Glossary
Schedule H1: the separate register and the boxed warning What the 2013 amendment added on top of Schedule H, and who keeps the three-year register.
Schedule H1 is Schedule H with two extra duties: a separate register at the point of supply and a red-bordered warning box on the pack. Here is what the rules say, who has to keep the register, and where a clinic comes in.
Published · Last reviewed · 3 min read
- Schedule H1 was inserted by G.S.R. 588(E) dated 30 August 2013 and is referred to by Rules 65 and 97 of the Drugs and Cosmetics Rules 1945.
- Rule 65(3)(1)(h): the supply of a Schedule H1 drug "shall be recorded in a separate register" with the prescriber's name and address, the patient's name, the drug and the quantity, kept for three years and open for inspection.
- Rule 97(1)(e): the label carries a red Rx and a boxed warning that the drug is "Not to be sold by retail without the prescription of a Registered Medical Practitioner".
Schedule H1 is a list of drugs added to the Drugs and Cosmetics Rules 1945 by G.S.R. 588(E) of 30 August 2013 whose retail supply must be "recorded in a separate register" kept "for three years" and whose label carries a boxed "SCHEDULE H1 DRUG – WARNING". The schedule is headed "SCHEDULE H1 (See Rules 65 and 97)" in the CDSCO's consolidated copy of the rules, and its note says the salts and preparations of the listed substances are covered too, except most products for topical or external use. The same 2013 notification amended Rule 65(9) so that Schedule H1 substances, like Schedule H and X, "shall not be sold by retail except on and in accordance with the prescription of a Registered Medical Practitioner".
What goes into the Schedule H1 register?
Rule 65(3)(1)(h) sets it out: "the supply of a drug specified in Schedule H1 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." This is on top of the ordinary prescription register under Rule 65(3)(1), which already takes the serial number, date, prescriber, patient, drug and quantity and, for Schedule H and H1 drugs, the manufacturer, batch number and expiry.
Who has to keep the register, the chemist or the doctor?
Rule 65 is headed "Condition of licences" and binds the holder of a sale licence in Forms 20, 20-A, 20-B, 20-F, 20-G, 21 and 21-B, so the register is the chemist's duty. A doctor who only writes the prescription keeps no H1 register. A doctor who dispenses to their own patients under Schedule K keeps the Schedule K register instead, which records the medicine, dose, patient, date and prescriber and is kept for at least two years; the Schedule K conditions in the 2016 consolidated copy name Schedules G, H and X, and a clinic that stocks an H1 item should ask its state drugs control office what it expects. The entries are built from the prescription, so the pad needs the prescriber's name, registration particulars and the patient's name in a form the chemist can copy.
How is a Schedule H1 pack labelled?
Rule 97(1)(e) says the formulation "shall be labeled with the symbol Rx which shall be in red conspicuously displayed on the left top corner of the label" and "in a box with a red border" the words "SCHEDULE H1 DRUG – WARNING. It is dangerous to take this preparation except in accordance with the medical advice. Not to be sold by retail without the prescription of a Registered Medical Practitioner." Plain Schedule H packs carry the Rx symbol and a one-line warning without the box.
What does it mean at a small clinic?
Take a two-room OPD with no medicine counter. The doctor writes the prescription with the generic name, strength, quantity and signature, and the patient takes it to a chemist. The chemist copies the prescriber's name and address and the patient's name into the H1 register, so an unsigned or unnamed prescription is the usual reason a patient is sent back. Legibility and the doctor's registration number on the pad matter for the same reason; the full list is in what a prescription must contain.
Questions
How long is the Schedule H1 register kept?
Rule 65(3)(1)(h) says the records "shall be maintained for three years and be open for inspection".
Does a doctor need a Schedule H1 register?
Rule 65 is a condition of the chemist's sale licence. A doctor who only prescribes keeps no H1 register. A doctor who dispenses to their own patients works under the Schedule K conditions and should confirm the position for H1 items with the state drugs control office.
Which drugs are in Schedule H1?
The list is printed in the Drugs and Cosmetics Rules under the heading Schedule H1 and has been amended since 2013. Read the current schedule on the CDSCO site rather than a summary.
Sources
- Central Drugs Standard Control Organisation, The Drugs and Cosmetics Act 1940 and the Drugs and Cosmetics Rules 1945, as amended up to 31 December 2016, Rules 65(3)(1)(h), 65(9), 97(1)(e), Schedule H1 and Schedule K (accessed 30 Oct 2026)
- National Medical Commission, Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations 2002, amended up to 8 October 2016, regulations 1.4.1 and 7.8 (accessed 30 Oct 2026)
This is operational guidance for clinics, not legal or tax advice. Confirm with your state authority, council or CA.
Drafted with AI assistance; every fact checked against the sources listed; reviewed by the Vitels team.