Day 1 - The Drugs and Cosmetics Act, 1940 — Structure, Definitions & Schedules
By Arvind Sharma, B.Pharm, M.Pharm, Assistant Professor, MUIT
INTRODUCTION: WHY THIS ACT IS MOST IMPORTANT
The Drugs and Cosmetics Act, 1940 (Act No. 23 of 1940) is the backbone of pharmaceutical regulation in India and the #1 HIGH YIELD topic for UPSC Drug Inspector exams. It was enacted on 10th April 1940 and came into force on 1st April 1947. The Act extends to the whole of India and is administered by the Central Government (through CDSCO) and State Governments (through State FDA).
STRUCTURE OF THE ACT
| Component | Details |
|---|---|
| Chapters | I to XVI |
| Sections | 1 to 36 |
| Schedules | A to Y (18 Schedules) |
| Rules | Drugs Rules, 1945 & Cosmetics Rules, 2020 |
KEY DEFINITIONS (Section 3) — HIGH YIELD
1. "Drug" [Section 3(b)]
Includes:
- All medicines for internal or external use of human beings or animals
- All substances intended to be used for diagnosis, treatment, mitigation, or prevention of disease
- Such substances (other than food) intended to affect any structure or function of human body or animals
- Medical devices (added via 2019 Amendment)
2. "Cosmetic" [Section 3(aaa)]
Any article intended to be rubbed, poured, sprinkled, or sprayed on, or introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering appearance.
3. "Misbranded Drug" [Section 17]
A drug is misbranded if:
- It is so coloured, coated, powdered, or polished that damage is concealed
- It is made to appear of greater therapeutic value than it really is
- Its label bears any statement/design likely to mislead
- It is not labeled in the prescribed manner
4. "Spurious Drug" [Section 17-B]
A drug is spurious if:
- It is manufactured under a name which belongs to another drug
- It is an imitation of another drug
- Its label bears the name of another manufacturer
- It has been substituted wholly or partly by another drug/substance
- It purports to be the product of a manufacturer who did not manufacture it
5. "Adulterated Drug" [Section 17-A]
A drug is adulterated if:
- It consists wholly or in part of any filthy, putrid, or decomposed substance
- It has been prepared, packed, or stored under insanitary conditions
- Its container is composed of any poisonous or deleterious substance
- It bears or contains a colour other than a prescribed colour
- It contains any harmful or toxic substance
6. "Manufacture" [Section 3(f)]
Includes any process or part of a process for making, altering, ornamenting, finishing, packing, labeling, breaking up, or otherwise treating or adopting any drug or cosmetic with a view to its sale or distribution.
IMPORTANT SCHEDULES — EXAM FAVORITES
| Schedule | Content | |
|---|---|---|
| Schedule A | Forms for various applications (licenses, permits) | |
| Schedule B | Fees for test or analysis by CDL | |
| Schedule C | Biological & Special products (Sera, Vaccines, Toxins, Antigens, Insulin, Pituitary hormones, Blood products) | |
| Schedule C(1) | Other special products (Adrenaline, Arsenic compounds, Digitalis, Ergot, Heparin, Hormones, Liver extract, Oxytocin, Penicillin, Streptomycin, etc.) | |
| Schedule D | List of drugs exempted from provisions of import | |
| Schedule E(1) | List of poisonous substances under the Ayurvedic, Siddha & Unani systems | |
| Schedule F | Provisions applicable to biological & special products (now largely superseded by GMP rules) | |
| Schedule G | List of drugs to be labeled "Caution: It is dangerous to take this preparation except under medical supervision" | |
| Schedule H | List of prescription drugs — cannot be sold without registered medical practitioner's prescription | |
| Schedule H1 | List of Narcotic & Psychotropic drugs requiring special record-keeping (added in 2013) | |
| Schedule J | List of diseases/disorders for which no drug may claim to cure (e.g., AIDS, Cancer, Diabetes, Epilepsy, etc.) | |
| Schedule K | List of drugs exempted from certain provisions (e.g., household remedies, drugs supplied to hospitals) | |
| Schedule L | Standards for surgical dressings | |
| Schedule M | GMP & requirements of factory premises, equipment, and personnel | |
| Schedule M-II | Requirements of factory premises for manufacture of medical devices | |
| Schedule N | List of minimum equipment for efficient running of a pharmacy | |
| Schedule O | Standards for disinfectant fluids | |
| Schedule P | Life period of drugs (before which they must be consumed) | |
| Schedule Q | List of permitted colours for use in drugs | |
| Schedule R | Standards for condoms & mechanical contraceptives | |
| Schedule S | Standards for cosmetics | |
| Schedule T | Requirements of factory premises for manufacture of Ayurvedic, Siddha & Unani drugs | |
| Schedule U | Particulars to be shown in manufacturing records | |
| Schedule V | Standards for patent or proprietary medicines | |
| Schedule X | List of Narcotic Drugs & Psychotropic Substances — stricter control than Schedule H | |
| Schedule Y | Requirements & guidelines for clinical trials |
SCHEDULE H vs SCHEDULE H1 vs SCHEDULE X — COMPARISON TABLE
| Parameter | Schedule H | Schedule H1 | Schedule X |
|---|---|---|---|
| Year Introduced | 1945 (original) | 2013 | 1945 (original) |
| Nature | Prescription drugs | Narcotic & Psychotropic drugs | Narcotic drugs & Psychotropic substances |
| Prescription Required | Yes | Yes (with special format) | Yes (with special format) |
| Record Keeping | Normal | Special register mandatory | Special register + Narcotics record |
| Storage | Normal | Locked cupboard | Double lock safe |
| Examples | Antibiotics, Antihypertensives | Alprazolam, Codeine, Tramadol | Morphine, Pethidine, Cocaine, Barbiturates |
| Penalty for Violation | Fine + imprisonment (up to 3 years) | Fine + imprisonment (up to 5 years) | Fine + imprisonment (up to 10 years under NDPS Act) |
DRUGS TECHNICAL ADVISORY BOARD (DTAB) — Section 5
| Aspect | Details |
|---|---|
| Constitution | Central Government |
| Composition | 18 members including ex-officio and nominated members |
| Chairman | Director General of Health Services (DGHS) |
| Functions | Advises Central & State Governments on technical matters; frames rules and schedules |
| Meetings | At least twice a year |
CENTRAL DRUGS LABORATORY (CDL) — Section 6
- Located at Kolkata (established 1945)
- Functions as the reference standard laboratory for India
- Headed by Director
- Responsible for:
- Testing of drug samples referred by courts
- Preparation of reference standards
- Research on drug standards
- Training of analysts
DRUGS CONSULTATIVE COMMITTEE (DCC) — Section 7
- Advises Central Government, DTAB, and State Governments on uniform administration of the Act
- Ensures coordination between Central and State authorities
LICENSING AUTHORITIES
| Level | Authority | Issues License For |
|---|---|---|
| Central | CDSCO (Central Drugs Standard Control Organization) | New drugs, blood banks, vaccines, r-DNA products, medical devices |
| State | State FDA / Drug Control Department | Manufacturing, sale, distribution of drugs within state |
PENALTIES UNDER THE ACT (Section 27 — HIGH YIELD)
| Offence | Imprisonment | Fine |
|---|---|---|
| Manufacture/sale of spurious drug likely to cause death/grievous hurt | 10 years to life | ₹10 lakh to ₹20 lakh |
| Manufacture/sale of spurious drug (not causing death) | 7 to 10 years | ₹1 lakh to ₹3 lakh |
| Manufacture/sale of adulterated drug | 3 to 5 years | ₹1 lakh to ₹3 lakh |
| Manufacture/sale of misbranded drug | Up to 1 year | Up to ₹20,000 |
| Subsequent offence | Double the penalty | Double the fine |
2026 CURRENT AFFAIRS LINK
- The Drugs, Medical Devices and Cosmetics Bill, 2023 (draft) proposes to replace the 1940 Act entirely with a modern framework. It is currently under parliamentary review.
- New Drugs and Clinical Trials Rules, 2019 have streamlined clinical trial approvals.
- Schedule M (GMP) was revised in 2024 to align with WHO GMP guidelines.
📝 PRACTICE TEST — 30 MCQs
Q1. The Drugs and Cosmetics Act, 1940 originally came into force on:
A) 10th April 1940
B) 1st April 1947
C) 15th August 1947
D) 26th January 1950
Correct Answer: B) 1st April 1947
Explanation: The Act was enacted on 10th April 1940 but came into force on 1st April 1947. This is a classic "date trap" question. [Previous Year Pattern: MPPSC 2019]
Q2. Which Schedule of the Drugs and Cosmetics Act contains GMP requirements for factory premises?
A) Schedule C
B) Schedule H
C) Schedule M
D) Schedule X
Correct Answer: C) Schedule M
Explanation: Schedule M lays down Good Manufacturing Practices (GMP) and requirements of premises, equipment, and personnel. It is one of the most frequently asked schedules. [Previous Year Pattern: UPSC 2018, RPSC 2020]
Q3. The Chairman of the Drug Technical Advisory Board (DTAB) is:
A) Drugs Controller General of India (DCGI)
B) Director General of Health Services (DGHS)
C) Secretary, Ministry of Health & Family Welfare
D) President of Pharmacy Council of India
Correct Answer: B) Director General of Health Services (DGGI)
Explanation: As per Section 5 of the Act, the DGHS is the Chairman of DTAB. Many candidates confuse this with DCGI. [Previous Year Pattern: MPSC 2021, TNPSC 2019]
Q4. Which of the following drugs is included in Schedule C of the Drugs and Cosmetics Act?
A) Paracetamol tablets
B) Insulin injection
C) Aspirin tablets
D) Vitamin C tablets
Correct Answer: B) Insulin injection
Explanation: Schedule C covers biological and special products including sera, vaccines, toxins, antigens, insulin, pituitary hormones, and blood products. [Previous Year Pattern: Odisha PSC 2020]
Q5. Schedule H1 was introduced in the Drugs and Cosmetics Act in which year?
A) 2008
B) 2013
C) 2019
D) 2020
Correct Answer: B) 2013
Explanation: Schedule H1 was introduced in 2013 to control the misuse of antibiotics and psychotropic substances. It mandates special record-keeping and prescription formats. [Previous Year Pattern: UPSC 2020, RPSC 2021]
Q6. The Central Drugs Laboratory (CDL) under the Act is located at:
A) New Delhi
B) Mumbai
C) Kolkata
D) Chennai
Correct Answer: C) Kolkata
Explanation: CDL is the apex reference laboratory located in Kolkata, headed by a Director. [Previous Year Pattern: MPPSC 2018, TNPSC 2020]
Q7. Which Schedule lists diseases for which NO drug may claim to cure?
A) Schedule G
B) Schedule H
C) Schedule J
D) Schedule K
Correct Answer: C) Schedule J
Explanation: Schedule J contains a list of 51 diseases/disorders (including AIDS, Cancer, Diabetes, Epilepsy) for which no drug can claim cure. Violation leads to misbranding charges. [Previous Year Pattern: UPSC 2019, MPSC 2022]
Q8. Under Section 27, the penalty for manufacturing/selling spurious drugs likely to cause death includes:
A) Up to 3 years imprisonment
B) 7 to 10 years imprisonment
C) 10 years to life imprisonment + ₹10-20 lakh fine
D) Only fine up to ₹50,000
Correct Answer: C) 10 years to life imprisonment + ₹10-20 lakh fine
Explanation: The 2019 Amendment enhanced penalties significantly. For spurious drugs causing death risk: 10 years to life + heavy fine. [Previous Year Pattern: RPSC 2021, Odisha PSC 2022]
Q9. Which of the following is NOT included in the definition of "Drug" under Section 3(b)?
A) Substances for diagnosis of disease
B) Substances intended to affect body structure/function
C) Food articles for nutritional purposes
D) Medical devices
Correct Answer: C) Food articles for nutritional purposes
Explanation: The definition explicitly excludes food. Medical devices were added in 2019. This is a favorite "negative" question type. [Previous Year Pattern: TNPSC 2018]
Q10. Schedule X of the Drugs and Cosmetics Act deals with:
A) GMP requirements
B) Narcotic drugs and psychotropic substances
C) Clinical trial guidelines
D) Cosmetic standards
Correct Answer: B) Narcotic drugs and psychotropic substances
Explanation: Schedule X contains stricter controlled substances than Schedule H1, including Morphine, Pethidine, Barbiturates. It operates in conjunction with the NDPS Act, 1985. [Previous Year Pattern: UPSC 2017, MPPSC 2020]
Q11. The Drugs and Cosmetics (Amendment) Act, 2019, primarily introduced which significant change?
A) Abolished Schedule H
B) Included medical devices under the definition of "drugs"
C) Removed Schedule M
D) Transferred powers from State to Centre
Correct Answer: B) Included medical devices under the definition of "drugs"
Explanation: The 2019 Amendment expanded the definition of "drug" to include medical devices, bringing them under regulatory control of CDSCO. [Previous Year Pattern: UPSC 2020, RPSC 2022]
Q12. Which Schedule specifies the life period of drugs?
A) Schedule M
B) Schedule P
C) Schedule T
D) Schedule Y
Correct Answer: B) Schedule P
Explanation: Schedule P specifies the expiry/life period for various drug formulations. For example, tablets/capsules generally have 3 years from manufacture. [Previous Year Pattern: MPSC 2019]
Q13. "Manufacture" under Section 3(f) of the Act includes:
A) Only production of active pharmaceutical ingredients
B) Packaging, labeling, and breaking up for sale/distribution
C) Only quality control testing
D) Only wholesale distribution
Correct Answer: B) Packaging, labeling, and breaking up for sale/distribution
Explanation: The definition is broad and includes any process with a view to sale or distribution. Even repackaging constitutes manufacture. [Previous Year Pattern: Odisha PSC 2019]
Q14. The Drugs Consultative Committee (DCC) under Section 7 advises on:
A) Pricing of drugs
B) Uniform administration of the Act across India
C) Export of drugs
D) Patent matters
Correct Answer: B) Uniform administration of the Act across India
Explanation: DCC ensures coordination between Central and State Governments for uniform implementation. [Previous Year Pattern: TNPSC 2021]
Q15. Which Schedule contains the list of permitted colours for use in drugs?
A) Schedule Q
B) Schedule R
C) Schedule S
D) Schedule T
Correct Answer: A) Schedule Q
Explanation: Schedule Q lists colours permitted for use in drugs. Using non-permitted colours makes the drug adulterated. [Previous Year Pattern: MPPSC 2017]
Q16. A drug is considered "spurious" under Section 17-B if:
A) It is expired
B) It purports to be the product of a manufacturer who did not manufacture it
C) It is stored at wrong temperature
D) It has a damaged label
Correct Answer: B) It purports to be the product of a manufacturer who did not manufacture it
Explanation: Spurious drugs involve identity fraud — imitation, substitution, or false manufacturer claims. Expired drugs fall under misbranding/adulteration, not spurious. [Previous Year Pattern: UPSC 2018, RPSC 2019]
Q17. Schedule E(1) of the Act deals with:
A) Allopathic poisonous substances
B) Ayurvedic, Siddha & Unani poisonous substances
C) Cosmetic poisonous substances
D) Food poisonous substances
Correct Answer: B) Ayurvedic, Siddha & Unani poisonous substances
Explanation: Schedule E(1) specifically lists poisonous substances under AYUSH systems (e.g., Aconite, Arsenic, Mercury compounds in traditional preparations). [Previous Year Pattern: MPSC 2020]
Q18. The penalty for a subsequent offence under the Act is:
A) Same as first offence
B) Reduced by 50%
C) Double the penalty
D) Only fine, no imprisonment
Correct Answer: C) Double the penalty
Explanation: Section 27(3) specifies that subsequent offences attract double the penalty. This is a deterrent provision. [Previous Year Pattern: TNPSC 2020, Odisha PSC 2021]
Q19. Which of the following is a characteristic of Schedule H1 drugs?
A) Can be sold without prescription
B) Require special prescription format and record-keeping
C) Available over-the-counter
D) No storage restrictions
Correct Answer: B) Require special prescription format and record-keeping
Explanation: Schedule H1 mandates that pharmacists maintain a separate register with patient details, doctor details, and quantity dispensed. [Previous Year Pattern: UPSC 2021, RPSC 2022]
Q20. The Central Drugs Standard Control Organization (CDSCO) operates under which Ministry?
A) Ministry of Chemicals and Fertilizers
B) Ministry of Health and Family Welfare
C) Ministry of Commerce and Industry
D) Ministry of Science and Technology
Correct Answer: B) Ministry of Health and Family Welfare
Explanation: CDSCO is the national regulatory body under the Ministry of Health & Family Welfare, headed by DCGI. [Previous Year Pattern: MPPSC 2018, MPSC 2019]
Q21. Under the Act, "adulterated drug" includes one which:
A) Has a wrong brand name
B) Contains a harmful or toxic substance
C) Is sold at a higher price
D) Is imported without license
Correct Answer: B) Contains a harmful or toxic substance
Explanation: Section 17-A defines adulterated drugs as those containing filthy, decomposed, or toxic substances, or prepared under insanitary conditions. [Previous Year Pattern: TNPSC 2019]
Q22. Schedule T of the Act specifies requirements for:
A) Allopathic drug manufacturing
B) Ayurvedic, Siddha & Unani drug manufacturing
C) Cosmetic manufacturing
D) Medical device manufacturing
Correct Answer: B) Ayurvedic, Siddha & Unani drug manufacturing
Explanation: Schedule T lays down GMP requirements for AYUSH manufacturing units, distinct from Schedule M (allopathic). [Previous Year Pattern: RPSC 2020, Odisha PSC 2021]
Q23. Which Schedule specifies standards for surgical dressings?
A) Schedule L
B) Schedule M
C) Schedule N
D) Schedule P
Correct Answer: A) Schedule L
Explanation: Schedule L specifies standards for surgical dressings. This is a less-asked but high-yield schedule for "match the following" questions. [Previous Year Pattern: MPSC 2017]
Q24. The 2019 Amendment to the Drugs and Cosmetics Act enhanced the maximum fine for spurious drug offences to:
A) ₹50,000
B) ₹1 lakh
C) ₹10-20 lakh
D) ₹50 lakh
Correct Answer: C) ₹10-20 lakh
Explanation: Pre-2019, the fine was much lower. The 2019 Amendment raised it to ₹10-20 lakh for spurious drugs causing death risk. [Previous Year Pattern: UPSC 2020]
Q25. Which of the following is exempted from certain provisions of the Act under Schedule K?
A) All prescription drugs
B) Household remedies and drugs supplied to hospitals
C) All antibiotics
D) All narcotic drugs
Correct Answer: B) Household remedies and drugs supplied to hospitals
Explanation: Schedule K provides exemptions for household remedies (e.g., antacids, antiseptics in small quantities) and institutional supply. [Previous Year Pattern: MPPSC 2019, TNPSC 2020]
Q26. Schedule Y of the Drugs and Cosmetics Act deals with:
A) GMP for biological products
B) Requirements and guidelines for clinical trials
C) List of banned drugs
D) Pricing of essential medicines
Correct Answer: B) Requirements and guidelines for clinical trials
Explanation: Schedule Y specifies requirements for clinical trials, including ethics committee approval, informed consent, and reporting of adverse events. [Previous Year Pattern: UPSC 2019, RPSC 2021]
Q27. A pharmacist selling a Schedule H drug without a valid prescription commits an offence punishable under:
A) Section 18
B) Section 27
C) Section 33
D) Section 36
Correct Answer: B) Section 27
Explanation: Violations of Schedules (H, H1, X) attract penalties under Section 27. [Previous Year Pattern: MPSC 2020, Odisha PSC 2022]
Q28. The "Drugs, Medical Devices and Cosmetics Bill, 2023" proposes to:
A) Abolish the Drugs and Cosmetics Act, 1940
B) Replace the 1940 Act with a new comprehensive law
C) Only amend Schedule M
D) Transfer all powers to State Governments
Correct Answer: B) Replace the 1940 Act with a new comprehensive law
Explanation: The 2023 Bill (draft) aims to replace the 1940 Act with a modern regulatory framework. This is a current affairs-linked question. [Previous Year Pattern: Current Affairs 2023-26]
Q29. Which of the following is included in Schedule C(1)?
A) Paracetamol
B) Penicillin
C) Aspirin
D) Ibuprofen
Correct Answer: B) Penicillin
Explanation: Schedule C(1) includes other special products like Penicillin, Streptomycin, Adrenaline, Digitalis, Ergot, Heparin, and hormones. [Previous Year Pattern: TNPSC 2018, MPPSC 2020]
Q30. The definition of "Cosmetic" under the Act specifically excludes:
A) Substances for cleansing
B) Substances for beautifying
C) Articles intended for internal consumption
D) Substances for altering appearance
Correct Answer: C) Articles intended for internal consumption
Explanation: Cosmetics are for external application only. Anything intended for internal use would be classified as a drug or food, not a cosmetic. [Previous Year Pattern: RPSC 2019]
🎯 QUICK REVISION — 10 FLASHCARDS
- 📌 Act enacted: 10th April 1940 | Came into force: 1st April 1947
- 📌 Structure: 16 Chapters, 36 Sections, 18 Schedules (A-Y)
- 📌 DTAB Chairman: DGHS (NOT DCGI) — MOST ASKED
- 📌 CDL Location: Kolkata — apex testing lab
- 📌 Schedule M: GMP requirements — #1 asked schedule
- 📌 Schedule H: Prescription drugs | Schedule H1: Narcotic & Psychotropic (2013) | Schedule X: Stricter narcotics control
- 📌 Schedule J: Diseases for which no cure claim allowed (AIDS, Cancer, Diabetes)
- 📌 Spurious Drug: Identity fraud — harshest penalty: 10 years to life + ₹10-20 lakh
- 📌 2019 Amendment: Medical devices included in "drug" definition + enhanced penalties
- 📌 2023 Bill: Proposes to replace 1940 Act entirely — CURRENT AFFAIRS LINK
✅ DAILY STUDY CHECKLIST
- Read Study Notes thoroughly
- Attempt all 30 MCQs
- Review incorrect answers with explanations
- Memorize 10 Quick Revision Flashcards
- Create your own mnemonics for Schedules
📢 NEXT DAY PREVIEW: Day 2 will cover The Drugs and Cosmetics Rules, 1945 — Licensing, Import, Manufacture & Sale Provisions with 30 fresh MCQs.