D&C Act – Schedules, Sale, Labeling & Administration
This unit continues the study of the Drugs & Cosmetics Act with four critical areas: (1) Detailed study of all important Schedules (G, H, M, N, P, T, U, V, X, Y) — the backbone of drug classification in India. (2) Regulations governing Sale of drugs (wholesale, retail, and restricted licenses). (3) Labeling and Packing requirements — every drug label must carry specific information as prescribed. (4) Administrative machinery — the regulatory bodies (DTAB, CDL, DCC) and officers (Drug Inspectors, Government Analysts) that enforce the Act.
Syllabus & Topics
- 1Schedule G: Drugs which shall be labeled with the warning ‘Caution: It is dangerous to take this preparation except under medical supervision.’ Examples: Tolbutamide (antidiabetic), Phenytoin (antiepileptic), most hormonal preparations, anthelmintics. Less restrictive than Schedule H — can be sold without prescription but must carry the caution label.
- 2Schedule H: Prescription drugs – shall not be sold without a valid prescription. Label must bear ‘Rx’ and the warning ‘Schedule H Drug – Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.’ Vast majority of modern drugs: antibiotics, antihypertensives, antidiabetics, etc. Schedule H1: Additional requirements – prescription must be retained for 3 years, register maintained (antibiotics like 3rd gen cephalosporins, anti-TB drugs).
- 3Schedule X: Most strictly regulated prescription drugs. Must be labeled ‘Schedule X Drug – WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.’ Prescription must be in DUPLICATE (one retained by pharmacist for 2 years). Examples: Diazepam, Alprazolam, Phenobarbital, Amphetamine, Barbiturates, Ketamine. Must be stored separately under lock and key.
- 4Schedule M: Good Manufacturing Practices (GMP). Part I: General requirements – factory building, water supply, disposal of waste, storage, QC lab, documentation. Part II: Specific requirements for different dosage forms (tablets, liquids, sterile products, blood products). Compliance mandatory for manufacturing license. WHO-GMP certification for export.
- 5Schedule N: List of minimum equipment required for running an efficient pharmacy. Includes: dispensing balance, refrigerator, mortar & pestle, spatulas, beakers, dispensing bottles, etc. Relevant for drug license application for retail/wholesale pharmacy.
- 6Schedule P: Shelf life periods for drugs. Lists the date of expiry to be given on labels of various categories of drugs. If no specific period is given, the default is 5 years from manufacture for most drugs, 3 years for parenteral preparations, and 2 years for most ophthalmic preparations.
- 7Schedules T, U, V, Y & Others: Schedule T: GMP for ASU (Ayurveda, Siddha, Unani) drugs. Schedule U: Standards for patent & proprietary medicines (ASU). Schedule V: Standards for patent & proprietary medicines. Schedule Y: Requirements for clinical trials and new drug approvals. Part XII B: Requirements for notified medical devices. Schedule F: Standards for biological and special products (sera, vaccines, toxins). DMR (OA): Drugs Manufactured in Outside Agreement.
- 8Sale of Drugs – Retail License (Form 20/21): Issued by State Licensing Authority. Conditions: (1) Full-time registered pharmacist must be present during business hours. (2) Adequate storage facilities. (3) Refrigeration for thermolabile drugs. (4) Schedule H/H1/X drugs sold only on prescription. (5) Proper record keeping. License valid for 5 years. Retail sale: directly to patients/consumers in small quantities.
- 9Sale of Drugs – Wholesale & Restricted License: Wholesale license (Form 20B/21B): Sale of drugs in bulk to retailers, hospitals, government institutions. Registered pharmacist required. Restricted License (Form 20A): For non-pharmacist shops (general stores) – can sell ONLY a limited list of household medicines (OTC) – paracetamol, cough drops, antacids, ORS. Cannot sell Schedule H/X drugs.
- 10Offences & Penalties – Sale: Sale of adulterated drug: imprisonment ≥1 year up to 3 years + fine ≥₹10,000. Sale of spurious drug: imprisonment ≥3 years up to life + fine ≥₹1 lakh to ₹10 lakh. Sale of drugs without license: imprisonment up to 1 year + fine. Sale violating labeling requirements: fine up to ₹500 (first offence), ₹1000 (subsequent).
- 11Labeling Requirements: Every drug label must contain: (1) Name of drug. (2) Net content. (3) Name and address of manufacturer. (4) Batch number. (5) Manufacturing date. (6) Expiry date. (7) MRP (Maximum Retail Price inclusive of all taxes). (8) Composition/ingredients. (9) ‘For external use only’ (if applicable, in RED). (10) Appropriate Schedule warning (G/H/X). (11) Storage conditions. (12) ‘Keep out of reach of children.’
- 12Specimen Labels: The Rules prescribe specific label formats for different categories. Inner label (immediate container), Outer label (carton), and Insert/Leaflet (patient information). Special labeling: ‘Poison’ in red for Schedule E drugs. ‘For animal treatment only’ for veterinary drugs. Ayurvedic/Unani drugs: label in Hindi or regional language.
- 13Permitted Colors: Only specified coal-tar colors approved for use in drugs (Schedule Q) and cosmetics. Prohibition on use of certain dyes (e.g., Rhodamine B banned in India). Colors must be certified by authorized agencies.
- 14Administration – DTAB, CDL, DCC: Drugs Technical Advisory Board (DTAB) (Section 5): Advisory body to Central Govt on technical matters – standards, testing methods. Central Drugs Laboratory (CDL, Kolkata) (Section 6): Tests drug samples referred by courts and Drug Inspectors. Government Analyst: Tests drug samples drawn by Drug Inspectors. Drugs Consultative Committee (DCC) (Section 7): Coordinates between Central and State governments on uniform administration.
- 15Drug Inspectors: Appointed by State Government (Section 21). Powers: (1) Inspect manufacturing/sale premises. (2) Draw samples for testing. (3) Seize adulterated/spurious/misbranded drugs. (4) Search with warrant. (5) Maintain records of inspections. Duties: Ensure compliance with Act/Rules, check licenses, verify labels, inspect storage conditions. Qualifications: Degree in Pharmacy/Pharmaceutical Chemistry + experience.
Learning Objectives
Exam Prep Questions
Q1. What Is the Difference Between Schedule H and Schedule X Drugs?
Under the Drugs and Cosmetics Act 1940 and its rules, Schedule H drugs can only be sold with a valid prescription and must carry the symbol “Rx” along with a cautionary statement on the label. In contrast, Schedule X drugs are subject to stricter control because of their high abuse potential. Their sale requires a prescription in duplicate (one copy retained by the pharmacist for two years), storage under lock and key, and maintenance of a detailed sales register. Violations involving Schedule X drugs attract much stricter penalties. Examples include drugs such as Diazepam, barbiturates, amphetamines, and Ketamine.
Q2. Can a Non-Pharmacist Sell Drugs?
Generally, drugs cannot be sold without the presence of a registered pharmacist. A full-time pharmacist must be physically present in the pharmacy during business hours to supervise dispensing. However, under Form 20A, a restricted license may be issued to general stores allowing them to sell a limited range of household medicines such as Paracetamol, oral rehydration salts, antacids, and simple cough preparations. These stores are not permitted to sell any drugs listed under Schedule G, Schedule H, or Schedule X.
Q3. What Is the Role of DTAB?
Drugs Technical Advisory Board is the highest statutory technical advisory body established under Section 5 of the Drugs and Cosmetics Act 1940. It advises both the central and state governments on technical matters related to drug regulation. Its responsibilities include recommending standards for drugs and testing methods, advising on classification and scheduling of medicines, guiding policies on import and manufacturing, and providing expert input on regulatory issues affecting pharmaceutical products. The board consists of government officials, pharmacopoeial experts, industry representatives, and medical professionals.
Q4. What Are the Penalties for Selling Spurious Drugs?
Selling counterfeit medicines is considered a serious offence under the Drugs and Cosmetics Act 1940. For the first offence, the punishment includes imprisonment of not less than three years, which may extend to life imprisonment, along with a fine of at least ₹1 lakh or up to ₹10 lakh, or three times the value of the confiscated drugs, whichever is greater. If the spurious drug causes grievous harm, the minimum imprisonment increases to seven years, and if it results in death, the minimum sentence is ten years and may extend to life imprisonment.
Q5. What Information Must Appear on a Drug Label?
According to labeling rules under the Drugs and Cosmetics Act 1940, a drug label must include several mandatory details. These include the name of the drug (generic or brand), composition statement, batch or lot number, manufacturing date, expiry date, maximum retail price (MRP) inclusive of taxes, and the name and address of the manufacturer. The label must also state the net content or quantity, dosage directions, storage conditions, and appropriate schedule warnings such as those under Schedule H or Schedule X if applicable. Additional warnings such as “Keep out of reach of children” and “For external use only” (in red color for topical preparations) must also be included.