Glossary
Prescription meaning: what makes one valid in India Rule 65 of the Drugs and Cosmetics Rules, Schedule H, and NMC regulation 1.5 on generic names, in one place.
Two rulebooks define a prescription in India: the drug rules the chemist works under, and the conduct regulations the doctor is registered under. This entry puts the governing lines of each side by side.
Published · Last reviewed · 4 min read
- Rule 65(10) of the Drugs and Cosmetics Rules, 1945: a prescription shall be in writing, signed with the prescriber's usual signature and dated, specify the patient's name and address, and indicate the total amount of medicine and the dose.
- Rule 65(9): Schedule H, H1 and X substances "shall not be sold by retail except on and in accordance with the prescription of a Registered Medical Practitioner".
- NMC regulation 1.5 (as amended 8 October 2016): "Every physician should prescribe drugs with generic names legibly and preferably in capital letters"; regulation 1.4.1 requires the registration number on every prescription.
A prescription is a Registered Medical Practitioner's written, signed and dated direction for the supply of medicine to a named patient. The Drugs and Cosmetics Rules, 1945 do not define the word in a single clause, but Rule 65(10) says what one must be: it "shall (a) be in writing and be signed by the person giving it with his usual signature and be dated by him; (b) specify the name and address of the person for whose treatment it is given ...; (c) indicate the total amount of the medicine to be supplied and the dose to be taken." The Rx symbol that opens the medicines section has its own entry: Rx.
Who can write a prescription in India?
For Schedule H, H1 and X medicines, a Registered Medical Practitioner. Rule 65(9)(a) says these substances "shall not be sold by retail except on and in accordance with the prescription of a Registered Medical Practitioner". Rule 2(ee) defines the term for the drug rules, and includes a person "registered or eligible for registration in a medical register of a State meant for the registration of persons practising the modern scientific system of medicine". Practitioners of other systems are governed by their own councils and the rules for their own medicines; this entry covers allopathic prescriptions.
What makes a prescription valid?
| Element | Rule |
|---|---|
| In writing, signed with the prescriber's usual signature, dated | D&C Rules, Rule 65(10)(a) |
| Name and address of the patient | Rule 65(10)(b) |
| Total amount of medicine to be supplied and the dose | Rule 65(10)(c) |
| Doctor's registration number | IMC regulations 2002, reg 1.4.1 |
| Drugs by generic name, legibly, preferably in capitals | IMC regulations 2002, reg 1.5 (amended 2016) |
| In duplicate for Schedule X, one copy kept by the chemist for two years | Rule 65(9)(a) |
Regulation 1.4.1 says every physician "shall display the registration number accorded to him by the State Medical Council / Medical Council of India in his clinic and in all his prescriptions, certificates, money receipts given to his patients". Regulation 1.5, substituted by a Gazette notification of 8 October 2016, reads: "Every physician should prescribe drugs with generic names legibly and preferably in capital letters and he/she shall ensure that there is a rational prescription and use of drugs." The full list, with a sample layout, is in our post on what a prescription must contain in India; the generic-name rule and its enforcement are in generic name prescription rules.
What does the chemist do with the prescription?
Rule 65(11) binds the dispenser: the prescription "must not be dispensed more than once unless the prescriber has stated thereon that it may be dispensed more than once", and "at the time of dispensing there must be noted on the prescription above the signature of the prescriber the name and address of the seller and the date on which the prescription is dispensed". Rule 65(11-A) bars substituting "any other preparation, whether containing the same substance or not". Schedule H medicines carry the label "Schedule H drug- Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only". So the doctor's prescription is the document the chemist's licence conditions turn on.
Is a printed or digital prescription valid?
Rule 65(10) asks for writing, a signature and a date; it does not say handwriting. A printed prescription signed by the doctor meets the words of the rule. Whether a prescription sent as an image or PDF is accepted by a chemist is a separate practical question, covered in our post on printed and digital prescriptions in India and the e-prescription entry. For telemedicine consults, the 2020 guidelines add their own limits on what may be prescribed by which mode; see telemedicine.
What does a compliant prescription look like at a small OPD?
A one-doctor clinic prints a pad with the clinic name, the doctor's name, qualification and registration number, and leaves space for the date, the patient's name, age, sex and address, the Rx section with each medicine's generic name in capitals, strength, dose, frequency and duration, the total quantity, advice, and the signature. A layout you can print is in our free prescription format tool.
Questions
What is a prescription in Indian law?
The Drugs and Cosmetics Rules, 1945 treat it as a Registered Medical Practitioner's written, signed and dated direction naming the patient and stating the amount and dose of medicine (Rule 65(10)). Schedule H, H1 and X drugs may be sold by retail only on such a prescription (Rule 65(9)).
Does a prescription need the doctor's registration number?
Yes. Regulation 1.4.1 of the IMC (Professional Conduct, Etiquette and Ethics) Regulations, 2002 requires the registration number on all prescriptions, certificates and money receipts.
Must medicines be written by generic name?
Regulation 1.5, as amended on 8 October 2016, says every physician should prescribe drugs with generic names legibly and preferably in capital letters.
Can a chemist refill a prescription?
Rule 65(11)(a) says a prescription for a Schedule H, H1 or X drug must not be dispensed more than once unless the prescriber has stated on it that it may be.
Sources
- Central Drugs Standard Control Organisation, The Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945 (as amended up to 2016), Rule 2(ee), Rule 65(9), (10), (11), (11-A) and Rule 97 labelling of Schedule H drugs (accessed 30 Oct 2026)
- Medical Council of India, Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 (amended up to 8 October 2016), regulations 1.4.1 and 1.5 (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.