Reviewed and updated as of July 2026.
What Is a Schedule X Drug?
Schedule X is the strictest drug classification under India’s Drugs and Cosmetics Rules, 1945 — reserved for habit-forming, high-abuse-potential medicines such as barbiturates, amphetamine-type stimulants, and dissociative anaesthetics.[1] A Schedule X drug can be sold at retail only against a prescription from a Registered Medical Practitioner (RMP), and by default that prescription cannot be dispensed a second time unless the prescriber has specifically authorised a repeat.[1] The pharmacy must retain the prescription for two years, store the drug under lock and key, and hold a distinct licence for this category.[1] Several Schedule X substances — including ketamine and the amphetamines — also fall under the Narcotic Drugs and Psychotropic Substances (NDPS) Act, 1985, which carries its own, harsher criminal penalties.[2] The sections below cover the full drug list, labelling, storage, licensing, and penalties under both Acts.
Also Known As: NRx and XRx Labelling
Three different label symbols appear across India’s prescription-drug schedules, and they are easy to mix up:
- Rx — an ordinary Schedule H drug: prescription-only, no further overlap.[1]
- NRx — a Schedule H drug that additionally falls under the NDPS Act, 1985.[1]
- XRx — a drug specified in Schedule X. Under the current labelling rule (Rule 97, as amended), the container must carry the symbol “XRx” in red, displayed conspicuously on the top-left corner, inside a red rectangular box, alongside the wording “Schedule X drug — Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.”[1]
Older reference material sometimes describes Schedule X drugs as carrying “NRx” instead of “XRx” — this reflects language from before the 2018 labelling amendment, and some sources still use the two terms loosely. For current compliance purposes, treat XRx as the Schedule‑X‑specific symbol and NRx as reserved for the NDPS‑overlapping subset of Schedule H.[1]
What Makes a Drug Schedule X
A drug is placed in Schedule X because of its central nervous system (CNS) activity and a correspondingly high potential for dependence, diversion, or non-medical misuse, even though it retains a genuine, recognised medical use.[1] The list itself is an appendix to the Drugs and Cosmetics Rules, 1945, and is not fixed — the government adds or removes substances by notification. Ketamine, for example, was brought into Schedule X by a 2013 notification, well after the Rules were first framed.[1] Once a substance is in Schedule X, every requirement that applies to Schedule H drugs applies to it as well, on top of Schedule X’s own, stricter conditions.[1]
The Schedule X Drugs List
The table below lists the substances specified in Schedule X, their general drug class, and whether each is also separately scheduled under the NDPS Act, 1985. Preparations, salts, and stereoisomeric forms of any substance below are covered by Schedule X in the same way as the parent substance.[1] Use the search box to find a specific drug, or use the “Download / Print PDF” button for a printable copy.
Schedule X Drugs — Searchable List Drugs and Cosmetics Rules, 1945, Schedule X
Showing 16 of 16 drugs
| Drug Name | Common Use / Class | NDPS Act Overlap |
|---|---|---|
| Amobarbital | Barbiturate; short/intermediate-acting sedative-hypnotic | Yes |
| Amphetamine | CNS stimulant; ADHD/narcolepsy use elsewhere, tightly restricted in India | Yes |
| Barbital | Barbiturate; early sedative-hypnotic, largely obsolete clinically | Yes |
| Cyclobarbital | Barbiturate; sedative-hypnotic | Yes |
| Dexamphetamine | CNS stimulant (dextro-isomer of amphetamine) | Yes |
| Ethchlorvynol | Non-barbiturate sedative-hypnotic; largely discontinued | Not currently listed* |
| Glutethimide | Non-barbiturate sedative-hypnotic; largely discontinued | Yes |
| Ketamine | Dissociative anaesthetic; investigated for treatment-resistant depression | Yes |
| Meprobamate | Older-generation anxiolytic / muscle relaxant | Yes |
| Methamphetamine | CNS stimulant; very limited medical use | Yes |
| Methylphenidate | CNS stimulant; used for ADHD | Yes |
| Methylphenobarbital | Barbiturate; anticonvulsant/sedative | Not currently listed* |
| Pentobarbital | Barbiturate; sedative-hypnotic | Yes |
| Phencyclidine (PCP) | Dissociative anaesthetic; clinical use discontinued | Yes |
| Phenmetrazine | CNS stimulant/anorectic; largely withdrawn | Yes |
| Secobarbital | Barbiturate; short-acting sedative-hypnotic | Yes |
No Schedule X drugs match that search.
Preparations, salts, and stereoisomeric forms of any substance above are also covered by Schedule X [1]. * No specific NDPS Schedule notification for this substance was located at the time of writing; NDPS schedules are amended periodically by government notification, so confirm current status against the official NDPS Act Schedule before relying on this table for compliance decisions.
Schedule X vs. Schedule H vs. Schedule H1 — Quick Comparison
Schedule X sits above Schedule H and Schedule H1 in India’s prescription-drug control framework. The table below is a quick-reference comparison; see the linked pages for full detail on each schedule.
| Feature | Schedule H | Schedule H1 | Schedule X (this page) |
|---|---|---|---|
| Label symbol | Rx (Rx + NRx if NDPS-overlapping)[1] | Rx in red, red-bordered warning box[1] | XRx in red, red-bordered warning box[1] |
| Introduced | Original 1945 Rules[1] | 2013 amendment (G.S.R. 588(E)), effective 2014[1] | Original 1945 Rules; individual entries added later (e.g., ketamine, 2013)[1] |
| Typical drugs | Broad range of prescription medicines[1] | 3rd/4th-generation antibiotics, select anti-TB drugs, some habit-forming psychotropics[1] | Barbiturates, amphetamine-type stimulants, dissociative anaesthetics[1] |
| Record-keeping | Purchase/sale bill retained per Rule 65[1] | Separate H1 register with patient and prescriber details[1] | Prescription retained 2 years; not dispensed more than once by default[1] |
| Storage | Standard licensed pharmacy storage[1] | Standard storage plus register[1] | Lock and key; separate licence required[1] |
| NDPS Act overlap | Occasional (labelled NRx where it occurs)[1] | Occasional, for habit-forming entries[1] | Common — many Schedule X entries are separately NDPS-scheduled[2] |
For drugs used under medical supervision that fall outside Schedules H, H1, and X on toxicity rather than abuse-potential grounds, see the Schedule G drugs list.
Storage, Licensing, and Sale Requirements
Rule 65 of the Drugs and Cosmetics Rules governs how Schedule X drugs must be sold and stored.[1] In summary:
- Storage: Schedule X drugs must be kept under lock and key, separately from general stock.[1]
- Prescription handling: the pharmacist must not dispense the same prescription more than once unless the prescriber has expressly authorised repeat dispensing; where repeats are authorised, they must follow the stated number of times or intervals exactly.[1] The seller’s name, address, and the date of dispensing must be noted on the prescription itself, above the prescriber’s signature, and the prescription must be retained for two years.[1]
- Retail licence: retail sale, stocking, or exhibition of Schedule X drugs requires a specific licence, distinct from a general Schedule H retail licence.[1]
- Manufacturing licence: manufacturing Schedule X drugs for sale or distribution requires a licence on Form 27B, which covers Schedules C, C(I), and X — a different form from the standard Form 27 used for most other Schedule C/C(I) drugs.[1]
- Supervision: as with all prescription medicines, supply must be effected by, or under the personal supervision of, a registered pharmacist.[1]
NDPS Act Overlap
A number of Schedule X drugs are, independently, listed as psychotropic substances under the Schedule to the Narcotic Drugs and Psychotropic Substances Act, 1985 — including amphetamine, dexamphetamine, methamphetamine, methylphenidate, phencyclidine, phenmetrazine, amobarbital, barbital, cyclobarbital, glutethimide, meprobamate, pentobarbital, secobarbital, and ketamine (added by a 2011 notification).[2] Where this overlap exists, a single drug is simultaneously subject to the Drugs and Cosmetics Rules’ Schedule X conditions and the NDPS Act’s own, separate control regime — including its own licensing, quantity thresholds, and penalty structure, which is considerably more severe than the Drugs and Cosmetics Act’s penalties.[2] Because NDPS schedules are amended by government notification from time to time, always confirm a substance’s current NDPS status before relying on it for a compliance decision.[2]
Penalties for Non-Compliance
Two separate laws carry penalties relevant to Schedule X drugs, and they are not interchangeable — which one applies depends on the nature of the violation and whether the specific substance also falls under the NDPS Act.
Under the Drugs and Cosmetics Act, 1940
- Manufacturing or selling a Schedule X (or other Schedule C/C(I)) drug without a valid licence: rigorous imprisonment for a term of not less than three years, extending up to five years, with a fine of not less than ₹1 lakh or three times the value of the drugs confiscated, whichever is more. A court may, for special reasons recorded in writing, impose a shorter term or smaller fine.[3]
- Contravening any other Rule 65 condition — such as dispensing without a valid prescription, failing to store the drug under lock and key, or failing to maintain the required prescription records: rigorous imprisonment for a term of not less than one year, extending up to two years, with a fine of not less than ₹20,000. Again, a court may reduce the term for special, recorded reasons.[3]
Under the NDPS Act, 1985 (for substances that overlap)
Where a Schedule X drug is also NDPS-scheduled, penalties are tiered by the quantity involved, and are markedly more severe than the Drugs and Cosmetics Act penalties above:[2]
- Small quantity: rigorous imprisonment up to one year, or a fine up to ₹10,000, or both.[2]
- More than small quantity, less than commercial quantity: rigorous imprisonment up to ten years, and a fine up to ₹1 lakh.[2]
- Commercial quantity: rigorous imprisonment of not less than ten years, extending up to twenty years, and a fine of not less than ₹1 lakh, extending up to ₹2 lakh (a court may impose a higher fine for reasons recorded in the judgment).[2]
“Small” and “commercial” quantity thresholds are set individually for each substance by government notification and vary considerably from one drug to another — they are not a single fixed weight across all NDPS-scheduled substances.[2] On top of criminal penalties, a licence-holder found in breach of either Act also risks suspension or cancellation of their drug licence.[1][3]
Frequently Asked Questions
What does Schedule X mean in a pharmacy?
It means the drug is subject to the highest level of retail control in India’s pharmacy regulations: sale only against an RMP’s prescription, no routine refilling of that prescription, two-year prescription retention, lock-and-key storage, and a separate retail or manufacturing licence.[1]
Is Schedule X the same as NDPS?
No. Schedule X is a category under the Drugs and Cosmetics Rules, 1945, administered through CDSCO and state drug control authorities.[1] The NDPS Act, 1985 is a separate law with its own schedule of narcotic drugs and psychotropic substances, administered with involvement from the Narcotics Control Bureau.[2] A drug can be Schedule X without being NDPS-scheduled, NDPS-scheduled without being Schedule X, or — as with ketamine and the amphetamines — both at once.[1][2]
Can a Schedule X prescription be refilled?
Not by default. Under Rule 65, a prescription for a Schedule X drug must not be dispensed more than once unless the prescriber has specifically stated on the prescription that it may be dispensed again, and any such repeat must follow exactly the number of times or intervals the prescriber specified.[1]
What is the difference between NRx and XRx?
NRx marks a Schedule H drug that also falls under the NDPS Act. XRx marks a drug specified in Schedule X itself. The two symbols are sometimes used loosely in older material, but under the current labelling rule they refer to two distinct, though sometimes overlapping, categories.[1]
How long must a pharmacy keep a Schedule X prescription on file?
Two years from the date of dispensing.[1]
References
- Central Drugs Standard Control Organisation. The Drugs Rules, 1945 (as amended up to 2024) [Internet]. New Delhi: Ministry of Health & Family Welfare, Government of India; [cited 2026 Jul]. Available from: https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2022/drug_rules/Drugs%20Rules%201945_2024%2009.pdf
- Government of India. The Narcotic Drugs and Psychotropic Substances Act, 1985 (Act No. 61 of 1985). New Delhi: Ministry of Law and Justice, Government of India.
- Government of India. The Drugs and Cosmetics Act, 1940 (Act No. 23 of 1940), Section 27 (as amended by Act 26 of 2008, w.e.f. 10 August 2009). New Delhi: Ministry of Health and Family Welfare, Government of India.
- Central Drugs Standard Control Organisation. Acts & Rules [Internet]. New Delhi: CDSCO; [cited 2026 Jul]. Available from: https://cdsco.gov.in/opencms/opencms/en/Acts-Rules/




