Drugs Rules, 1945 — India

Schedule X drugs list — all 16 substances, the XRx label rule and every licence form

The short answer

Schedule X to the Drugs Rules, 1945 specifies 16 substances — six barbiturates, five CNS stimulants, two non-barbiturate hypnotics, two dissociative anaesthetics and one anxiolytic. Retail sale requires a prescription in duplicate, one copy kept for two years; stock is held under lock and key; every movement is entered in a bound, serially page-numbered register with separate pages for each drug; and the retail licence is Form 20F, which a Schedule H licence does not cover and which is granted only to a pharmacy.[1]

Written and reviewed by Darshan Singh — 23+ years in pharmaceutical QA/QC and drug regulatory affairs Last reviewed 18 August 2026

substances specified in Schedule X

columns the Rule 65(21) register must carry

2 yrs

retention for the duplicate prescription and signed orders

licence routes: retail, wholesale, two manufacturing, import

01 — The list

The Schedule X drugs list

Schedule X is an appendix to the Drugs Rules, 1945 and is referenced by rules 23, 61, 75, 97 and 105A. Any stereoisomeric form of a listed substance, any salt of it, and any preparation containing it are covered in exactly the same way as the parent substance.[1]

Barbiturates CNS stimulants Non-barbiturate hypnotics Dissociative anaesthetics Anxiolytic

Search Schedule X drugs by name

Showing 16 of 16 substances

Substances specified in Schedule X, Drugs Rules, 1945
Substance	Class and clinical role	NDPS Act, 1985
Amobarbital	Intermediate-acting sedative-hypnoticBarbiturate	Psychotropic
Amphetamine	CNS stimulant; no routine Indian marketing authorisationCNS stimulant	Psychotropic
Barbital	Long-acting sedative-hypnotic, clinically obsoleteBarbiturate	Psychotropic
Cyclobarbital	Short-acting sedative-hypnoticBarbiturate	Psychotropic
Dexamphetamine	Dextro-isomer of amphetamineCNS stimulant	Psychotropic
Ethchlorvynol	Non-barbiturate sedative-hypnotic, discontinuedGazette spelling: Ethclorvynol	Confirm current status
Glutethimide	Non-barbiturate sedative-hypnotic, discontinuedNon-barbiturate hypnotic	Psychotropic
Ketamine	Dissociative anaesthetic; added to Schedule X in 2013, after the Rules were framedDissociative anaesthetic	Psychotropic
Meprobamate	Older anxiolytic and muscle relaxant; combinations may be exempted by the licensing authority on evidence of low misuse riskAnxiolytic	Psychotropic
Methamphetamine	CNS stimulant; very limited medical useCNS stimulant	Psychotropic
Methylphenidate	CNS stimulant used for ADHD; the Schedule X substance most often dispensed in India todayCNS stimulant	Psychotropic
Methylphenobarbital	Barbiturate anticonvulsant and sedativeAlso written Methylphenobarbitone	Confirm current status
Pentobarbital	Short-acting sedative-hypnoticBarbiturate	Psychotropic
Phencyclidine	Dissociative anaesthetic; human clinical use discontinuedPCP	Psychotropic
Phenmetrazine	Stimulant anorectic, withdrawnGazette spelling: Phenometrazine	Psychotropic
Secobarbital	Short-acting sedative-hypnoticBarbiturate	Psychotropic

Swipe the table sideways to see all three columns.

On the two rows marked “confirm current status”: no substance-specific NDPS Schedule entry for ethchlorvynol or methylphenobarbital was located at the time of writing. That is not the same as confirming their absence. NDPS schedules are amended by notification, so check the current Schedule to the Act before relying on this column for a compliance decision.[7]

A note on spellings. The gazette text of Schedule X uses “Ethclorvynol” and “Phenometrazine”. Most secondary lists silently correct these to the INN spellings. Quote the gazette spelling in a licence application; use the INN spelling everywhere else.[1]

02 — Labelling

XRx, NRx and Rx — what actually goes on the carton

Rule 97 was rewritten by the Drugs and Cosmetics (Fifth Amendment) Rules, 2018, notified as G.S.R. 408(E) on 26 April 2018. That amendment is what established XRx as the Schedule X symbol and changed how the warning box is printed.[2]

The detail almost every reproduction gets wrong. Under G.S.R. 408(E) the symbol is in red, top-left. The warning text is not. It is printed in legible black font inside a completely red rectangular box. Artwork that sets the warning in red type on white — the common pattern before 2018 — no longer matches the rule. Rule 97A made the new format voluntary only until 31 March 2019; it has been mandatory since.[2]

Schedule H

Ordinary prescription-only medicine

Prescription-only, no narcotic or psychotropic overlap. Schedule H1 also uses Rx in red, with its own caution wording.[2]

Schedule H + NDPS

Narcotic Schedule H medicine

A Schedule H substance that also comes within the purview of the NDPS Act, 1985. NRx marks that overlap — it is not the Schedule X symbol.[2]

Schedule X

The Schedule X symbol

Required on every drug specified in Schedule X. Red symbol, top-left, conspicuous; warning in black inside a solid red box.[2]

So which symbol goes on ketamine? This is the question that generates the most disagreement in practice, because ketamine is both a Schedule X drug and an NDPS psychotropic substance. Read literally, Rule 97 assigns NRx to a substance specified in Schedule H that falls under the NDPS Act, and XRx to a substance specified in Schedule X. Ketamine was moved out of Schedule H into Schedule X in 2013, so on the text of the rule the Schedule X clause is the one that applies and the carton carries XRx.[2] Some published guidance nevertheless shows NRx on ketamine packs. If you are approving artwork, get the position confirmed in writing by your State Licensing Authority rather than relying on either reading — a carton is expensive to reprint and misbranding is a Section 27 exposure, not a cosmetic one.

For the neighbouring categories, see the Schedule H drugs guide, the Schedule H1 drug list, and the Schedule G drugs list — Schedule G being restricted on toxicity grounds rather than abuse potential, and carrying a caution rather than a symbol.

03 — Licensing

Which Schedule X licence do you need, and what does it cost?

A Schedule H licence does not cover Schedule X. Retail, wholesale, manufacture and import each need their own application, and on the manufacturing side the route depends on whether the product also sits in Schedule C or C(1).

Licence finder

Answer both questions. The application form, the licence form, the issuing authority and the governing rule appear below.

1. What do you intend to do with the Schedule X drug?

2. Is the product also specified in Schedule C or C(1)?

Apply on

—

The application form you submit

Licence issued on

—

The number you quote as your licence

Pick an option in each question above. Both answers are used together: question 2 only changes the outcome for manufacture, but the finder will tell you when it does not apply.

Schedule X licence routes, governing rules and statutory fees under the Drugs Rules, 1945[1]
Activity	Apply	Licence	Rule	Fee and authority
Retail sale	19C	20F	59, 61(3), 64	Rs 500 with the application. State Licensing Authority. Granted only to a pharmacy; where no pharmacy operates in the area, it may be granted to a chemist and druggist.
Wholesale	19C	20G	59, 61(3)	Rs 500 with the application. State Licensing Authority.
Manufacture — not in Schedule C / C(1)	24F	25F	69, 70	State Licensing Authority. Fee is set by rule and revised periodically — confirm the current figure with your State FDA before filing.
Manufacture — also in Schedule C / C(1)	27B	28B	75, 76	State Licensing Authority. Same caution on the fee.
Import	8A	10A	23, 24	Rs 10,000 for a single drug, Rs 1,000 for each additional drug. CDSCO, not the State. Valid three years.

Swipe the table sideways to see the rule and fee columns.

Keeping the sale licence alive. Forms 20F and 20G no longer expire on a fixed date. Under Rule 63 they stay valid provided a licence retention fee — equal to the original grant fee — is deposited before the end of every succeeding five-year period from the date of issue. Miss the date and a late fee of 2% of the licence fee per month, or part of a month, for up to six months applies; if it is still unpaid after that, the licence is deemed to have been cancelled. Losing a Form 20F this way is administrative, not disciplinary, and it is entirely avoidable.[1]

The distinction people get wrong. Forms 19C, 24F, 27B and 8A are applications. Forms 20F, 20G, 25F, 28B and 10A are the licences that issue against them. Quoting an application number as a licence number in a tender or a due-diligence pack is a recurring error in this category — and an easy one for a buyer’s counsel to spot.

04 — Duties by role

What each licence holder actually has to do

The obligations differ by role, and inspectors check different things at a pharmacy counter, a wholesale godown and a manufacturing site. Pick your role.

Retail — Form 20F

The prescription

Must be in duplicate. One copy is retained by the licensee for two years. At dispensing, note the seller’s name and address and the date on the prescription above the prescriber’s signature.[1]

Repeats

Not dispensed more than once unless the prescriber has stated on it that it may be. Where a stated number of times or stated intervals are given, they must be followed exactly.[1]

Storage

Under lock and key in a cupboard or drawer reserved solely for these substances, or in a part of the premises separated from the remainder to which only responsible persons have access.[1]

No substitution

No other preparation may be supplied in lieu — even one containing the same substance. This is stricter than the general substitution position.[1]

The register trap

Schedule X is excluded from the ordinary prescription register under Rule 65(3). It has its own register under Rule 65(21) — see below. Recording a Schedule X sale only in the general register is a finding.[1]

Who may supply

Supply against a prescription must be effected by, or under the personal supervision of, a registered pharmacist. The Form 20F premises must be a pharmacy.[1]

05 — Records

The Rule 65(21) register: format and the ten columns

This is the single most commonly failed Schedule X requirement, because the rule prescribes the physical format of the book as well as its contents.[1]

The supply of drugs specified in Schedule X must be recorded at the time of supply in a register that is bound and serially page-numbered, maintained specially for the purpose, with separate pages allotted to each drug. A loose-leaf file, a shared ledger covering several drugs on one page, or a book written up at the end of the day does not meet the rule as drafted.

1Date of transaction
2Quantity received, with the supplier’s name, address and licence number
3Name of the drug
4Quantity supplied
5Manufacturer’s name
6Batch number or lot number
7Name and address of the patient or purchaser
8Reference number of the prescription against which supplies were made
9Bill number and date for purchases and supplies
10Signature of the person under whose supervision the drugs were supplied

Do not model this on the H1 register. The Schedule H1 register under Rule 65(3)(h) records the prescriber, the patient, the drug and the quantity, and is kept for three years. The Schedule X register is a different book with a different column set and a different physical specification, and the two are not interchangeable. A pharmacy that runs one H1-style book for both has a Schedule X record-keeping failure regardless of how carefully it is written.[1]

Alongside the register, registers and records generally are preserved for not less than two years from the date of the last entry, the duplicate prescription copy for two years, and signed written orders from practitioners and institutions for two years. An Inspection Book in Form 35 must be available for the inspector to record findings.[1]

06 — Comparison

Schedule H vs Schedule H1 vs Schedule X

The practical differences are in the label, the register and the licence.

Feature	Schedule H	Schedule H1	Schedule X
Label symbol	Rx in red — NRx where the substance is also under NDPS	Rx in red, with its own caution	XRx in red
Warning format	Black text in a solid red rectangular box	Black text in a solid red rectangular box	Black text in a solid red rectangular box
Prescription	Standard RMP prescription	Standard RMP prescription	In duplicate; one copy kept two years
Register	Prescription register or cash/credit memo	Separate H1 register, kept three years	Separate bound register, separate page per drug, ten columns
Storage	Standard licensed storage	Standard storage plus register	Lock and key, reserved cupboard or separated area
Retail licence	Form 20 or 21	Covered by the general retail licence	Form 20F — pharmacy only
Substitution	Restricted	Restricted	No other preparation in lieu, same substance or not
NDPS overlap	Occasional — marked NRx where it occurs	Occasional	Usual — 14 of 16 entries confirmed

Swipe the table sideways to compare all three schedules.

07 — Two laws at once

The NDPS overlap, and why it is not the same list

Fourteen of the sixteen Schedule X substances are, independently, listed as psychotropic substances under the Schedule to the Narcotic Drugs and Psychotropic Substances Act, 1985. Where that overlap exists a single product sits under two control regimes at once, each with its own licensing and its own penalties. Satisfying Schedule X does not discharge NDPS obligations, and the reverse is equally true.[4]

The two lists are not the same thing and do not move together. Ketamine makes the sequence visible: it was notified as a psychotropic substance under the NDPS Act on 10 February 2011, its quantity thresholds were fixed on 21 June 2011, and only on 7 November 2013 was it brought into Schedule X of the Drugs Rules. For nearly three years it was NDPS-controlled and still a Schedule H drug. The 2011 notification was challenged and upheld by the Delhi High Court in 2017.[5]

Thresholds are per substance, not universal

Small and commercial quantities are notified individually for each substance and vary enormously. For ketamine the notified figures are 10 g small quantity and 500 g commercial quantity.[5] That matters commercially as well as criminally: 500 g of API is not a large quantity in a manufacturing context, and the gap between the two tiers decides whether an offence carries up to ten years or a minimum of ten. Do not carry a threshold across from one substance to another.

NDPS schedules and quantity notifications are amended from time to time. Confirm a substance’s current status and its current thresholds against the official Schedule and the latest notifications before relying on either for a compliance decision — the figures here record the position at the time of writing, not a permanent classification.[7]

08 — Advertising

Where the advertising bar actually sits — and what is changing

It is widely repeated that no advertisement of a drug specified in Schedule H, H1 or X may be made without the previous sanction of the Central Government. That statement is accurate, but its placement usually is not. The restriction is a condition of the manufacturing licence. It is not among the general conditions of the sale licence in Rule 65, which is why a distributor or an online seller has not been caught by it in the same way a manufacturer is.[6]

The Drugs Consultative Committee took this up at its meeting on 17 November 2025. Recording concern about unchecked promotion of potent and prescription-only drugs — psychotropics, narcotics, antibiotics, hormonal preparations, injectables and oncology products — the DCC noted the existing manufacturer-side provision and recommended that similar provisions be made in the Rules for licensees holding licences for sale or distribution. A parallel proposal would make every drug licence explicitly prohibit advertising of Schedule G, H, H1 and X medicines, with the draft to go before the Drugs Technical Advisory Board.[6]

Status as at the date of this review: a DCC recommendation and a draft proposal, not a notified amendment. No gazette notification extending the advertising bar to sale and distribution licensees had been traced when this page was last reviewed. Anyone planning digital promotion of prescription-only products should treat this as live and check the CDSCO gazette and draft notification pages before committing spend.[7]

09 — Consequences

Penalties, and which statute applies

Two separate laws carry penalties here and they are not interchangeable. Which one applies depends on the nature of the contravention and on whether the specific substance also falls under the NDPS Act.

Act 23 of 1940 · Section 27

Drugs and Cosmetics Act, 1940

Without a valid licence under section 18(c)

Imprisonment of not less than 3 years, extending to 5 years, and a fine of not less than Rs 1 lakh or three times the value of the drugs confiscated, whichever is more. Stocking Schedule X on a Form 20 or 21 licence is squarely in this tier.[3]

Contravening any other provision or rule

Failing to keep the Rule 65(21) register, dispensing without a duplicate prescription, or storing outside a locked reserved cupboard: imprisonment of not less than 1 year, extending to 2 years, and a fine of not less than Rs 20,000.[3]

Judicial discretion

For that lower tier the court may, for adequate and special reasons recorded in the judgment, impose a term of less than one year. The proviso is about the term of imprisonment; it is not a general power to waive the fine.[3]

Licence consequences

Independently of any prosecution, the licensing authority may suspend or cancel the licence after a show-cause opportunity — and in practice this arrives long before a criminal court does.[1]

Act 61 of 1985 · Section 22

NDPS Act, 1985 — overlapping substances only

Small quantity

Rigorous imprisonment up to 1 year, or a fine up to Rs 10,000, or both. The maximum was raised from six months to one year with effect from 1 May 2014.[4]

More than small, less than commercial

Rigorous imprisonment up to 10 years, and a fine up to Rs 1 lakh.[4]

Commercial quantity

Rigorous imprisonment of not less than 10 years, extending to 20 years, and a fine of not less than Rs 1 lakh extending to Rs 2 lakh — and the court may impose a fine exceeding Rs 2 lakh for reasons recorded in the judgment.[4]

What triggers it

Section 22 bites on contravention of the Act, of any rule or order made under it, or of a condition of a licence granted under it — so a licensing lapse, not only trafficking, can engage it.[4]

10 — FAQ

Frequently asked questions

How many drugs are in Schedule X?

What is the difference between NRx and XRx?

Is there an NRx drugs list, and is it the same as this one?

Can a Schedule X prescription be refilled?

What register format is required for Schedule X drugs?

Is methylphenidate a Schedule X drug in India?

Which licence do I need to manufacture a Schedule X drug?

Is Schedule X the same as NDPS?

Related on laafon.com

Where to go next

Schedule H drugs — the 2026 regulatory guide The base prescription-only category, its labelling and its retail restrictions. Start here if you are working out which schedule a molecule falls into. Schedule H1 drug list The tier below Schedule X: the H1 register, the three-year retention and the antibiotics and habit-forming molecules it captures. Schedule G drugs list and warning labels Restricted on inherent toxicity rather than abuse potential, and carrying a printed caution instead of a symbol. Useful for label artwork sign-off. Revised Schedule M — the key points The GMP obligations that sit behind any Form 25F or Form 28B manufacturing licence, with the phased implementation dates.

References

Sources

Central Drugs Standard Control Organisation. The Drugs Rules, 1945, as amended vide G.S.R. 360(E) dated 1 July 2024. New Delhi: Ministry of Health and Family Welfare, Government of India. Rules 21, 23, 24, 25A, 26, 28, 59, 61, 63, 64, 65, 65B, 66, 69, 70, 75, 76 and Schedule X. 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, substituting clauses (a) to (e) of sub-rule (1) of rule 97; and rule 97A, inserted with effect from 20 March 2019, making the amended format voluntary until 31 March 2019 and mandatory thereafter. New Delhi: Government of India.
The Drugs and Cosmetics Act, 1940 (Act No. 23 of 1940), section 27, as substituted by the Drugs and Cosmetics (Amendment) Act, 2008 with effect from 10 August 2009. New Delhi: Ministry of Law and Justice, Government of India.
The Narcotic Drugs and Psychotropic Substances Act, 1985 (Act No. 61 of 1985), section 22, as substituted by Act 9 of 2001 with effect from 2 October 2001 and amended with effect from 1 May 2014. New Delhi: Ministry of Law and Justice, Government of India.
Ministry of Finance, Department of Revenue. Notification S.O. 311(E) dated 10 February 2011 (ketamine listed as a psychotropic substance) and notification S.O. 1430(E) dated 21 June 2011 (small quantity 10 g, commercial quantity 500 g). Ministry of Health and Family Welfare. Notification G.S.R. 724(E) dated 7 November 2013 (ketamine added to Schedule X). The 2011 listing was upheld by the High Court of Delhi in 2017. Notification numbers, dates and thresholds taken from secondary regulatory reporting; verify against the gazette before relying on them.
Drugs Consultative Committee. Deliberations of the meeting held on 17 November 2025 on amendment of the Drugs Rules, 1945 under Chapter VI with respect to advertisement. Reported in: Roy S. No ads for high-risk medicines: govt panel recommends major amendments to Drugs Rules 1945. Medical Dialogues, 8 December 2025. Available from: medicaldialogues.in. Accessed August 2026.
Central Drugs Standard Control Organisation. Gazette Notifications. New Delhi: Ministry of Health and Family Welfare, Government of India. Available from: cdsco.gov.in gazette notifications. Accessed August 2026.

This page is a technical and educational regulatory reference for pharmaceutical professionals. It is not medical, legal or investment advice, and it is not a substitute for the official text of the Acts, Rules and notifications, which prevail in the event of any discrepancy. Indian statutory instruments and pharmacopoeial texts change frequently, and several positions above are subject to state-level variation. Verify current status before acting.

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Schedule X Drugs List: 16 Drugs, XRx Label & Forms (PDF)

Schedule X drugs list — all 16 substances, the XRx label rule and every licence form

The Schedule X drugs list