Schedule H, H1 and X drugs: prescription and register rules

Last reviewed: 7 October 2026 · Pharma Mithra

What Schedules H, H1 and X are

The schedules are lists of substances at the back of the Drugs Rules, 1945. The schedules also cover salts and preparations of the listed substances, subject to the exceptions in their notes.

• Schedule H is the long list of prescription drugs. It includes antibiotics as a class and many everyday medicines, for example amlodipine and atorvastatin.
• Schedule H1 is a shorter list that needs extra record-keeping. It includes antibiotics such as cefixime, ceftriaxone, levofloxacin and moxifloxacin; anti-tuberculosis drugs such as isoniazid, rifampicin and pyrazinamide; and habit-forming medicines such as alprazolam, codeine, tramadol and zolpidem.
• Schedule X is the tightest category. It includes amphetamine, methylphenidate, ketamine hydrochloride and several barbiturates. Schedule X drugs need their own licence and their own register.

The lists are amended from time to time by notification, so check the current schedule rather than an old printed chart.

The prescription rule

Drugs in Schedules H, H1 and X must not be sold by retail except on, and in accordance with, the prescription of a Registered Medical Practitioner. For this purpose a prescription must:

• be in writing, signed by the prescriber with his or her usual signature, and dated;
• give the name and address of the patient (or of the owner, for an animal); and
• state the total amount of medicine to be supplied and the dose to be taken.

When you dispense such a prescription:

• dispense it only once, unless the prescriber has written that it may be dispensed more than once, and follow any stated number of times or intervals;
• note on the prescription, above the prescriber's signature, your name and address and the date you dispensed it; and
• do not supply any other preparation in its place, even one containing the same substance.

Supplies of these drugs to Registered Medical Practitioners, hospitals, dispensaries and nursing homes must be made only against a signed order in writing, which you must keep for two years.

Recording prescription sales

A supply made on a prescription (other than of a Schedule X drug) is recorded at the time of supply in a prescription register, and the serial number of the entry is written on the prescription. Each entry gives the serial number, date, prescriber's name and address, patient's name and address, the drug and quantity, and the signature of the registered pharmacist. For Schedule C, H and H1 drugs the entry must also give the manufacturer, batch number and expiry date. Where drugs are supplied in the manufacturer's original containers, the Rules allow these details to be kept instead in serially numbered cash or credit memo books, if you opted for that in writing when you applied for the licence.

The Schedule H1 register

Since 2014, every supply of a Schedule H1 drug must also be recorded in a separate register at the time of supply. The entry gives:

1. the name and address of the prescriber;
2. the name of the patient;
3. the name of the drug; and
4. the quantity supplied.

The H1 register must be kept for three years and be open for inspection. Keep it separate from your general prescription register, and write it up at the counter, not at the end of the day from memory.

Schedule X: licence, prescriptions, register and storage

The licence

Schedule X drugs may be sold by retail only under a licence in Form 20F and by wholesale only under a licence in Form 20G. A Form 20F licence is granted only to a pharmacy, except that in areas where no pharmacy is operating it may be granted to a chemist and druggist. See drug licence forms 20, 21, 20B and 21B for the other forms.

Prescriptions in duplicate

A Schedule X prescription must be in duplicate. You keep one copy for two years.

The Schedule X register

Every supply of a Schedule X drug is recorded at the time of supply in a bound register with serially numbered pages, kept for the purpose, with separate pages for each drug. Each entry gives:

• the date of the transaction;
• any quantity received, with the supplier's name, address and licence number;
• the name of the drug, the quantity supplied and the manufacturer's name;
• the batch or lot number;
• the name and address of the patient or purchaser;
• the reference number of the prescription;
• the bill number and date for purchases and supplies; and
• the signature of the person under whose supervision the drug was supplied.

Storage

In a retail shop, Schedule X drugs must be kept either under lock and key in a cupboard or drawer used only for them, or in a separate part of the premises to which only responsible persons have access.

Wholesale supply

A Form 20G wholesaler may sell Schedule X drugs only to buyers who hold the requisite licence for them, apart from the exceptions in the licence (government purchasers, hospitals and similar institutions, Registered Medical Practitioners for their patients, and licensed manufacturers of Schedule X preparations). It must also send the licensing authority copies of its invoices for sales to retail dealers.

Label warnings

Rule 97 sets the warning that must appear on the container of a medicine for internal use. The words are printed in legible black lettering in a completely red rectangular box, and the symbol is displayed conspicuously at the top left corner of the label:

• Schedule H: the symbol Rx, with "SCHEDULE H PRESCRIPTION DRUG - CAUTION" and "Not to be sold by retail without the prescription of a Registered Medical Practitioner."
• Schedule H1: the symbol Rx in red, with "SCHEDULE H1 PRESCRIPTION DRUG - CAUTION", a warning that it is dangerous to take the preparation except in accordance with medical advice, and that it is not to be sold by retail without a Registered Medical Practitioner's prescription.
• Schedule X: the symbol XRx in red, with "SCHEDULE X PRESCRIPTION DRUG - WARNING" and "To be sold by retail on the prescription of a Registered Medical Practitioner only."
• Schedule H or H1 drugs also covered by the NDPS Act: the symbol NRx in red in place of Rx. For a Schedule H drug the boxed words then read "SCHEDULE H PRESCRIPTION DRUG - WARNING" and "To be sold by retail on the prescription of a Registered Medical Practitioner only."

A pack of a scheduled drug without the right warning is a reason to question where it came from. A drug not labelled in the prescribed manner is misbranded under the Act; see NSQ and spurious drugs.

How long to keep the records

• Schedule H1 register: three years.
• Your copy of each Schedule X prescription: two years.
• Signed orders from doctors, hospitals and nursing homes: two years.
• Carbon copies of wholesale cash or credit memos: three years from the date of sale.
• Other registers and records kept under the Rules, including the prescription register and the Schedule X register: at least two years from the date of the last entry, unless a rule says otherwise.

This guide is general information about Indian drug and tax law for businesses, not legal advice. Rules and procedures can differ by state; your state drug control department or GST office has the final word on any individual case.