Schedule H Drugs List 2026: 526 Molecules, Labelling and Dispensing Rules

Last verified: 8 August 2026

Schedule H is the list of drug substances under the Drugs and Cosmetics Rules, 1945 that may be sold by retail in India only against the prescription of a Registered Medical Practitioner. This page carries the complete searchable list, the exact labelling wording the Rules require, and the dispensing, record-keeping and licensing obligations that follow from it — written for manufacturers, marketers, distributors, pharmacies and compliance teams.

The complete Schedule H drugs list

Type a molecule to check it, or browse all 526 entries alphabetically. The search also matches INN equivalents and alternative spellings, so you do not need to know the gazette’s spelling — searching “Allopurinol” will find the notified entry “Aliopurinol”.

Frequently checked: Pantoprazole Ondansetron Alprazolam Metformin Nimesulide Cetirizine

Method and known limits

How this list was compiled

Most Schedule H lists online are copies of copies. This one states its provenance and its gaps, because a labelling or licensing decision taken on an unverified list is worse than no list at all.

• Source. The Schedule H annexure to the Drugs and Cosmetics Rules, 1945, as amended, transcribed and reconciled entry by entry.
• De-duplication. 19 molecules that appeared twice in the earlier transcription were reduced to one entry each — the whole D–E block had been duplicated.
• Vacant serials. 25 serial positions carry no molecule name. They align with where entries omitted to Schedule H1 in 2013 would fall alphabetically: Alprazolam sits exactly between Alphachymotrypsin and Alprostadil, and a run of cephalosporins follows Cefazolin Sodium. They are recorded but not reproduced as rows, which is why published counts of Schedule H vary between roughly 526 and 550.
• Gazette spellings retained. The notified text uses several non-standard spellings — Aliopurinol, Aminepline, Cefatoxime, Genodeoxycholic, Methylprednisone, Primonidine. These are shown as notified, with the standard INN added underneath and made searchable.
• Class entries counted once. Broad entries such as “Antibiotics”, “Corticosteroids” and “Ergot Alkaloids” appear as single entries covering whole classes, and are counted as one each.

Open item. Reconciling the 25 vacant serials against the 2013 omission notification is in progress. Until that is complete, treat 526 as the count of confirmed live entries rather than a definitive total. If you hold the gazette copy and spot an omission, tell us and we will correct it.

Definition and legal basis

What Schedule H actually is

The core definition

Schedule H is an appendix to the Drugs and Cosmetics Rules, 1945, listing drug substances that a chemist may not sell by retail without a written directive from a qualified doctor. In international terminology these are Prescription-Only Medicines. The Drugs and Cosmetics Act, 1940 supplies the statutory framework — it defines what a drug is and creates the power to regulate — while the Rules of 1945 carry the operative detail, including the schedules themselves.

Why the schedule exists

• Patient safety. Many listed molecules have narrow therapeutic indices or interaction profiles that need professional monitoring.
• Antimicrobial resistance. Restricting antibiotic access is India’s principal regulatory tool against drug-resistant infection. The most sensitive antibiotics were moved out of Schedule H into the stricter Schedule H1 in 2013 precisely for this reason.
• Prevention of misuse. Sedatives, hormonal preparations and potent analgesics can be abused or misapplied without a diagnosis.

How the list changes

Schedule H is not static. It is amended by gazette notification on the advice of the Drugs Technical Advisory Board (DTAB), with notifications issued through the Central Drugs Standard Control Organisation (CDSCO) under the Ministry of Health and Family Welfare. The current consolidated rules, including Schedule H itself, are published on the CDSCO Acts and Rules portal — that is the text to check before any labelling or licensing decision. Molecules are added as new drugs are approved for marketing, and removed or reclassified when safety concerns emerge.

Who enforces it

The Central Government notifies the schedule; enforcement sits largely with State Drug Controllers. Drug Inspectors appointed by state governments inspect retail pharmacies, wholesalers and hospitals to confirm that Schedule H drugs are not being sold over the counter or without documentation. This is why practice varies noticeably between states even though the underlying rule does not. Our Drugs and Cosmetics Act coverage tracks the notifications as they issue.

Broad therapeutic categories

Schedule H spans hundreds of active pharmaceutical ingredients. Indicative groupings, with examples drawn from the list above:

• Anti-infectives — Ciprofloxacin, Clarithromycin, Metronidazole, Fluconazole-class antifungals, Acyclovir.
• Cardiovascular — Atenolol, Amlodipine Besylate, Ramipril Hydrochloride, Atorvastatin, Telmisartan.
• Anti-diabetics — Glimepiride, Gliclazide, Repaglinide, Pioglitazone Hydrochloride. Note that Metformin is a Schedule G drug, not Schedule H, and does not appear in the list above — see the Schedule G drugs list for where it and the insulin preparations sit.
• Psychotropics — Sertraline, Olanzapine, Risperidone, Quetiapine Fumarate, and sedatives not controlled under Schedule X.
• Corticosteroids and hormones — a class entry for corticosteroids plus specific topical steroids, and the androgenic, anabolic, oestrogenic and progestational substances entry.
• Analgesics and NSAIDs — Diclofenac, Ibuprofen, Meloxicam, Nimesulide, Tramadol Hydrochloride.

What the pack actually says

Decoding “Schedule H Prescription Drug – Caution”

The most misread line on an Indian medicine strip. It is a sale-control marking — not a safety grade, and not an indication.

Where each element comes from

• The ℞ symbol. Rule 97(1)(b) requires it conspicuously on the left top corner of the label of the innermost container and every other covering in which the container is packed.
• The red rectangular box. The Drugs and Cosmetics (Fifth Amendment) Rules, 2018, notified vide G.S.R. 408(E) dated 26 April 2018, amended Rule 96(1)(xi) so that the Schedule G, H, H1 or X caution is printed in legible black coloured font inside a completely red rectangular box, without disturbing the other particulars on the label.
• NRx in place of ℞. Applies where the Schedule H substance also falls within the NDPS Act, 1985. The symbol is printed in red.
• A second warning about medical advice. That is Schedule H1, not Schedule H — see the comparison below.
• Generic name larger than the brand. Separately, the Drugs and Cosmetics (First Amendment) Rules, 2018, G.S.R. 222(E) dated 13 March 2018, amended Rule 96 to require the proper (generic) name in the same font but at least two font sizes larger than the brand name.

What the caution does not tell you. It is word-for-word identical on an antihypertensive tablet, an antibiotic and a cytotoxic injection. It carries no information about the indication, the strength, the risk profile or the dose. If you are trying to work out what a tablet is for, the caution box is not the place to look — the pack insert and the prescription are.

Where Schedule H sits

Schedule H vs H1 vs X vs G

Four control levels, four label markings, four record obligations. Confusing them is the most common cause of a retail licence action.

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On the “subset” myth. Schedule H1 is commonly described as a subset of Schedule H. The notification that created it — the Drugs and Cosmetics (Fourth Amendment) Rules, 2013, G.S.R. 588(E) dated 30 August 2013 — also directed that the corresponding entries be omitted from Schedule H. That is consistent with Schedule H’s serial numbering running past 550 while carrying fewer live entries. Treat H and H1 as parallel lists and check which one a molecule is actually on — the Schedule H1 drug list carries the H1 side, and the Ministry’s own statement of the H1 selling conditions sets out the register and labelling requirements as notified.

On OTC. India has no positively defined OTC schedule. Medicines sold without a prescription generally rely on the exemptions in Schedule K or on simply not being scheduled at all. A molecule’s absence from Schedule H therefore proves nothing on its own — check H1, X and G before concluding that a product is unrestricted. The Schedule X drugs list is the shortest of the three and the fastest to rule out.

At the counter

Prescription and dispensing rules

The point of sale is where Schedule H compliance is tested most often, and where inspection findings concentrate.

Who may prescribe

Only a Registered Medical Practitioner. In practice this means a qualification recognised by the National Medical Commission (MBBS, MD and above) or by the Dental Council of India (BDS, MDS) within the scope of dental practice.

On AYUSH practitioners: practitioners of Ayurveda, Unani, Siddha and Homoeopathy may prescribe within their own systems. Whether they may prescribe allopathic Schedule H drugs is contested and turns on state-level notifications rather than the central Rules, so the position differs between states. Treat it as a state-specific question, not a settled national one.

What makes a prescription valid

• Date of issue.
• Patient’s name, with age and sex.
• Prescriber’s name, qualification, registration number and signature.
• Drug name, strength, dosage and duration.

Rules the dispensing pharmacist must follow

• No substitution. Rule 65(11-A) provides that a person dispensing a prescription containing a Schedule H, H1 or X drug shall not supply any other preparation in its place, whether or not it contains the same substances. This is a rule, not a commercial judgement call.
• Supply only the quantity prescribed. The amount dispensed must match the prescription.
• No repeat dispensing by default. A Schedule H prescription is treated as valid for a single dispensing event unless the prescriber has expressly authorised a repeat on the prescription itself.
• Partial dispensing is permitted where a patient cannot take the full course at once, provided the quantity supplied is endorsed on the original prescription.
• Registered pharmacist supervision. The sale must be made by or under the personal supervision of a registered pharmacist, and the entry signed accordingly.

Documentation

Record-keeping and audit trail

Documentation is the pharmacy’s primary defence in an inspection. The obligations differ sharply between H and H1, and this is where most sites get it wrong.

Schedule H: no dedicated register

Unlike H1 and X, Schedule H does not require a separate “Schedule H register”. What Rule 65 does require:

• Prescription register. Supply against a prescription is recorded at the time of supply in a prescription register maintained for the purpose, with the serial number of the entry endorsed on the prescription itself.
• Purchase records. Invoices from wholesalers, retained and available.
• Cash or credit memo for each sale, bearing the date, the licensee’s name, address and licence number, the drug name and quantity, and — for Schedule H and H1 substances — the manufacturer’s name, batch number and date of expiry, under Rule 65(5)(f).
• Signed written orders. Supplies of Schedule H, H1 or X drugs to Registered Medical Practitioners, hospitals, dispensaries and nursing homes are made only against a signed order in writing, which the licensee preserves for two years under Rule 65(9)(a).

Schedule H1: three years, separate register

Where a molecule is in Schedule H1, Rule 65(9)(h) requires the supply to be recorded in a separate register at the time of supply, giving the prescriber’s name and address, the patient’s name, the drug name and the quantity supplied. That register must be maintained for three years and be open to inspection. Entries may not be mixed into the general prescription register.

Practical points that survive an inspection

• A POS system that captures the Rule 65 fields automatically is worth more than a neat manual register, because it removes the transcription gap inspectors probe first.
• Scanning prescriptions is not mandatory for plain Schedule H, but it demonstrates diligence and costs nothing.
• Keep the H1 register physically distinct and currently written up. An H1 register reconstructed after an inspection notice is worse than an incomplete one.

Upstream of the counter

Manufacturing, import and distribution controls

Licences

• Form 25 — licence to manufacture for sale or distribution drugs other than those specified in Schedules C and C(1). Manufacturing premises must also meet Revised Schedule M GMP requirements.
• Form 28 — licence to manufacture drugs specified in Schedules C and C(1).
• Form 20 / 21 — retail sale. Form 20-B / 21-B — wholesale. These cover Schedule H; no additional licence class is needed for it.
• Form 20-F / 20-G — retail and wholesale of Schedule X drugs specifically. A Schedule H licence does not cover Schedule X.

Distribution restrictions

A wholesaler may supply Schedule H drugs only to another licensed retailer or wholesaler, to a hospital or dispensary, or to a registered medical practitioner or research institution against a signed order. Direct supply to consumers is not permitted. Marketers operating on a PCD or franchise model and companies supplying under third-party manufacturing arrangements sit inside this chain and carry the same distribution obligations.

Pharmacovigilance

Marketing authorisation holders are expected to monitor adverse drug reactions for their Schedule H products and report to the Pharmacovigilance Programme of India (PvPI). For manufacturers pursuing export registration, a documented PV system is increasingly a dossier requirement in African and Southeast Asian markets, not merely a domestic obligation.

Promotion

Advertising, promotion and ethics

Direct-to-consumer advertising is prohibited

Under the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, read with the Drugs and Cosmetics Rules, advertising prescription medicines to the public is not permitted. This is why no antibiotic or antihypertensive brand is advertised on Indian television, and why social media promotion of a Schedule H brand to a general audience is a live enforcement risk rather than a grey area.

Promotion to healthcare professionals

Schedule H products may be promoted only to Registered Medical Practitioners, governed by the Uniform Code of Pharmaceutical Marketing Practices (UCPMP). Promotional material must be scientifically accurate and balanced. Gifts, travel, hospitality or monetary inducements to prescribers breach both the UCPMP and National Medical Commission professional conduct rules, and expose the prescriber as well as the company.

Digital health

E-prescriptions and online pharmacies

E-pharmacy growth has moved Schedule H enforcement into territory the 1945 Rules never anticipated, and the position is still consolidating.

When a digital prescription is valid

Under the Telemedicine Practice Guidelines, 2020, an electronically generated prescription issued by an RMP and transmitted to the patient or pharmacy is valid where it carries the prescriber’s identifying details and signature. A photograph of an old paper prescription forwarded by a patient, without a date or identifiable prescriber, generally is not.

Telemedicine medicine lists

• List O — may be prescribed through any mode of consultation.
• List A — may be prescribed on a first video consultation, or re-prescribed.
• List B — an add-on list for a follow-up consultation.
• Prohibited list — may not be prescribed through telemedicine at all. Schedule X and NDPS-controlled substances sit here.

E-pharmacy obligations

An online pharmacy must verify a valid prescription before dispatching a Schedule H medicine, and remains subject to the same Rule 65 record obligations as a physical retailer. Automatic refills against an expired or previously used prescription are a compliance exposure. Note also that the regulatory framework for online pharmacy operation in India remains unsettled and has been the subject of litigation and repeated draft rules — verify the current position before building a process around it.

Enforcement

Common compliance pitfalls and penalties

What inspections actually find

1. Counter prescribing — supplying an antibiotic or analgesic on the customer’s description of symptoms, with no prescription.
2. Missing or incomplete records — cash memos without prescriber details, or signed orders not retained for the full two years.
3. H1 entries in the general register — a very common finding, and an easy one for an inspector to establish.
4. Physician samples on the shelf — “Physician Sample – Not for Sale” packs offered for retail sale.
5. Expired stock not segregated from saleable stock.
6. Substitution against a scheduled prescription, contrary to Rule 65(11-A).

Consequences

Contraventions relating to sale without a valid prescription or without a licence are dealt with under Section 27 of the Drugs and Cosmetics Act, which provides for imprisonment and fine, with the term depending on the nature of the contravention. Separately and often more immediately, the State Drug Controller may suspend or cancel the retail licence in Form 20/21, which stops the business. Where the molecule is also NDPS-controlled, the NDPS Act operates independently and carries substantially heavier consequences. On the manufacturing side, our CDSCO Schedule M compliance dashboard covers the parallel GMP exposure.

Self-check before an inspection

• Is the ℞ caution legible on all stock, in a red rectangular box per G.S.R. 408(E)?
• Is there a valid prescription on record for every Schedule H item sold today?
• Do cash memos carry prescriber name, patient name, batch number and expiry?
• Is the Schedule H1 register separate, current, and complete for three years back?
• Are signed orders to RMPs and institutions filed and retained two years?
• Is the licence displayed, and is the registered pharmacist actually present during sale hours?
• Is expired stock physically segregated from saleable stock?

Takeaways by role

Prescribers

• Prescribe within your registered qualification and system of medicine.
• Include every element that makes the prescription dispensable — date, patient details, registration number, signature.
• If you intend a repeat, say so explicitly on the prescription; the default is single dispensing.
• Check the telemedicine list category before prescribing remotely.

Pharmacies

• No prescription, no sale — including for the customer you have served for fifteen years.
• Keep the H1 register separate and three years deep.
• Never substitute against a scheduled prescription, even for the identical molecule.

Hospitals

• SOPs must physically and procedurally separate H, H1 and X stock.
• Nursing staff administer Schedule H drugs only against a written order on the chart.

Manufacturers and marketers

• Artwork is where Schedule H compliance most often fails at scale — box colour, font legibility, symbol placement and generic-name sizing are all separately specified, and a defect means a recall, not a correction.
• Confirm which schedule a molecule sits on before the artwork proof, not after.
• Hold UCPMP discipline across the field force; the exposure is corporate, not individual.
• Planning a new unit for these products? The pharma plant setup cost calculator models the section-package cost by GMP standard.

Common questions

Frequently asked questions

Related schedules

References

1. Central Drugs Standard Control Organisation. The Drugs and Cosmetics Rules, 1945 (as amended) — Schedule H, and Rules 65, 96 and 97. Ministry of Health and Family Welfare, Government of India. cdsco.gov.in
2. Ministry of Law and Justice. The Drugs and Cosmetics Act, 1940 (23 of 1940). indiacode.nic.in
3. Ministry of Health and Family Welfare. Drugs and Cosmetics (Fourth Amendment) Rules, 2013 — G.S.R. 588(E) dated 30 August 2013, inserting Schedule H1 and omitting the corresponding Schedule H entries. Selling conditions as stated by the Ministry: pib.gov.in
4. Ministry of Health and Family Welfare. Drugs and Cosmetics (Fifth Amendment) Rules, 2018 — G.S.R. 408(E) dated 26 April 2018, amending Rule 96(1)(xi) to require the caution in a completely red rectangular box.
5. Ministry of Health and Family Welfare. Drugs and Cosmetics (First Amendment) Rules, 2018 — G.S.R. 222(E) dated 13 March 2018, generic name font size relative to brand name.
6. Board of Governors in supersession of the Medical Council of India. Telemedicine Practice Guidelines, 2020. Ministry of Health and Family Welfare. mohfw.gov.in
7. Department of Revenue. The Narcotic Drugs and Psychotropic Substances Act, 1985 (61 of 1985), Ministry of Finance, Government of India.
8. Ministry of Health and Family Welfare. Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954.
9. Vijay Malik. Drugs and Cosmetics Act, 1940, 21st edition, pp. 409–416.
10. Kuchekar, B. S. Pharmaceutical Jurisprudence. Nirali Prakashan, 2019.

Disclaimer. This page is educational and professional reference material, not legal or regulatory advice. Schedules and rules are amended by gazette notification and enforcement practice varies between states. Always verify against the current official text published by CDSCO or the Ministry of Health and Family Welfare, and take qualified advice before acting on any point above. Written and maintained by Darshan Singh, pharmaceutical QA and regulatory affairs professional, 23 years in quality control, quality assurance and drug regulatory affairs.