Schedule H, H1 and X Drugs 2026: Register Format and Rules

Schedule H, H1 and X are lists in the Drugs Rules, 1945 (formerly the Drugs and Cosmetics Rules) of medicines that may be sold only on a registered medical practitioner's prescription, with the controls getting stricter from H to H1 to X. A Schedule H drug needs a prescription and the "Rx" warning label. A Schedule H1 drug also needs an entry in a separate H1 register — prescriber's name and address, patient's name, drug and quantity — kept for three years and open to inspection. A Schedule X drug needs a separate licence, a prescription in duplicate with one copy kept for two years, storage under lock and key, and its own bound register. Schedule H1 has grown from 46 drugs in 2014 to 50 today, with pregabalin added from about 16 November 2026 and high-alcohol oral liquids from about 9 January 2027.

This guide is for hospital pharmacists, pharmacy in-charges and hospital administrators. It sets out exactly what Rule 65 requires, the current H1 list, the 2026 changes and drafts, how the rules apply to inpatient issues, and how to keep the register without a second set of paperwork. Rule numbers and notifications were checked on 5 November 2026.

Key takeaways

• H1 register = four facts, three years. Rule 65(3)(1)(h) requires every Schedule H1 supply to be recorded "in a separate register at the time of the supply", with prescriber's name and address, patient's name, drug name and quantity, kept for three years. Ordinary sale records are kept for two years.
• Pregabalin becomes Schedule H1 under G.S.R. 377(E) of 13 May 2026, in force 180 days after Gazette publication on 20 May 2026 — about 16 November 2026.
• Oral liquids with more than 12% alcohol in packs above 30 ml join Schedule H1 under G.S.R. 607(E) of 8 July 2026, in force six months after publication — about 9 January 2027.
• More is proposed: flupentixol, zopiclone, gabapentin and carisoprodol for H1 (draft of 19 August 2026), and CCTV over every prescription sale with three months of recordings (draft of 8 September 2026).
• Private hospital pharmacies are not exempt. Only hospitals run or supported by government or a local body are exempt from the sale licence. A private hospital pharmacy holding Form 20 and 21 licences keeps the same registers as any chemist.

Schedule H vs H1 vs X at a glance

The Schedule H1 drug list (November 2026)

Schedule H1 was created by G.S.R. 588(E) of 30 August 2013 and came into force on 1 March 2014 with 46 drugs. Preparations containing these drugs and their salts are covered too, except those for topical or external use (ophthalmic, ear and nose preparations remain covered).

The original 46 drugs (in force since 1 March 2014)

• Cephalosporins: cefdinir, cefditoren, cefepime, cefetamet, cefixime, cefoperazone, cefotaxime, cefpirome, cefpodoxime, ceftazidime, ceftibuten, ceftizoxime, ceftriaxone.
• Carbapenems and penems: doripenem, ertapenem, faropenem, imipenem, meropenem.
• Fluoroquinolones: balofloxacin, gemifloxacin, levofloxacin, moxifloxacin, prulifloxacin, sparfloxacin.
• Anti-tuberculosis and anti-leprosy drugs: capreomycin, clofazimine, cycloserine, ethambutol, ethionamide, isoniazid, pyrazinamide, rifabutin, rifampicin, sodium para-aminosalicylate, thiacetazone.
• Benzodiazepines and hypnotics: alprazolam, chlordiazepoxide, diazepam, midazolam, nitrazepam, zolpidem.
• Opioids and others: buprenorphine, codeine, diphenoxylate, pentazocine, tramadol.

Additions since 2014

Count from the dates in your own copy of the Gazette before you change practice; the dates above are 180 days and six months from the publication dates.

Proposed, not yet law

• Flupentixol, zopiclone, gabapentin and carisoprodol as H1 entries 53–56 (draft G.S.R. 745(E), 19 August 2026). Gabapentin is the one hospital pharmacies stock most.
• CCTV over prescription sales: a new Rule 65(2A) requiring every non-wholesale supply on prescription to be made under CCTV at the licensed premises, with recordings kept for at least three months (draft G.S.R. 791(E), 8 September 2026). Some districts and union territories already require CCTV at chemists by local order.
• No advertising of Schedule H, H1 or X drugs by licensees without central approval (draft G.S.R. 861(E), 28 September 2026).
• A blue vertical strip on antimicrobial labels (draft G.S.R. 51(E), 21 January 2026).

Separately, Schedule H2 — which requires a QR code or barcode on the label — was extended by G.S.R. 506(E) of 22 June 2026 to all vaccines, antimicrobials, NDPS drugs and anticancer drugs, from 1 July 2027 (1 July 2028 for antimicrobials). That is a manufacturer's labelling duty, but it will put scannable batch data on most of the H1 drugs a hospital stocks.

What Rule 65 requires, clause by clause

Every prescription supply (Schedule H included)

Rule 65(3)(1) requires every supply on prescription, other than Schedule X, to be entered in a prescription register at the time of supply, with the entry's serial number written on the prescription. Each entry records the serial number, date, prescriber's name and address, patient's name and address, drug name and quantity, and for Schedule C, H and H1 drugs the manufacturer, batch number and expiry date, signed by the registered pharmacist. Where drugs are supplied in original containers, the same particulars may be recorded instead in a serially numbered cash or credit memo book, provided the licensee has declared that option in writing to the Licensing Authority.

Schedule H1

Rule 65(3)(1)(h): "the supply of a drug specified in Schedule H1 shall be recorded in a separate register at the time of the supply giving the name and address of the prescriber, the name of the patient, the name of the drug and the quantity supplied and such records shall be maintained for three years and be open for inspection."

Prescriptions themselves

Rule 65(10) requires the prescription to be in writing, signed and dated by the prescriber, with the patient's name and address and the total quantity and dose. Under Rule 65(11) it may not be dispensed more than once unless the prescriber says so, and the pharmacy notes its own name, address and date of supply on it. Rule 65(11-A) bars substituting another drug.

Schedule X

Schedule X drugs need a prescription in duplicate, one copy of which the pharmacy keeps for two years (Rule 65(9)(a)); storage under lock and key in a place reserved for them (Rule 65(12)); and a bound register with serially numbered pages and a separate page for each drug, recording date, quantity received and supplier's licence, drug, quantity supplied, manufacturer, batch, patient's name and address, prescription reference, bill number and signature (Rule 65(21)).

Supervision, inspection and retention

Prescription drugs may be supplied only by or under the personal supervision of a registered pharmacist (Rule 65(2)). All registers must be produced to a Drugs Inspector on demand (Rule 65(6)). Unless a longer period is specified, records are kept for at least two years from the last entry (Rule 65(7)). A breach can lead to suspension or cancellation of the licence under Rule 66, and contravening the rules is an offence under Section 27(d) of the Drugs and Cosmetics Act.

A Schedule H1 register format that satisfies the rule

The rule fixes the content, not the layout. The format used in the National Quality Assurance Standards toolkit for public hospitals adds a serial number and the patient's registration number, which makes each entry traceable to the hospital record. A practical layout for a hospital pharmacy:

Hospital pharmacies and inpatient issues

Hospital pharmacists often ask whether H1 drugs issued to the ward against a doctor's order need register entries. Rule 65 contains no separate exception for inpatient issues. The only exemption from the sale licence, in Schedule K, covers hospitals and dispensaries maintained or supported by government or a local body. A private hospital pharmacy operating on Form 20 and 21 licences is bound by Rule 65, and the safe reading is that every H1 supply on a prescription or medication order — OPD counter or ward — is recorded in the H1 register.

Two other rules matter in hospitals:

• Supplies to a hospital of Schedule H, H1 or X drugs (for example, from a wholesaler or a separate pharmacy licensee) must be against a signed written order, preserved for two years (Rule 65(9)(b)).
• Narcotic drugs such as morphine fall under the NDPS Act as well. Hospitals that stock Essential Narcotic Drugs need Recognised Medical Institution status (NDPS Rules 52A–52R, inserted in 2015) and keep the NDPS forms — 3D for the ward's daily account, 3E for the patient record, and 3H for the main store.

Can the H1 register be kept in software?

Rule 65 prescribes what must be recorded, not the medium, and we found no CDSCO circular either accepting or rejecting a computerised H1 register. Regulators are moving towards electronic records: Jammu and Kashmir's Drug Controller requires computerised billing and CCTV at retail outlets, an advisory the High Court upheld on 8 May 2025, and Haryana has piloted an app to track psychotropic sales with prescription images. A printed, signed and dated report from your pharmacy software that carries every required field — kept in a file for three years — is the approach most inspectors accept, but check with your state Drug Controller's office, because practice varies by state.

Whatever you choose, the register has to be complete at the time of supply. A software report only works if the bill captures the prescriber and patient on every H1 sale.

A compliance checklist for the hospital pharmacy

• Tag every item in the drug master with its schedule — H, H1, X, narcotic, OTC — and review the tags when pregabalin and the high-alcohol liquids change category.
• Make the prescriber and patient compulsory on every bill that contains an H1 or X item.
• Record batch and expiry at the point of sale, not from memory later.
• Print and sign the H1 register daily or weekly and keep it for three years; keep Schedule X prescriptions and the bound X register for two years.
• Store Schedule X drugs under lock and key, with access limited to the pharmacist in charge.
• Keep NDPS Forms 3D, 3E and 3H if you stock narcotics, and file your annual estimate on time.
• Keep the Inspection Book (Form 35) and every inspection note.
• Plan for CCTV over the dispensing counter now; several districts already require it.

How Healthixio's pharmacy module supports the registers

Healthixio's hospital pharmacy is built for the counter and the ward, and it records most of what the registers need as a side effect of billing:

• Schedule tagging: each medicine in the item master carries a category — Narcotics, Schedule H1, Schedule H, Schedule X, General or OTC — shown as a badge on stock and usable as a filter on Stock and Stock Valuation.
• Who, what and which batch on every bill: the sale bill records the patient, the prescribing doctor, the batch and expiry of each item, and the user who made the sale.
• A sale list for chosen medicines: the Item Wise Sale report lists every sale of the items you select, with bill number, date, patient, batch, expiry and quantity, and the Doctor Wise Sale report shows sales by prescriber. Together they hold the data an H1 register needs.
• Ward issues on the patient's bill: pharmacy bills for admitted patients move onto the IPD bill, so inpatient H1 issues are recorded against the same patient and admission.
• Batch-wise stock with expired and expiring-in-30/60/90-days filters, purchase and challan entry, purchase and sale returns, GST billing with HSN and GSTR-1 export, multiple stores and stock transfer.
• A log of every pharmacy edit, so a changed bill can be explained to an inspector.

Healthixio does not print a ready-made register in the statutory layout, and the bill holds the patient's mobile number rather than an address. Most hospital pharmacies print the Item Wise Sale report for their H1 items and sign it, adding the address of any outside prescriber. See the pharmacy module, our hospital pharmacy inventory guide and GST 2.0 for hospital pharmacies.

Frequently Asked Questions

What is the difference between Schedule H, H1 and X drugs?

All three are prescription-only. Schedule H drugs need a prescription and the Rx label. Schedule H1 drugs also need an entry in a separate register, kept for three years, and a red boxed warning on the label. Schedule X drugs need a separate licence, a prescription in duplicate, lock-and-key storage and a bound register for each drug.

How many drugs are in Schedule H1 in 2026?

Fifty entries are in force on 5 November 2026: the original 46 from 2014, oxytocin (2018), tapentadol (2021) and oseltamivir and zanamivir (2024). Pregabalin becomes the 51st about 16 November 2026, and high-alcohol oral liquids the 52nd about 9 January 2027.

Is pregabalin a Schedule H1 drug now?

It has been notified as one. G.S.R. 377(E) of 13 May 2026, published in the Gazette on 20 May 2026, adds pregabalin and its formulations to Schedule H1 from 180 days after publication — about 16 November 2026.

What must a Schedule H1 register contain?

Under Rule 65(3)(1)(h): the prescriber's name and address, the patient's name, the drug's name and the quantity supplied, recorded at the time of supply. Most pharmacies also record the date, a serial number, batch, expiry and the pharmacist's signature.

How long must a Schedule H1 register be kept?

Three years, open for inspection. Other sale and purchase records are kept for at least two years from the last entry, and Schedule X prescriptions for two years.

Does a hospital pharmacy need an H1 register for IPD patients?

A private hospital pharmacy working on Form 20 and 21 licences is bound by Rule 65, which has no exception for inpatient issues. The safe practice is to record every H1 supply, counter or ward, in the register. Only hospitals run or supported by government or a local body are exempt from the sale licence.

Can the Schedule H1 register be kept on a computer?

The rule fixes the content, not the medium, and no central circular forbids a computerised register. Many pharmacies print a signed report from their software and keep it for three years. Confirm with your state Drug Controller, as practice varies.

Is CCTV mandatory in medical stores?

Not nationally yet. A draft rule of 8 September 2026 would require CCTV over every prescription sale, with recordings kept for three months. Some states, union territories and districts already require it by local order.

Run a pharmacy that is ready for inspection

Tag your schedules once, capture the prescriber and batch on every bill, and the register becomes a report rather than a second job. Book a demo of Healthixio's hospital pharmacy or see the screens on the product tour.

Sources

• Drugs and Cosmetics Act, 1940 and Rules, 1945 (CDSCO consolidated text; Rules 61, 65, 66, 97, Schedules H1 and K): cdsco.gov.in
• G.S.R. 377(E), 13 May 2026, pregabalin in Schedule H1: Gazette copy
• G.S.R. 607(E), 8 July 2026, high-alcohol oral formulations in Schedule H1: TeamLease RegTech
• Draft G.S.R. 791(E), 8 September 2026, CCTV at pharmacies: Medical Dialogues
• Draft G.S.R. 745(E), 19 August 2026, four CNS drugs proposed for Schedule H1: Medical Dialogues
• NHSRC Schedule H1 register and NDPS forms: nhsrcindia.org

Last reviewed 5 November 2026. This is a practical guide, not legal advice; confirm dates with your state Drug Controller.