Drugs and Cosmetics Act 1940 and Rules 1945

The Drugs and Cosmetics Act of 1940 is an Indian law that governs the import, production, and distribution of drugs in the country. The act's principal goal is to ensure that pharmaceuticals and cosmetics sold in India are safe, effective, and meet state quality standards.

The accompanying Drugs and Cosmetics Rules, 1945, contain requirements for classifying drugs into schedules, as well as requirements for storing, selling, displaying, and prescribing each category.

History - chain of events

British rule – No proper healthcare infrastructure, no pharmacy rules

Drug Enquiry Committee led by Chopra committee made observations and gave report and recommended Government of India to develop rules for conduct of Pharmacy Industry

Drug and Cosmetics Act 1940 was introduced

Drug and Cosmetics Rules under the Act, 1945 was introduced

Rules and acts were extended to whole India

Drugs and Cosmetics Act 1940

Drugs and Cosmetics Act, 1940 was introduced by Government of India to regulate the import, manufacture, distribution and sale of drugs and cosmetics in India.
This act can be considered as landmark in the history of drug legislation in India.
It is Act no. 23 of 1940 and was introduced on 5th April, 1940 and enacted on 10th April, 1940.

Objective-

This act was passed to regulate the –

• Import of drugs in India by preventing the entry of spurious or substandard drug into the country
• Control over the sale and distribution of drugs by only trained & qualified personnel
• Production by prohibiting the manufacturing of substandard and spurious drugs in the country
• Control over the manufacture, sale and distribution of Ayurvedic, Siddha, Unani and Homeopathic drugs
• To carry out regular inspection of Licensed pharmacies or dispensaries by Registered Drug Inspectors
• To have control over the standards of Drugs and Cosmetics by taking samples and analysing them at approved test laboratories
• To provide special provisions to regulate the preparation, standardization and storage of biological and special products
• To describe the manner of labelling  and packing of various classes of drugs and cosmetics

Salient features of the Drugs & Cosmetics Act, 1940

•  Maximum penalty life imprisonment and fine of Rs. 10 lakhs or 3 times the value of the confiscated goods, whichever is more
•  Some of the offences are non-bailable
•  Besides officers from the Drug Controller’s Office, other gazette officers from Narcotics, Custom Office were also authorized to launch prosecution under the Act
•  Specially designated courts for trial of offences covered under the Act
•  Provision for compounding of minor offences.

Definitions (AS PER THE DRUGS AND COSMETICS ACT, 1940)

DRUGS (section 3) – 

 All medicines for internal or external use of human beings or animals

 All substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals

 Preparations applied on human body for the purpose of repelling insects like mosquitoes

 COSMETICS – 

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

MISBRANDED DRUGS and COSMETICS (section 9 and 9C) :

 If drug or cosmetic is coloured, coated, powdered or polished to conceal or hide the damage

 If it is not labelled in the prescribed manner

 If its label or container bears any statement, design or device which makes any false claim for the drug or is misleading

ADULTERATED DRUG (section 9A)

 If it consists, in whole or in part, of any filthy, putrid or decomposed substance

 If it has been prepared, packed or stored under insanitary conditions whereby it may have been contaminated

 If its container is composed of any poisonous or deleterious substance

SPURIOUS DRUGS and COSMETICS (section 9B and 9C)

 If it is imported under a name which belongs to another drug or cosmetic

 If it is an imitation of, or a substitute for, another drug or resembles another drug in a manner likely to deceive

 If it has been substituted wholly or in part by another drug or substance

PATENT or PROPRIETARY MEDICINE :

A drug which is a remedy or prescription presented in a form ready for internal or external administration of human beings or animals and which is not included in the edition of the Indian Pharmacopoeia for the time being or any other Pharmacopoeia authorized in this behalf by the Central Government. 

MANUFACTURE :

In relation to any drug or cosmetic, it includes any process or part of a process for making, altering, finishing, packing, labelling, breaking up or otherwise treating or adopting any drug or cosmetic with a view to its sale or distribution but does not include the compounding or dispensing of any drug.

DRUG INSPECTOR (section 21):

The State Government or Central Government, by notification in Official Gazette, appoint a person having prescribed qualifications and may have power to perform or exercise to fulfil his duties as may prescribed.

Persons having qualification for appointment as Government Analyst for allopathic drugs having a degree in ayurved, sidha or unani system and not less than three year post graduate experience in the analysis of drugs in a laboratory under control of

a government analyst

a chemical examiner

head of an institution specially approved for this purpose.

POWER OF INSPECTORS (SECTION 22)

(a) Inspect-

any premises where in any drug or cosmetic is being manufactured

any premises where in any drug or cosmetic is being sold, or stocked or exhibited or offered for sale, or distributed

(b) Take samples of any drug or cosmetic –

which is being manufactured or being sold or is stocked or exhibited or offered for sale, or is being distributed from any person who is in the course of conveying, delivering or preparing to deliver such drug or cosmetic to a purchaser or a consignee.

STANDARDS OF QUALITY

a. In relation to a drug, that the drug complies with the standard set out in [the Second Schedule]

b. In relation to a cosmetic, that the cosmetic compiles with such standard as may be prescribed.

Administration of the act and rules-

A) Advisory :

• Drugs Technical Advisory Board-DTAB
• Drugs Consultative Committee-D.C.C

B) Analytical :

• Central Drugs Laboratory – CDL
• Drug Control Laboratory in states
• Government Analysts

C) Executives :

• Licensing authorities
• Controlling authorities
• Drug Inspectors

Drugs and Cosmetics, Rules 1945-

It contains 168 rules from 1 to 168 and 25 Schedules from Schedule A to Schedule Y.
Different type of forms is also given for the different type of approvals from drug authorities.

Following are the schedules:

Schedule A: Forms and applications

Schedule B: Fees for test or analysis by the Central Drugs Laboratories or State Drugs Laboratories 

Schedule C: Biological and Special Products

Schedule C(1): Other Special Products

Schedule D: Class of Drugs: Extent and conditions of the exemption

Schedule D(I): Information and undertaking required to be submitted by the manufacturer of his authorized agent with the application form for a Registration Certificate. The format shall be properly filled in for each application in Form 40. The detailed information, secret in nature, may be furnished on a computer floppy.

Schedule D(II): Information required to be submitted by the manufacturer or his authorized agent with the application form for the registration of a bulk drug/formulation/special product for its import into India. The format shall be properly filled in and the detailed information, secret in nature, may be furnished on a computer floppy.

Schedule E: Omitted

Schedule E(1): List of Poisonous Substances under the Ayurvedic (including Siddha) and Unani Systems of Medicine

Schedule F:
Part I to Part XII-A: Omitted
Part XII-B: Requirements for the functioning and operation of a Blood Bank and/ or for preparation of Blood Components
(I) Blood Banks/ Blood Components
(II) Blood Donation Camps
(III) Processing of Blood Components from whole blood by a Blood Bank
Part XII-C:
(I) Requirements for manufacture of Blood Products
(II) Requirements for manufacture of Blood products from bulk finished products
Part XIII: General

Schedule F(I):
Part I: Vaccines
(A) Provisions applicable to the production of Bacterial Vaccines 
(B) Provisions applicable to the production of Viral Vaccines 
Part II: Antisera 
Provisions applicable to the production of all sera from living animals 
Part II: Diagnostic Antigens
Provisions applicable to the manufacture and standardization of Diagnostic Agents (Bacterial Origin) 
Part IV: General

Schedule F(II): Standards for Surgical Dressings

Schedule F(III): Standards for umbilical Tapes

Schedule FF: Standards for Ophthalmic Preparations

Schedule G:

Schedule H: Prescription Drugs

Schedule I: Omitted

Schedule J: Disease and ailment (by whatever name described ) which a drug does not purport to prevent or cure.

Schedule K: Class of drug: Extent and conditions of the exemption 

Schedule L1: Good Laboratory Practice

Schedule M: Good manufacturing practices and requirements of premises, plant and equipment for Pharmaceutical product. 
Part I: Good manufacturing practices for premises and materials.
Part I-A: Specific requirements for manufacture of sterile products, parenteral preparation (small volume injectables and large volume parenteral) and sterile ophthalmic preparation. 
Part I-B: Specific requirement for manufacturing of oral solid dosage forms (Tablet and Capsules).
Part I-C: Specific requirement for manufacture of oral liquids (Syrups, elixirs, emulsions and suspensions).
Part I-D: Specific requirements for manufacture of topical products i.e. external preparation (creams, ointments, pastes, emulsions, lotions, solutions, dusting powders and identical products) 
Part I-E: Specific requirements for manufacture of metered-dose-inhalers (MDI)
Part I-F: Specific requirements of premises, plant and materials for manufacture of active pharmaceutical ingredients ( Bulk Drugs ). 
Part II: Requirements of plant and equipment.

Schedule M-I:

1. Requirements of factory premises for manufacture of homoeopathic preparations. 
2. Requirements of plants and equipment.

Schedule M-II: Requirements of factory premises for manufacture of cosmetics.

Schedule M-III: Requirements of factory premises for manufacture of medical devices.
Part I-B: Specific requirement for manufacturing of oral solid dosage forms (Tablet and Capsules).
Part I-C: Specific requirement for manufacture of oral liquids ( Syrup, elixirs, emulsions and suspensions).
Part I-D: Specific requirements for manufacture of topical products i.e. external preparation ( creams, ointments, pastes, emulsions, lotions, solutions, dusting powders and identical products ) 
Part I-E: Specific requirements for manufacture of metered-dose-inhalers (MDI)
Part I-F: Specific requirements of premises, plant and materials for manufacture of active pharmaceutical ingredients (Bulk Drugs). 
Part II: Requirements of plant and equipment.

Schedule N: List of Minimum Equipment for the Efficient Running of a Pharmacy

Schedule O: Standard for Disinfectant Fluids

Schedule P: Life Period of Drugs

Schedule P1: Pack Sizes of Drugs

Schedule Q: List of Dyes, colors and Pigments permitted to be used in Cosmetics and Soaps as given under IS: 4707 (Part I)-1988 as amended by the Bureau of Indian Standards

Schedule R: Standards for condoms made of rubber latex intended for single use and other mechanical contraceptives

Schedule S: Standard for cosmetics.

Schedule T: Good manufacturing practices for Ayurvedic, Siddha and all Unani medicines.

Schedule U:

I – Particulars to be shown in the manufacturing records.

II – Records of Raw Materials.
III – Particulars to be recorded in the analytical records.

Schedule U(I):

I – Particulars to be shown in manufacturing records.
II – Records of Raw Material.

Schedule V: Standards for patent or proprietary medicines.

Schedule W: Omitted

Schedule X

Schedule Y: Requirements and guidelines for permission to import and/or manufacture of New Drug for sale or to undertake clinical Trials. 

Summary

The Drug Act, as it was initially termed, was passed in 1940. The initial statute was drafted in response to the Chopra Committee's recommendations from 1930. In 1945, the Drugs Rules were enacted. The legislation has been amended numerous times since 1940, and it is currently known as the Drugs and Cosmetics Act, 1940.

The act's definition of "drug" encompasses a wide range of substances, diagnostics, and medical equipment.

The statute defines "cosmetic" as any product intended for use on the human body for the purpose of beautification or cleaning.

Soaps, on the other hand, are not included in the definition. The statute was revised in 1964 to cover Ayurvedic and Unani medications.

The act's Section 16 establishes quality criteria for pharmaceuticals. The term "misbranding" is defined in Section 17. If a medicine purports to have more therapeutic benefit than it actually does, it is deemed misbranded. Under Section 18, the manufacturer of such a medicine may be requested to stop producing it. Fake and contaminated pharmaceuticals are dealt with under Section 27.

More of the drug's components must be listed on the label, according to the act.

REFERENCE-

THE DRUGS AND COSMETICS ACT AND RULES