Schedule H Prescription Medicines

Schedule H medicines are medicines that cannot legally be sold by retail without a prescription from a registered medical practitioner. Under the Drugs Rules, 1945, their retail supply is subject to prescription, dispensing and labelling requirements intended to ensure medical supervision.

Restrictions on retail sale and dispensing

Rule 65 governs the conditions under which licensed sellers may supply these medicines. The central restriction is on retail sale without a valid prescription, rather than a prohibition on their therapeutic use.

• A Schedule H medicine may be sold by retail only on, and in accordance with, the prescription of a registered medical practitioner.
• Supply against a prescription must be carried out by, or under the personal supervision of, a registered pharmacist.
• The dispenser must not supply another preparation in place of the prescribed preparation, even if it contains the same substance.

Prescription requirements and repeat dispensing

A prescription must identify the prescriber and patient and provide sufficient directions for dispensing. Repeat dispensing is controlled so that an earlier prescription does not automatically become permission for indefinite purchases.

• The prescription must be in writing, signed and dated by the prescriber, and must specify the prescriber's name and address.
• It must specify the patient's name and address, the total amount of medicine to be supplied and the dose to be taken.
• The prescription must not be dispensed more than once unless the prescriber expressly authorises repetition.
• Where the prescriber specifies the number of repeats or the intervals between them, dispensing must follow those directions.
• At dispensing, the seller's name and address and the date of dispensing must be noted on the prescription.

Mandatory labelling and distinction from Schedule H1

Rule 97 requires a Schedule H medicine's label to display the symbol Rx conspicuously at the top-left corner. It must also carry the warning: "Schedule H drug: Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only."

• The warning communicates a legal restriction on retail sale; it is not merely advice to consult a doctor.
• Schedule H1 is a separate category with additional safeguards, including a separate supply register whose records must be maintained for three years.
• The special Schedule H1 register requirement should not be treated as a blanket requirement for every Schedule H medicine.