Search any medicine sold in India and see whether it is OTC, Schedule H, Schedule H1 or Schedule X under the Drugs & Cosmetics Rules — and exactly what you must record before dispensing it.
The Drugs & Cosmetics Rules, 1945 group prescription medicines into schedules that determine how a retail pharmacy may sell them:
| Class | Prescription | What the pharmacist must do |
|---|---|---|
| OTC | Not required | Genuinely over-the-counter — analgesic balms, antiseptics, and similar. Normal sale and purchase records apply. |
| NOT CONFIRMED | Treat as required | Schedule not confirmed — ask your pharmacist. Our reference catalogue carries no verified schedule for this medicine. That is an absence of data, not a finding that it is over-the-counter — most of an Indian pharmacy's shelf is Schedule H. Treat it as prescription-only until you have confirmed otherwise against the Gazette of India lists. |
| SCHEDULE H | Required | Dispense only against a valid prescription from a registered medical practitioner. The label carries the Rx symbol and the "to be sold by retail on the prescription of a Registered Medical Practitioner only" warning. |
| SCHEDULE H1 | Required + register | Everything Schedule H requires, plus a separate Schedule H1 register entry with the patient's name, the prescriber's name and address, the drug name, and the quantity dispensed — retained for three years under Rule 65(3)(h). Packs carry a red-border warning label. Covers third/fourth generation antibiotics, certain habit-forming psychotropics, and anti-tubercular drugs. |
| SCHEDULE X | Required, in duplicate | The most restricted class (narcotic and psychotropic substances). Requires a separate Schedule X licence (Form 20F), prescriptions in duplicate with one copy retained for two years (Rule 65(9)), and storage in a cupboard or drawer reserved solely for Schedule X drugs, under lock and key (Rule 65(12)). Records are subject to inspection. |
Rule 65(3)(h) of the Drugs & Cosmetics Rules, 1945 is the exact source of the requirement — shorter than most summaries of it:
So, for every Schedule H1 supply, a separate register must record:
The register must be retained for three years from the date of the last entry and be open for inspection by drug inspectors. Note the phrase "at the time of the supply" — an entry written up later, at closing time, does not satisfy the rule even if the details are correct. Many pharmacies keep this register digitally; the requirement is that the record exists, is complete, contemporaneous, and can be produced on inspection.
What Rule 65(3)(h) requires, applied to one real-shaped sale:
| Field | Example entry |
|---|---|
| S. No. | 214 |
| Date of supply | 12/09/2026 |
| Drug and quantity supplied | Augmentin 625 Duo — 1 strip of 10 tablets |
| Patient name | R. Kumar (full name as written on the prescription) |
| Prescriber name and address | Dr. A. Sharma, MBBS, Reg. No. MH-12345, Shivaji Nagar Clinic, Pune |
The serial number and date of supply are not named in Rule 65(3)(h) itself, but Rule 65(3)(1) requires them for the same supply — in the prescription register or a serially numbered cash or credit memo, together with the patient's address and, for Schedule C, H and H1 drugs, the manufacturer, batch number and expiry, signed by the registered pharmacist. For the complete column set plus a free downloadable Excel/CSV register template, see the Schedule H1 register format guide.
Section 27 of the Drugs & Cosmetics Act, 1940 sets four separate penalty bands, not one range — which clause applies depends on what is actually wrong with the sale, not just that a prescription was missing:
| Section 27 clause | Covers | Imprisonment | Fine |
|---|---|---|---|
| 27(d) | A genuine drug sold in contravention of the Rules — e.g. a Schedule H/H1 medicine dispensed without a valid prescription, with no other defect in the drug itself | 1–2 years | Not less than ₹20,000 |
| 27(b) | An adulterated drug (not covered by 27(a)), or any drug sold without a valid drug licence | 3–5 years | Not less than ₹1 lakh, or 3× the value of the drugs seized, whichever is more |
| 27(c) | A spurious drug (not covered by 27(a)) | 7 years to life | Not less than ₹3 lakh, or 3× value, whichever is more |
| 27(a) | A spurious or adulterated drug that causes death or grievous hurt | 10 years to life | Not less than ₹10 lakh, or 3× value, whichever is more |
Courts may impose a sentence below the stated minimum under clauses (b)–(d) "for any adequate and special reasons to be recorded in the judgment." Beyond the criminal penalty, the state drug control authority can independently suspend or cancel the retail drug licence. These bands are the statutory text of the Act; which clause a specific case falls under is a legal determination that depends on the facts — consult a lawyer or your state drug control department.
Nesayo is pharmacy billing software for Indian retail pharmacies. Inside the product, medicines in the 2,54,034-medicine catalog carry an advisory schedule flag, Schedule H/H1 medicines are flagged at billing, and Schedule H1 sales are logged at billing (patient, prescriber, medicine, batch, quantity); the pharmacist adds the prescriber's address to complete the Rule 65(3)(h) register. This free checker uses the same reference catalog. Real pharmacies have billed on Nesayo from a phone since April 2026.
Both require a valid prescription. Schedule H1 adds a separate register (prescriber's name and address, patient, drug, quantity) retained for three years, and packs carry a red-border warning label. H1 covers third and fourth generation antibiotics, certain habit-forming psychotropics, and anti-tubercular drugs.
Rule 65(3)(h): the prescriber's name and address, the patient's name, the drug name, and the quantity supplied — in a separate Schedule H1 register, written at the time of supply, retained for three years and open to inspection.
Section 27 sets four bands, not one figure. An ordinary case — a genuine medicine dispensed without a valid prescription — falls under clause 27(d): 1–2 years imprisonment and a fine of at least ₹20,000. If the drug is also spurious or adulterated, or sold without a valid drug licence, the harsher clauses 27(a)–(c) apply: up to life imprisonment and fines from ₹1 lakh to ₹10 lakh or three times the value seized, whichever is more. Licence suspension or cancellation is also possible.
Schedule H1 was added by the Drugs and Cosmetics (Fourth Amendment) Rules, 2013 (G.S.R. 588(E), notified 30 August 2013, effective 1 March 2014), originally covering 46 medicines — mainly third/fourth generation antibiotics, habit-forming psychotropics, and anti-tubercular drugs. The list has been amended since, so check a specific medicine above rather than an old summary list.
No. It is a free reference tool from Nesayo. Classifications come from a reference catalog and are advisory — verify against the official gazette lists published by CDSCO before relying on them. It is not legal advice.