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Rule 65

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(11)(c) requires a separate register recording the prescriber's name and address, the patient's name, the drug and the quantity supplied, retained for three years. 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 →

Related terms

Schedule H1Prescription-only medicines that additionally require a dedicated register entry under Rule 65. Schedule HA class of prescription-only medicines under the Drugs & Cosmetics Rules 1945. Drug licence (Form 20 / Form 21)The retail licence required to sell medicines in India, issued by the state authority. Narcotic registerThe dedicated record required for narcotic and psychotropic substances. Pharmacist registrationThe state pharmacy council registration a practising pharmacist must hold.

All terms

Batch numberBreakage and damageCDSCOCGST, SGST and IGSTCold chainCredit noteDPCO (Drugs Prices Control Order)Drug licence (Form 20 / Form 21)Expiry 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.