# Drugs and Cosmetics Act 1940 > Drugs and Cosmetics Act 1940 notes for Pharmacy: schedules H, H1, X, M and Y, misbranded, adulterated and spurious definitions, licence forms and DTAB for PCI exams. - Canonical URL: https://prepelephant.com/topics/allied/pharmacy/drugs-and-cosmetics-act - Exam / course: Allied Health · Subject: Pharmacy - Publisher: PrepElephant (https://prepelephant.com) — Prepared and reviewed by the PrepElephant Academic Review Team - First published: 2026-10-02 - Last updated: 2026-10-02 - How to cite: "Drugs and Cosmetics Act 1940", PrepElephant, https://prepelephant.com/topics/allied/pharmacy/drugs-and-cosmetics-act ## Direct answer The Drugs and Cosmetics Act, 1940 exists to guarantee that a medicine sold in India is what it claims to be — it regulates the import, manufacture, distribution and sale of drugs and cosmetics, and its Rules of 1945 carry the schedules (H, H1, X, C, M, Y and the rest) that decide a product's licence, label and record-keeping obligations. The Act's three dirty words — misbranded (section 17), adulterated (17A) and spurious (17B) — are the classic definition questions, and the licence forms 20, 20-B, 21 and 21-B for retail and wholesale sale are the numbers every paper recycles. Administration runs through the CDSCO under the Drugs Controller General of India, advised by the Drugs Technical Advisory Board, with the Central Drugs Laboratory at Kolkata as the appellate analyst. ## What you must remember - Definitions: a drug includes substances used in diagnosis, treatment, mitigation or prevention of disease in humans or animals, and notified devices; misbranded = false or misleading label; adulterated = filthy, putrid or foreign-substance contaminated; spurious = imitating or sold under a name that belongs to another drug, or labelled by a non-existent manufacturer. - Schedule C and C(1): biological and special products — sera, vaccines, insulin, antibiotics — needing Form 21/21-B licences and stricter storage. - Schedule H: prescription-only; the label warns it is to be sold by retail only on a registered medical practitioner's prescription. - Schedule H1 (effective 2014): certain antibiotics and anti-tuberculosis medicines; separate register entry with purchase and sale details, copy of prescription retained for three years. - Schedule X: narcotic and habit-forming drugs — double-lock storage, special register, prescriptions retained two years. - Schedule M: Good Manufacturing Practices — premises, plant and personnel standards for factories; Schedule Y covered clinical trials and new drugs (now largely under the New Drugs and Clinical Trials Rules 2019). - Schedule P fixes periods of potency (shelf-life); Schedule K exempts specified classes from parts of the Rules. - Licence forms: 20 (retail sale of drugs other than Schedule C), 20-B (wholesale, same), 21 (retail of Schedule C products), 21-B (wholesale of Schedule C); manufacture runs on the Form 25/26 family with loan-licence variants. - Penalties climb from fines for misbranded drugs to imprisonment for adulterated ones (aggravated if consumption causes grievous hurt or death) and enhanced punishment for repeat offenders. - Cosmetics were brought under a separate Cosmetics Rules 2020 regime, splitting what the parent Act had governed together. ## Reading a schedule into shop-floor obligations The schedules only matter because each converts into duties, so practise the translation. A wholesaler receives an order for a Schedule H1 antibiotic: this is not an ordinary line item — the sale requires a valid prescription copy to be retained, both purchase and sale entered in a separate register kept for three years, and no counter or loose supply is lawful. A hospital pharmacy stocks a Schedule X sedative: the products live in a cupboard under double lock, a register tracks every ampoule from receipt to administration, and prescriptions are kept two years. A retailer holding Form 21 stocks insulin and a vaccine (Schedule C): the licence differs from the ordinary Form 20, and the cold chain obligation rides with the product regardless of paperwork. Run the same translation up the supply chain. A manufacturer of any drug works under Schedule M's GMP — designed layout, dedicated areas, documented processes, qualified personnel — and the licence to make products other than Schedule C belongs to the Form 25 family, with separate forms for biologicals. A firm developing a new drug navigates what was Schedule Y territory, now the New Drugs and Clinical Trials Rules 2019, with ethics-committee and CDSCO approvals. When an inspector arrives, powers under section 22 (inspection, sampling, seizure) are what he exercises — and the sample he draws is analysed against standards of quality, with the appellate route ending at the Central Drugs Laboratory, Kolkata. ## Where candidates blur the boundaries Misbranded, adulterated and spurious are routinely swapped. Anchor the images: misbranded is a lying label on a real drug; adulterated is a contaminated or degraded product — filth, putrid matter, or a cheaper substance substituting the drug wholly or partly; spurious is fraud at identity level — fake manufacturer, another's name, or colourable imitation of a popular brand. "Not of standard quality" is the umbrella the Act uses when a drug fails its prescribed tests without fitting the three named categories. The second blur is H versus H1: both need prescriptions, but H1 adds the register, the three-year record and the retained prescription copy — the 2014 answer to antibiotic resistance and irrational sales. The third blur is institutional: the DTAB advises (it is the statutory expert committee), the DCGI approves (licences for import and new drugs at the centre), state licensing authorities license (manufacture and sale locally), and the CDL Kolkata referees disputed analyses — four different verbs again. And the evergreen memory error: the Act is 1940, the Rules are 1945 — the pair of dates is a one-mark question asked almost ceremonially. ## Frequently asked questions ### Define spurious drug under the Act. A drug sold under a name that belongs to another drug, or imitating another drug, or labelled with the name of a person other than the real manufacturer — including drugs purporting to be the product of a nonexistent manufacturer. ### What distinguishes Schedule H1 from Schedule H? Both are prescription-only, but H1 drugs (certain antibiotics, anti-TB medicines) additionally require entry in a separate register with details of purchase and sale, and retention of a copy of the prescription for three years. ### Which licence forms govern retail and wholesale sale? Form 20 for retail sale of drugs other than Schedule C, Form 21 for retail of Schedule C products, Form 20-B and 21-B for their wholesale counterparts; manufacture uses the Form 25/26 family. ### What does Schedule M prescribe? Good Manufacturing Practices: requirements for premises, plant, equipment, staff and quality-control documentation in pharmaceutical factories. ### What is the DTAB and its role? The Drugs Technical Advisory Board — a statutory expert body constituted under the Act to advise the central and state governments on drug standards and technical matters arising under the Rules.