Regulatory position last verified: 23 August 2026, based on notifications published up to that date, including draft G.S.R. 745(E) of 19 August 2026 · Reviewed by Darshan Singh, 23 years in pharmaceutical QC, QA and drug regulatory affairs
In brief
Schedule H1 of the Drugs Rules, 1945 was inserted by the Drugs and Cosmetics (Fourth Amendment) Rules, 2013 under G.S.R. 588(E) dated 30 August 2013, and came into force on 1 March 2014 with 46 entries.[3][5] Later amendments have extended the Schedule, and the draft notification of 19 August 2026 refers to entries running to at least serial number 52.[14] The 51 entries we can name from published sources are listed below; see the note on the numbering gap.
The Central Government has separately notified the inclusion of pregabalin at serial number 51 through G.S.R. 377(E), dated 13 May 2026, published in the Gazette on 20 May 2026.[1][2] The notification provides that the amendment comes into force 180 days after publication in the Official Gazette, so it is not yet operative as at the review date above.[11] Until that effective date, verify the operative Schedule H1 list and any transition instructions issued by CDSCO or the relevant State Licensing Authority.
Where Schedule H1 applies, a drug may be sold by retail only against the prescription of a Registered Medical Practitioner, the supply must be entered in a separate register kept for three years and open to inspection, and the pack must carry the red Rx symbol together with a red-bordered warning box.[3][4]
How the Schedule has grown since 2013
Most summaries of Schedule H1 online still reproduce only the original 46 names. The Schedule has been amended several times since, and the serial numbering runs consecutively, which is why the pregabalin entry is numbered 51 rather than 47.
| Serial | Entry | Notification | Status |
|---|---|---|---|
| 1–46 | Original list of 46 substances | G.S.R. 588(E), 30 Aug 2013 | In force from 1 Mar 2014[5] |
| 47 | Oxytocin (moved out of Schedule H) | G.S.R. 795(E), 21 Aug 2018 | Reported in force[12] |
| 48 | Tapentadol | G.S.R. 258(E), 7 Apr 2021 | Reported in force[12] |
| 49 | Oseltamivir | G.S.R. 95(E), 5 Feb 2024 (draft G.S.R. 686(E), 25 Sep 2023) | In force[1][13] |
| 50 | Zanamivir | G.S.R. 95(E), 5 Feb 2024 | In force[1][13] |
| 51 | Pregabalin | G.S.R. 377(E), 13 May 2026 | Notified; commences 180 days after publication[1][11] |
| 52 | Not identified in published sources | Referenced by G.S.R. 745(E), 19 Aug 2026 | Existence confirmed by the draft notification; entry name unverified[14] |
| 53–56 | Flupentixol, Zopiclone, Gabapentin, Carisoprodol | Draft G.S.R. 745(E), 19 Aug 2026 | Draft only. Not in force. 30-day objection window, then 180 days from publication of the final rules[14][15] |
This table scrolls sideways on a narrow screen. Serial numbers 47 and 48 are taken from a trade-press index of Drugs Rules notifications rather than from a gazette PDF we could open directly. Confirm the serial assignment for oxytocin and tapentadol against the current consolidated Drugs Rules, 1945 before relying on the number itself.
An open numbering gap, stated plainly
The draft notification of 19 August 2026 inserts its new entries after serial number 52.[14] That is direct evidence that Schedule H1 contains an entry at serial 52 which we have not been able to identify from any published notification or gazette index. CDSCO’s own gazette notifications page shows only one Schedule H1 amendment in 2026, the pregabalin notification.[1]
Two things follow. First, the list below should be read as the entries we can name and source, not as a certified complete Schedule. Second, if you need a legally reliable list, obtain the current consolidated Schedule H1 from the Drugs Rules, 1945 or from your State Licensing Authority rather than from any website, including this one. We will update this page when the entry at serial 52 can be identified from a primary source.
What the 2026 pregabalin notification means in practice
The Ministry of Health and Family Welfare acted on reports from several states of misuse among young people, who were taking pregabalin for sedative, euphoric and dissociative effects, and on seizures of illegally stocked and unauthorised stock.[2] A draft notification, G.S.R. 54(E), was issued on 21 January 2026 and the final notification, G.S.R. 377(E), followed on 13 May 2026.[1]
The notified entry is Pregabalin. In practice this is understood to cover pregabalin-containing formulations, but the entry as notified is the substance name, and CDSCO has titled the notification as covering pregabalin and its drug formulations.[1]
Preparing for the commencement date
Manufacturers and marketers should prepare revised artwork and obtain written regulatory advice on batches already manufactured, released, or held in the distribution chain. The notification’s commencement clause and any subsequent CDSCO or State Licensing Authority guidance should govern stock disposition.
Retailers and wholesalers should plan for the register and labelling controls to apply from the effective date, and should not assume the position on the day of notification is the position on the day of enforcement. If you manufacture or market pregabalin under a third-party or PCD arrangement, agree in writing now who carries the cost of artwork revision and of any stock that cannot be sold through before the change.
Schedule H1 list: the 51 entries we can name and source
Use the list below to check whether a molecule is in Schedule H1. Each entry carries one serial number and one substance; the count of entries and the count of substances are therefore the same. Serial 51, pregabalin, is shown but marked as not yet in force, and serial 52 is omitted because it could not be identified from a published source. Spellings for serials 1 to 46 are as printed in the 2013 Schedule; where the modern INN differs it is shown alongside. The four drugs proposed in August 2026 are listed separately below, because a draft notification changes nothing until it is finalised.
Showing 51 of 51 entries
- 1Alprazolam
- 2Balofloxacin
- 3Buprenorphine
- 4Capreomycin
- 5Cefdinir
- 6Cefditoren
- 7Cefepime
- 8Cefetamet
- 9Cefixime
- 10Cefoperazone
- 11Cefotaxime
- 12Cefpirome
- 13Cefpodoxime
- 14Ceftazidime
- 15Ceftibuten
- 16Ceftizoxime
- 17Ceftriaxone
- 18Chlordiazepoxide
- 19Clofazimine
- 20Codeine
- 21Cycloserine
- 22Diazepam
- 23Diphenoxylate
- 24Doripenem
- 25Ertapenem
- 26Ethambutol Hydrochloride
- 27Ethionamide
- 28Feropenem
- 29Gemifloxacin
- 30Imipenem
- 31Isoniazid
- 32Levofloxacin
- 33Meropenem
- 34Midazolam
- 35Moxifloxacin
- 36Nitrazepam
- 37Pentazocine
- 38Prulifloxacin
- 39Pyrazinamide
- 40Rifabutin
- 41Rifampicin
- 42Sodium Para-aminosalicylate
- 43Sparfloxacin
- 44Thiacetazone
- 45Tramadol
- 46Zolpidem
- 47Oxytocin
- 48Tapentadol
- 49Oseltamivir
- 50Zanamivir
- 51PregabalinNot yet in force
No entry in Schedule H1 matches that search. If the drug is not listed here, check whether it falls under Schedule H or Schedule X instead.
Proposed additions: four CNS drugs, draft stage only
On 19 August 2026 the Ministry of Health and Family Welfare published draft notification G.S.R. 745(E), proposing to insert four further substances into Schedule H1 after serial number 52.[14] The proposal follows the 68th meeting of the Drugs Consultative Committee on 20 March 2026, which examined a list of drugs for Schedule H1 and Schedule X in light of misuse and intoxication. Dicyclomine was considered and retained in Schedule H rather than moved up.[16]
| Proposed serial | Substance | Class | Why it is on the list |
|---|---|---|---|
| 53 | Flupentixol | Thioxanthene antipsychotic | Widely used in India in fixed-dose combination with melitracen for anxiety and depressive symptoms; long-term unsupervised use is the concern |
| 54 | Zopiclone | Cyclopyrrolone hypnotic, a Z-drug | Same dependence profile as zolpidem, which has been in Schedule H1 at serial 46 since 2014 |
| 55 | Gabapentin | Gabapentinoid | Closes the gap left by the pregabalin notification; the two share a mechanism and a misuse pattern |
| 56 | Carisoprodol | Centrally acting muscle relaxant | Metabolised to meprobamate, with recognised abuse and dependence potential |
This table scrolls sideways on a narrow screen. Classes and mechanisms are standard pharmacology; the committee did not publish a per-drug rationale, so the final column is our reading of why each substance was examined, not a quotation from the notification.
Nothing changes yet
G.S.R. 745(E) is a draft published for objections and suggestions, under section 12(1) and section 33(1) of the Drugs and Cosmetics Act, 1940. The notice states that the draft rules will be taken into consideration on or after the expiry of thirty days from the date the Gazette copies are made available to the public. Objections go to the Under Secretary (Drugs), Ministry of Health and Family Welfare, or to drugsdiv-mohfw@gov.in.[14]
The draft’s own commencement clause then provides that the rules shall come into force after one hundred and eighty days of publication of the final rules in the Official Gazette. Two waiting periods therefore run in sequence, and the earliest realistic effective date falls well into 2027. Until the final rules are published, flupentixol, zopiclone, gabapentin and carisoprodol remain outside Schedule H1 and no register, red Rx or warning-box obligation attaches to them.
What to do during the consultation window
If you manufacture or market any of the four: this is the only stage at which the scope can still be influenced. If a fixed-dose combination, a strength or an indication would be disproportionately affected, a written submission within the thirty-day window is worth more than any amount of preparation afterwards. Flupentixol-melitracen combinations are the obvious case.
Either way, start the artwork work now, do not execute it. Draft the revised label with the red Rx and the warning box, cost the printed-material obsolescence, and agree in writing with your third-party or PCD partners who carries that cost. Do not print revised packs against a draft: the final entry wording, and the substances in it, can change between draft and final.
Retailers and wholesalers: take no action yet. Adding a drug to your H1 register before it is scheduled creates a record you then have to explain. Watch for the final notification and count 180 days from its publication.
Two points the summaries usually get wrong
Generation of the cephalosporins. Only cefepime and cefpirome in this list are fourth-generation. Cefixime, cefpodoxime, ceftriaxone, cefoperazone and cefdinir are third-generation. It is a small distinction that matters when you are writing product literature or a tender response.
Faropenem. The Schedule prints the name as Feropenem. If you discuss the modern INN faropenem in your own documentation, cite an authoritative nomenclature or product-standard source and explain the correspondence, rather than silently substituting one spelling for the other. Under the WHO AWaRe classification (latest available edition) faropenem sits in the Reserve group, the most tightly restricted tier.[10] India is one of the markets where an oral penem has been used at significant volume in general practice, which is the prescribing pattern AWaRe was designed to discourage.[9]
The four compliance controls
Schedule H1 is a classification and control regime under the Drugs Rules; it is not, by itself, a separate licence category. It is a set of four operating controls layered on top of an ordinary retail or wholesale drug licence. Each tab below is one control.
Label: red Rx plus a red-bordered warning box
The pack of any drug containing a Schedule H1 substance must carry the symbol Rx in red, conspicuously displayed on the left top corner of the label, together with a boxed warning in a red-bordered box.[3] The exact wording, positioning and box specification should be verified against the current Rule 97 of the Drugs Rules, 1945 before releasing artwork. This is an artwork element that should be checked carefully during regulatory review when a molecule is added to Schedule H1.
Rx
Schedule H1 Drug – Warning:
It is dangerous to take this preparation except in accordance with the medical advice.
Not to be sold by retail without the prescription of a Registered Medical Practitioner.
Reproduced from the notified wording; confirm the exact text and box specification against the current Drugs Rules before releasing artwork.
Sale: prescription only, dispensed by a registered pharmacist
Rule 65(9)(a) of the Drugs Rules, 1945 states that substances specified in Schedule H, Schedule H1 or Schedule X shall not be sold by retail except on a prescription.[4] Two practical consequences follow.
- The sale is made by the licensed retailer through a registered pharmacist, against a prescription written by a Registered Medical Practitioner. The prescriber and the seller are different people, and a widely repeated claim that H1 drugs are sold by the doctor is simply wrong.
- No substitution. A person dispensing a prescription containing a Schedule H, H1 or X substance may not supply a different preparation in its place.[4]
Register: four notified fields, recorded at the time of supply
The supply of a Schedule H1 drug must be recorded in a separate register at the time of supply. The notified fields are:[3]
- Name and address of the prescriber
- Name of the patient
- Name of the drug
- Quantity supplied
Those four are the statutory minimum. In practice, many inspectors also expect a date column and a serial number, because a register without them cannot be reconciled. Under the Schedule H1 register clause, retaining a photocopy of the prescription is generally treated as good practice rather than a strict statutory requirement; separate prescription-retention obligations may apply under Schedule X or other programmes.
As an operational best practice, if you already run ALCOA-aligned documentation on the manufacturing side, apply the same discipline here: attributable, legible, contemporaneous, original, accurate. No overwriting, no back-dating, no pencil.
Retention: three years, open to inspection
The register must be maintained for three years and be open for inspection.[3] As an operational interpretation, many pharmacies treat the three-year period as running from the date of each entry rather than from the end of the financial year, which means a register in continuous use will always contain live and expired entries together. On that reading, archive by completed volume rather than by date, and label each volume with its first and last entry dates. Confirm the approach your State Licensing Authority expects.
Schedule H vs Schedule H1 vs Schedule X
These three schedules are routinely confused, including in material published by pharmacy software vendors. The distinction is one of control intensity, not of drug potency. The table below is a descriptive comparison, not a legal definition of any schedule.
| Control point | Schedule H | Schedule H1 | Schedule X |
|---|---|---|---|
| Prescription required | Yes | Yes | Yes |
| Separate register of supply | No | Yes | Yes |
| Prescription retained by the seller | No general prescription-retention requirement under Schedule H alone; specific programmes or State instructions may impose additional conditions | Generally treated as good practice rather than a strict statutory requirement | Yes |
| Record retention | Not specified for Schedule H alone | Three years | Two years from the date of the last entry, subject to the specific record type and applicable rule |
| Label symbol | Rx | Rx in red, top left, plus red-bordered warning box | NRx in red |
| Separate licence needed | No | No | Additional Schedule X-specific licensing and record controls may apply depending on the activity (manufacture, sale, distribution) and applicable form |
| Typical content | Generally includes a broad prescription-only list | Examples include higher-generation antibiotics, anti-TB drugs, antivirals and habit-forming agents | Examples include psychotropics and drugs with high dependence potential |
This table scrolls sideways on a narrow screen. Full detail: Schedule H, Schedule X and Schedule G.
What applies to you
The interactive tool below narrows the guidance to your licence type and the schedule status of the molecule you are handling. Choose one option in each row.
Your role
The molecule you are handling
Choose one option in each row
The controls that apply to you depend on both your licence type and the schedule status of the molecule.
Penalties
Read this before using the table
This table is a high-level compliance summary, not a charging opinion. The applicable provision depends on the facts, licence status, drug classification, quantity and prosecution theory. Obtain a current legal review before relying on the penalty figures.
Separately, many pages online still quote a maximum of three years and a fine of ten thousand rupees for Schedule H1 offences. Those figures pre-date the Drugs and Cosmetics (Amendment) Act, 2008, which raised the penalties substantially.
| What happened | Provision | Punishment |
|---|---|---|
| Selling H1 drugs without a valid licence | Drugs and Cosmetics Act, 1940, s.27(b)(ii) | Imprisonment not less than 3 years, up to 5 years, and fine not less than one lakh rupees or three times the value of the drugs confiscated, whichever is more |
| Licensed, but sold without prescription, or failed to keep the H1 register | Drugs and Cosmetics Act, 1940, s.27(d) | Imprisonment not less than 1 year, up to 2 years, and fine not less than twenty thousand rupees |
| Dealing in a molecule that is also NDPS-notified, in more than a small but less than a commercial quantity | NDPS Act, 1985, s.22(b) | Rigorous imprisonment up to 10 years and fine up to one lakh rupees |
| Same, in commercial quantity | NDPS Act, 1985, s.22(c) | Rigorous imprisonment 10 to 20 years and fine of one lakh to two lakh rupees |
Figures are based on the Drugs and Cosmetics Act as amended;[6] sentencing may be affected by provisos and repeat-offence provisions. Courts may record adequate and special reasons to impose less than the minimum under some clauses. This table scrolls sideways on a narrow screen.
Beyond the criminal exposure, the licensing authority can suspend or cancel the sale licence. In practice that is the consequence retailers feel first, because it stops the business immediately while a prosecution takes years.
Where the NDPS overlap actually bites
Schedule H1 and the NDPS Act are separate regimes that happen to overlap on a few molecules. Tramadol is the clearest case: it has been in Schedule H1 since 2014 and was additionally notified as a psychotropic substance under the NDPS Act, 1985 by S.O. 1761(E) and S.O. 1762(E) dated 26 April 2018, after large-scale diversion in Punjab, Haryana and Rajasthan.[7] Some other Schedule H1 substances may also be regulated under the NDPS Act or related notifications, depending on the substance, formulation, concentration, quantity and notified exemptions. For those molecules, an H1 register entry does not discharge any separate NDPS obligations, and additional penalty exposure under the NDPS Act may apply depending on the facts.[8]
Why the Schedule exists
Schedule H1 functions as an antimicrobial stewardship instrument wearing a licensing costume. India carries a very high burden of drug-resistant infection, and the 2013 amendment was widely understood to target over-the-counter sale of higher-generation antibiotics and of anti-TB drugs, where incomplete or unsupervised courses drive multi-drug-resistant and extensively drug-resistant tuberculosis. The 2024 addition of oseltamivir and zanamivir extended the same logic from antibacterials to antivirals.[1]
Since 2018 the direction of travel has changed again. Oxytocin, tapentadol and pregabalin, and now the four substances proposed in August 2026, are not stewardship additions at all: they are dependence and diversion additions. If the 2026 draft is finalised, more than a fifth of Schedule H1 will consist of CNS-active substances added because of misuse rather than resistance.[14][16] For anyone planning a product portfolio, that is the more useful signal: a molecule with a documented recreational-use pattern in India is now a plausible future Schedule H1 candidate regardless of its therapeutic class.
Internationally, the same logic is expressed through the WHO AWaRe classification (latest available edition), which sorts antibiotics into Access, Watch and Reserve groups to steer prescribing away from broad-spectrum agents and preserve last-line options.[9] The overlap is instructive: cefixime, ceftriaxone, cefepime, levofloxacin, meropenem, imipenem and ertapenem are Watch-group agents, and faropenem is Reserve, under the WHO AWaRe classification (latest available edition).[10] Reading the Schedule H1 list next to the AWaRe list is the fastest way to see which of your own products carry stewardship risk as well as regulatory risk.
Frequently asked questions
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Forty-six entries were notified by G.S.R. 588(E) dated 30 August 2013 and came into force on 1 March 2014; oxytocin, tapentadol, oseltamivir and zanamivir were added by later amendments as serials 47 to 50, and pregabalin is notified at serial 51 pending a 180-day commencement. The draft notification of 19 August 2026 refers to entries running to serial 52, so the Schedule is at least that long, but the entry at 52 could not be identified from any published source. Treat any published list, including this one, as indicative and confirm against the consolidated Drugs Rules, 1945.
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It has been notified but is not yet in force. G.S.R. 377(E) dated 13 May 2026 inserts pregabalin at serial number 51, and was published in the Gazette of India Extraordinary on 20 May 2026. The notification provides that the amendment comes into force 180 days after publication, so verify the operative date and any CDSCO or State Licensing Authority transition instructions before changing your procedures.
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Not yet. Gabapentin appears at proposed serial 55 in draft notification G.S.R. 745(E) dated 19 August 2026, alongside flupentixol, zopiclone and carisoprodol. That is a draft published for objections, with a thirty-day comment window, and the draft rules would then come into force 180 days after publication of the final rules. Until the final notification issues, gabapentin remains outside Schedule H1 and no register or warning-box obligation applies to it.
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Flupentixol, zopiclone, gabapentin and carisoprodol, at proposed serial numbers 53 to 56, under draft notification G.S.R. 745(E) dated 19 August 2026. The proposal follows the 68th meeting of the Drugs Consultative Committee on 20 March 2026, which examined a set of drugs for Schedule H1 and Schedule X in light of misuse and intoxication. Dicyclomine was considered and retained in Schedule H rather than moved up.
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Both require a prescription from a Registered Medical Practitioner. Schedule H1 adds three controls on top: a separate register of every supply kept for three years and open to inspection, a red Rx symbol on the top left of the label, and a red-bordered warning box on the pack. Schedule H alone carries none of those three.
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Four fields are notified: the name and address of the prescriber, the name of the patient, the name of the drug, and the quantity supplied. The entry is made at the time of supply, and the register must be kept for three years and be open for inspection. In practice many inspectors also expect a date and a serial number so the register can be reconciled.
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Schedule H1 is a classification and control regime rather than a separate licence category, and an ordinary retail or wholesale drug licence covers the sale. What changes is how you sell and what you record. Additional Schedule X-specific licensing and record controls may apply to Schedule X drugs depending on the activity concerned.
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For a licensed seller, section 27(d) of the Drugs and Cosmetics Act, 1940 provides imprisonment of not less than one year extending to two years, and a fine of not less than twenty thousand rupees. Selling without a valid licence attracts section 27(b)(ii). These are high-level summaries rather than a charging opinion, and the applicable provision depends on the facts. The licensing authority can separately suspend or cancel the licence.
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No. Most of the list is antibiotics and anti-tuberculosis drugs, which have no dependence potential at all. Some Schedule H1 substances may also be regulated under the Narcotic Drugs and Psychotropic Substances Act, 1985 or related notifications, depending on the substance, formulation, concentration, quantity and notified exemptions. Tramadol is the clearest documented example.
Related on Laafon
From Laafon Galaxy Pharmaceuticals
Handling a schedule change on a live product?
A molecule moving into Schedule H1 means revised artwork, a stock disposition decision and a documentation change at every distributor, on a commencement timetable set by the notification. We handle that sequence as part of end-to-end plant and product regulatory support.
References
- Central Drugs Standard Control Organization. Gazette Notifications: G.S.R. 377(E) dated 13 May 2026, amendment in Schedule H1 for inclusion of Pregabalin and its drug formulations; draft G.S.R. 54(E) dated 21 January 2026; G.S.R. 95(E) dated 5 February 2024, inclusion of Oseltamivir and Zanamivir in Schedule H1; draft G.S.R. 686(E) dated 25 September 2023. New Delhi: Ministry of Health and Family Welfare. Available from: https://cdsco.gov.in/opencms/opencms/en/Notifications/Gazette-Notifications/ Accessed August 2026.
- Press Information Bureau, Government of India. Union Health Ministry Brings Pregabalin Under Schedule H1 to Strengthen Regulation and Prevent Misuse. New Delhi; May 2026. Available from: https://www.pib.gov.in/PressReleasePage.aspx?PRID=2263975 Accessed August 2026.
- Press Information Bureau, Government of India. Rules for Selling of Drugs Under Schedule H1. New Delhi. Available from: https://www.pib.gov.in/newsite/PrintRelease.aspx?relid=101251 Accessed August 2026.
- Ministry of Health and Family Welfare. The Drugs Rules, 1945 (as amended), Rule 65. New Delhi: Central Drugs Standard Control Organization. Available from: https://cdsco.gov.in/opencms/opencms/en/Acts-and-rules/Drugs-Rules/ Accessed August 2026.
- PharmaTutor. Health Ministry notified on implementation of Schedule H1 drugs in D and C rules. 2013. Available from: https://www.pharmatutor.org/pharma-news/health-ministry-notified-on-implementation-of-schedule-h1-drugs-cosmetic-rules-no-more-otc-selling-of-antibiotics Accessed August 2026. [Trade press, used only for the reproduced 46-name list and the 1 March 2014 enforcement date.]
- Government of India. The Drugs and Cosmetics Act, 1940, section 27, as amended by the Drugs and Cosmetics (Amendment) Act, 2008. Available from: https://cdsco.gov.in/opencms/opencms/en/Acts-and-rules/Drugs-and-Cosmetics-Act/ Accessed August 2026.
- Food and Drugs Administration, Government of Goa. Notification No. S.O. 1761(E) and S.O. 1762(E) dated 26 April 2018 regarding inclusion of the drug Tramadol in the list of Psychotropic Substances in the Schedule to the Narcotic Drugs and Psychotropic Substances Act, 1985. Available from: https://www.dfda.goa.gov.in/circulars-orders-notifications/notification/330-notification-no-s-o-1761-e-s-o-1762-e-dated-26-04-2018-regarding-inclusion-of-drug-tramadol-in-the-list-of-psychotropic-substances-in-the-schedule-to-the-narcotic-drugs-and-psychotropic-substances-act-1985 Accessed August 2026.
- Government of India. The Narcotic Drugs and Psychotropic Substances Act, 1985, section 22. Available from: https://lawgist.in/narcotic-drugs-and-psychotropic-substances-act/22 Accessed August 2026.
- World Health Organization. AWaRe classification of antibiotics for evaluation and monitoring of use, 2023. Geneva: WHO; 2023. WHO/MHP/HPS/EML/2023.04. Available from: https://www.who.int/publications/i/item/WHO-MHP-HPS-EML-2023.04 Accessed August 2026.
- World Health Organization. WHO Antibiotics Portal: AWaRe antibiotic list. Available from: https://aware.essentialmeds.org/list Accessed August 2026.
- Medical Dialogues. Pregabalin to be sold only under tighter prescription monitoring: Health Ministry. 2026. Available from: https://medicaldialogues.in/news/industry/pharma/pregabalin-to-be-sold-only-under-tighter-prescription-monitoring-health-ministry-171188 Accessed August 2026. [Trade press, cited for its quotation of the commencement clause and the serial number 51.]
- The Health Master. Drug Rules notifications index: G.S.R. 795(E) dated 21 August 2018, Oxytocin inclusion in Schedule H1 omitting from Schedule H; G.S.R. 258(E) dated 7 April 2021, inclusion of Tapentadol in Schedule H1. Available from: https://thehealthmaster.com/drug-rules-notifications/ Accessed August 2026. [Trade press index, cited for the notification numbers and dates; verify against the consolidated Drugs Rules.]
- Medical Dialogues. By doctors prescription only: Oseltamivir and Zanamivir added into Schedule H1 drugs. Available from: https://medicaldialogues.in/news/industry/pharma/by-doctors-prescription-only-oseltamivir-and-zanamivir-added-into-schedule-h1-drugs-124638 Accessed August 2026. [Trade press, cited for the serial numbers 49 and 50.]
- Ministry of Health and Family Welfare (Department of Health and Family Welfare). Notification G.S.R. 745(E), New Delhi, 19 August 2026. Draft rules further to amend the Drugs Rules, 1945, inserting serial numbers 53 to 56 in Schedule H1 after serial number 52. F. No. X.11014/11/2026-DR. Published in the Gazette of India Extraordinary. [Draft notification for objections and suggestions; commencement one hundred and eighty days after publication of the final rules.]
- Business Standard. Centre imposes strict curbs on sale of four nerve-relaxing drugs. 21 August 2026. Available from: https://www.business-standard.com/industry/news/centre-puts-stricter-controls-on-sale-of-4-cns-drugs-over-abuse-concerns-126082100936_1.html Accessed August 2026. [Trade and national press, cited for the thirty-day feedback window and the draft status.]
- Medical Dialogues. Govt panel tightens prescription norms, brings 4 drugs under Schedule H1, retains Dicyclomine in Schedule H. Available from: https://medicaldialogues.in/news/industry/pharma/govt-panel-tightens-prescription-norms-brings-4-drugs-under-schedule-h1-retains-dicyclomine-in-schedule-h-169110 Accessed August 2026. [Trade press, cited for the 68th Drugs Consultative Committee meeting of 20 March 2026 and the dicyclomine decision.]
Scope and disclaimer. This article is technical and educational content for pharmaceutical, regulatory and pharmacy professionals. It is not medical advice, legal advice or investment advice, and it is not a substitute for reading the current statutory text. Indian statutory instruments and pharmacopoeial texts change frequently, and state licensing authorities apply some requirements differently. Verify the operative wording in the current Drugs and Cosmetics Act, 1940 and Drugs Rules, 1945, and in the relevant gazette notification, before acting. Do not self-medicate with any drug in this list.
About the author. Darshan Singh has 23 years of experience in pharmaceutical quality control, quality assurance and drug regulatory affairs, covering tablets, capsules, oral liquids and injectables. This article was written from the primary notifications cited above wherever those were obtainable; where a secondary or trade-press source was used, it is labelled as such in the reference list and the underlying position should be confirmed against the consolidated Drugs Rules before it is relied on commercially.
