3. DRUGS AND COSMETICS ACT, 1940 AND RULES 1945 AND NEW AMENDMENT

DRUGS AND COSMETICS ACT, 1940 AND RULES, 1945: A TEACHER’S COMPREHENSIVE GUIDE

Welcome, future pharmacists and healthcare professionals!

The Drugs and Cosmetics Act, 1940 and Rules, 1945 form the cornerstone of pharmaceutical regulation in India. This comprehensive legislation ensures that drugs and cosmetics are manufactured, distributed, and sold only by qualified persons having a licence for this purpose. Continuous use of cosmetics in luxury items may prove harmful as they may contain harmful ingredients—therefore, there is a need to control cosmetics. Timely amendments are made to this Act and its Rules to keep pace with evolving scientific knowledge and public health needs.

As a pharmacy educator with years of experience teaching Pharmacy Law and Ethics, I have observed that students often find this Act overwhelming due to its extensive provisions and numerous schedules. However, understanding the Drugs and Cosmetics Act is essential for every pharmacist—it governs everything from import and manufacture to sale and distribution of drugs and cosmetics. In this comprehensive guide, I will break down the Act into manageable sections, explaining the objectives, definitions, import provisions, manufacturing requirements, and the various schedules. Let us begin our journey.

Dpharmguru’s exam insights:

The Drugs and Cosmetics Act, 1940 is one of the most frequently tested topics in pharmacy law exams. Remember: The Act was passed in 1940 and the Rules were framed in 1945. A major amendment was made in 1982 in which Schedules E, I, and L were eliminated, Schedules G and H were revised and expanded, and Schedule X was added. The Act aims to regulate import, manufacture, distribution, and sale of drugs and cosmetics. Pay special attention to the definitions, schedules, and penalties—these are almost always asked in exams!

OBJECTIVES OF DRUGS AND COSMETICS ACT

• To prevent substandard drugs and maintain high medical standards.
• To control the import, manufacture, distribution, and sale of drugs and cosmetics through licensing.
• To ensure that drugs and cosmetics are manufactured, distributed, and sold only by qualified persons.
• To control the manufacture and sale of Ayurvedic, Siddha, and Unani drugs.
• To establish Drugs Technical Advisory Board (DTAB) and Drugs Consultative Committee (DCC) for allopathic and allied drugs and cosmetics.

Dpharmguru’s exam insights:

The five objectives of the Drugs and Cosmetics Act are frequently tested. Remember them as: (1) Prevent substandard drugs, (2) Control through licensing, (3) Qualified persons only, (4) Control Ayurvedic/Siddha/Unani drugs, (5) Establish DTAB and DCC. This is a common long-answer question in exams!

DEFINITIONS UNDER THE ACT

1. Cosmetic

A cosmetic means any article intended to be rubbed, poured, sprinkled, sprayed on, introduced into, or otherwise applied to the human body or any part of it for cleansing, beautifying, promoting attractiveness, or altering appearance. It also includes any article intended to be used as a component of a cosmetic.

2. Drug

Drug includes:

• All medicines for internal or external use of human beings or animals and substances used for diagnosis, treatment, mitigation, or prevention of disease.
• Substances (other than food) intended to affect the structure or function of the human body or destroy disease-causing insects or vermin.
• All substances intended to be used as components of drugs, including empty gelatin capsules.
• Certain medical devices used for diagnosis, treatment, mitigation, or prevention of disease, as notified by the Central Government.

3. Misbranded Drugs

A drug is considered misbranded if:

• It is coloured, coated, powdered, or polished to conceal damage or make it appear of greater therapeutic value.
• It is not labelled in the prescribed manner.
• Its label or container contains false or misleading claims.

4. Adulterated Drugs

A drug is considered adulterated if:

• It contains filthy, putrid, or decomposed substances.
• It is prepared, packed, or stored under insanitary conditions.
• Its container contains poisonous or harmful substances.
• It contains an unapproved colouring agent.
• It contains toxic substances harmful to health.
• Any substance is mixed to reduce its quality or strength.

5. Spurious Drugs

A drug is considered spurious if:

• It is manufactured under a name belonging to another drug.
• It imitates or resembles another drug in a deceptive manner.
• The manufacturer mentioned on the label does not exist.
• It is wholly or partly substituted by another substance.
• It falsely claims to be the product of a certain manufacturer.

6. Manufacture

Manufacture includes processes such as making, altering, ornamenting, finishing, packing, labelling, breaking up, or treating any drug or cosmetic for sale or distribution. It does not include compounding or dispensing drugs in the ordinary course of retail business.

7. Import

Import means bringing a drug or cosmetic into India.

Dpharmguru’s exam insights:

Definitions are frequently tested in exams. Remember: Cosmetic is for beautifying/altering appearance; Drug includes medicines, diagnostic substances, and medical devices; Misbranded involves false labelling; Adulterated involves contamination or quality reduction; Spurious involves imitation or deception; Manufacture includes multiple processes but excludes retail compounding. Pay special attention to the distinction between misbranded, adulterated, and spurious drugs!

LEGAL DEFINITIONS OF SCHEDULES

Schedules to the Act

• First Schedule: Includes the names of authoritative books under Ayurvedic, Siddha, Unani, and Tibb systems of medicine.
• Second Schedule: Includes standards to be complied with by drugs imported, manufactured, sold, stocked, or distributed.

Schedules to the Rules

The Drugs and Cosmetics Rules have 18 parts. Below is a comprehensive list of the most important schedules:

Licensing and Procedural Schedules

• Schedule A: Proforma for application for licences, issue and renewal of licences, for sending memoranda under the Act.
• Schedule B: Rates of fees for testing or analysis by the Central Drugs Laboratory or Government Analyst.

Drug Classification Schedules

• Schedule C: List of biological and special products whose import, sale, distribution and manufacture are governed by special provisions.
• Schedule C₁: List of other special products whose import, sale, distribution and manufacture are governed by special provisions.
• Schedule D: List of drugs exempted from the provisions of import of drugs.
• Schedule G: List of substances to be used only under medical supervision and which are to be labelled accordingly.
• Schedule H: List of prescription drugs.
• Schedule H₁: Sensitive antibiotics, habit-forming drugs, and drugs with severe side effects.
• Schedule X: List of habit-forming, narcotic, and psychotropic drugs governed by special provisions.

Manufacturing and Quality Schedules

• Schedule M: Good Manufacturing Practices (GMP) requirements for factory premises, plant, and equipment.
• Schedule M1: Requirements of factory premises, etc., for manufacture of homeopathic preparations.
• Schedule M2: Requirements of factory premises for the manufacture of cosmetics.
• Schedule M3: Requirements of factory premises for manufacture of medical devices.
• Schedule N: List of minimum equipment for efficient running of a pharmacy.
• Schedule P: Life period (expiry period) of drugs.
• Schedule P1: Pack sizes of drugs.

Product Standards Schedules

• Schedule Q: List of dyes, colours, and pigments permitted in cosmetics and soaps.
• Schedule R: Standards for condoms made of rubber latex and other mechanical contraceptives.
• Schedule R1: Standards for medical devices.
• Schedule S: Standards for cosmetics.
• Schedule T: Requirements for Ayurvedic (including Siddha) and Unani drugs.

Record Keeping and Clinical Trial Schedules

• Schedule U: Particulars to be shown in manufacturing, raw material, and analytical records of drugs.
• Schedule U1: Particulars to be shown in manufacturing, raw material, and analytical records of cosmetics.
• Schedule W: List of drugs to be marketed under generic names only.
• Schedule Y: Requirements and guidelines on clinical trials for import and manufacture of new drugs.

Dpharmguru’s exam insights:

The schedules are a goldmine for exam questions. Remember the key ones: Schedule C (biological products), Schedule G (medical supervision), Schedule H (prescription drugs), Schedule M (GMP), Schedule N (pharmacy equipment), Schedule P (expiry period), Schedule X (narcotic/psychotropic drugs), and Schedule Y (clinical trials). These are frequently tested—especially the labelling requirements for Schedule G, H, and X drugs!

IMPORT OF DRUGS

The Drugs and Cosmetics Act and Rules regulate the import of drugs and cosmetics in India. Drugs and cosmetics that are not prohibited can be imported only under a licence issued by the appropriate authority. However, certain drugs and cosmetics may be imported without a licence if they are of standard quality and satisfy the prescribed import conditions.

Classes of Drugs and Cosmetics Prohibited from Import

• Any drug or cosmetic of non-standard quality.
• Any misbranded, spurious, or adulterated drug.
• Any misbranded or spurious cosmetic.
• Any drug or cosmetic that requires an import licence but does not have one.
• Any patent or proprietary medicine unless the true formula is displayed on the label.
• Drugs claiming to prevent or cure diseases specified in Schedule J.
• Drugs whose manufacture, sale, or distribution is prohibited in the country of origin.
• Biological and special products listed in Schedule C and C₁ that are expired.
• Any new drug without permission from the licensing authority.

Import under Licence or Permit

Import licences are granted by the licensing authority for the following categories:

• Drugs listed in Schedule C and C₁ excluding Schedule X.
• Drugs listed in Schedule X.
• Small quantities of drugs imported for examination, testing, or analysis.
• Drugs for personal use prescribed by a Registered Medical Practitioner.
• New drugs.

Dpharmguru’s exam insights:

Import provisions are frequently tested. Remember: Import licences are granted for Schedule C, C₁, X drugs, new drugs, and drugs for personal use. The licence remains valid until 31 December of the same year. Appeals against cancellation go to the High Court. The Central Government can prohibit import in public interest under Section 10A.

OFFENCES AND PENALTIES FOR IMPORT

Offence	First Conviction	Subsequent Conviction
Import of adulterated or spurious drugs, spurious cosmetics, or cosmetics containing harmful ingredients	Imprisonment up to 3 years and fine up to ₹5,000	Imprisonment up to 5 years or fine up to ₹10,000, or both
Import of drugs or cosmetics (other than above) whose import is prohibited	Imprisonment up to 6 months or fine up to ₹500, or both	Imprisonment up to 1 year or fine up to ₹1,000, or both
Import in contravention of any notification issued under Section 10A	Imprisonment up to 3 years or fine up to ₹5,000, or both	Imprisonment up to 5 years or fine up to ₹10,000, or both

MANUFACTURE OF DRUGS

Under the Drugs and Cosmetics Act, manufacture includes processes such as making, altering, finishing, packing, labelling, breaking up, or preparing drugs for sale or distribution. It does not include compounding or dispensing drugs in retail practice.

Main requirements for manufacturing:

• Proper infrastructure and facilities.
• Qualified technical staff.
• Analytical laboratory facilities.
• Maintenance of records.
• Inspection and sampling of drugs.

Prohibition of Manufacture and Sale

The following drugs cannot be manufactured or sold:

• Drugs of non-standard quality, misbranded, adulterated, or spurious drugs.
• Cosmetics that are misbranded or spurious.
• Patent or proprietary medicines without disclosure of formula.
• Drugs claiming to cure diseases listed in Schedule J.
• Cosmetics containing harmful ingredients.

Types of Manufacturing Licences

• Licence for manufacture of biological products in Schedule C and C₁.
• Licence for manufacture of Schedule X drugs.
• Licence for manufacture of drugs for examination, testing, or analysis.
• Licence for manufacture of patent and proprietary medicines.
• Licence for manufacture of new drugs.
• Loan Licence.
• Repacking Licence.

Loan Licence

A Loan Licence is issued to a person who manufactures drugs using the facilities of another licensed manufacturer because the applicant does not possess their own manufacturing premises or equipment.

Key Points:

• Loan licences are granted for drugs other than those specified in Schedule X.
• The licensee must comply with all conditions applicable to manufacturing licences, except having their own manufacturing facilities.
• Records of testing must be maintained for 5 years from the date of manufacture.

Repacking Licence

A Repacking Licence is required for repacking drugs other than those specified in Schedules C and C₁.

Conditions:

• Operations must be carried out under the supervision of a Competent Person.
• The licensee must arrange for analysis and testing of each batch.
• Records must be preserved for 3 years from the date of manufacture.
• Repacked drugs must display the licence number preceded by “Rpg. Lic. No.”

Dpharmguru’s exam insights:

Manufacturing licences are frequently tested. Remember: Loan Licence is for those without their own facilities; Repacking Licence is for repacking drugs; both have specific conditions. Schedule X drugs cannot be manufactured under Loan Licence. Records must be maintained for specific periods—5 years for manufacturing records, 3 years for repacking records.

OFFENCES AND PENALTIES FOR MANUFACTURE

Offence	Penalty
Manufacture of adulterated or spurious drugs that may cause death or serious bodily injury (Section 320 IPC)	Imprisonment up to 5 years and fine of not less than ₹10,000
Manufacture of drugs without licence or manufacture of adulterated drugs not causing serious injury	Imprisonment 1–3 years and fine of not less than ₹5,000
Manufacture of drugs in contravention of other provisions of the Act	Imprisonment 1–2 years and fine
Failure to maintain records or disclose required information	Imprisonment up to 1 year and/or fine up to ₹1,000
False warranty given by manufacturer to purchaser	Imprisonment or fine up to ₹500, or both

IMPORTANT SCHEDULES IN DETAIL

Schedule C and C₁: Biological and Special Products

Schedule C includes biological and special products such as sera, toxins, antigens, antitoxins, insulin, vaccines, and antibiotics administered parenterally.

Licensing requirements:

• Form 28 – Licence for manufacture issued by the Drug Department.
• Form 21 – Licence for retail sale.
• Form 21B – Licence for wholesale sale and distribution.

Schedule G: Medical Supervision Required

Drugs listed under Schedule G must carry the warning:

“It is dangerous to take this preparation except under medical supervision.”

Other requirements:

• Proper bill of sale must be issued.
• Records of purchase and sale must be maintained for 2 years.

Examples: Aminopterin, Bleomycin, Busulphan, Chlorambucil, Glibenclamide, Hydantoin, Insulin, Metformin.

Schedule H: Prescription Drugs

Schedule H contains prescription drugs, which can be sold only on the prescription of a Registered Medical Practitioner (RMP).

Labelling requirements:

• The symbol “Rx” must appear on the label.
• The label must carry the warning: “To be sold by retail on the prescription of a Registered Medical Practitioner only.”
• If the drug also falls under NDPS Act, it must carry the symbol “NRx”.

Schedule H contains approximately 551 drugs.

Schedule H₁: Sensitive Antibiotics

Schedule H₁ includes sensitive antibiotics, habit-forming drugs, and drugs with severe side effects if used without medical supervision.

Labelling requirements:

• The symbol “Rx” must be printed in red colour on the left corner of the label.
• A warning statement must be enclosed in a red-bordered box.

Examples: Alprazolam, Gemifloxacin, Isoniazid, Cefixime, Levofloxacin, Clofazimine, Zolpidem.

Schedule K: Exempted Drugs

Drugs listed under Schedule K are exempted from certain provisions of Chapter IV of the Act, provided the specified conditions are satisfied.

Examples:

• Drugs labelled “Not for Medical Use.”
• Quinine and certain antimalarial drugs.
• Drugs supplied by registered medical practitioners to their own patients.
• Certain household remedies: Aspirin tablets, Paracetamol tablets, Analgesic balms, Antacid preparations, Gripe water, Cough syrups, Liniments, Skin ointments, etc.

Schedule P: Life Period of Drugs

Schedule P specifies the life period (expiry period) of drugs and the storage conditions.

Important temperature definitions:

• Cool place: 10–25°C
• Cold place: Below 8°C

Examples:

Drug	Life Period (Months)	Storage
Adriamycin	30	Cool place
Ampicillin	36	Cool place
Ampicillin Sodium	36	Cool place

Schedule X: Narcotic and Psychotropic Drugs

Schedule X includes habit-forming, narcotic, and psychotropic drugs considered unsafe for use without the supervision of a Registered Medical Practitioner.

Examples: Amobarbital, Amphetamine, Barbital, Cyclobarbital, Dexamphetamine, Glutethimide, Meprobamate, Methaqualone, Pentobarbital, Phencyclidine, Phenobarbital, Secobarbital.

Dispensing Guidelines:

• The prescription must not be dispensed more than once unless specified.
• The pharmacist must write seller details and date on the prescription.
• No substitution is allowed.
• Prescriptions must be in duplicate—one copy retained for 2 years.
• Drugs must be stored in a locked cabinet or drawer.

Dpharmguru’s exam insights:

Schedule X is frequently tested. Remember: These drugs require special control; prescriptions in duplicate; retained for 2 years; stored under lock and key; no substitution allowed; cannot be sold without RMP prescription. Also remember the distinction between Schedule H (Rx), Schedule H₁ (Rx in red), and Schedule X (narcotic/psychotropic).

SALE OF DRUGS

Sale is the process of passage of drugs from manufacturers to consumers. After the implementation of the Drugs and Cosmetics Act, 1940, selling of drugs became a restricted practice, and only licensed individuals can involve in wholesale, retail, compounding, or dispensing of drugs.

Wholesale of Drugs

A wholesaler with a valid trade licence can approach the drug manufacturer for supplying medicine for selling to retailers.

Conditions for wholesale of Schedule C and C₁ drugs:

• Adequate premises not less than 10 square meters in area.
• Drugs should be sold to persons with licence to retail them.
• Records of purchases and sales must be maintained for at least 3 years.
• Licence should be displayed in the premises.

Retail Sale of Drugs

Types of retail establishments:

• Chemists and Druggists Establishments: Under supervision of a registered pharmacist but do not compound drugs.
• Pharmacies: Under supervision of a Registered Pharmacist and engaged in compounding of drugs.
• Drug Stores: Do not have a registered pharmacist and sell household remedies.

Restricted Licences

Restricted licences can be given to:

• Dealers whose sale does not need supervision by a qualified person.
• Itinerant vendors in exceptional cases.
• Vendors distributing drugs in sparsely populated areas.
• Travelling agents of firms for drug distribution.

Dpharmguru’s exam insights:

Sale provisions are frequently tested. Remember: Wholesale requires 10 sq m area; records for 3 years. Retail has three types: Chemists/Druggists (no compounding), Pharmacies (with compounding), Drug Stores (household remedies only). Restricted licences are for special cases like itinerant vendors. Licences are required for each premise where drugs are sold.

RECORDS TO BE KEPT IN A PHARMACY

Records for Dispensing and Compounding

• Serial number of the entry
• Date of supply
• Prescriber’s name and address
• Patient’s name
• Names and quantities of the drugs
• Manufacturer’s name, batch number, and expiry date for Schedule C and H drugs
• Signature of the Registered Pharmacist

Records for Sale of Schedule X Drugs

• Date of supply and opening/closing stocks
• Drug name, manufacturer’s name, and batch number
• Purchaser’s name and address
• Date of prescription and RMP’s name and address
• Signature of Registered Pharmacist

Records for Schedule C Drugs

• Serial number of the entry
• Date of supply
• Purchaser’s name and address
• Name and quantity of drugs supplied
• Manufacturer’s name and batch number
• Expiry date
• Signature of Registered Pharmacist

ADMINISTRATION OF THE ACT

The Drugs and Cosmetics Act forms the following agencies:

1. Advisory Bodies

• Drugs Technical Advisory Board (DTAB)
• Drugs Consultative Committee (DCC)

2. Analytical Bodies

• Central Drugs Laboratory (CDL)
• State Drug Control Laboratory
• Government Analyst

3. Executive Bodies

• Licensing Authorities
• Controlling Authorities
• Drug Inspectors

Drugs Technical Advisory Board (DTAB)

DTAB is a committee established under the Drugs and Cosmetics Act, 1940. It is part of the Central Drugs Standard Control Organization (CDSCO).

Constitution of DTAB:

Ex-Officio Members:

• Director-General of Health Services (Chairman)
• Drugs Controller of India
• Director, Central Drugs Laboratory, Kolkata
• Director, Central Research Institute, Kasauli
• Director, Indian Veterinary Research Institute, Izzatnagar
• President, Pharmacy Council of India
• President, Medical Council of India
• Director, Central Drugs Research Institute, Lucknow

Functions of DTAB:

• Advises Central and State Governments on technical matters.
• Makes modifications and amendments in the Act.
• Carries out other functions assigned by the Act.

Central Drugs Laboratory (CDL)

The Central Drugs Laboratory is established in Calcutta under the control of a Director.

Functions of CDL:

• Analyses or tests drug or cosmetic samples sent by customs collectors or courts.
• Carries out duties assigned by the Central or State Governments.

Note: Biological and microbiological tests are conducted at Central Research Institute, Kasauli (for human vaccines) and Indian Veterinary Institute, Izzatnagar (for veterinary products).

Drugs Consultative Committee (DCC)

DCC comprises two representatives nominated by the Central Government and one nominee of each State Government.

Function of DCC:

• Advises Central Government, State Governments, and DTAB on matters to secure uniformity throughout India in the administration of the Act.

Government Analysts

Government analysts analyse drug and cosmetic test samples sent by drug inspectors.

Qualifications:

• Graduate in medicine, science, pharmacy, or pharmaceutical chemistry with 5 years experience, OR
• Postgraduate with 3 years experience, OR
• Associateship Diploma of Institution of Chemists (India) with 3 years experience.

Duties:

• Analyse and test drug and cosmetic samples.
• Prepare reports of test or analysis.
• Involve in research work.

Drug Inspectors

Drug inspectors are appointed by the Central or State Governments for their respective areas.

• • Degree in pharmacy or pharmaceutical sciences, OR

• • Degree in medicine with specialisation in clinical pharmacology or microbiology, OR

• • Associateship Diploma of Institution of Chemists (India).

Duties of Drug Inspectors:

• • Inspect premises licensed for sale or manufacture of drugs.

• • Obtain and send drug samples for analysis.

• • Investigate written complaints.

• • Enter and search places where offences are believed to be committed.

• • Seize stocks of illegal drugs.

• • Institute legal proceedings.

Dpharmguru’s exam insights:

The administrative bodies are frequently tested. Remember: DTAB advises on technical matters and has the DGHS as Chairman; CDL is in Calcutta; DCC ensures uniformity across States; Government Analysts have specific qualifications; Drug Inspectors have specified duties including inspection, sampling, and prosecution. The distinction between DTAB and DCC is important—DTAB is technical advisory, DCC is for uniformity.

NEW AMENDMENTS TO DRUGS AND COSMETICS ACT, 1940

The Drugs and Cosmetics (11th Amendment) Rules, 2019 were announced by the Central Government on July 17, 2019 to ensure proper implementation of permanent drug licences for manufacturing and sale.

Key Amendments

• • Omission of Renewal Provisions: Rules 150J, Form 26J, and Form 33 relating to licence renewal/certificates have been omitted.

• • Licence Duration: A licence issued in Form 28, Form 28B, and Form 28D remains valid if the licensee deposits a licence retention fee every 5 years.

• • Late Fee: If the fee is not paid on time, a late fee of 2% per month is charged for up to 6 months, after which the licence is presumed to be cancelled.

• • Homoeopathic Medicines: Form 24C now includes provisions for renewal for Homoeopathic medicines.

Dpharmguru’s exam insights:

The 2019 amendments are important—they introduced permanent licences with retention fees instead of periodic renewals. Remember: Licence retention fee must be paid every 5 years; late fee is 2% per month; after 6 months of non-payment, licence is cancelled. This change streamlines the licensing process for manufacturers.

OFFENCES AND PENALTIES FOR SALE

Offence	Penalty
Sale of drugs which may cause death or serious hurt (Section 320 IPC)	Imprisonment 5 years to life and fine of not less than ₹10,000
Sale of spurious drugs	First conviction: 1–3 years and fine up to ₹5,000; Subsequent: 2–6 years and fine up to ₹10,000
Sale in contravention of other provisions	First conviction: 1–2 years and fine; Subsequent: 2–4 years and/or ₹5,000 fine
Failure to keep records	Imprisonment 1 year and/or fine up to ₹1,000
False warranty to purchaser	First conviction: 1 year and fine up to ₹5,000; Subsequent: up to 2 years or fine or both

FREQUENTLY ASKED QUESTIONS (FAQs)

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

The main purpose is to regulate the import, manufacture, distribution, and sale of drugs and cosmetics in India to ensure their quality, safety, and efficacy.

2. What is the difference between Schedule H and Schedule H₁ drugs?

Schedule H contains prescription drugs with “Rx” symbol. Schedule H₁ contains sensitive antibiotics with “Rx” in red colour and a warning in a red-bordered box. Schedule H₁ was introduced in 2013 to regulate antibiotic misuse.

3. What are the storage requirements for Schedule X drugs?

Schedule X drugs must be stored in a locked cabinet or drawer reserved exclusively for these drugs, accessible only to authorized persons. A separate register must be maintained for these drugs.

4. What is the minimum area required for a dispensing pharmacy?

According to Schedule N, the dispensing area must be a minimum of 6 m² for one pharmacist, with an additional 2 m² for each additional pharmacist. The minimum height of the premises must be 2.5 m.

5. What is a Loan Licence?

A Loan Licence is issued to a person who manufactures drugs using the facilities of another licensed manufacturer because they do not possess their own manufacturing premises or equipment. Loan licences are not granted for Schedule X drugs.

6. Who is the Chairman of DTAB?

The Director-General of Health Services (DGHS) is the Chairman of the Drugs Technical Advisory Board (DTAB).

7. How long must manufacturing records be maintained?

Manufacturing records must be preserved for 5 years from the date of manufacture, or 2 years after the expiry date for drugs with expiry dates.

SUMMARY

The Drugs and Cosmetics Act, 1940 and Rules, 1945 form the comprehensive legal framework governing the import, manufacture, distribution, and sale of drugs and cosmetics in India. The Act establishes quality standards for drugs and cosmetics, regulates licensing of manufacturing and sale, creates advisory and analytical bodies (DTAB, CDL, Government Analysts), and provides for enforcement through Drug Inspectors.

The numerous schedules to the Act and Rules provide detailed provisions for classification, labelling, storage, and quality control. Key schedules include Schedule C (biological products), Schedule G (medical supervision), Schedule H (prescription drugs), Schedule M (GMP), Schedule N (pharmacy equipment), Schedule P (expiry period), Schedule X (narcotic drugs), and Schedule Y (clinical trials).

As I always tell my students: “The Drugs and Cosmetics Act is the pharmacist’s professional compass—it guides everything we do, from manufacturing to dispensing. Understanding it is not optional; it is essential for safe and legal practice.”

REFERENCES AND FURTHER READING

• • Ministry of Health and Family Welfare. (2022). Drugs and Cosmetics Act, 1940 and Rules, 1945. Government of India.

• • Drugs and Cosmetics (11th Amendment) Rules, 2019. Government of India.

• • Central Drugs Standard Control Organization (CDSCO). (2022). Guidelines on Drug Regulations. Retrieved from https://cdsco.gov.in.

• • Pharmacy Council of India (PCI). (2022). Pharmacy Act, 1948. New Delhi: PCI.

• • World Health Organization (WHO). (2022). Good Manufacturing Practices Guidelines. Retrieved from https://www.who.int.

Disclaimer: This article is for educational purposes only and does not constitute legal advice. Pharmaceutical laws and regulations may change over time—always refer to the latest official gazette notifications and consult qualified legal professionals for specific legal matters.

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