A customer walks in at 8:40 in the evening with a prescription for cefixime 200 mg, ten tablets. Cefixime is a Schedule H1 drug. Before the strip leaves your counter, the sale must go into a separate Schedule H1 register with the prescriber's name and address, the patient's name, the drug and the quantity. That register has to be kept for three years and shown to a drugs inspector on request.
That is the whole legal requirement in two sentences. The trouble is in the doing. Registers get filled at closing time from memory, strengths go missing, and nobody checks whether the register agrees with the stock. This guide covers what to record, a column layout that holds up at inspection, and a weekly check that catches gaps before an inspector does.
What is Schedule H1, and why does it need its own register?
Schedule H1 was added to the Drugs and Cosmetics Rules, 1945 (now titled the Drugs Rules, 1945) by notification G.S.R. 588(E) dated 30 August 2013, and has applied since March 2014. It pulled out a group of medicines that were being sold too freely over the counter: third and fourth generation antibiotics, anti-TB drugs and certain habit-forming drugs.
All Schedule H drugs need a prescription. H1 drugs need a prescription and a written trail. The idea is that a regulator, or the TB programme, can look at your register and see who prescribed what, to whom, and how much left your shop.
What must the Schedule H1 register record?
The licence condition in Rule 65 says the supply of a Schedule H1 drug must be recorded in a separate register at the time of supply, giving four things:
The name and address of the prescriber
The name of the patient
The name of the drug
The quantity supplied
The records must be kept for three years and be open for inspection. Note the words "at the time of the supply". Writing up the day's H1 sales from bills at night is common, and it is exactly what the rule does not allow.
The government's own guidance to chemists under the TB programme also asks you to retain a copy of the prescription, and its sample register format adds bill number, batch number and expiry. None of these extra columns is in the four-item list, but they are what make the register checkable, so keep them.
Which medicines are on the H1 list in 2026?
The original list had 46 entries. Familiar ones on a retail counter include alprazolam, cefixime, cefpodoxime, ceftriaxone, codeine, diazepam, levofloxacin, moxifloxacin, rifampicin, isoniazid, tramadol and zolpidem.
The list has grown since. Tapentadol was added in 2021, and oseltamivir and zanamivir were added by G.S.R. 95(E) dated 5 February 2024. Most recently, the Health Ministry notified pregabalin under Schedule H1 through G.S.R. 377(E) dated 13 May 2026. The PIB release on pregabalin asks retailers to sell it only on a valid prescription and to keep a separate register of prescription and sale details.
We have seen different statements about the exact date from which the pregabalin entry applies, and the press release itself does not give one. Confirm the date with your State Drugs Control office. In practice, pregabalin is a high-volume molecule in most shops, so setting it up as H1 in your item master now costs you nothing and avoids a scramble later.
A register layout that survives an inspection
A ruled notebook is acceptable, as long as it is a separate register and is filled at the counter. Whatever you use, the columns below cover the four legal items plus the details that let you prove each entry.
Column | Required by rule? | Why keep it |
|---|---|---|
Serial number and date | Good practice | Shows entries were made in order, not added later |
Bill number | Good practice | Links the register line to your sales invoice |
Patient name | Yes | Core requirement |
Prescriber name and address | Yes | Core requirement; "Dr Mehta" alone is not an address |
Drug name and strength | Yes (name) | Strength separates cefixime 100 mg from 200 mg in stock checks |
Batch number and expiry | Good practice | Needed for a recall and for matching against purchase bills |
Quantity supplied | Yes | Write it in units you stock (tablets or strips), the same way every time |
Pharmacist's initials | Good practice | Shows who dispensed, useful when the shop has two pharmacists |
Two small habits make a big difference. Keep a rubber stamp or a printed slip with your regular doctors' full names and clinic addresses, so the address column is never left blank. And pick one quantity unit per drug. A register that says "1 strip" on one line and "10 tab" on the next is very hard to reconcile.
Worked example: one week's H1 reconciliation
Say you run a medical shop in Adajan, Surat. Every Saturday you check one or two H1 molecules against stock. This week it is cefixime 200 mg, stocked in strips of 10.
Opening stock on Monday: 40 strips
Purchased on Tuesday from your distributor, one bill: 60 strips
Supplied as per the H1 register (31 entries): 72 strips
Expected closing stock = 40 + 60 − 72 = 28 strips. The shelf count is 26 strips. Two strips have left the shop without a register line.
Now check the sales side. Your billing software shows 74 strips of cefixime 200 mg sold in the week. So the bills agree with the shelf (40 + 60 − 74 = 26) and the register is the odd one out. Filter the week's bills for that item, tick each one against the register, and you will find the two bills with no matching entry. If the strip MRP is ₹109.50, the money involved is only 2 × ₹109.50 = ₹219. The compliance exposure is much larger: two H1 supplies with no prescriber on record.
Fix it the honest way. Add a dated note in the register explaining the late entry with the bill numbers, record the details if you have the prescription copies, and tell the counter staff what happened. Do not squeeze back-dated lines into the gaps.
The mistakes we see most often in medical shop books
One register for everything. Schedule H1 needs its own register. Mixing H1 lines into a general prescription book defeats the point of the rule.
End-of-day write-ups. Entries copied from bills at night tend to drop the prescriber address and sometimes whole sales.
H1 not flagged in the item master. If your counter staff cannot see at billing time that a product is H1, they will not stop to write the register.
Brand names only. Writing just the brand makes it hard for an inspector to see the molecule. Write the generic name and strength too.
Throwing old registers away. Three years means three full years from the entry. Store completed registers with your purchase bills, not in the back of the godown.
The rules allow the licensing authority to suspend or cancel a sale licence for breach of licence conditions, so this is not a register you can afford to treat as optional.
How does the H1 register connect to your accounts?
The register is a regulatory record, not an accounting one. Still, it depends on your books being right. If purchase bills are posted late, or posted without batch and expiry, the weekly check in the example above cannot be done. If sales bills do not carry item, strength and batch, you cannot tie a bill to a register line.
So the order of work matters: post purchases with batch and expiry the day they arrive, bill every sale through the system, and then reconcile the register against item-wise sales for H1 molecules. We covered the batch side of this in our guide to batch tracking and expiry management for medical shops.
Where hisabkitab fits in
hisabkitab does not replace the H1 register. What it does is keep the stock and sales side clean enough to check the register against. hisabkitab for pharma prints batch, expiry and your drug licence number on invoices, and its AI OCR reads distributor purchase bills so batch and expiry are captured without retyping, as explained in reading pharma purchase invoices with OCR.
At the counter, POS billing keeps every sale on a numbered bill, and the audit trail shows any later edit. That gives you the item-wise sales figure you need for the Saturday check, and a bill number for every register line.
Frequently asked questions
How long do I need to keep the Schedule H1 register?
Three years, and it must be available for inspection during that period. Keep the prescription copies for the same period so each entry can be supported.
Can I keep the Schedule H1 register on a computer?
The rule asks for a separate register made at the time of supply, and many shops now keep it digitally. Before you drop the paper register, ask your State Drugs Control office whether they accept a computerised H1 register and in what form they want it printed or signed.
Is a Schedule H1 register needed for Schedule H drugs?
No. Ordinary Schedule H drugs need a prescription but not this separate register. The register applies to drugs listed in Schedule H1. Schedule X drugs have their own, stricter record rules.
What details are mandatory in the H1 register?
Prescriber's name and address, patient's name, name of the drug and quantity supplied. Bill number, batch, expiry and strength are not in the rule but make the register far easier to defend.
Is pregabalin a Schedule H1 drug now?
Pregabalin was notified under Schedule H1 by G.S.R. 377(E) dated 13 May 2026. Check the date from which it applies with your State Drugs Control office, and start recording its sales in the H1 register from then at the latest.
Want batch-wise stock and sales you can check your H1 register against? Start a free trial or compare plans.
Continue Reading
