Schedule H1 Drugs - Complete List and Compliance Guide (India)
Schedule H1 is a restricted prescription category under the Drugs and Cosmetics Rules, 1945. It covers broad-spectrum antibiotics, anti-tuberculosis drugs, opioids, benzodiazepines, antivirals, and (from 2026) Pregabalin. This page is a reference for pharmacists, manufacturers, and regulatory affairs teams.
The original schedule was introduced by G.S.R. 588(E), dated 30 August 2013, effective 1 March 2014. It currently contains 51 confirmed entries.
Quick Reference: H vs H1 Requirements
| Requirement | Schedule H | Schedule H1 |
|---|---|---|
| Prescription required | Yes | Yes |
| Label symbol | Rx | NRx (red) |
| Warning text on label | Standard Rx warning | "Warning: It is dangerous to take this preparation except under medical supervision." |
| Separate dispensing register | No | Yes - mandatory |
| Register retention period | - | 3 years minimum |
| OTC sale | Prohibited | Prohibited |
| DTC advertising | Prohibited | Prohibited |
Schedule H1 Drug List
Source: G.S.R. 588(E) dated 30 August 2013 and subsequent amendments. Verified as of October 2026. Always verify against the official gazette for the current authoritative list.
Carbapenems and Penems
| S.No. | Drug Name | Clinical Use |
|---|---|---|
| 24 | Doripenem (all formulations) | Carbapenem - hospital/ICU infections |
| 25 | Ertapenem (all formulations) | Carbapenem - community/complicated infections |
| 28 | Faropenem (all formulations) | Oral penem - respiratory/skin infections |
| 30 | Imipenem (all formulations) | Carbapenem - serious hospital/ICU infections |
| 33 | Meropenem (all formulations) | Carbapenem - serious hospital/ICU infections |
Cephalosporins (3rd and 4th Generation)
| S.No. | Drug Name | Generation |
|---|---|---|
| 5 | Cefdinir | 3rd |
| 6 | Cefditoren | 3rd |
| 7 | Cefepime | 4th |
| 8 | Cefetamet | 3rd |
| 9 | Cefixime | 3rd (oral) |
| 10 | Cefoperazone | 3rd (anti-Pseudomonal) |
| 11 | Cefotaxime | 3rd |
| 12 | Cefpirome | 4th |
| 13 | Cefpodoxime | 3rd (oral) |
| 14 | Ceftazidime | 3rd (anti-Pseudomonal) |
| 15 | Ceftibuten | 3rd (oral) |
| 16 | Ceftizoxime | 3rd |
| 17 | Ceftriaxone | 3rd (widely used) |
Fluoroquinolones
| S.No. | Drug Name |
|---|---|
| 2 | Balofloxacin |
| 29 | Gemifloxacin |
| 32 | Levofloxacin |
| 35 | Moxifloxacin |
| 38 | Prulifloxacin |
| 43 | Sparfloxacin |
Anti-Tuberculosis Drugs
| S.No. | Drug Name |
|---|---|
| 4 | Capreomycin |
| 19 | Clofazimine |
| 21 | Cycloserine |
| 26 | Ethambutol hydrochloride |
| 27 | Ethionamide |
| 31 | Isoniazid |
| 39 | Pyrazinamide |
| 40 | Rifabutin |
| 41 | Rifampicin |
| 42 | Sodium para-aminosalicylate |
| 44 | Thiacetazone |
Opioids and Controlled Analgesics
| S.No. | Drug Name |
|---|---|
| 3 | Buprenorphine |
| 20 | Codeine |
| 23 | Diphenoxylate |
| 37 | Pentazocine |
| 45 | Tramadol |
| 48 | Tapentadol |
Benzodiazepines and Sedatives
| S.No. | Drug Name |
|---|---|
| 1 | Alprazolam |
| 18 | Chlordiazepoxide |
| 22 | Diazepam |
| 34 | Midazolam |
| 36 | Nitrazepam |
| 46 | Zolpidem |
Antivirals (Influenza)
| S.No. | Drug Name |
|---|---|
| 49 | Oseltamivir |
| 50 | Zanamivir |
Hormonal
| S.No. | Drug Name |
|---|---|
| 47 | Oxytocin (all formulations) |
2026 Amendments
Pregabalin - Added (Transition Period Active)
Pregabalin was added to Schedule H1 by G.S.R. 377(E), dated 13 May 2026. The 180-day transition period makes full H1 compliance mandatory approximately November 2026.
Proposed Additions - Draft Only (Not Yet in Force)
Draft G.S.R. 745(E), dated 19 August 2026, proposes adding: Flupentixol, Zopiclone, Gabapentin, Carisoprodol. These are not yet notified. Standard Schedule H requirements apply until a final gazette is issued.
Pharmacist Compliance Checklist
- Verify the prescription is from a Registered Medical Practitioner (RMP). Check the NMC registration number - it is required for the H1 register entry.
- Enter in the separate H1 register (not the general prescription register): drug name and strength; quantity dispensed; prescription date; patient name and age; prescribing doctor's name and NMC registration number.
- Retain the register for 3 years minimum. Keep it available for Drug Inspector inspection.
- Never dispense without a prescription - OTC dispensing of any Schedule H1 drug is illegal.
- Check the label: Schedule H1 products should display "NRx" in red. If a product is listed in H1 but its label shows only "Rx", apply H1 dispensing protocol regardless - the label may be transitional or older stock.
- For FDCs containing an H1 API (e.g., a Cefixime + Clavulanate combination): apply Schedule H1 dispensing requirements to the whole product.
Frequently Asked Questions
Is Cefixime (a common oral antibiotic) really Schedule H1?
Yes. Cefixime has been in Schedule H1 since the original notification in 2014 (S.No. 9). Despite being commonly dispensed OTC in practice, it legally requires a prescription and a separate H1 register entry. Enforcement has been inconsistent, but the legal requirement is clear.
Does Schedule H1 apply to FDC products containing an H1 API?
Yes. If an FDC contains a Schedule H1 drug (e.g., a Ceftriaxone injection, Cefixime + Potassium Clavulanate tablet), the FDC product is subject to Schedule H1 dispensing requirements.
My pharmacy only stocks Levofloxacin eye drops. Does H1 apply?
Schedule H1 lists Levofloxacin under "all formulations" without exemptions. Consult your State Drug Controller for current guidance on topical/ophthalmic preparations if uncertain.
How do I verify whether a new drug has been added to Schedule H1?
Check the CDSCO gazette notifications page at cdsco.gov.in or the official gazette at egazette.nic.in. State Drug Controllers also circulate amendments via circular.
Are Gabapentin and Zopiclone currently Schedule H1?
No - not yet. They are in the draft G.S.R. 745(E) dated 19 August 2026, but this draft has not been finalised. They remain Schedule H drugs until a final notification is issued. Monitor CDSCO gazette notifications for updates.
Sources
- Ministry of Health and Family Welfare. G.S.R. 588(E) - Drugs and Cosmetics (Fourth Amendment) Rules, 2013 - Introduction of Schedule H1. 30 August 2013. Official Gazette of India. egazette.nic.in
- Ministry of Health and Family Welfare. G.S.R. 377(E) - Addition of Pregabalin to Schedule H1. 13 May 2026. Official Gazette of India.
- Ministry of Health and Family Welfare. Draft G.S.R. 745(E) - Proposed additions to Schedule H1. 19 August 2026. [Draft - not yet in force.]
- CDSCO. Gazette Notifications archive. cdsco.gov.in
This reference page reflects publicly available gazette notifications as of October 2026. Schedule H1 is amended periodically; entries may be added or removed. Always verify the current list against the official gazette before making compliance or regulatory decisions. This page is for informational purposes only and does not constitute legal advice.
