Schedule H1 register: format, entries and the 3-year rule Who the register binds, what each line must contain, and where a dispensing doctor stands.

A Schedule H1 register is a separate record, filled at the time of supply, of every Schedule H1 drug dispensed: the prescriber's name and address, the patient's name, the drug's name and the quantity supplied, kept for three years and open to inspection. That is rule 65(3)(1)(h) of the Drugs and Cosmetics Rules, 1945, inserted by G.S.R. 588(E) on 30 August 2013. The rule is a licence condition, so it binds a retail chemist or a clinic that holds a sale licence. A doctor who supplies medicines to their own patients without a licence is exempt from that chapter under Schedule K, item 5, and keeps the register that item 5 describes instead. This post gives both, and the format that satisfies either.

Whether your clinic needs a licence at all, and the full list of Schedule K conditions, is in dispensing medicines at a clinic under Schedule K. This post goes only into the register.

What is Schedule H1?

Schedule H1 is a list of drugs added to the Rules by G.S.R. 588(E) of 30 August 2013, headed "(See Rules 65 and 97)". The CDSCO consolidated copy lists the substances; we do not reproduce drug names here. Two rules hang off the schedule. Rule 97(1)(e) sets the label: the pack carries the symbol Rx in red at the top left and the words, in a box with a red border, "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." Rule 65 sets the register.

What must the Schedule H1 register contain?

Rule 65(3)(1) requires a licensee to record every prescription supply in a prescription register with the serial number, date, prescriber's name and address, patient's name and address, drug and quantity, and for Schedule C, H and H1 drugs the manufacturer, batch number and expiry. Clause (h), added in 2013, then carves out Schedule H1:

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.

Four facts, and the rule says nothing about columns, page size or binding. The words that bite are "separate", "at the time of the supply" and "three years". A general prescription register with H1 drugs mixed in does not meet "separate". A register written up at closing time does not meet "at the time of the supply". A register discarded when the year's books are cleared does not meet "three years".

Does the H1 register apply to a doctor who dispenses without a licence?

Not as rule 65. Rule 65 opens with the words "Licences in Forms 20, 20-A, 20-B, 20-F, 20-G, 21 and 21-B shall be subject to the conditions stated therein and to the following general conditions". It is a licence condition. Schedule K, item 5 exempts "drugs supplied by a registered medical practitioner to his own patient" from "all the provisions of Chapter IV of the Act and the Rules made thereunder", provided the doctor is not keeping an open shop, selling across the counter, or trading in drugs. Item 5 then attaches its own conditions, and condition 2 names "Schedule G, H or X". It does not name Schedule H1, which was added to the Rules in 2013.

So a doctor dispensing an H1 drug to their own patient under item 5 is not bound by the three-year "separate register" clause by its terms. They are bound by item 5's register for Schedule G, H and X medicines, and we could not find any amendment that adds H1 to item 5. Two cautions follow. First, a drug inspector under the Act can examine records and may read the gap differently; keeping H1 supplies in the item 5 register costs nothing and removes the argument. Second, the item 5 exemption is lost the moment the clinic sells to someone who is not its own patient, and at that point rule 65 and its H1 register apply in full.

Item 5, condition 2 asks for these entries, "at the time of supply in register to be maintained for the purpose": "the name of the medicine or ingredients of the preparation and the quantities thereof, the dose prescribed, the name of the patient & the date of supply and the name of the person who gave the prescription". The entry gets a number, the same number goes on the label of the container, and "the register and the prescription, if any, on which the medicines are issued shall be preserved for not less than two years from the date of the last entry in the register or the date of the prescription".

The two registers side by side

Setting the register up in a small clinic

1. Decide which regime you are in. No licence and own patients only: Schedule K, item 5. A sale licence: rule 65, and a separate H1 register on top of the prescription register.
2. Use a bound book with numbered pages, or a software register that numbers entries and cannot be edited after the fact. The rules do not prescribe a form; they prescribe the entries and the timing.
3. Fill the line before the medicine leaves the counter. "At the time of supply" is in both rules.
4. Put the entry number on the label of the container (item 5, condition 2(d)), with the clinic's name and address.
5. Keep purchase invoices with batch numbers alongside; item 5, condition 1 requires purchase records showing names, quantities, batch numbers and the manufacturer's name and address, open to inspection.
6. Retain for three years if you are a licensee, two years under item 5; the longer period costs nothing and covers both.
7. Mark the prescription too. Regulation 3.7.1 of the 2002 conduct regulations says the "Prescription should also make clear if the Physician himself dispensed any medicine", so a tick or a line on the parchi matches the register entry.