Legal reference
Schedules of the Drugs and Cosmetics Rules, 1945 — A to Y, with current status
Most lists of "the 25 schedules" treat all of them as live. They are not: some are omitted, two have moved to the Cosmetics Rules 2020, Schedule Y is superseded for clinical trials, and Schedule M was rewritten in December 2023. This table says which is which — and shows, from 408 bank questions and the official previous papers, how often each schedule is actually examined.
Status checked as of 17 September 2026. Rule pinpoints are given only where certain; a schedule's subject is stated without one rather than with a guess.
| Schedule | What it covers | Rule | Status | Bank | PYQ |
|---|---|---|---|---|---|
| A | Forms — applications, licences, certificates, registers and reports referred to throughout the Rules. The form numbers exams ask (20, 21, 20B, 21B, 25, 28 …) are all Schedule A forms. | — | in force | 6 | 0 |
| B | Fees for test or analysis by the Central Drugs Laboratory or a Government Analyst. Schedule B1 carries the corresponding fees for Ayurvedic, Siddha and Unani drugs. | — | in force | 1 | 0 |
| C | Biological and special products — sera, vaccines, toxins, antigens, antitoxins, insulin, pituitary and adrenal extracts, antibiotics and their preparations. Drives the split in licence forms: Schedule C/C(1) drugs need Form 21 (retail) / 21B (wholesale) / 28 (manufacture) rather than 20 / 20B / 25. | — | in force | 20 | 1 |
| C(1) | Other special products — digitalis, ergot, antihistamines, fish-liver oil, vitamins, hormones, liver extract and similar preparations. Read together with Schedule C; the same form consequences apply. | — | in force | 6 | 0 |
| D | Classes of drugs exempted from the import provisions of Chapter III of the Act, subject to conditions. | — | in force | 24 | 1 |
| D(I) | Information and undertaking to be furnished by a foreign manufacturer applying for a Registration Certificate to import drugs (with D(II) for the drugs and the manufacturing site). | Rule 24A | in force | 3 | 0 |
| E(1) | List of poisonous substances under the Ayurvedic (including Siddha) and Unani systems of medicine. Triggers the caution labelling and dispensing conditions for ASU drugs containing them. | — | in force | 0 | 0 |
| F | Requirements for blood banks and blood products (Part XII-B) and standards for sera and vaccines; F(II) standards for surgical dressings; F(III) standards for umbilical tapes. | — | in force | 10 | 1 |
| FF | Standards for ophthalmic preparations. | — | in force | 0 | 0 |
| G | Drugs that must carry the label "Caution: it is dangerous to take this preparation except under medical supervision". A caution label, not a prescription requirement — the classic H-versus-G trap. | Rule 97 | in force | 6 | 0 |
| H | Prescription drugs — sale by retail only on and in accordance with the prescription of a Registered Medical Practitioner; the "Rx" label and warning. | Rules 65, 97 | in force | 18 | 1 |
| H1 | The 2014 tightening: specified antibiotics (third and fourth generation cephalosporins, carbapenems, newer fluoroquinolones), anti-tuberculosis drugs and habit-forming psychotropics — sold only on prescription, with a separate register (prescriber, patient, drug, quantity) kept for three years under Rule 65(3)(h), and a red-bordered warning box on the label. In force from 1 March 2014. | Rules 65, 97 | in force | 7 | 1 |
| I | — Omitted; no longer part of the Rules. | — | omitted | 1 | 0 |
| J | Diseases and ailments which a drug may not purport to prevent or cure — cancer, cataract, sexual impotence, diabetes and others. An advertisement claiming a cure from this list is itself the offence. | Rule 106 | in force | 3 | 1 |
| K | Classes of drugs exempted from specified provisions of Chapter IV of the Act (manufacture and sale), subject to conditions — household remedies, drugs supplied by a registered practitioner to their own patient, and others. | Rule 123 | in force | 10 | 0 |
| L1 | Good Laboratory Practices and requirements of premises and equipment for laboratories testing drugs. Inserted by G.S.R. 780(E) of 10 November 2008, mandatory from 1 November 2010. The original Schedule L is omitted. | — | in force | 0 | 0 |
| M | Good Manufacturing Practices and requirements of premises, plant and equipment for pharmaceutical products. Comprehensively revised by G.S.R. 922(E) of 28 December 2023 — built around a pharmaceutical quality system, quality risk management and validation — with phased compliance timelines for smaller manufacturers. | — | in force | 181 | 3 |
| N | Minimum equipment for the efficient running of a pharmacy (compounding on premises). | — | in force | 2 | 0 |
| O | Standards for disinfectant fluids. | — | in force | 2 | 0 |
| P | Life period (shelf life) of drugs and the storage conditions to be stated on the label. | Rule 96 | in force | 4 | 2 |
| P1 | Pack sizes of drugs. | — | in force | 0 | 0 |
| Q | Dyes, colours and pigments permitted (and prohibited) in cosmetics. Cosmetics regulation now sits in the Cosmetics Rules, 2020; the corresponding schedule lives there. | — | moved | 0 | 0 |
| R | Standards for mechanical contraceptives (condoms and similar devices). R1 (standards for medical devices) is superseded by the Medical Devices Rules, 2017. | — | in force | 8 | 2 |
| S | Standards for cosmetics (Bureau of Indian Standards specifications). Now governed under the Cosmetics Rules, 2020. | — | moved | 19 | 7 |
| T | Good Manufacturing Practices for Ayurvedic, Siddha and Unani medicines. | Rule 157 | in force | 2 | 2 |
| U | Particulars to be shown in manufacturing records. | — | in force | 12 | 2 |
| V | Standards for patent or proprietary medicines — permitted ranges of vitamin content. | — | in force | 12 | 1 |
| W | — Omitted (formerly drugs to be marketed under generic names). | — | omitted | 1 | 1 |
| X | Habit-forming and psychotropic drugs (amphetamines, barbiturates, methaqualone and others): sale only under a special licence, on a prescription in duplicate with one copy retained by the licensee for two years (Rule 65(9)), the distinctive "XRx" label, storage under lock and key. | Rules 65, 97 | in force | 16 | 3 |
| Y | Requirements and guidelines for permission to import or manufacture new drugs and to conduct clinical trials. New-drug approval and clinical trials are governed by the New Drugs and Clinical Trials Rules, 2019. Coaching pages that still teach trials under Schedule Y are out of date; exams expect the 2019 Rules. | — | superseded | 34 | 7 |
Bank = servable Drug Inspector questions mentioning the schedule; PYQ = official UPSC previous-paper questions mentioning it. Both are counted at build time from the live bank.
Schedule H vs H1 vs X — the prescription ladder
One mark in nearly every paper. All three are prescription-only; what changes is the licence, the record and the label.
| Schedule | Licence to sell | Prescription | Record | Label |
|---|---|---|---|---|
| H | Ordinary retail licence (Form 20 / 21) | Required — RMP prescription | Prescription register / cash-memo as per licence conditions | "Rx" symbol and the Schedule H warning |
| H1 | Ordinary retail licence | Required — RMP prescription | Separate register: patient, prescriber, drug, quantity — preserved three years | Warning inside a red-bordered box; "Rx" in red |
| X | Special licence (Schedule X forms) | Required — in duplicate; copy retained two years | Register of purchase and sale; stock under lock and key | "XRx" in red; conspicuous warning |
Schedule G is the trap next to this ladder: it requires a caution label ("dangerous to take except under medical supervision"), not a prescription.
Three currency points coaching notes miss
- Schedule M is the 2023 text. The revision notified by G.S.R. 922(E) on 28 December 2023 rebuilt GMP around a pharmaceutical quality system, quality risk management and validation. Questions on Schedule M written from pre-2023 notes will teach you the wrong structure.
- Schedule Y is not the clinical-trial law. The New Drugs and Clinical Trials Rules, 2019 are. A question about trial permissions, ethics committees or compensation is a 2019 Rules question.
- Cosmetics have left the 1945 Rules. The Cosmetics Rules, 2020 now govern cosmetics, including their standards and permitted colours; the cosmetics schedules of the 1945 Rules (Q and S) are no longer where you study them.
Practise the schedules with real questions
Independent preparation resource — not affiliated with UPSC or CDSCO. Source: Drugs and Cosmetics Rules, 1945 as amended; Cosmetics Rules, 2020; Medical Devices Rules, 2017; New Drugs and Clinical Trials Rules, 2019.