The rule in the Drugs & Cosmetics Rules 1945 setting out sale conditions and record-keeping.
Rule 65 sets the conditions attached to a retail drug licence — how prescription medicines may be supplied, and what records must be kept. It is the rule most often cited in an inspection because almost every record-keeping obligation traces back to it.
For Schedule H1 medicines, Rule 65(3)(h) — inserted by G.S.R. 588(E) of 30 August 2013, in force 1 March 2014 — says the supply “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.”
That separate register is in addition to the ordinary record of the same supply, not a substitute for it. Under Rule 65(3)(1)(a)–(g), a supply made on a prescription is entered in a prescription register, or on a serially numbered cash or credit memo, with the serial number, the 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, signed by the registered pharmacist who supplied it. So for an H1 sale the patient's address, the batch, the expiry and the pharmacist's signature are all statutory, even though clause (h) itself names only four particulars. Purchase and sale records for ordinary stock are required more generally.
Enforcement sits with state drug control authorities, and their expectations differ — notably on whether a digital register is acceptable in place of a printed and signed one. Several still expect a physical register to be produced on the spot.
The practical test of a Rule 65 record is not whether it exists but whether it reconciles: entries that cannot be tied back to a purchase invoice, or that disagree with what the shelf holds, are what an inspection actually finds.
Free, no signup — Schedule H1 register format.
Open Schedule H1 register format →Batch numberCDSCOCGST, SGST and IGSTCold chainCredit noteDPCO (Drugs Prices Control Order)Drug licence (Form 20 / Form 21)Expiry and breakageExpiry returnFEFO (First Expiry First Out)Generic vs branded medicineGSTR-1GSTR-3BHSN codeInput tax credit (ITC)Loose sale (cut strip)MRP (Maximum Retail Price)Narcotic registerNear-expiry stockNPPAPack factor (units per pack)Pharmacist registrationPTR (Price to Retailer)PTS (Price to Stockist)Purchase invoiceRed-border warning labelReorder levelRetail vs wholesale drug licenceReturn to vendor (RTV)Rule 65Rx symbolSalt compositionSchedule HSchedule H1Schedule XScheme goods (free goods)Shortbook (short book)Stock rotationStockist
This glossary is a practical reference for Indian retail pharmacy, not legal, tax or clinical advice. Requirements under the Drugs & Cosmetics Rules are enforced by state drug control authorities and vary; GST treatment should be confirmed with your CA. Verify anything you intend to rely on against the current notified position. As of August 2026.