Under the Drugs and Cosmetics Rules, medicines are grouped into schedules that set how they may be sold, who can buy them, and what records you must keep. For a retail pharmacy, the ones to know are H, H1 and X — getting them right protects your licence.
Schedule H — prescription only
Most prescription medicines, including many antibiotics, fall here. They may be sold only against a valid prescription from a registered medical practitioner, and the pack carries the 'Rx' warning. Sell them over the counter and you put your licence at risk.
Schedule H1 — a stricter sub-set
H1 covers certain antibiotics, habit-forming drugs and anti-TB medicines that are more tightly controlled to curb misuse and resistance. These must be recorded in a separate H1 register with the prescriber and patient details, and that register is kept for the period the rules require.
Schedule X — the most controlled
Schedule X includes certain narcotic and psychotropic drugs. They need a special licence, a prescription retained in duplicate, secure (locked) storage and strict records. Many small pharmacies choose not to stock these at all.
OTC / non-scheduled
Over-the-counter and general-sale products — common pain relief, antacids, antiseptics and the like — can be sold without a prescription, which is why they are your fast-moving front-of-store lines.
Why it matters for your shop
Handling H, H1 and X correctly — proper prescriptions, registers and storage — is what keeps your licence safe in an inspection. Train your staff so everyone follows the same process.
This is a general overview, not legal advice. Schedules and rules are updated from time to time, so always follow the current Drugs and Cosmetics Rules and the guidance of your State Drugs Control Department.
Frequently asked questions
What is the difference between Schedule H and H1?
Both need a prescription, but Schedule H1 covers certain antibiotics and habit-forming drugs that also require a separate H1 register recording prescriber and patient details.
Can a pharmacy sell Schedule H drugs without a prescription?
No — Schedule H and H1 medicines may only be sold against a valid prescription from a registered medical practitioner.
Check the current rules at the source
This guide is general information, not legal or tax advice. Rules change, so confirm anything that affects your licence or your filings with the authority itself:
Related guides
Pharmacy registers and records: staying inspection-ready in ten minutes a day · How to open a medical shop (pharmacy) in Tamil Nadu: an overview · Fast-moving medicines every pharmacy should keep in stock
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