Drugs Rules, 1945 — India · updated August 2026
Schedule G drugs list: the red-box label, the prescription gap, and the plan to abolish it
Schedule G is the schedule most reference material still gets wrong. The caution text changed in 2018, Schedule G on its own has never made a medicine prescription-only, and in February 2026 the Drugs Technical Advisory Board agreed the whole schedule should be folded into Schedule H. This page carries the full substance list as it is actually printed in the Rules, the current label wording, and what a manufacturer or pharmacist has to do about it now.
01 — Definition
What a Schedule G drug actually is
Schedule G is a labelling schedule, not a sales-restriction schedule. It is an appendix to the Drugs Rules, 1945 listing substances that carry enough inherent therapeutic risk that every internal-use preparation containing them must display a specific cautionary box on the label.[1] Schedule G says nothing about who may buy the medicine or whether a prescription is needed. That is governed separately by Rule 65(9), which names Schedule H, Schedule H1 and Schedule X — and does not name Schedule G.[1]
The distinction matters commercially. If your product contains a Schedule G substance, your artwork changes and your labelling SOP changes. Whether your distributor needs to see a prescription depends on whether the same molecule also appears in Schedule H, H1 or X — a separate check most people skip.
The substances themselves fall into five recognisable therapeutic families: cytotoxic and antineoplastic agents, oral antidiabetics and insulin, anticonvulsants, diuretics, and first-generation antihistamines. What unites them is a narrow therapeutic window or a dose-dependent organ toxicity that makes unsupervised use genuinely dangerous — not abuse potential, which is what Schedule X addresses.
The citation most articles get wrong
The Rules were retitled. Since the Cosmetics Rules, 2020 carved cosmetics out into their own instrument, the correct short title is the Drugs Rules, 1945 — the words “and Cosmetics” were omitted from rule 1(1). Every gazette notification and DTAB minute issued since uses “Drugs Rules, 1945”.[1] The parent statute is still the Drugs and Cosmetics Act, 1940. Citing “Drugs and Cosmetics Rules, 1945” in a regulatory dossier is not fatal, but it dates the document.
02 — Labelling
“SCHEDULE G PRESCRIPTION DRUG” — the red box on the strip
If you have arrived here after reading that phrase off a tablet strip or a syrup carton, this is what it means. The wording is prescribed by Rule 97(1)(a) of the Drugs Rules, 1945, and it must appear in legible black lettering inside a completely red rectangular box.[1]
A large amount of published reference material — including textbooks, exam guides and pharmacy blogs — still prints the pre-2018 wording and states that Schedule G carries no red border. That is out of date. Clauses (a) to (e) of Rule 97(1) were substituted in full by the Drugs and Cosmetics (Fifth Amendment) Rules, 2018, notified as G.S.R. 408(E) on 26 April 2018 and in force from 1 November 2018.[2] The old formulation — a caution “surrounded by a line within which there shall be no other words” — no longer describes the requirement.
SCHEDULE G PRESCRIPTION DRUG – CAUTION
It is dangerous to take this preparation except under medical supervision.
Legible black font inside a completely red rectangular box, on the innermost container and every outer covering.[1]
Caution: it is dangerous to take this preparation except under medical supervision
Plain rule around the text, no colour specified, no schedule name in the box. Still quoted as current by many sources.
Three points artwork reviewers miss
- Internal use only. Rule 97(1) opens with “the container of a medicine for internal use”, and the Note appended to Schedule G confirms it: preparations containing the listed substances are covered excluding those intended for topical or external use.[1] A diphenhydramine cream does not need the box. A diphenhydramine syrup does.
- The catch-all proviso. Rule 96(1)(xi), as substituted by the same 2018 amendment, requires the red-box caution or warning for a listed set of pharmacological categories — narcotic analgesics, hypnotics, sedatives, tranquillisers, corticosteroids, hormones, hypoglycaemics, antimicrobials, antiepileptics, antidepressants, anticoagulants and anticancer drugs — whether or not the molecule appears in G, H, H1 or X. Where it falls in none of them, the Schedule H warning applies by default.[2] Do not assume a molecule’s absence from Schedule G exempts the carton.
- Both boxes can apply. Rule 97(1) clauses operate independently. A substance in Schedule G and Schedule H attracts the Schedule G caution and the Rx symbol plus the Schedule H box. In practice most manufacturers print the Schedule H box and drop the Schedule G one, which is a labelling deviation a drug inspector can cite.
03 — The list
The Schedule G drugs list, as printed and as spelled today
Sixty named substances are specified, plus one open class entry covering tetra-N-substituted derivatives of ethylenediamine or propylenediamine. Because several entries carry “its salts”, “its derivatives” or “all types”, the number of finished products affected is far larger than sixty.[1]
Why your search of the Rules returns nothing
Schedule G has never been retyped. Around a dozen entries carry spellings that no longer match any pharmacopoeial or INN name — Primadone, Procarpazine, Quinthazone, Cytarrabine, Mammomustine, Elurophosphate, Phenindomine, Triprolidone, benzothiadrazine. If a compliance officer searches the consolidated Rules for “Primidone” or “Procarbazine”, it will not be found. Both columns below are given for exactly this reason.
| As printed in Schedule G | Current standard name | Therapeutic class |
|---|---|---|
| Aminopterin | Aminopterin | Folate antagonist, antineoplastic |
| Bleomycin | Bleomycin | Antitumour antibiotic |
| Busulphan; its salts | Busulfan | Alkylating antineoplastic |
| Carbutamide | Carbutamide | Sulfonylurea, antidiabetic |
| Chlorambucil; its salts | Chlorambucil | Alkylating antineoplastic |
| Chlorthiazide and other derivatives of 1, 2, 4 benzothiadrazine | Chlorothiazide; benzothiadiazine class | Thiazide diuretic |
| Chlorpropamide; its salts | Chlorpropamide | Sulfonylurea, antidiabetic |
| Chlorthalidone and other derivatives of Chlorbenzene compound | Chlortalidone | Thiazide-like diuretic |
| Cis-Platin | Cisplatin | Platinum antineoplastic |
| Cyclophosphamide; its salts | Cyclophosphamide | Alkylating antineoplastic |
| Cytarrabine | Cytarabine | Pyrimidine antimetabolite |
| Daunorubicin | Daunorubicin | Anthracycline antineoplastic |
| Di-Isopropyl Elurophosphate | Di-isopropyl fluorophosphate | Cholinesterase inhibitor, ophthalmic |
| Disodium Stilboestrol Diphosphate | Fosfestrol (stilboestrol diphosphate) | Oestrogen, hormonal antineoplastic |
| Doxorubicin Hydrochloride | Doxorubicin hydrochloride | Anthracycline antineoplastic |
| Ethacrynic Acid; its salts | Etacrynic acid | Loop diuretic |
| Ethosuximide | Ethosuximide | Anticonvulsant, absence seizures |
| Glibenclamide | Glibenclamide (glyburide) | Sulfonylurea, antidiabetic |
| Hydantoin; its salts, its derivatives, their salts | Hydantoin class, including phenytoin | Anticonvulsant class entry |
| Insulin, all types | Insulin, all types | Antidiabetic |
| Hydroxyurea | Hydroxycarbamide | Antineoplastic, antimetabolite |
| Lomustine Hydrochloride | Lomustine | Nitrosourea antineoplastic |
| Mammomustine; its salts | Mannomustine | Nitrogen mustard |
| Mercaptopurine; its salts | Mercaptopurine | Purine antimetabolite |
| Metformin; its salts | Metformin | Biguanide, antidiabetic |
| Methsuximide | Mesuximide | Anticonvulsant |
| Mustine; its salts | Chlormethine (mustine) | Nitrogen mustard, vesicant |
| Paramethadione | Paramethadione | Oxazolidinedione anticonvulsant |
| Phenacemide | Phenacemide | Anticonvulsant, last-resort |
| Phenformin; its salts | Phenformin | Biguanide, withdrawn in India |
| 5-Phenylhydantoin, its alkyl and aryl derivatives; its salts | Phenylhydantoin derivatives | Anticonvulsant class entry |
| Primadone | Primidone | Anticonvulsant |
| Procarpazine Hydrochloride | Procarbazine hydrochloride | Antineoplastic, weak MAO inhibitor |
| Quinthazone | Quinethazone | Thiazide-like diuretic |
| Sarcolysine | Melphalan (L-sarcolysin) | Alkylating antineoplastic |
| Sodium 2 Mercaptoethanesulfonate | Mesna | Uroprotectant, cytotoxic support |
| Tamoxifen Citrate | Tamoxifen citrate | Anti-oestrogen, hormonal antineoplastic |
| Testolactone | Testolactone | Steroidal aromatase inhibitor |
| Thiotepa | Thiotepa | Alkylating antineoplastic |
| Tolbutamide | Tolbutamide | Sulfonylurea, antidiabetic |
| Tretamine; its salts | Triethylenemelamine | Alkylating antineoplastic |
| Troxidone | Trimethadione | Oxazolidinedione anticonvulsant |
| Antazoline | Antazoline | First-generation antihistamine |
| Bromodiphenhydramine | Bromazine (bromodiphenhydramine) | First-generation antihistamine |
| Buclizine | Buclizine | Piperazine antihistamine |
| Chlorcyclizine | Chlorcyclizine | Piperazine antihistamine |
| Chlorpheniramine | Chlorphenamine (chlorpheniramine) | First-generation antihistamine |
| Clemizole | Clemizole | Benzimidazole antihistamine |
| Cyproheptadine | Cyproheptadine | Antihistamine, antiserotonergic |
| Diphenhydramine | Diphenhydramine | First-generation antihistamine |
| Diphenyl pyraline | Diphenylpyraline | First-generation antihistamine |
| Doxylamine Succinate | Doxylamine succinate | Antihistamine, sedative, antiemetic |
| Isothipendyl | Isothipendyl | Azaphenothiazine antihistamine |
| Mebhydrolin Napadisylate | Mebhydrolin napadisilate | First-generation antihistamine |
| Meclozine | Meclozine (meclizine) | Piperazine antihistamine, antiemetic |
| Phenindomine | Phenindamine | First-generation antihistamine |
| Pheniramine | Pheniramine | First-generation antihistamine |
| Promethazine | Promethazine | Phenothiazine antihistamine |
| Thenalidine | Thenalidine | First-generation antihistamine |
| Triprolidone | Triprolidine | First-generation antihistamine |
| Substances being tetra-N-substituted derivatives of Ethylene Diamine or Prophylenediamine | Tetra-N-substituted ethylenediamine and propylenediamine derivatives | Open class entry, antihistamine |
Swipe the table sideways on a phone. Entries are reproduced as printed; the middle column gives the name a modern search or pharmacopoeial index will recognise.
04 — The prescription question
Does a Schedule G drug need a prescription?
Not by virtue of Schedule G alone. Rule 65(9)(a) of the Drugs Rules, 1945 provides that substances specified in Schedule H and Schedule H1, or Schedule X, shall not be sold by retail except on and in accordance with the prescription of a Registered Medical Practitioner. Schedule G is not in that list, and no other rule supplies the omission.[1] A Schedule G substance becomes prescription-only when it is also specified in Schedule H, H1 or X.
Most of the cytotoxics in Schedule G are covered, because they appear in Schedule H as well — bleomycin, cisplatin and doxorubicin hydrochloride are all listed there.[1] The gap sits in the oral antidiabetic and antihistamine blocks. Checking the two highest-volume examples against the Schedule H list in the consolidated Rules:
Worked check — metformin and glibenclamide
Schedule H runs alphabetically and includes gliclazide, glimepiride, glucagon and glydiazinamide, but not glibenclamide; and metaxalone, methicillin sodium and methocarbamol, but not metformin.[1] Both molecules are in Schedule G. Neither is in Schedule H, H1 or X. Under the letter of Rule 65(9) neither is therefore a statutory prescription-only medicine in India — only a medicine that must carry the Schedule G caution box.
This is a description of the rule as written, not clinical advice. Sulfonylureas cause severe hypoglycaemia and metformin carries a real risk of lactic acidosis in renal impairment. Neither should ever be started, stopped or dose-adjusted without a doctor. The regulator agrees the gap is a problem, which is exactly why it is being closed — see section 07.
Two practical consequences for anyone working in the trade:
- Verify per molecule, not per schedule. The Schedule H list is amended by notification and the salts-and-derivatives Notes to both schedules extend cover beyond the printed names. Check your specific active against the current consolidated text before writing an SOP position.
- Advertising follows the same split. The restriction requiring prior sanction of the Central Government applies to advertisements of drugs specified in Schedule H, H1 and X. In its 93rd meeting DTAB recommended putting that restriction on a clearer statutory footing for sale licensees — again naming H, H1 and X, and again not naming G.[3]
05 — Artwork tool
Which caution box does your product need?
Answer three questions about the finished pack. The tool applies Rule 97(1), the Note to Schedule G and Rule 65(9) in the order a drug inspector would.
Select an option in each question
The verdict and the governing provision will appear here.
Drugs Rules, 1945
Indicative guidance for artwork review only. Confirm against the current consolidated Rules and your State Licensing Authority before releasing a pack.
06 — Comparison
Schedule G against H, H1, H2 and X
Five schedules are commonly confused. They control different things: G controls the caution, H and H1 control the prescription, H2 controls traceability, X controls storage and licensing.
Schedule G — inherent toxicity, controlled by caution
Substances whose therapeutic index or organ toxicity makes unsupervised use dangerous. The control instrument is the label, not the counter.
Schedule H — the general prescription schedule
The main prescription-only list, and the destination DTAB has chosen for Schedule G. Sale by retail is lawful only against an RMP prescription.
Schedule H1 — prescription plus a dedicated register
Introduced in 2013 to slow antimicrobial resistance and the misuse of certain habit-forming molecules. Everything in Schedule H applies, with an extra record.
Schedule H2 — traceability, not prescription
Schedule H2 sits under the labelling rule and requires a barcode or QR code on the pack for authentication across the supply chain. It is routinely misdescribed as a prescription schedule; it is not one, and it changes nothing about dispensing.
Schedule X — abuse potential, controlled by licence
The strictest retail category, and the clearest contrast with Schedule G. Schedule X is about diversion risk; Schedule G is about toxicity.
Full detail on each: Schedule H drugs list · Schedule H1 drug list · Schedule X drugs list
07 — What changed in 2026
Schedule G is being merged into Schedule H
On 16 February 2026 the Drugs Technical Advisory Board took up a proposal to amend the Drugs Rules, 1945 to prohibit advertisements of drugs specified in Schedule G. It declined — and the reason it gave is the significant part.
The Board recorded that DTAB had already recommended, in its 92nd meeting on 24 April 2025, that all drugs mentioned under Schedule G be shifted to Schedule H for better regulatory control. It then agreed to withdraw the draft notification G.S.R. 375(E) dated 10 July 2024 proposing the advertising ban, on the reasoning that once the substances move to Schedule H the advertising question resolves itself.[3]
Read together, that is a regulator saying the caution-label-only model no longer works. Moving the list into Schedule H would, in one step, make every Schedule G substance prescription-only under Rule 65(9), bring it inside the existing advertising restriction, and close the metformin and glibenclamide gap described above.
A transparency note on the source trail
The merger recommendation is recorded in the approved minutes of the 93rd meeting. The published minutes of the 92nd meeting, where it was actually made, deal with the Schedule H review at Agenda No. 11 and record only that DTAB agreed with the sub-committee report and recommended appropriate amendments — the contents of that report are not reproduced.[5] The 93rd minutes are therefore the primary citable record of the recommendation. Both are linked below.
What has and has not happened
- Recommended, not yet notified. As at 16 August 2026 no gazette notification transferring Schedule G into Schedule H has been traced. A DTAB recommendation is advice to the Central Government; it takes a draft notification, a 30-day objection window and a final notification before anything binds.
- The advertising ban is dead. The 2024 draft G.S.R. 375(E) has been withdrawn.[3] Any article still describing an imminent ban on Schedule G advertising is describing a proposal the Board has abandoned.
- Plan artwork on a lead time. If the transfer is notified, every affected pack picks up the Rx symbol and the Schedule H box, and every retail licensee picks up a prescription obligation on molecules currently sold without one. For a mid-size formulation portfolio that is a serious artwork and stock-run-out exercise. Start the impact assessment now rather than at notification.
08 — Consequences
What a labelling failure actually costs
A drug that is not labelled in the manner prescribed by the Rules is a misbranded drug under section 17 of the Drugs and Cosmetics Act, 1940. Missing or non-compliant Schedule G caution artwork is a labelling contravention, not an adulteration or spurious-drug offence, so it falls to the residual penalty clause.
| Provision | Covers | Penalty |
|---|---|---|
| Section 27(d) | Any drug in contravention of any other provision of Chapter IV or any rule made under it — the clause a Schedule G labelling defect normally attracts | Imprisonment not less than one year, up to two years, and a fine not less than ₹20,000. A court may impose less for adequate and special reasons recorded in the judgment[4] |
| Section 27(b) | Adulterated drugs, and manufacture or sale without a valid licence | Imprisonment not less than three years, up to five years, and a fine not less than ₹1 lakh or three times the value of the drugs confiscated, whichever is more[4] |
| Section 27(c) | Drugs deemed spurious under section 17B, other than those causing death or grievous hurt | Imprisonment not less than seven years, up to life, and a fine not less than ₹3 lakh or three times the value confiscated[4] |
| Licence action | Independently of prosecution, breach of a licence condition | Suspension or cancellation of the licence by the State Licensing Authority under Rule 66[1] |
Several published guides state that a Schedule G misbranding offence carries three to five years’ imprisonment. That is the penalty under section 27(b), which covers adulterated drugs and unlicensed manufacture — not labelling defects. Quoting it in a compliance training deck overstates the exposure by a factor of two and, more damagingly, signals that the source has not been read.[4] The correct starting point for a labelling contravention is section 27(d). Which clause a prosecutor actually charges depends on the facts.
09 — FAQ
Frequently asked questions
It means the pack contains a substance listed in Schedule G of the Drugs Rules, 1945, and the manufacturer is required by Rule 97(1)(a) to print that caution in black inside a completely red rectangular box. The message is that the medicine carries enough inherent risk that it should be taken only under a doctor’s supervision. It is a safety warning about the molecule, not a statement that the pharmacist broke a rule by selling it to you.
Sixty named substances are specified, plus one open class entry covering tetra-N-substituted derivatives of ethylenediamine or propylenediamine. Because many entries are written as the substance and its salts or derivatives, and because insulin is listed as all types, the number of finished formulations caught by the schedule is considerably larger than sixty.
Schedule G by itself does not create a prescription requirement. Rule 65(9)(a) restricts retail sale to prescription for substances specified in Schedule H, Schedule H1 and Schedule X only. Most Schedule G cytotoxics are also in Schedule H and are therefore prescription-only through that route. A handful of entries, including metformin and glibenclamide, are not — which is precisely the gap DTAB proposes to close by moving the whole schedule into Schedule H. None of this means these medicines are safe to self-medicate.
Schedule G controls the label: it requires a red-box caution stating that the preparation is dangerous without medical supervision. Schedule H controls the counter: it makes retail sale unlawful without a Registered Medical Practitioner’s prescription and requires the Rx symbol and its own red-box warning. The two overlap heavily but are not the same, and a molecule can be in one without the other.
No. Rule 97(1) applies to the container of a medicine for internal use, and the Note appended to Schedule G expressly excludes preparations intended for topical or external use. A diphenhydramine or promethazine topical preparation is outside the schedule; the same actives in a syrup or tablet are inside it. Note that Schedule H takes the opposite position for steroids and hydroquinone, which are covered even for topical use.
Metformin and its salts are specified in Schedule G. Metformin does not appear in the Schedule H list in the consolidated Drugs Rules, 1945, which runs alphabetically from metaxalone to methicillin sodium without it. Its packs must therefore carry the Schedule G red-box caution, and under the rule as written it is not a statutory prescription-only medicine. If the DTAB recommendation to move Schedule G into Schedule H is notified, that changes.
No. The draft notification G.S.R. 375(E) dated 10 July 2024, which proposed prohibiting advertisements of Schedule G drugs, was withdrawn on the recommendation of DTAB at its 93rd meeting on 16 February 2026. The Board reasoned that shifting Schedule G substances into Schedule H would bring them inside the existing advertising restriction automatically, making the separate notification unnecessary.
Rule 97(1)(a) of the Drugs Rules, 1945, as substituted by the Drugs and Cosmetics (Fifth Amendment) Rules, 2018, notified vide G.S.R. 408(E) dated 26 April 2018 and in force from 1 November 2018. Rule 96(1)(xi), amended by the same notification, adds the requirement that the caution appear in legible black font in a completely red rectangular box without disturbing the other particulars on the label.
Sources
References
- Central Drugs Standard Control Organisation. The Drugs Rules, 1945 — consolidated text as amended vide G.S.R. 360(E) dated 1 July 2024. New Delhi: Ministry of Health and Family Welfare; 2024. Schedule G and its Note, Schedule H and its Notes, rules 65, 96 and 97. Available from: cdsco.gov.in. Accessed August 2026.
- Ministry of Health and Family Welfare. Drugs and Cosmetics (Fifth Amendment) Rules, 2018. Notification G.S.R. 408(E) dated 26 April 2018, in force 1 November 2018; substituting rule 96(1)(xi) and rule 97(1) clauses (a) to (f). Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i). Index available from: cdsco.gov.in gazette notifications. Accessed August 2026.
- Central Drugs Standard Control Organisation. Minutes of the 93rd meeting of the Drugs Technical Advisory Board held on 16 February 2026, Agenda Nos. 5 and 14. New Delhi: CDSCO; 2026. Available from: cdsco.gov.in. Accessed August 2026.
- Government of India. The Drugs and Cosmetics Act, 1940 (Act 23 of 1940), sections 17 and 27, as amended by Act 26 of 2008 with effect from 10 August 2009. New Delhi: Ministry of Health and Family Welfare. Available from: cdsco.gov.in acts and rules. Accessed August 2026.
- Central Drugs Standard Control Organisation. Minutes of the 92nd meeting of the Drugs Technical Advisory Board held on 24 April 2025, Agenda No. 11. New Delhi: CDSCO; 2025. Available from: cdsco.gov.in. Accessed August 2026.
This page is a regulatory reference written for pharmaceutical professionals. It is not medical advice, and nothing here should be used to start, stop or change any medicine. It is also not a substitute for the official text of the Act and Rules, which prevail over any summary. Indian drug schedules are amended by government notification and a recommendation is not a rule — verify current status before making a compliance decision.
Related on laafon.com
The rest of the schedule cluster
Reclassifying a portfolio before the merger lands
If Schedule G moves into Schedule H, every affected SKU needs new artwork, a revised labelling SOP and a stock-run-out plan. We review schedule classification, caution-box artwork and labelling SOPs against the current consolidated Rules — backed by 23+ years in pharmaceutical QA, QC and drug regulatory affairs.
