamivir
50	Zanamivir

Note: Preparations containing the above substances (including their salts) are covered under this schedule, except those intended for topical/external use - UNLESS they are ophthalmic, ear, or nose preparations (those ARE included).

H1 Register - What Must Be Recorded

As per Rule 65(3)(h), every pharmacy must maintain a separate H1 register with the following details recorded at the time of each supply:

Column	Details Required
Date	Date of supply
Prescriber Name	Full name of the Registered Medical Practitioner (RMP)
Prescriber Address	Full address / registration number
Patient Name	Full name of the patient
Patient Address	Address of the patient
Drug Name	Name of the Schedule H1 drug dispensed
Quantity Supplied	Quantity dispensed
Prescription Copy	A copy of the prescription must be kept on file

Key Compliance Rules for Pharmacies

Prescription mandatory - Only dispensed against a valid prescription from a Registered Medical Practitioner; no OTC sale permitted.
Separate register - Must be a dedicated H1 register, not merged with other records.
3-year retention - Records must be preserved for 3 years and kept available for inspection by drug authorities.
Labeling - The drug label must carry:
- Symbol "Rx" in red on the top-left corner
- A red-bordered box stating: "Schedule H1 Drug Warning: It is dangerous to take this preparation except in accordance with medical advice. Not to be sold by retail without the prescription of a Registered Medical Practitioner."
No advertisement - Direct or indirect advertising of H1 drugs is prohibited.
Licence risk - Violation of H1 provisions can lead to spot suspension or cancellation of the retail drug licence.

Schedule H vs H1 - Quick Difference

Feature	Schedule H	Schedule H1
Register required	No	Yes (mandatory separate register)
Prescription copy retention	No	Yes (3 years)
Red-box warning label	No	Yes
Drugs covered	General Rx drugs	3rd/4th gen antibiotics, anti-TB, habit-forming drugs
Advertising	Restricted	Prohibited

The Schedule H1 framework is India's primary tool to combat antimicrobial resistance and curb misuse of high-risk prescription drugs at the retail pharmacy level.

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