Last updated: 3 October 2026
If you are searching for the Schedule H1 drugs list 2026, there is an important point to understand first: Schedule H1 is not simply an “antibiotics list.” It is a specific regulatory category under the Drugs Rules, 1945, containing medicines that are subject to additional prescription and record-keeping requirements.
As of 3 October 2026, 50 Schedule H1 entries are currently operative. In addition, two further entries have been notified during 2026 but have delayed commencement: Pregabalin as entry 51 and certain oral formulations containing more than 12% v/v ethyl alcohol in packs above 30 mL as entry 52.
A separate August 2026 draft notification proposes four more substances—Flupentixol, Zopiclone, Gabapentin and Carisoprodol—but these should not be treated as current operative Schedule H1 entries unless and until a final notification is issued and becomes effective.
Schedule H1 Drugs List 2026 — Quick Answer
- Currently operative Schedule H1 entries: 50
- Pregabalin: notified as Schedule H1 entry 51; commencement is 180 days after Gazette publication.
- Entry 52: certain oral formulations containing more than 12% v/v ethyl alcohol, packed and sold in containers/bottles above 30 mL; notified in July 2026 with a six-month commencement period.
- Proposed entries: Flupentixol, Zopiclone, Gabapentin and Carisoprodol.
- Prescription: Schedule H1 drugs are subject to prescription-based retail supply.
- Separate register: Supply of Schedule H1 drugs must be recorded in a separate register.
- Record retention: Schedule H1 supply records must be maintained for three years and remain open for inspection.
What Is Schedule H1?
Schedule H1 is a schedule under the Drugs Rules, 1945 containing specified medicines that are subject to additional controls.
Schedule H1 was introduced through G.S.R. 588(E), dated 30 August 2013. The original Schedule H1 contained 46 entries and included certain antibiotics, anti-tubercular drugs and habit-forming medicines.
The important thing to remember is:
Schedule H1 is a legal/regulatory classification, not a clinical classification of all antibiotics.
Many Schedule H1 entries are antimicrobial or anti-tubercular drugs, but not every antibiotic is automatically a Schedule H1 drug.
The schedule has subsequently been amended. For example, Oxytocin and Tapentadol were added through earlier amendments, while Oseltamivir and Zanamivir were added as entries 49 and 50 in 2024.
Schedule H1 Drugs List 2026: Complete Current List
The following are the 50 currently operative Schedule H1 entries as of 3 October 2026.
| No. | Schedule H1 Drug |
|---|---|
| 1 | Alprazolam |
| 2 | Balofloxacin |
| 3 | Buprenorphine |
| 4 | Capreomycin |
| 5 | Cefdinir |
| 6 | Cefditoren |
| 7 | Cefepime |
| 8 | Cefetamet |
| 9 | Cefixime |
| 10 | Cefoperazone |
| 11 | Cefotaxime |
| 12 | Cefpirome |
| 13 | Cefpodoxime |
| 14 | Ceftazidime |
| 15 | Ceftibuten |
| 16 | Ceftizoxime |
| 17 | Ceftriaxone |
| 18 | Chlordiazepoxide |
| 19 | Clofazimine |
| 20 | Codeine |
| 21 | Cycloserine |
| 22 | Diazepam |
| 23 | Diphenoxylate |
| 24 | Doripenem |
| 25 | Ertapenem |
| 26 | Ethambutol Hydrochloride |
| 27 | Ethionamide |
| 28 | Faropenem |
| 29 | Gemifloxacin |
| 30 | Imipenem |
| 31 | Isoniazid |
| 32 | Levofloxacin |
| 33 | Meropenem |
| 34 | Midazolam |
| 35 | Moxifloxacin |
| 36 | Nitrazepam |
| 37 | Pentazocine |
| 38 | Prulifloxacin |
| 39 | Pyrazinamide |
| 40 | Rifabutin |
| 41 | Rifampicin |
| 42 | Sodium Para-aminosalicylate |
| 43 | Sparfloxacin |
| 44 | Thiacetazone |
| 45 | Tramadol |
| 46 | Zolpidem |
| 47 | Oxytocin |
| 48 | Tapentadol |
| 49 | Oseltamivir |
| 50 | Zanamivir |
The first 46 entries form the original Schedule H1 list, while entries 47–50 were added through subsequent amendments. The official consolidated CDSCO material lists these entries and the 2024 notification confirms the addition of Oseltamivir and Zanamivir as entries 49 and 50.
Important note about the list
Schedule H1 applies to specified drug substances and covered preparations. The official schedule also contains a note covering preparations containing the listed substances and their salts, subject to the exclusions stated in the schedule, including certain topical/external preparations. Therefore, the presence of a drug name in this table should not be interpreted as meaning that every possible formulation or route is automatically covered without checking the exact regulatory wording.
Latest Schedule H1 Changes in 2026
2026 is particularly important for this topic because the Central Government has issued multiple notifications affecting Schedule H1.
There are three different regulatory situations that should not be mixed together:
- Existing operative entries
- Final notifications with delayed commencement
- Draft proposals
This distinction is important when preparing an updated Schedule H1 list.
1. Pregabalin Added as Schedule H1 Entry 51
The Ministry of Health and Family Welfare issued G.S.R. 377(E), dated 13 May 2026, adding:
51. Pregabalin
to Schedule H1.
However, the notification states that the Drugs (Second Amendment) Rules, 2026 will come into force 180 days after publication in the Official Gazette. The notification was published in May 2026, so on 3 October 2026, Pregabalin had been notified but its Schedule H1 amendment had not yet reached its commencement date.
Therefore:
Is Pregabalin a Schedule H1 drug in 2026?
Yes, it has been officially notified for inclusion, but it should be clearly described as a notified future entry when discussing the position on 3 October 2026.
This is different from saying that Pregabalin was already an operative Schedule H1 entry on that date.
2. Alcohol-Containing Oral Formulations Added as Entry 52
The Drugs (Tenth Amendment) Rules, 2026, notified through G.S.R. 607(E), add a new Schedule H1 entry concerning certain oral formulations containing alcohol.
The new entry is:
52. All oral formulations containing more than 12% alcohol v/v (Ethyl Alcohol) packed and sold in packings or bottles of more than 30 milliliters.
The same notification modifies the relevant Schedule K exemption.
However, the notification states that the amendment will come into force after six months from publication in the Official Gazette. Therefore, this is another important example of a notification that was issued in 2026 but has a delayed commencement date.
Entry 52 status
| Entry | Description | Status on 3 Oct 2026 |
|---|---|---|
| 52 | Certain oral formulations >12% alcohol v/v and >30 mL | Notified; delayed commencement |
3. Four More Drugs Proposed in August 2026
On 19 August 2026, the Ministry of Health and Family Welfare published G.S.R. 745(E) as a draft notification proposing four additional Schedule H1 entries.
The proposed entries are:
| Proposed Entry | Drug | Status |
|---|---|---|
| 53 | Flupentixol | Draft proposal |
| 54 | Zopiclone | Draft proposal |
| 55 | Gabapentin | Draft proposal |
| 56 | Carisoprodol | Draft proposal |
The draft specifically states that these would be inserted after entry 52 and that the proposed rules would come into force 180 days after publication of the final rules.
Are these four drugs currently Schedule H1 drugs?
Not yet as operative entries as of 3 October 2026.
They are part of a draft proposal.
This distinction is extremely important because many online articles may simply copy the proposed list and label it as the “new Schedule H1 list.”
For an accurate 2026 article, they should be displayed separately under proposed additions.
Schedule H1 2026: Current vs Notified vs Proposed
This is the easiest way to understand the current regulatory position.
| Category | Entries | Status |
|---|---|---|
| Current operative list | 1–50 | Currently operative |
| Pregabalin | 51 | Final notification; delayed commencement |
| Alcohol-containing oral formulations | 52 | Final notification; delayed commencement |
| Flupentixol | 53 | Draft proposal |
| Zopiclone | 54 | Draft proposal |
| Gabapentin | 55 | Draft proposal |
| Carisoprodol | 56 | Draft proposal |
CDSCO’s Gazette notification index lists the May 2026 Pregabalin notification, July 2026 alcohol-related amendment and August 2026 draft proposal separately, supporting this distinction.
Schedule H1 Prescription Rules in India
Schedule H1 drugs are subject to prescription-based retail supply.
The regulatory framework also imposes an additional record-keeping requirement specifically for Schedule H1.
According to Rule 65, supply of a Schedule H1 drug must be recorded in a separate register at the time of supply.
The record includes:
- Name and address of the prescriber
- Name of the patient
- Name of the drug
- Quantity supplied
These records must be:
- maintained for three years, and
- kept open for inspection.
Schedule H1 Register: What Details Are Required?
A simple way for pharmacy students to remember the requirement is:
Doctor + Patient + Drug + Quantity
The Schedule H1 register records:
| Required information | Example |
|---|---|
| Prescriber | Name and address of prescriber |
| Patient | Name of patient |
| Drug | Name of drug supplied |
| Quantity | Quantity supplied |
The register requirement is separate from merely checking the prescription. The supply itself must be appropriately recorded.
How Long Should Schedule H1 Records Be Maintained?
Three years.
This is one of the most frequently tested facts about Schedule H1.
The Drugs Rules require the Schedule H1 supply records to be maintained for three years and to remain open for inspection.
Exam point:
Schedule H1 register → 3 years
Schedule H1 Label and Warning
Schedule H1 medicines have specific labelling requirements.
The formulation is required to carry the Rx symbol in red, conspicuously displayed at the upper-left portion of the label, along with the Schedule H1 warning in a red-bordered box.
The regulatory warning is:
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.
The wording and formatting requirements should be checked against the current Drugs Rules when used for actual regulatory or manufacturing purposes.
Why Was Schedule H1 Introduced?
Schedule H1 was introduced in 2013 as an additional regulatory control for specified medicines.
The original Schedule H1 included:
- certain third- and fourth-generation antibiotics,
- anti-tubercular medicines, and
- certain habit-forming drugs.
One of the major regulatory concerns associated with the introduction of Schedule H1 was inappropriate or indiscriminate use of antimicrobial medicines and the broader problem of antimicrobial resistance.
The framework therefore added additional controls beyond ordinary prescription requirements, particularly the separate dispensing register and retention of records.
Is Schedule H1 the Same as the Antibiotics List?
No.
This is one of the most common misconceptions among pharmacy students.
A large number of Schedule H1 entries are antibiotics or anti-tubercular drugs, but Schedule H1 is a legal regulatory schedule, not a complete clinical list of antibiotics.
For example, the Schedule H1 list includes medicines such as:
- Alprazolam
- Buprenorphine
- Chlordiazepoxide
- Codeine
- Diazepam
- Midazolam
- Nitrazepam
- Tramadol
- Zolpidem
- Tapentadol
along with numerous antimicrobial and anti-tubercular medicines.
Therefore:
Not every antibiotic is a Schedule H1 drug, and not every Schedule H1 drug is an antibiotic.
Schedule H1 vs Schedule H vs Schedule X
These three schedules are frequently confused.
| Feature | Schedule H | Schedule H1 | Schedule X |
|---|---|---|---|
| Prescription control | Yes | Yes | Yes |
| Special H1 register | No specific H1 register | Yes | Separate Schedule X requirements |
| Symbol | Rx | Rx in red | XRx in red |
| Additional warning | Schedule H warning | Schedule H1 warning | Schedule X warning |
| Three-year H1 register requirement | No | Yes | Different requirements |
The key point is that Schedule H1 has additional record-keeping requirements beyond the ordinary Schedule H framework. The Schedule X category has its own separate regulatory provisions.
Schedule H1 vs Schedule H — Easy Difference
For exam preparation, remember:
Schedule H
Prescription-controlled drug category.
Schedule H1
Prescription-controlled category plus additional H1 dispensing-record requirements and specific H1 labelling.
One-line exam answer:
Schedule H1 is a prescription-controlled category with additional record-keeping and labelling requirements.
Schedule H1 vs Schedule X
Schedule H1 and Schedule X should not be treated as the same thing.
Both involve prescription controls, but Schedule X has its own specific regulatory framework, including separate requirements concerning dispensing, storage and records.
For an examination answer, avoid writing:
“Schedule H1 and Schedule X are the same.”
They are not.
Schedule H1 Drugs for Drug Inspector Exams
Schedule H1 is an important topic for students preparing for Drug Inspector examinations, pharmacy government jobs and pharmaceutical regulatory examinations.
Questions can be based on both:
1. Drug identification
Examples:
- Which drug is included in Schedule H1?
- Is Tramadol in Schedule H1?
- Is Rifampicin in Schedule H1?
- Is Oseltamivir in Schedule H1?
2. Regulatory requirements
Examples:
- How long are Schedule H1 records maintained?
- Which register is used?
- What information is entered?
- What symbol appears on the label?
- What warning is required?
- Who can prescribe Schedule H1 drugs?
Important facts to revise
- Schedule H1 meaning
- Schedule H1 drug list
- Schedule H vs H1
- Schedule H1 vs Schedule X
- Prescription requirement
- H1 label
- H1 warning
- Separate register
- Three-year record retention
- Major Schedule H1 amendments
For the broader Drug Inspector recruitment picture, see our Drug Inspector Vacancy 2026: UPSC, UPPSC and MPSC Posts Compared.
Schedule H1 and Pharmacy Practice
For a pharmacist, Schedule H1 compliance involves more than simply recognizing the medicine.
A practical compliance approach includes:
1. Check the prescription
Ensure the supply is being made according to the applicable prescription requirements.
2. Identify the exact drug
Check the active substance and formulation against the current regulatory schedule.
3. Record the supply
Enter the required details in the separate Schedule H1 register.
4. Maintain records
Keep the required Schedule H1 records for three years.
5. Check the label
Where applicable, verify the required Rx symbol and Schedule H1 warning.
6. Follow current regulatory requirements
The Drugs Rules and subsequent Gazette notifications can change, so pharmacists and pharmacy owners should rely on the current regulatory position rather than an old list.
Schedule H1 2026 Timeline
| Date | Development | Status |
|---|---|---|
| 30 August 2013 | Schedule H1 introduced with 46 entries | Original framework |
| 2024 | Oseltamivir and Zanamivir added as entries 49 and 50 | Final / operative |
| 13 May 2026 | G.S.R. 377(E) notified Pregabalin as entry 51 | Final notification; 180-day commencement |
| 8 July 2026 | G.S.R. 607(E) notified entry 52 concerning certain alcohol-containing oral formulations | Final notification; six-month commencement |
| 19 August 2026 | G.S.R. 745(E) proposed entries 53–56 | Draft proposal |
The 2024 addition of Oseltamivir and Zanamivir is confirmed by the official Gazette notification, while the 2026 amendments are listed in CDSCO’s Gazette notification index.
Is Pregabalin a Schedule H1 Drug in India?
Pregabalin has been officially notified for inclusion in Schedule H1 as entry 51.
However, G.S.R. 377(E) states that the Drugs (Second Amendment) Rules, 2026 come into force 180 days after publication in the Official Gazette.
Therefore, on 3 October 2026, Pregabalin should be described as a notified future Schedule H1 entry, rather than an already operative entry.
Is Gabapentin a Schedule H1 Drug in India?
As of 3 October 2026, Gabapentin is included in the August 2026 draft proposal for additional Schedule H1 entries.
It should therefore not be presented as a current operative Schedule H1 drug unless a final notification is subsequently issued and becomes effective.
The draft proposes Gabapentin as entry 55.
Is Zopiclone a Schedule H1 Drug in India?
Zopiclone is included in the August 2026 draft proposal as proposed entry 54.
As of 3 October 2026, this remains a draft proposal, not a current operative Schedule H1 entry.
Is Flupentixol a Schedule H1 Drug in India?
Flupentixol is included as proposed entry 53 in G.S.R. 745(E), dated 19 August 2026.
Because the notification is a draft, it should not be presented as an operative Schedule H1 entry as of 3 October 2026.
Is Carisoprodol a Schedule H1 Drug in India?
Carisoprodol is included as proposed entry 56 in the August 2026 draft notification.
Its status should be checked again against a later final Gazette notification before treating it as an operative Schedule H1 entry.
Can Schedule H1 Drugs Be Sold Without a Prescription?
No, Schedule H1 drugs are subject to prescription-based retail supply.
The Drugs Rules also impose additional record-keeping requirements for Schedule H1 supply.
The Schedule H1 framework specifically states that the drug is not to be sold by retail without the prescription of a Registered Medical Practitioner.
How Long Should Schedule H1 Records Be Maintained?
Schedule H1 supply records must be maintained for:
3 years
The records must also remain open for inspection.
What Information Is Recorded for Schedule H1 Drugs?
The separate Schedule H1 register records:
- Name and address of prescriber
- Name of patient
- Name of drug
- Quantity supplied
The entry is required at the time of supply.
What Is the Schedule H1 Warning?
The Schedule H1 labelling requirement includes a red Rx symbol and a specific warning in a red-bordered box.
The warning states that it is dangerous to take the preparation except in accordance with medical advice and that it should not be sold by retail without the prescription of a Registered Medical Practitioner.
Is Every Antibiotic a Schedule H1 Drug?
No.
Schedule H1 is a specific regulatory schedule.
Although many Schedule H1 entries are antibiotics or anti-tubercular drugs, not every antibiotic automatically becomes a Schedule H1 drug.
Always check the actual Drugs Rules and subsequent Gazette amendments.
What Is the Difference Between Schedule H and H1?
Both are prescription-controlled categories, but Schedule H1 has additional requirements.
The most important difference for pharmacy students is:
Schedule H1 requires a separate register for supply records, with the records maintained for three years and open to inspection.
Schedule H1 also has its own labelling warning requirements.
What Is the Difference Between Schedule H1 and Schedule X?
Schedule H1 and Schedule X are separate regulatory categories.
Both involve prescription controls, but Schedule X has its own specific requirements under the Drugs Rules.
Therefore, they should not be treated as interchangeable schedules.
Important Exam Facts About Schedule H1
If you are preparing for a B.Pharm, M.Pharm, Drug Inspector or pharmacy government examination, remember these points:
Schedule H1
Introduced: 2013
Original entries: 46
Current operative entries as of 3 October 2026: 50
Register: Separate register
Record retention: 3 years
Prescription: Required
Label: Red Rx symbol + Schedule H1 warning
Recent operative additions: Oseltamivir and Zanamivir were added as entries 49 and 50 in 2024.
2026 notified addition: Pregabalin — entry 51, delayed commencement.
2026 notified entry: Certain oral formulations containing >12% v/v alcohol in packs/bottles >30 mL — entry 52, delayed commencement.
2026 draft proposals: Flupentixol, Zopiclone, Gabapentin and Carisoprodol.
Common Mistakes Students Make About Schedule H1
Mistake 1: Calling every antibiotic a Schedule H1 drug
Wrong.
Schedule H1 is a specific legal schedule.
Mistake 2: Including proposed drugs in the current list
For example, listing:
- Gabapentin
- Zopiclone
- Flupentixol
- Carisoprodol
as current Schedule H1 drugs without mentioning that the August 2026 notification is a draft would be misleading.
Mistake 3: Saying Pregabalin was already operative on 3 October 2026
The final notification exists, but it contains a 180-day commencement provision.
Mistake 4: Forgetting the three-year register requirement
This is one of the most important practical and examination points.
Mistake 5: Confusing Schedule H1 with Schedule X
They are separate regulatory categories with different requirements.
Related Pharmacy Articles on Sumit Pharmacy
If you are preparing for pharmacy government jobs or pharmaceutical regulatory careers, these articles may also be useful:
Drug Inspector Recruitment
Drug Inspector Vacancy 2026: UPSC, UPPSC and MPSC Posts Compared
This is particularly relevant because Schedule H1 is an important part of pharmaceutical regulatory knowledge for Drug Inspector aspirants.
Regulatory Affairs Career
Regulatory Affairs Career in India: Scope, Salary, Jobs & Career Guide
This article is useful if you are interested in regulatory careers in the pharmaceutical industry.
Official Sources for Schedule H1 Updates
For future updates, always check the official regulatory sources rather than relying only on old pharmacy websites.
Key 2026 notifications
- G.S.R. 377(E), 13 May 2026 — Pregabalin: Official CDSCO Gazette PDF
- G.S.R. 745(E), 19 August 2026 — Draft four additional Schedule H1 drugs: Official CDSCO Gazette PDF
- G.S.R. 607(E), July 2026 — Alcohol-containing oral formulations: available through the CDSCO Gazette Notifications index.
- 2024 G.S.R. 95(E) — Oseltamivir and Zanamivir: Official CDSCO Gazette PDF
Final Takeaway
The Schedule H1 Drugs List 2026 should not be treated as just a copied list of drug names. The effective date of each amendment matters.
As of 3 October 2026:
- 50 entries are currently operative
- Pregabalin is notified as entry 51 but has delayed commencement
- Entry 52 concerning specified high-alcohol oral formulations has also been notified with delayed commencement
- Flupentixol, Zopiclone, Gabapentin and Carisoprodol remain draft proposals
- Schedule H1 supply requires a separate register
- The register must be maintained for three years
- The record contains the prescriber, patient, drug and quantity supplied
- Schedule H1 medicines carry specific Rx and warning requirements.
For B.Pharm, M.Pharm and Drug Inspector aspirants, the best way to study Schedule H1 is to learn both the drug list and the regulatory requirements attached to the schedule.
Last verified: 3 October 2026.
Regulatory schedules can change through subsequent Gazette notifications, so this page should be updated whenever CDSCO or the Ministry of Health and Family Welfare publishes another amendment.