Key takeaways
- Schedule H1 drugs — including several newer antibiotics and anti-TB drugs — can be sold only on a doctor’s prescription.
- Each sale is recorded in a separate register with the prescriber, the patient, the drug and the quantity.
- The register is kept for three years and must be open to inspection.
What is Schedule H1?
Schedule H1 was added to the Drugs and Cosmetics Rules, 1945 in 2013 and came into force in March 2014, to curb the misuse of certain antibiotics and habit-forming drugs. It lists drugs — including third- and fourth-generation antibiotics and anti-tuberculosis drugs — that need tighter control than ordinary prescription (Schedule H) medicines.
Their packs carry the symbol “Rx” in red and a boxed warning that the drug must not be sold by retail without a registered medical practitioner’s prescription.
What the register must record
For every supply of a Schedule H1 drug, the chemist records, in a separate register at the time of sale:
- The name and address of the prescriber.
- The name of the patient.
- The name of the drug and the quantity supplied.
Many pharmacies also note the batch number and the prescription’s number and date, which makes any later question easy to answer.
The register is kept for three years and must be open to inspection by the drugs inspector.
Schedule H, H1 and X compared
| Schedule | Prescription | Record |
|---|---|---|
| H | Required | Prescription-only sale |
| H1 | Required | Separate register, kept three years |
| X | Required, in duplicate — the chemist keeps a copy | Strict records of purchase and sale |
Keeping the register in Suiteloom
Mark each medicine’s schedule in its details. When a prescription medicine is billed, the POS asks for the prescription: patient name and address, doctor and registration number, prescription number and date. Schedule H1 and X lines also record the batch they were sold from.
The schedule register report then lists every H1 and X sale for any period, ready to print for an inspection.
A note on the rules
This is general information, not legal advice. The Drugs and Cosmetics Rules and your state drug controller’s instructions are the authority — check them for the drugs you stock.
This guide is general information, checked on 23 October 2026. It is not legal or tax advice. Rules, rates and limits are notified by the government and change; check the GST portal and official notifications, or ask your accountant, for your business.