3. Drugs and Cosmetics Act, 1940: A Complete Guide to Rules, Schedules, and New Amendments

DRUGS AND COSMETICS ACT, 1940 AND RULES, 1945: A TEACHER’S COMPREHENSIVE GUIDE TO REGULATIONS, SCHEDULES, AND NEW AMENDMENTS

Welcome, future pharmacists and healthcare professionals!

As a pharmacy law and ethics educator with years of experience teaching pharmaceutical legislation, I have observed that the Drugs and Cosmetics Act, 1940, and Rules, 1945, form the cornerstone of pharmaceutical regulation in India. Continuous use of cosmetics in luxury items may prove harmful as they may contain harmful ingredients. Therefore, there is a need to control cosmetics. This Act verifies that drugs and cosmetics should be manufactured, distributed, and sold only by qualified persons having a licence for this purpose. Central and State Drugs Control authorities are recognised to control these actions. The main aim of the Act is to regulate the import, manufacture, distribution, and sale of drugs and cosmetics.

In this comprehensive guide, I will take you through the objectives, definitions, schedules, import provisions, manufacture and sale regulations, administration, and new amendments of the Drugs and Cosmetics Act and Rules. By the end of this article, you will have a thorough understanding of the legal framework governing drugs and cosmetics in India. Let us begin.

OBJECTIVES OF DRUGS AND COSMETICS ACT

The Drugs and Cosmetics Act, 1940, was enacted with several important objectives:

1. Preventing substandard drugs and maintaining high medical standards
2. Controlling import, manufacture, distribution, and sale of drugs and cosmetics by licensing
3. Ensuring manufacture, distribution, and sale is done by qualified persons only
4. Controlling manufacture and sale of Ayurvedic, Siddha, and Unani drugs
5. Establishing Drugs Technical Advisory Board (DTAB) and Drugs Consultative Committees (DCC)

DEFINITIONS UNDER THE ACT

Cosmetic

Any article intended to be rubbed, poured, sprinkled, or sprayed on, or introduced into, or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance, including any article intended for use as a component of cosmetic.

Drug

• All medicines for internal or external use of human beings or animals
• Substances intended for diagnosis, treatment, mitigation, or prevention of disease
• Substances intended to affect body structure or function
• Substances intended for use as components of a drug (including empty gelatin capsules)
• Devices intended for diagnosis, treatment, mitigation, or prevention of disease

Misbranded Drugs

• If damage is concealed by colouring, coating, powdering, or polishing
• If not labelled in prescribed manner
• If label or container bears any false or misleading claim

Adulterated Drugs

• Contains filthy, putrid, or decomposed substance
• Prepared, packed, or stored under insanitary conditions
• Container composed of poisonous or deleterious substance
• Contains harmful or toxic substance
• Any substance mixed to reduce quality or strength

Spurious Drugs

• Imported under a name belonging to another drug
• Imitation of or substitute for another drug
• Label bears name of fictitious or non-existent manufacturer
• Substituted wholly or partly by another drug or substance
• Purports to be product of a manufacturer of whom it is not truly a product

SCHEDULES TO THE ACT AND RULES

Schedules to the Act

• First Schedule: Books under Ayurvedic, Siddha, Unani, and Tibb systems
• Second Schedule: Standards for imported and manufactured drugs

Schedules to the Rules

• Schedule A: Proforma for licence applications, issue, renewal
• Schedule B: Rates of fee for test or analysis
• Schedule C and C₁: Biological and special products (sera, vaccines, hormones, toxins, antitoxins)
• Schedule D: Drugs exempted from import provisions
• Schedule F: Blood bank requirements; vaccine production standards
• Schedule F₂: Standards for surgical dressings
• Schedule FF: Standards for ophthalmic preparations
• Schedule G: Drugs requiring medical supervision (“It is dangerous to take this preparation except under medical supervision”)
• Schedule H: Prescription drugs (551 drugs; label with “Rx”)
• Schedule H₁: Sensitive antibiotics, habit-forming medications (red Rx label)
• Schedule J: Diseases which a drug may not prevent or cure
• Schedule K: Drugs exempted from certain manufacture provisions (household remedies, etc.)
• Schedule M: Good Manufacturing Practices (GMP) requirements
• Schedule N: Minimum equipment for efficient running of a pharmacy
• Schedule P: Life periods of drugs (expiry dates)
• Schedule P₁: Pack sizes of drugs
• Schedule Q: Dyes, colours, and pigments permitted in cosmetics
• Schedule R: Standards for condoms and medical devices
• Schedule S: Standards for cosmetics
• Schedule T: Factory premises for Ayurvedic, Siddha, Unani drugs
• Schedule U: Manufacturing and analytical records
• Schedule W: Drugs to be marketed under generic names only
• Schedule X: Habit-forming and narcotic drugs (addictive potential; special storage)
• Schedule Y: Requirements and guidelines for clinical trials of new drugs

IMPORT OF DRUGS

Classes of Drugs and Cosmetics Prohibited from Import

• Non-standard quality drugs or cosmetics
• Misbranded, spurious, or adulterated drugs
• Drugs requiring licence for import (without licence)
• Patent/proprietary medicines without true formula on label
• Drugs claiming to cure diseases specified in Schedule J
• Cosmetics containing unsafe or harmful ingredients
• Drugs prohibited in country of origin
• Drugs not labelled and packed in prescribed manner
• Expired biological products (Schedule C and C₁)
• New drugs without express permission of licensing authority

Import under Licence or Permit

• Schedule C and C₁ drugs (excluding Schedule X)
• Schedule X drugs
• Small quantities for examination, test, or analysis
• Drugs for personal use prescribed by RMP
• New drugs

MANUFACTURE OF DRUGS

Types of Manufacturing Licences

• Schedule C and C₁ drugs (biological and special products)
• Schedule X drugs (habit-forming/narcotic drugs)
• Schedules C, C₁ and X drugs
• Drugs for examination, test, or analysis
• Patent and proprietary medicines
• New drugs
• Loan licence (manufacturing at another person’s premises)
• Repacking licence

Offences and Penalties for Manufacture

Offence	Penalty
Manufacture of adulterated/spurious drug causing death or serious hurt	Imprisonment 5 years + fine not less than ₹10,000
Manufacture without licence or adulterated drug (no death/serious hurt)	Imprisonment 1-3 years + fine not less than ₹5,000
Manufacture in contravention of any other provision	Imprisonment 1-2 years + fine
Failure to keep records or disclose required information	Imprisonment up to 1 year and/or fine up to ₹1,000

SALE OF DRUGS

Licences Required for Sale

• Wholesale: From fixed premises or motor vehicles; separate licences for Schedule C/C₁ and other drugs
• Retail – Chemists and Druggists: Under supervision of registered pharmacist (no compounding)
• Retail – Pharmacies: Under supervision of registered pharmacist (compounding allowed)
• Drug Stores: No registered pharmacist; only household remedies
• Restricted Licences: For vendors in sparsely populated areas, travelling agents

Schedule X and H Drugs – Special Conditions

• Retail only on RMP prescription
• Prescription not dispensed more than once (unless specified)
• No substitution allowed
• Schedule X prescriptions in duplicate; retained for 2 years
• Separate bound registers maintained
• Schedule X drugs stored in locked cabinet/drawer

Schedule N – Minimum Requirements for Pharmacy

• Dispensing department area: minimum 6 m² (plus 2 m² per additional pharmacist)
• Minimum height: 2.5 m
• Poison cupboard marked “POISON” in red letters
• Apparatus: dispensing balance (30 mg sensitivity), counter balance (3 kg, 1 g sensitivity), beakers, prescription bottles, mortars and pestles, pipettes, thermometers, water still, weights (1 mg-100 g), etc.
• Books: Indian Pharmacopoeia (current), National Formulary of India, Drugs and Cosmetics Act and Rules, Pharmacy Act, Narcotic Drugs and Psychotropic Substances Act

ADMINISTRATION OF THE ACT AND RULES

Drugs Technical Advisory Board (DTAB)

• Chairman: Director-General of Health Services
• Members: Drugs Controller of India, Director CDL, Director CRI Kasauli, President PCI, President MCI, and others
• Functions: Advises Central/State Governments on technical matters; recommends modifications/amendments

Central Drugs Laboratory (CDL)

• Established in Calcutta
• Analyses drug/cosmetic samples sent by courts or customs collectors
• Sera, vaccines, etc., sent to Central Research Institute, Kasauli
• Veterinary products sent to Indian Veterinary Institute, Izzatnagar

Drugs Consultative Committee (DCC)

• 2 Central Government nominees + 1 nominee from each State Government
• Advises on securing uniformity in administration of the Act

Drug Inspectors

• Appointed by Central or State Governments
• Qualifications: Degree in pharmacy/pharmaceutical sciences/medicine with clinical pharmacology/microbiology
• Duties: Inspect licenced premises, obtain samples, investigate complaints, institute legal proceedings, seize stocks if necessary
• Inspect premises at least twice a year

NEW AMENDMENTS (2019)

• Permanent licences for manufacturing introduced
• Licence remains valid if retention fee paid every 5 years
• Late fee of 2% per month for delayed payment (up to 6 months)
• Non-payment beyond 6 months results in deemed cancellation
• Renewal provisions omitted for many forms

SUMMARY: OFFENCES AND PENALTIES FOR SALE

Offence	Penalty
Sale of drugs causing death or serious hurt	Imprisonment 5 years to life + fine not less than ₹10,000
Sale of spurious drugs	1-3 years + fine up to ₹5,000 (first); 2-6 years + fine ₹10,000 (subsequent)
Sale in contravention of other provisions	1-2 years imprisonment + fine
False warranty to purchaser	Imprisonment 1 year + fine up to ₹5,000 (first); up to 2 years (subsequent)

A TEACHER’S LEGAL INSIGHTS

Over my years of teaching pharmaceutical legislation, I have developed a few key insights about the Drugs and Cosmetics Act that I always share with my students:

• The Drugs and Cosmetics Act, 1940, is the foundation of pharmaceutical regulation in India. Understanding its provisions is essential for any pharmacy professional.
• The various schedules classify drugs based on their nature, use, and potential for abuse. Schedule H, H1, and X drugs require special handling and prescription requirements.
• The distinction between misbranded, adulterated, and spurious drugs is important for understanding offences and penalties under the Act.
• The 2019 amendments introduced permanent licences, simplifying the regulatory process for manufacturers while ensuring continued compliance through retention fees.

FREQUENTLY ASKED QUESTIONS (FAQs)

1. What is the Drugs and Cosmetics Act, 1940?

The Drugs and Cosmetics Act, 1940, is the primary legislation regulating the import, manufacture, distribution, and sale of drugs and cosmetics in India.

2. What is the difference between misbranded and spurious drugs?

Misbranded drugs have false or misleading labels, while spurious drugs are imitations or substitutes of another drug, often with a non-existent manufacturer.

3. What are Schedule H drugs?

Schedule H drugs are prescription drugs (551 drugs) that must be labelled with “Rx” and can only be dispensed on a prescription from a Registered Medical Practitioner.

4. What is Schedule X?

Schedule X includes habit-forming and narcotic drugs with addictive potential. These drugs require special storage in a locked cabinet and strict prescription records.

5. What is the minimum area required for a dispensing department?

Under Schedule N, the dispensing department area must be a minimum of 6 m², plus 2 m² per additional pharmacist.

6. What are the 2019 amendments to the Act?

The 2019 amendments introduced permanent licences for manufacturing, with licence validity maintained by paying a retention fee every 5 years, and late fee provisions for delayed payments.

7. Who appoints Drug Inspectors?

Drug Inspectors are appointed by Central or State Governments and must have a degree in pharmacy/pharmaceutical sciences/medicine with clinical pharmacology/microbiology.

SUMMARY

The Drugs and Cosmetics Act, 1940, and Rules, 1945, form the cornerstone of pharmaceutical regulation in India. The Act regulates the import, manufacture, distribution, and sale of drugs and cosmetics through licensing and quality control mechanisms. The various schedules classify drugs based on their nature, use, and potential for abuse. The 2019 amendments introduced permanent licences for manufacturing, simplifying the regulatory process. Understanding the provisions of the Act and Rules is essential for pharmacy professionals to ensure compliance with the law and protect public health.

As I always tell my students: “The Drugs and Cosmetics Act is not just a set of rules—it is a commitment to public health. Every provision in this Act is designed to ensure that patients receive safe, effective, and high-quality medicines.”

REFERENCES AND FURTHER READING

• The Drugs and Cosmetics Act, 1940. Government of India.
• The Drugs and Cosmetics Rules, 1945. Government of India.
• Ministry of Health and Family Welfare. (2022). Drugs and Cosmetics Act Amendments. Government of India.
• Central Drugs Standard Control Organization (CDSCO). (2022). Guidelines on Drug Regulation. Retrieved from https://cdsco.gov.in.
• Pharmacy Council of India. (2022). Pharmacy Practice Regulations. New Delhi: PCI.

Disclaimer: This article is for educational purposes only and does not constitute legal advice. Always refer to the latest regulatory guidelines and consult legal experts for compliance matters.