Schedule H Drugs in India: Meaning, Label Warning, Selling Rules and Examples (2026)
By the Trumac Healthcare team, Panchkula · PCD pharma franchise company since 2007 · Updated 14 November 2026 · About us · WhatsApp +91 90416 77932
Schedule H is the main list of prescription-only medicines in India. Drugs in Schedule H of the Drugs Rules, 1945 may be sold by a chemist only against a registered medical practitioner’s prescription, and every pack carries the Rx symbol and the caution “Schedule H Prescription Drug – Caution”. This guide explains what that means for patients, chemists and distributors, how Schedule H differs from Schedules G, H1 and X, and which common medicines fall in it.
What is a Schedule H drug?
Schedule H lists several hundred substances – most allopathic medicines that need a doctor’s judgement. The list was revised in 2006; in 2013 the higher antibiotics, anti-TB drugs and some habit-forming drugs were moved out of it into a stricter new list, Schedule H1. A molecule is therefore in one schedule or the other, not both.
हिंदी में: शेड्यूल H की दवाएँ केवल रजिस्टर्ड डॉक्टर के पर्चे पर ही बेची जा सकती हैं; पैक पर Rx और “Schedule H Prescription Drug – Caution” लिखा होता है।
Schedule H label: what the warning says
The label must show the symbol Rx at the top left (NRx in red if the drug is also controlled under the NDPS Act, with a WARNING wording instead) and this caution:
Since the Drugs and Cosmetics (Fifth Amendment) Rules, 2018 (G.S.R. 408(E), 26 April 2018) the caution is printed in black inside a completely red rectangular box, so that it stands out on strips and cartons.
Rules for selling Schedule H drugs
- Prescription: retail sale only against a prescription from a Registered Medical Practitioner, and only the quantity prescribed.
- Licence: no special licence – a normal retail (Forms 20/21) or wholesale (Forms 20B/21B) drug licence covers Schedule H. See the medical store licence guide.
- Records: each sale is entered in the prescription register, or on a cash/credit memo carrying the required particulars – there is no separate Schedule H register like the H1 register.
- No substitution: the chemist may not supply another preparation in place of the one prescribed (the same rule applies to H1 and X).
- Overlap with NDPS: where a substance is also covered by the NDPS Act, its NDPS obligations apply as well and the label shows NRx.
- Penalty: selling without a prescription is a contravention of the Drugs and Cosmetics Act; the licensing authority can also suspend or cancel the licence.
शेड्यूल H दवा क्या होती है? (हिंदी में)
शेड्यूल H दवाएँ वे हैं जो सिर्फ रजिस्टर्ड डॉक्टर के पर्चे पर बेची जा सकती हैं। इनके पैक पर बाईं ओर ऊपर Rx लिखा होता है और लाल बॉक्स में चेतावनी होती है – “SCHEDULE H PRESCRIPTION DRUG – CAUTION: Not to be sold by retail without the prescription of a Registered Medical Practitioner”।
ज़्यादातर एलोपैथिक दवाएँ – जैसे एटोरवास्टेटिन, एम्लोडिपिन, टेल्मिसार्टन, पैंटोप्राज़ोल, सिप्रोफ्लोक्सासिन – शेड्यूल H में हैं। केमिस्ट इन्हें पर्चे के बिना नहीं बेच सकता और बिक्री का रिकॉर्ड रखता है। ज़्यादा सख़्त दवाएँ शेड्यूल H1 में हैं, जिनका अलग रजिस्टर 3 साल रखना होता है।
Schedule G vs H vs H1 vs X – the difference
| Schedule G | Schedule H | Schedule H1 | Schedule X | |
|---|---|---|---|---|
| Prescription | Not required by Schedule G alone | Required | Required | Required – kept by the chemist |
| Label | “Caution: It is dangerous to take this preparation except under medical supervision” | Rx + Schedule H caution in a red box | Red Rx + red-bordered H1 warning box | XRx + Schedule X caution |
| Register | No | Prescription register or cash/credit memo | Separate H1 register, kept 3 years | Bound register, a page per drug |
| Licence | Normal drug licence | Normal drug licence | Normal drug licence | Separate Schedule X licence |
| Examples | Metformin, insulin preparations | Amlodipine, atorvastatin, pantoprazole, ciprofloxacin | Cefixime, ceftriaxone, levofloxacin, tramadol, zolpidem, pregabalin (from 16 Nov 2026) | Amobarbital, amphetamine, methylphenidate |
All 16 Schedule X substances, the XRx label and the Form 20F licence: Schedule X drugs list.
Schedule H2: QR codes on medicine packs (2027–2028)
Schedule H2 is not a prescription schedule – it lists products that must carry a bar code or QR code for authentication. It began with the top 300 brands (from August 2023). G.S.R. 506(E) of 22 June 2026 extended it to all vaccines, antimicrobials, NDPS narcotic and psychotropic drugs, and anti-cancer drugs:
- The QR code goes on the primary pack label (or the secondary pack if there is no space) and carries the unique product code, generic and brand names, manufacturer’s name and address, batch number, manufacturing and expiry dates and manufacturing licence number.
- From 1 July 2027: vaccines, NDPS drugs and anti-cancer drugs.
- From 1 July 2028: all antimicrobials – which covers most antibiotic ranges sold through PCD and wholesale channels.
Common Schedule H medicines (examples)
A few well-known molecules confirmed in the current Schedule H list, by group. This is not the full list – check the current Drugs Rules for any specific molecule before printing a label.
| Group | Examples in Schedule H |
|---|---|
| Heart and blood pressure | Atenolol, amlodipine, ramipril, telmisartan, losartan, atorvastatin |
| Diabetes | Glimepiride, gliclazide, pioglitazone (metformin is Schedule G) |
| Anti-infectives | Ciprofloxacin, clarithromycin, metronidazole, acyclovir |
| Pain and inflammation | Diclofenac, ibuprofen |
| Allergy and respiratory | Cetirizine, levocetirizine, montelukast |
| Stomach | Pantoprazole |
What Schedule H means for PCD partners and distributors
- Most of a typical PCD range – cardiac, diabetic, gastro, respiratory and pain products – is Schedule H. Chemists sell these on prescription, so doctor promotion drives the volume.
- Antibiotic and anti-TB ranges are mostly Schedule H1 and need the chemist’s H1 register – see the Schedule H1 drug list.
- You need a wholesale drug licence (Forms 20B/21B) to distribute – wholesale drug licence guide; GST is 5% on most medicines – GST on medicines.
- Check that packs carry the correct schedule caution and the generic name in larger font than the brand (Drugs and Cosmetics (First Amendment) Rules, 2018).
Sources: Drugs Rules, 1945 (Rules 96–97) and G.S.R. 408(E) 2018; G.S.R. 588(E) 2013; Health Ministry notification of 16 March 2006 revising Schedule H; current Schedule H list as compiled by Laafon Galaxy (verified August 2026). Updated 14 November 2026. Business summary for chemists and distributors, not legal or medical advice.
Related guides: Schedule G drugs list · Schedule H1 list · Schedule X list · Revised Schedule M (GMP) · drug licence guide
Frequently asked questions
What is a Schedule H drug?
A Schedule H drug is a medicine listed in Schedule H of the Drugs Rules, 1945. It may be sold by retail only against the prescription of a Registered Medical Practitioner, and its label must carry the Rx symbol and the Schedule H caution in a red box.
What does ‘Schedule H Prescription Drug – Caution’ on a strip mean?
It means the medicine is prescription-only: a chemist may not sell it by retail without a doctor’s prescription. The caution is printed in a red rectangular box with the Rx symbol at the top left of the label.
What is the difference between Schedule H and Schedule H1?
Both need a prescription. Schedule H1 drugs – higher antibiotics, anti-TB drugs, some habit-forming drugs and, from 16 November 2026, pregabalin – also need a separate H1 register at the chemist and a stricter red Rx label. The H1 drugs were taken out of Schedule H when Schedule H1 was created in 2013.
Is metformin a Schedule H drug?
No. Metformin and insulin preparations are listed in Schedule G, whose caution reads that it is dangerous to take the preparation except under medical supervision.
Is paracetamol a Schedule H drug?
Plain paracetamol is not in Schedule H, which is why it is widely sold without a prescription. Combinations and other strengths can fall under other rules – check the label of each product.
Do I need a special licence to sell Schedule H drugs?
No. A normal retail drug licence (Forms 20 and 21) or wholesale licence (Forms 20B and 21B) covers Schedule H drugs. Schedule X drugs are different and need a separate licence.
Is there a register for Schedule H drugs?
Schedule H sales are recorded in the prescription register or on cash/credit memos with the required particulars. The separate, three-year register is a Schedule H1 requirement.
Can a chemist sell a Schedule H drug without a prescription in an emergency?
The rule does not make an exception: retail sale requires a Registered Medical Practitioner’s prescription. Selling without one can lead to suspension of the licence and prosecution under the Drugs and Cosmetics Act.
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