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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Two parts of Rule 65 decide the columns. Rule 65(3)(h) requires a separate register for Schedule H1, written at the time of the supply, giving the prescriber's name and address, the patient's name, the name of the drug and the quantity supplied — maintained for three years and open for inspection. Rule 65(3)(1) then lists the particulars a prescription supply must carry: serial number, date of supply, the prescriber's name and address, the patient's name and address, the drug and its quantity, and — for Schedule C, H and H1 drugs — the manufacturer, batch number and date of expiry, with the signature of the registered pharmacist. One H1 register with all of these columns covers both. The columns marked Practice are not in the rule; they are what make the register reconcilable against your stock and bills when an inspector asks.
| Column | Status | What goes in it |
|---|---|---|
| S. No. | Required | Rule 65(3)(1)(a). Consecutive, no gaps, and the same serial is written on the prescription. A missing serial is the first thing an inspector looks for. |
| Date of supply | Required | Rule 65(3)(1)(b). The date the medicine was handed over, not the prescription date. |
| Medicine (brand name) | Required | As printed on the pack, with the manufacturer's name — Rule 65(3)(1)(f) asks for the manufacturer of a Schedule C, H or H1 drug. |
| Salt / composition | Practice | Makes the entry findable when the brand changes but the molecule doesn't. |
| Batch no. | Required | Rule 65(3)(1)(f), for Schedule C, H and H1 drugs. It also ties the entry to a specific lot in a recall. |
| Expiry | Required | Rule 65(3)(1)(f): the date of expiry. Month and year as printed. |
| Quantity supplied | Required | State the unit and stay consistent — strips or loose units, not a mix. |
| Patient name | Required | As given on the prescription. |
| Patient address | Required | Rule 65(3)(1)(d) asks for the patient's name and address. The separate-register clause, 65(3)(h), names only the patient's name, but the same supply must carry the address under 65(3)(1). |
| Prescriber name | Required | The registered medical practitioner who wrote it. |
| Prescriber reg. no. | Practice | State medical council registration. Strongly advisable — it is what makes the prescriber identifiable. |
| Prescriber address | Required | Named in Rule 65(3)(h) and 65(3)(1)(c), and the field most often left blank — the rule asks for the prescriber's name and address, not the name alone. |
| Invoice / bill no. | Practice | Links the register to the sale so the two can be reconciled. |
| Dispensed by | Required | Rule 65(3)(1)(g): the signature of the registered pharmacist by or under whose supervision the medicine was supplied. |
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.
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.
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.
Rule 65(3)(h): the records shall be maintained for three years and be open for inspection. Rule 65 asks for prescription copies to be kept only for Schedule X, but keeping Schedule H1 prescriptions on file for the same period is still sensible — the register records that a prescription existed, and the prescription proves it.
A register is rarely faulted for looking untidy. It is faulted for the things that make it impossible to verify against anything else.
A jump from 214 to 217 raises the obvious question of what happened to the missing two, 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.
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.
"Dr. Sharma" with no address does not satisfy Rule 65(3)(h), which names the prescriber's name and address explicitly. It is also the entry most likely to be tested, because it is the easiest to check. The registration number is the field most people assume is the compulsory one — it is not in the rule at all. Record it anyway, because it is what makes a prescriber identifiable, but the address is the one whose absence makes the entry defective.
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 records that a prescription existed; the prescription proves it. Rule 65 requires prescription copies to be retained only for Schedule X, but a register with nothing behind it is hard to defend if a supply is ever questioned — keep them.
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 September 2026.
A register of every Schedule H1 supply kept under Rule 65 — serial number, date, the drug with its manufacturer, batch and expiry, quantity, patient name and address, prescriber name and address, and the registered pharmacist's signature. Maintained for three years and open for inspection.
Yes, for every Schedule H1 medicine dispensed, and it is separate from the ordinary sale record.
Three years, under Rule 65(3)(h). Rule 65 requires prescription copies to be retained only for Schedule X; keeping H1 prescriptions for the same period is sensible practice.
Widely done, but state authorities differ and many still expect a printed signed register. Keep the digital record as the source and print periodically.
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.
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.
No — one register in date order covering all H1 supplies is normal practice.
Yes. No signup, no email, no account.
Nesayo logs every Schedule H1 sale as you bill it — patient, prescriber, medicine, batch and quantity — so your register starts from the bill instead of from memory. The bill screen does not ask for the prescriber's address yet, so add it to the register yourself. Billing is free, with no invoice limit and no card.
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