Schedule X drugs list: the short answer
The Schedule X drugs list in the Drugs Rules, 1945 names 16 substances: six barbiturates, five CNS stimulants, two non-barbiturate hypnotics, two dissociative anaesthetics and one anxiolytic. Their salts, stereoisomers and preparations are covered in the same way.[1]
A Schedule X drug may be sold by retail only on a prescription in duplicate, with one copy kept for two years. Stock is held under lock and key, and every supply goes into a bound, page-numbered register with a separate page for each drug. Retail sale needs its own licence, Form 20F, which is granted to a pharmacy (or to a chemist and druggist only where no pharmacy operates).[1] All 16 substances are also psychotropic substances under the NDPS Act, 1985.[2]
शेड्यूल X दवाएँ क्या हैं? (हिंदी में सारांश)
ड्रग्स रूल्स, 1945 की शेड्यूल X में 16 पदार्थ हैं, जैसे मिथाइलफेनिडेट, केटामाइन और कई बार्बिट्यूरेट। ये दवाएँ केवल पंजीकृत चिकित्सक के दो प्रतियों वाले पर्चे पर ही बेची जा सकती हैं, और दुकानदार एक प्रति दो साल तक रखता है। दवा ताले में रखी जाती है, हर बिक्री एक अलग रजिस्टर में दर्ज होती है, और लेबल पर लाल रंग में XRx लिखा होता है। इन्हें बेचने के लिए अलग लाइसेंस (फॉर्म 20F या 20G) चाहिए। ये सभी 16 पदार्थ NDPS अधिनियम, 1985 के तहत भी नियंत्रित हैं।
List of Schedule X drugs in India (all 16)
Schedule X is not as old as the Rules themselves. It was inserted by G.S.R. 462(E) of 22 June 1982, and the CDSCO text shows two omitted slots in the list, recorded as words omitted by G.S.R. 673(E) of 27 October 1993 and G.S.R. 647(E) of 28 October 1998. Ketamine hydrochloride is the only addition since, made by G.S.R. 724(E) of 7 November 2013.[1] The Schedule is referred to in rules 23, 61, 75, 97 and 105A.
Showing 16 of 16 substances
| Substance | Class | Clinical status | NDPS Act |
|---|---|---|---|
| Amobarbital | Barbiturate | Sedative-hypnotic | Psychotropic |
| Amphetamine | CNS stimulant | Stimulant | Psychotropic |
| Barbital | Barbiturate | Sedative-hypnotic, clinically obsolete | Psychotropic |
| Cyclobarbital | Barbiturate | Sedative-hypnotic | Psychotropic |
| Dexamphetamine | CNS stimulant | Dextro-isomer of amphetamine | Psychotropic |
| EthchlorvynolGazette spelling: Ethclorvynol | Non-barbiturate hypnotic | Sedative-hypnotic, largely withdrawn | Psychotropic |
| Glutethimide | Non-barbiturate hypnotic | Sedative-hypnotic, largely withdrawn | Psychotropic |
| Ketamine hydrochlorideAdded 7 Nov 2013 | Dissociative anaesthetic | Anaesthetic, in clinical use as injection | Psychotropic |
| Meprobamate | Anxiolytic | Anxiolytic; some combinations can be exempted (see note) | Psychotropic |
| Methamphetamine | CNS stimulant | Stimulant | Psychotropic |
| Methylphenidate | CNS stimulant | Stimulant used in ADHD | Psychotropic |
| MethylphenobarbitalAlso written methylphenobarbitone | Barbiturate | Anticonvulsant and sedative | Psychotropic |
| Pentobarbital | Barbiturate | Sedative-hypnotic | Psychotropic |
| Phencyclidine | Dissociative anaesthetic | No human clinical use | Psychotropic |
| PhenmetrazineGazette spelling: Phenometrazine | CNS stimulant | Stimulant anorectic, withdrawn | Psychotropic |
| Secobarbital | Barbiturate | Sedative-hypnotic | Psychotropic |
No Schedule X substance matches that name. It may sit in Schedule H, H1 or another schedule instead; see the related guides further down.
Swipe the table sideways to see all four columns.
The two notes printed under the Schedule. Any stereoisomer, salt or preparation of a listed substance is covered. Preparations of meprobamate in combination with other drugs may be exempted, but only by the central Licensing Authority under rule 21(b), and only on satisfactory evidence that they are not liable to misuse.[1]
Spellings. The gazette text prints “Ethclorvynol” and “Phenometrazine”. Quote those spellings in a licence application, and use the INN spellings everywhere else.
The NDPS column is confirmed for every row. All 16 substances appear in the Schedule of psychotropic substances under the NDPS Act, 1985. This includes ethchlorvynol and methylphenobarbital, which an earlier version of this page could not confirm.[2][3] Ketamine joined that Schedule in 2011, two years before it entered Schedule X.[4]
Schedule X drug label: XRx, NRx and Rx wording under Rule 97
Rule 97(1) sets a symbol and a boxed warning for each prescription schedule. The current wording comes from G.S.R. 408(E) of 26 April 2018. Rule 97A made it voluntary until 31 March 2019 and mandatory from then on.[5] For every schedule, the warning is printed “in legible black coloured font size in completely red rectangular box”, in the rule’s own words. Approve your artwork against that wording.[1]
XRx in red, top-left corner, conspicuously displayed. Bulk containers of a Schedule X substance must also carry the symbol in red letters (Rule 97(5)).
NRx in red, top-left. This is for a Schedule H substance that also falls under the NDPS Act. It is not the Schedule X symbol.
Rx, top-left. Unlike NRx, XRx and the H1 Rx, the rule does not require this symbol to be red.
Two errors widely reproduced online. First, the Schedule H box says CAUTION and “Not to be sold by retail without…”. It is not the WARNING wording used for NRx and XRx. Second, the Schedule X box begins “SCHEDULE X PRESCRIPTION DRUG”. Artwork that drops “PRESCRIPTION” does not match Rule 97(1)(d).[1]
Which symbol goes on ketamine? Ketamine is both a Schedule X drug and an NDPS psychotropic. NRx is defined for a Schedule H substance under the NDPS Act, and XRx for any substance in Schedule X. Ketamine left Schedule H for Schedule X in 2013, so on the text of the rule the carton carries XRx. Some published artwork still shows NRx. Because misbranding exposure falls under Section 27, get your State Licensing Authority’s position in writing before printing.
Pack-size limits under Rule 105A
Schedule X drugs may only be marketed in packs no larger than these:[1]
Hospital and dispensary packs are exempt, on two conditions. The manufacturer or distributor must supply them direct to the hospital or dispensary, and they must never go to a retail dealer or an individual Registered Medical Practitioner.
Schedule X licence: forms, fees and who issues them
A general drug licence does not cover Schedule X. Retail, wholesale, manufacture and import each have their own application and licence forms. For manufacture, the route depends on whether the product is also in Schedule C or C(1).
Licence finder
Choose an answer to question 1
Question 2 changes the result only for manufacture.
| Activity | Apply | Licence | Rules | Fee and authority |
|---|---|---|---|---|
| Retail sale | 19C | 20F | 59(2), 61(3), 64 | Rs 500 with the application. State Licensing Authority. Granted only to a pharmacy, or to a chemist and druggist where no pharmacy operates in the area.[1] |
| Wholesale | 19C | 20G | 59(2), 61(3), 64 | Rs 500 with the application. State Licensing Authority. Sales only to holders of the requisite Schedule X licence, apart from Government buyers, hospitals, institutions and Registered Medical Practitioners as listed in Form 20G. |
| Manufacture, not in Schedule C/C(1) | 24F | 25F | 69(1)(b), 69(2)(b), 70, 74 | Rs 6,000 licence fee and Rs 1,500 for each subsequent inspection, up to ten items per Schedule M category. Each extra item costs Rs 300. State Licensing Authority. |
| Manufacture, also in Schedule C/C(1) | 27B | 28B | 75(2), 76, 78 | Rs 6,000 licence fee and Rs 1,500 for every inspection, up to ten items per category. Under the proviso to rule 75(2), the applicant must also hold a Form 28 licence. State Licensing Authority. |
| Import | 8A | 10A | 21, 23, 24, 28 | Rs 10,000 for one drug and Rs 1,000 for each additional drug. Repeat applications for the same manufacturer cost Rs 1,000 a drug. Needs a Form 41 Registration Certificate. Central Licensing Authority (CDSCO). Valid three years. |
Swipe the table sideways to see the rules and fees.
No loan-licence route. The loan-licence rules for ordinary and Schedule C/C(1) products (rules 69A, 75A and 76A) all exclude Schedule X. A brand owner cannot have a Schedule X product made on another firm’s licence the way it can for most products under a Form 25A or 28A loan licence. The manufacturing site itself must hold Form 25F or 28B.[1]
Keeping a sale licence alive. Forms 20F and 20G stay valid as long as a retention fee, equal to the grant fee, is paid before the end of every five-year period from issue. A late payment attracts 2% of the licence fee per month for up to six months. After that the licence is deemed cancelled (Rule 63).
Applications versus licences. Forms 19C, 24F, 27B and 8A are applications. Forms 20F, 20G, 25F, 28B and 10A are the licences. Quoting an application number as a licence number in a tender or due-diligence pack is a common, easily spotted error.
What each Schedule X licence holder must do
Inspectors check different things at a pharmacy counter, a wholesale godown, a manufacturing site and an importer’s premises. Pick your role.
- Prescription · Rule 65(9)(a)
- Sell by retail only on a Registered Medical Practitioner’s prescription, issued in duplicate. Keep one copy for two years.[1]
- Repeats · Rule 65(11)
- Dispense once only, unless the prescriber has written that it may be dispensed again. Follow any stated number of times or intervals exactly. When dispensing, note your name and address and the date on the prescription above the prescriber’s signature.
- No substitution · Rule 65(11A)
- Do not supply any other preparation in its place, even one with the same substance. The same bar applies to Schedule H and H1 prescriptions.
- Storage · Rule 65(12)
- Keep the stock under lock and key in a cupboard or drawer reserved solely for these substances. Alternatively, keep it in a separated part of the premises that only responsible persons can enter.
- Who supplies · Rule 65(2)
- A registered pharmacist must make the supply, or personally supervise it.
- Institutions · Rule 65(9)(b)
- Supplies to doctors, hospitals, dispensaries and nursing homes go only against a signed written order. Keep the order for two years.
- Record · Rule 65(21)
- Schedule X is excluded from the ordinary prescription register. It has its own bound register; see section 05.
- DraftCCTV · G.S.R. 791(E)
- A draft rule 65(2A) published on 8 Sep 2026 would require CCTV coverage of all non-wholesale supply against a prescription, with recordings kept for three months. It is not yet in force.[6]
- Who you may sell to · Form 20G
- Only to a person holding the requisite Schedule X licence. The exceptions listed in the licence form include Government purchasers, hospitals and medical, educational or research institutions, nursing homes and Registered Medical Practitioners.[1]
- Signed orders · Rule 65(9)(b)
- Supplies to practitioners and institutions go only against a signed written order. Keep the order for two years.
- Register · Rule 65(21)
- Record every supply when it is made, in the bound Schedule X register, with a separate page for each drug.
- Premises · Rule 64
- The licence is granted only if the premises are adequate, have proper storage for preserving the drugs, and are in charge of a person the licensing authority considers competent.
- Quarterly returns · Rule 74(m)(i)
- A Form 25F holder sends a statement of sales every three months to the licensing authorities of the States where the drug is made and supplied. The statement covers sales to manufacturers, wholesalers, retailers, hospitals, dispensaries, nursing homes and doctors.[1]
- Three accounts · Rule 74(m)(ii)
- Keep a bound, serially page-numbered register with three accounts: (A) Schedule X material used in manufacture, (B) production, with anticipated yield, actual yield and wastage, and (C) manufactured drugs sold, with each purchaser’s name and address. Keep it for five years, or one year after expiry, whichever is later. Rule 78 carries the same requirements for Form 28B.
- Bulk storage · Rule 74(n)
- Store Schedule X substances in bulk form. When material is needed for manufacture away from that store, keep it in a separate place under the direct custody of a responsible person.
- Advertising · Rules 74(p), 78(8)
- No advertisement of a Schedule H, H1 or X drug without the previous sanction of the Central Government. This has long been a manufacturing-licence condition; see section 08 for the 2026 draft that extends it to sale licences.
- Labels and packs · Rules 97, 105A
- XRx artwork, red-symbol bulk labels, and pack sizes within 100 doses, 300 ml or 5 ml. GMP sits behind both licences. Revised Schedule M is now being enforced; track it on the Schedule M compliance dashboard.
- Licence · Rules 23, 24
- Apply on Form 8A, with the manufacturer’s Form 9 undertaking and a Form 41 Registration Certificate. The licence issues on Form 10A, never Form 10.[1]
- Validity · Rule 28
- Three years from issue. If a fresh application is made three months before expiry, the licence continues until orders are passed.
- Separate record · Rule 26
- Keep a separate register for sale or distribution of Schedule X drugs. It records the drug, batch, manufacturer, transaction date, opening stock, quantities received, purchaser details with licence number, and closing balance.
- NDPS
- All 16 substances are NDPS psychotropics. Import also needs NDPS-side authorisation, which a Form 10A does not replace.
Schedule X register format: the ten columns of Rule 65(21)
This is the Schedule X requirement most often failed at inspection, because the rule fixes the physical book as well as its contents. Every supply must be recorded at the time of supply. The register must be bound and serially page-numbered, kept specially for the purpose, with separate pages for each drug.[1] A loose-leaf file, a shared ledger, or a book written up at the end of the day does not meet the rule.
- Date of transaction
- Quantity received, with the supplier’s name, address and licence number
- Name of the drug
- Quantity supplied
- Manufacturer’s name
- Batch number or lot number
- Name and address of the patient or purchaser
- Reference number of the prescription the supply was made against
- Bill number and date for purchases and supplies
- Signature of the person who supervised the supply
Do not model it on the H1 register. The Schedule H1 register under Rule 65(3)(1)(h) records only the prescriber, patient, drug and quantity, and is kept for three years. The Schedule X book has a different column set and a different physical format. A pharmacy running one H1-style book for both has a Schedule X record-keeping failure.[1]
Schedule H vs Schedule H1 vs Schedule X drugs
The practical differences are in the label, the register, the storage and the licence.[1]
| Feature | Schedule H | Schedule H1 | Schedule X |
|---|---|---|---|
| Symbol | Rx, top-left (colour not specified); NRx in red if also under NDPS | Rx in red | XRx in red |
| Boxed words | PRESCRIPTION DRUG – CAUTION (WARNING for NRx) | Its own two-part caution | PRESCRIPTION DRUG – WARNING |
| Prescription | Registered Medical Practitioner | Registered Medical Practitioner | In duplicate; one copy kept two years |
| Repeats | Only if the prescriber says so | Only if the prescriber says so | Only if the prescriber says so |
| Substitution | No other preparation in lieu | No other preparation in lieu | No other preparation in lieu |
| Register | Prescription register (or cash/credit memo option) | Separate H1 register, three years | Bound register, page per drug, ten columns |
| Storage | General licence conditions | General licence conditions | Lock and key, or separated restricted area |
| Retail licence | Form 20 (Form 21 for C/C(1)) | Form 20 or 21 | Form 20F, pharmacy only |
| Pack-size cap | None under Rule 105A | None under Rule 105A | 100 doses / 300 ml / 5 ml |
| NDPS overlap | Some molecules (NRx) | Some molecules | All 16 |
Swipe the table sideways to compare all three schedules.
An earlier version of this page described Schedule X substitution as “stricter”. It is not. Rule 65(11A) bars substitution identically for H, H1 and X.
For the neighbouring schedules, see the Schedule H drugs list and dispensing rules and the Schedule H1 drug list and register rules.
Schedule X, the NDPS Act and the NRx drugs list
Every Schedule X substance is also a psychotropic substance under the NDPS Act, 1985. A Schedule X product therefore sits under two control regimes, each with its own licensing and its own penalties. Meeting the Drugs Rules does not discharge the NDPS obligations, and the reverse is equally true.[2][3]
The two lists do not move together: ketamine
- 10 Feb 2011Ketamine is notified as a psychotropic substance under the NDPS Act.[7]
- 21 Jun 2011S.O. 1430(E) fixes ketamine’s thresholds at 10 g small quantity and 500 g commercial quantity.[4]
- 7 Nov 2013G.S.R. 724(E) moves ketamine hydrochloride from Schedule H into Schedule X.[1]
- Apr 2017The Delhi High Court upholds the 2011 NDPS listing.[7]
For nearly three years ketamine was controlled under the NDPS Act while still being a Schedule H drug. Thresholds are notified per substance, in S.O. 1055(E) of 19 October 2001 as amended. Never carry one substance’s figures across to another. 500 g of API is not a large quantity in a manufacturing store.[2]
Is there an NRx drugs list?
NRx is not a schedule. It is the label symbol for a Schedule H drug that is also under the NDPS Act. The Narco-Coordination Centre’s published list of Schedule H drugs under the NDPS Act includes alprazolam, chlordiazepoxide, clobazam, clonazepam, codeine, diazepam, diphenoxylate, lorazepam, midazolam, nitrazepam, pentazocine, tramadol and zolpidem.[3] Several of these are also in Schedule H1. That list is undated, so confirm a molecule’s current schedule before you design artwork around it.
Advertising Schedule X drugs, and the 2026 draft rules
Today. No advertisement of a drug in Schedule H, H1 or X may be made without the previous sanction of the Central Government. That bar is a condition of the manufacturing licences: rules 74(p) and 78(8), and 74B(7) for loan licences. It is not among the conditions of the sale licences in Rule 65.[1]
DraftG.S.R. 861(E), 28 September 2026. The draft inserts a new rule 65(22), placing the same sentence among the conditions of retail and wholesale licences. If finalised, a pharmacy, distributor or online seller would need Central Government sanction before advertising any Schedule H, H1 or X drug. Objections were invited for 30 days from the date the Gazette copies were made available, addressed to the Under Secretary (Drugs), MoHFW. The rule takes effect only on final publication.[8]
DraftG.S.R. 791(E), 8 September 2026. The draft inserts a new rule 65(2A). It would require non-wholesale supply of any drug against a prescription to be made under CCTV surveillance at the licensed premises, with recordings kept for at least three months.[6]
Status on 20 October 2026: both are draft rules. Neither appeared as a final notification on CDSCO’s gazette page up to its latest entry of 13 October 2026. If you are planning digital promotion of prescription-only products, or fitting out a pharmacy, plan for both now, and re-check the gazette before committing spend.
Penalties for Schedule X violations
Two statutes carry penalties here, and they are not interchangeable. Which applies depends on the contravention. Because every Schedule X substance is also an NDPS psychotropic, both may be engaged at once.
Drugs and Cosmetics Act, 1940 · s.27
- Without a valid licence · s.27(b)(ii)
- Imprisonment of 3 to 5 years, and a fine of at least Rs 1 lakh or three times the value of the drugs confiscated, whichever is more. Stocking Schedule X on an ordinary Form 20 or 21 licence falls here. For adequate and special reasons recorded in the judgment, the court may go below both minimums.[9]
- Other contraventions · s.27(d)
- Missing register entries, dispensing without a duplicate prescription, or storage outside a locked reserved cupboard. Imprisonment of 1 to 2 years and a fine of at least Rs 20,000. The court may impose less than one year for adequate and special reasons.
- The licence
- Separately from any prosecution, the licensing authority can suspend or cancel the licence after giving an opportunity to show cause. In practice this comes long before any criminal court.
NDPS Act, 1985 · s.22
- Small quantity
- Rigorous imprisonment up to 1 year, or a fine up to Rs 10,000, or both. The maximum term was raised from six months with effect from 1 May 2014.[10]
- Above small, below commercial
- Rigorous imprisonment up to 10 years, and a fine up to Rs 1 lakh.
- Commercial quantity
- Rigorous imprisonment of 10 to 20 years, and a fine of Rs 1 to 2 lakh. The court may exceed Rs 2 lakh for reasons recorded in the judgment.
- What triggers it
- Contravention of the Act, a rule or order under it, or a licence condition. A licensing lapse, not only trafficking, can engage s.22.
Schedule X drugs: frequently asked questions
Sixteen. They are amobarbital, amphetamine, barbital, cyclobarbital, dexamphetamine, ethchlorvynol, glutethimide, ketamine hydrochloride, meprobamate, methamphetamine, methylphenidate, methylphenobarbital, pentobarbital, phencyclidine, phenmetrazine and secobarbital. Their salts, stereoisomers and preparations are covered too.
Yes. The one-page PDF linked at the top of this page lists all 16 substances with the label, prescription, storage, register, pack-size and licence rules. The official source is CDSCO’s compilation of the Drugs Rules, 1945, where Schedule X appears on page 848 of 963.
XRx, in red, marks a Schedule X drug. NRx, in red, marks a Schedule H drug that also falls under the NDPS Act. Rx marks an ordinary Schedule H drug, and Rule 97 does not require it to be red; the Schedule H1 Rx must be red. XRx and NRx carry a WARNING box, while plain Schedule H carries a CAUTION box.
No, it is a different group. NRx goes on Schedule H drugs that are also under the NDPS Act, such as alprazolam, clonazepam, diazepam, lorazepam, midazolam, nitrazepam, codeine, tramadol and zolpidem. Schedule X drugs carry XRx instead. Confirm the current schedule of a molecule before printing artwork.
Only if the prescriber has written on it that it may be dispensed more than once. Any stated number of repeats or interval must then be followed exactly. Each dispensing is noted on the prescription with the seller’s name, address and date.
Rule 65(21) requires a bound, serially page-numbered register kept only for this purpose, with separate pages for each drug, written up at the time of supply. It has ten columns, from the date of transaction to the signature of the supervising person.
Yes. Methylphenidate is listed in Schedule X and is also a psychotropic substance under the NDPS Act. It needs a duplicate prescription, an XRx label, lock-and-key storage, the Rule 65(21) register entry and a Form 20F licence at retail.
Form 25F, applied for on Form 24F, if the product is not also in Schedule C or C(1). Form 28B, applied for on Form 27B, if it is. Each costs Rs 6,000 plus inspection fees and is issued by the State Licensing Authority. There is no loan-licence route for Schedule X.
No. Schedule X belongs to the Drugs Rules, 1945, while the NDPS Act has its own much longer Schedule of psychotropic substances. All 16 Schedule X substances are on the NDPS Schedule, but many NDPS substances are not in Schedule X. Each law has its own licences and penalties.
Manufacturers already need prior Central Government sanction to advertise Schedule H, H1 or X drugs. Draft rule 65(22) in G.S.R. 861(E) of 28 September 2026 would apply the same bar to retail and wholesale licensees. As of 20 October 2026 it is a draft, not yet in force.
Where to go next
Applying for a Schedule X licence, or approving XRx artwork?
We review Form 19C, 24F and 27B applications, storage and Rule 65(21) register SOPs, and XRx label artwork against the current rule text. This is backed by 23+ years in pharmaceutical QA/QC and drug regulatory affairs.
Sources
- Central Drugs Standard Control Organisation. The Drugs Rules, 1945, as amended vide G.S.R. 360(E) dated 1 July 2024: rules 21, 23, 24, 26, 28, 59, 61, 63, 64, 65, 69, 69A, 70, 74, 74B, 75, 75A, 76, 76A, 78, 97, 97A, 105A and Schedule X (p. 848) with amendment footnotes 1286 to 1289. New Delhi: Ministry of Health and Family Welfare; 2024. Available from: cdsco.gov.in. Accessed October 2026.
- Central Bureau of Narcotics. Notification S.O. 1055(E) dated 19 October 2001 specifying small and commercial quantities of narcotic drugs and psychotropic substances, as amended. Gwalior: Central Bureau of Narcotics. Available from: cbn.gov.in. Accessed October 2026. (Scanned copy; individual figures should be read against the gazette.)
- Narco-Coordination Centre (NCORD). List of Schedule H, H1 and X drugs under the NDPS Act. New Delhi: Ministry of Home Affairs; undated. Available from: narcoordindia.gov.in. Accessed October 2026.
- Ministry of Finance, Department of Revenue. Notification S.O. 1430(E) dated 21 June 2011, inserting ketamine at serial 238E of the Table to S.O. 1055(E) (small quantity 10 g; commercial quantity 500 g). New Delhi: Government of India; 2011. Copy available from: taxindiaonline.com (secondary host). Accessed October 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 rule 97(1)(a) to (e); format made mandatory after 31 March 2019 by rule 97A. New Delhi: Government of India; 2018. As incorporated in reference 1.
- Ministry of Health and Family Welfare. Draft Drugs (Amendment) Rules, 2026, notification G.S.R. 791(E) dated 8 September 2026 (proposed rule 65(2A), CCTV at sales premises). New Delhi: Government of India; 2026. Available from: CDSCO gazette notifications. Accessed October 2026.
- Delhi HC upholds listing of ketamine as psychotropic substance under NDPS Act. LiveLaw. 12 April 2017. Available from: livelaw.in. Accessed October 2026.
- Ministry of Health and Family Welfare. Draft Drugs (Amendment) Rules, 2026, notification G.S.R. 861(E) dated 28 September 2026 (proposed rule 65(22), advertisement of Schedule H, H1 and X drugs). New Delhi: Government of India; 2026. Available from: cdsco.gov.in. Accessed October 2026.
- The Drugs and Cosmetics Act, 1940 (Act 23 of 1940), section 27, as amended by the Drugs and Cosmetics (Amendment) Act, 2008 (Act 26 of 2008). New Delhi: Ministry of Law and Justice. Amendment Act available from: prsindia.org. Accessed October 2026.
- The Narcotic Drugs and Psychotropic Substances Act, 1985 (Act 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. Text consulted at: lawx.in (secondary). Accessed October 2026.
This page is a technical and educational regulatory reference for pharmaceutical professionals. It is not medical, legal or investment advice, and it does not replace the official text of the Acts, Rules and notifications, which prevail if anything here differs. Indian statutory instruments change often, draft rules can change before final publication, and several positions above are subject to State-level practice. Verify the current status before acting. Last reviewed 20 October 2026.
