Schedule H1 Drugs List 2026: All 51 Entries, Pregabalin Update, Register and Label Rules (H vs H1 vs X)

By the Trumac Healthcare team, Panchkula · PCD pharma franchise company since 2007 · Updated 14 November 2026 · About us · WhatsApp +91 90416 77932

Schedule H1 is the list of prescription drugs under the Drugs Rules, 1945 that chemists may sell only against a doctor’s prescription and must record in a separate register – mainly third- and fourth-generation antibiotics, anti-TB drugs and habit-forming drugs. It was created in 2013 with 46 drugs and now has 50 entries in force, with pregabalin becoming the 51st on 16 November 2026.

What is a Schedule H1 drug?

A Schedule H1 drug is a prescription medicine listed in Schedule H1 of the Drugs Rules, 1945. A chemist may sell it only against a registered medical practitioner’s prescription, must record each sale in a separate H1 register, and the pack must carry a red Rx and a boxed warning. Like Schedule H drugs, all Schedule H1 drugs are prescription-only; H1 adds the register and the stricter label.

हिंदी में: शेड्यूल H1 दवाएँ केवल डॉक्टर के पर्चे पर बेची जा सकती हैं, और केमिस्ट को हर बिक्री अलग H1 रजिस्टर में डॉक्टर, मरीज़, दवा और मात्रा के साथ दर्ज करनी होती है, जिसे तीन साल तक रखना होता है।

Schedule H1 drugs list (all 51 entries)

Entries 1–46 are the original list notified on 30 August 2013 (in force from 1 March 2014); entries 47–51 were added later. Spellings follow the Schedule – it prints Feropenem for faropenem.

Proposed additions (draft only – not in force)

On 19 August 2026 the Health Ministry published draft rules (G.S.R. 745(E)) to add four central-nervous-system drugs to Schedule H1 after a Drugs Consultative Committee review of misuse. The draft allowed 30 days for objections; the change would apply 180 days after the final rules are published. Until then these remain Schedule H drugs.

Rules for selling Schedule H1 drugs

• Prescription: sell by retail only against the prescription of a Registered Medical Practitioner.
• Separate register: at the time of supply, record the prescriber’s name and address, the patient’s name, the drug and the quantity. Keep the register for three years, open to inspection.
• Label: the symbol Rx in red at the top left, and a red-bordered Schedule H1 warning box stating that it is dangerous to take the preparation except in accordance with medical advice, and that it is not to be sold by retail without the prescription of a Registered Medical Practitioner.
• Penalties: sale without prescription or without the register is an offence under the Drugs and Cosmetics Act, 1940, and the licensing authority can also suspend or cancel the sale licence.
• Overlap with NDPS: tramadol is also a psychotropic substance under the NDPS Act (notified April 2018), so its NDPS obligations apply on top of the H1 register.

Schedule H1 drug warning (label text)

The 2013 rules require the symbol Rx in red on the top left of the label and these words in a box with a red border:

Check the exact layout against Rule 97 of the current Drugs Rules before approving artwork; the Health Ministry’s May 2026 pregabalin release summarises the same caution.

Schedule H1 register format

The register is kept at the time of supply and preserved for three years. A simple format that captures what the rule asks for:

Bill number and batch number are not named in the rule but make inspections and recalls easier; the mandatory items are prescriber name and address, patient name, drug name and quantity.

Difference between Schedule H, H1 and X drugs

More: Schedule H drugs (meaning, label, examples) · Schedule X drugs list (16 drugs).

What Schedule H1 means for PCD partners and distributors

• Anti-infective ranges are H1-heavy: cefixime, cefpodoxime, cefdinir, faropenem, levofloxacin and moxifloxacin tablets and dry syrups, and ceftriaxone, cefoperazone, cefepime, ceftazidime and meropenem injections are all H1. Chemists you supply keep an H1 register for them, so doctor prescriptions – not counter sales – drive these lines.
• Pregabalin combinations (with methylcobalamin, nortriptyline or duloxetine) are among the largest neuro and pain molecules. From 16 November 2026 they follow the same register and label rules, so prescription-led promotion matters even more.
• Before you print or re-order, check that packs carry the label required for the date of manufacture, and keep batch-wise purchase and sale records as your wholesale licence requires.
• From 1 July 2028 every antimicrobial pack must also carry a QR code for authentication under Schedule H2 (G.S.R. 506(E), June 2026) – see Schedule H and H2.
• For licence basics see the medical store licence guide (retail Forms 20/21) and the wholesale drug licence guide (Forms 20B/21B).

Trumac brands containing Schedule H1 molecules

Oral and injectable packs in our range that contain a Schedule H1 molecule (eye/ear drops and topical products are not listed). Full ranges: antibiotic PCD franchise, injectables, neuro-psychiatry.

Sources: PIB, 22 May 2026 (pregabalin, G.S.R. 377(E)); CDSCO Gazette notifications; Drugs and Cosmetics (Fourth Amendment) Rules 2013, G.S.R. 588(E); G.S.R. 258(E) 2021 (tapentadol); G.S.R. 95(E) 2024 (oseltamivir, zanamivir); draft G.S.R. 745(E) 2026. Updated 14 November 2026. This page is a business summary for chemists and distributors, not legal advice – check the current Drugs Rules, 1945 or your State Drugs Control office before acting.

Related guides: H1 register format (free Excel) · Schedule G drugs list · Schedule H drugs · Schedule X list · Revised Schedule M (GMP) · drug licence guide

Frequently asked questions

Looking for an antibiotic, injectable or neuro range for your area? WhatsApp +91 90416 77932 with your district; we send the price list (3000+ products) and confirm monopoly availability. Related: PCD pharma franchise · GST on medicines · DPCO guide · PCD for chemists.