Schedule H1 Register Format

The register you must keep under Rule 65 of the Drugs & Cosmetics Rules — every column set out below, plus a ready-to-use Excel sheet. Landscape, pre-bordered, 200 blank rows, prints straight from the file.

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The columns, in full

Rule 65(11)(c) sets the minimum: the prescriber's name and address, the patient's name, the drug and the quantity supplied, retained for three years. The rest of the columns below are not statutory — they are what makes the register reconcilable against your stock and bills when an inspector asks, which is the difference between a register that exists and one that survives an inspection.

ColumnStatusWhat goes in it
S. No.PracticeConsecutive, no gaps. A missing serial is the first thing an inspector looks for.
Date of supplyRequiredThe date the medicine was handed over, not the prescription date.
Medicine (brand name)RequiredAs printed on the pack.
Salt / compositionPracticeMakes the entry findable when the brand changes but the molecule doesn't.
Batch no.PracticeThe single most useful non-statutory column — it ties the entry to a specific lot in a recall.
ExpiryPracticeMonth and year as printed.
Quantity suppliedRequiredState the unit and stay consistent — strips or loose units, not a mix.
Patient nameRequiredAs given on the prescription.
Patient addressRequiredThe statutory field is the address. A phone number is useful but does not replace it.
Prescriber nameRequiredThe registered medical practitioner who wrote it.
Prescriber reg. no.PracticeState medical council registration. Strongly advisable — it is what makes the prescriber identifiable.
Prescriber addressRequiredNamed explicitly in Rule 65(11)(c).
Invoice / bill no.PracticeLinks the register to the sale so the two can be reconciled.
Dispensed byPracticeThe registered pharmacist who supplied it.
Schedule H is not Schedule H1. A Schedule H medicine needs a valid prescription but no separate register. Schedule H1 needs the prescription and this register entry, and H1 packs carry the red-border warning box. Schedule X is stricter again — prescriptions in duplicate, one copy retained two years, and its own register.

How to keep it so it survives an inspection

1. Write at the counter, not at closing time

Entries reconstructed at the end of the day are where gaps and guessed batch numbers come from. The register is meant to be contemporaneous with the supply.

2. Keep the serial unbroken

If an entry is wrong, strike it through with a single line, initial it, and write the correction on the next serial. Do not overwrite, erase or tear out a page — a discontinuity is far more damaging than a visible correction.

3. Reconcile against stock

The quantities in this register should agree with what left the shelf. If the register says ten capsules went out and the batch shows none moved, that discrepancy is what an inspection finds.

4. Retain for three years, with the prescriptions

Three years from the last entry. Keep the prescriptions filed against the same period — a register without the underlying prescriptions answers only half the question.

On keeping it digitally. Digital records are common in practice, but Rule 65 is enforced by state drug control authorities and their expectations differ. Several still expect a printed, signed register produced on the spot. The safe approach is to keep the digital record as the source of truth and print and sign it periodically. Confirm what your own state authority accepts before relying on a screen.

What actually fails an inspection

A register is rarely faulted for looking untidy. It is faulted for the things that make it impossible to verify against anything else.

Gaps in the serial

A jump from 214 to 217 raises the obvious question of what happened to the missing three, and there is no good answer available afterwards. If a page is spoiled, strike it through and carry the numbering forward rather than removing it.

Entries that do not reconcile with stock

If the register records a supply from a batch that the stock record shows was never opened — or that had already expired on the date of supply — the discrepancy is visible without any effort. This is the most common failure in shops keeping the register separately from their billing, because the two are only ever compared by the inspector.

A prescriber who cannot be identified

"Dr. Sharma" with no registration number and no address does not satisfy Rule 65(11)(c), which names the prescriber's address explicitly. It is also the entry most likely to be tested, because it is the easiest to check.

Quantities in mixed units

Ten in one row meaning ten tablets and ten in the next meaning ten strips makes the whole register unreconcilable. Pick one unit convention and hold it — the template's guidance row says so for this reason.

The register kept, but the prescriptions not

The register records that a prescription existed. The prescription proves it. Both are needed for the same period, and a complete register with no supporting prescriptions answers only half the question.

This template and page are a practical reference, not legal advice, and they are not an official government form. Rule 65 and the Schedule H1 list have been amended over time and are enforced by state drug control authorities whose requirements vary. Verify the current requirements and the current Schedule H1 list notified in the Gazette of India before relying on this. As of August 2026.

Frequently asked questions

What is the Schedule H1 register format?

A register of every Schedule H1 sale kept under Rule 65 — date, drug, quantity, patient name and address, and prescriber name, registration and address. Retained three years, produced on inspection.

Is a Schedule H1 register mandatory?

Yes, for every Schedule H1 medicine dispensed, and it is separate from the ordinary sale record.

How long must it be kept?

Three years from the last entry, with the prescriptions retained alongside.

Can it be kept digitally?

Widely done, but state authorities differ and many still expect a printed signed register. Keep the digital record as the source and print periodically.

What happens if it is not maintained?

Failure to maintain Rule 65 records is a licence condition breach and can lead to suspension or cancellation. Dispensing H1 without a valid prescription is a separate, more serious offence under Section 27.

Which drugs are Schedule H1?

Certain third and fourth generation antibiotics, some habit-forming psychotropics and anti-tubercular drugs, notified in 2013 and amended since. Check a specific pack with the Schedule H1 checker — older summaries reproduce only the original list.

Do I need a separate register per drug?

No — one register in date order covering all H1 supplies is normal practice.

Is this template free?

Yes. No signup, no email, no account.

Related free tools

Schedule H1 checkerIs a medicine OTC, Schedule H, H1 or X — and what you must record Expiry date decoderTurn a printed pack expiry into the real last sellable day PTR / PTS calculatorPrice to Retailer and Stockist from MRP, with the GST step Medicine GST calculatorHSN code and GST slab, with the CGST/SGST split Medicine searchFind substitutes across 2.5 lakh medicines

Or let the register write itself

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