Glossary
Schedule H meaning: the prescription-only drug list in India What the Rx label means, who may sell these drugs, and what a clinic has to do.
The schedule behind the red Rx on a strip and the "prescription of a Registered Medical Practitioner only" warning, read from the rules themselves: what it covers, what it asks of the chemist, and what it asks of the doctor's prescription.
Published · Last reviewed · 3 min read
- Schedule H sits in the Drugs and Cosmetics Rules 1945 under the heading "Prescription drugs" and is referred to by Rules 65 and 97.
- Rule 65(9)(a) says Schedule H substances "shall not be sold by retail except on and in accordance with the prescription of a Registered Medical Practitioner".
- Rule 97(1)(b) requires the Rx symbol on the label with the words "Schedule H drug- Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only".
Schedule H is the list of "prescription drugs" in the Drugs and Cosmetics Rules 1945 which, under Rule 65(9)(a), "shall not be sold by retail except on and in accordance with the prescription of a Registered Medical Practitioner". The schedule itself is headed "SCHEDULE - H (See Rules 65 and 97) PRESCRIPTION DRUGS" and runs to several hundred named substances in the CDSCO's consolidated copy of the rules (as amended up to 31 December 2016). A note under the list says the salts, esters, derivatives and preparations of those substances are also covered, except most preparations "intended for topical or external use".
Can Schedule H drugs be sold without a prescription?
Not by retail. Rule 65(9)(a) ties the retail sale of Schedule H, H1 and X substances to a registered medical practitioner's prescription. Rule 65(9)(b) adds a second route for the trade: supply "to Registered Medical Practitioners, Hospitals, Dispensaries and Nursing Homes shall be made only against the signed order in writing which shall be preserved by the licensee for a period of two years". So a doctor buying stock for the clinic signs a written order; a patient at the counter needs a prescription. Rule 65(2) also requires the supply of any drug on a prescription to be "by or under the personal supervision of a registered Pharmacist".
What does the Rx symbol on the pack mean?
It is the Rule 97 label. Rule 97(1)(b) says a medicine for internal use that contains a Schedule H substance must "be labelled with the symbol Rx and conspicuously displayed on the left top corner of the label" together with the words "Schedule H drug- Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only". Rule 97(1)(c) uses NRx in red for Schedule H substances that also fall under the Narcotic Drugs and Psychotropic Substances Act 1985, and Rule 97(1)(d) uses XRx in red for Schedule X. The Rx on a doctor's pad is a different thing; see Rx.
What does Schedule H ask of the doctor?
Two things. The prescription has to exist and be in order, because the chemist's register under Rule 65(3) records "the name and address of the prescriber" against each supply, and for Schedule H drugs also the manufacturer, batch number and expiry. And regulation 7.8 of the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations 2002 makes "Selling Schedule 'H' & 'L' drugs and poisons to the public except to his patient" gross professional misconduct. Dispensing to the doctor's own patient is handled by Schedule K.
What does this look like in a small OPD?
A single-doctor clinic with no medicine counter writes the prescription and the patient takes it to a chemist, who records it and keeps the entry. If the clinic keeps a small stock for its own patients, the Schedule K conditions apply instead: the medicine is labelled with the doctor's name and address, the supply goes into a register, and the register is kept for at least two years. What the pad itself must carry is in our guide on what a prescription must contain.
Questions
Is Schedule H the same as Schedule H1?
No. Schedule H1 is a separate, shorter list inserted by G.S.R. 588(E) of 30 August 2013. Its drugs carry an extra boxed warning under Rule 97(1)(e) and go into a separate register kept for three years under Rule 65(3)(1)(h). See the Schedule H1 entry.
Can a doctor buy Schedule H drugs for the clinic?
Rule 65(9)(b) lets a licensee supply Schedule H drugs to registered medical practitioners, hospitals, dispensaries and nursing homes against a signed written order, which the licensee keeps for two years.
Does Schedule H cover ointments and creams?
The note under Schedule H excludes preparations intended for topical or external use, except ophthalmic and ear or nose preparations containing antibiotics or steroids. Check the schedule and the label for the product in question.
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 and 97 and Schedule H (accessed 30 Oct 2026)
- National Medical Commission, Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations 2002, amended up to 8 October 2016, regulation 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.