Key Aspects of the DRUGS AND COSMETICS ACT - Download PDF
This resource offers a detailed examination of the DRUGS AND COSMETICS ACT, 1940, and its associated Rules. Download our comprehensive PDF, notes, and PowerPoint presentations to understand the various definitions integral to the Act and to get an enlisted overview of the numerous Schedules that form part of this crucial legislation. This Act is fundamental to regulating the import, manufacture, distribution, and sale of drugs and cosmetics in India.
Essential for students of pharmacy, legal professionals, pharmaceutical manufacturers, and regulatory affairs personnel, these materials simplify complex legal text into understandable concepts. Download the content for offline study or view it online.
Focus Areas:
- Clear definitions of terms like 'Drug', 'Cosmetic', 'Misbranded Drug', 'Adulterated Drug', 'Spurious Drug', 'Manufacture', etc.
- A comprehensive list and brief explanation of the Schedules to the Act and Rules (e.g., Schedule H, Schedule G, Schedule X, Schedule M, Schedule Y).
- The significance of these definitions and schedules in the regulatory framework.
Keywords:
Drugs and Cosmetics Act 1940 PDF, D&C Act Definitions, Schedules of Drugs and Cosmetics Act, Pharmaceutical Law India Notes, Drug Regulation PPT, Cosmetic Regulation India, Misbranded Drugs, Adulterated Drugs, Schedule H Drugs, Schedule M GMP, Download Free Legal Notes, View Online Pharmacy Law.
Navigating the DRUGS AND COSMETICS ACT, 1940: Definitions and Schedules
The Drugs and Cosmetics Act, 1940, along with the Drugs and Cosmetics Rules, 1945, forms the cornerstone of pharmaceutical and cosmetic regulation in India. Its primary objective is to ensure that drugs and cosmetics sold in India are safe, effective, and conform to prescribed quality standards. Understanding this Act begins with its definitions and the structure provided by its Schedules.
Various Definitions Used in Drugs and Cosmetics Act
Section 3 of the Act provides definitions for key terms. Some of the most important ones include:
- Drug: This definition is extensive and includes:
- 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, including preparations applied on the human body for the purpose of repelling insects like mosquitoes.
- Substances (other than food) intended to affect the structure or any function of the human body or intended to be used for the destruction of vermin or insects which cause disease in human beings or animals.
- Substances intended for use as a component of a drug including empty gelatin capsules.
- Such devices intended for internal or external use in the diagnosis, treatment, mitigation, or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette, after consultation with the Drugs Technical Advisory Board (DTAB). (This part has been significantly expanded over time to include medical devices).
- Cosmetic: 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 the appearance, and includes any article intended for use as a component of cosmetic.
- Ayurvedic, Siddha or Unani Drug: Includes all medicines intended for internal or external use for or in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, and manufactured exclusively in accordance with the formulae described in, the authoritative books of Ayurvedic, Siddha and Unani Tibb systems of medicine, specified in the First Schedule.
- Misbranded Drug: A drug shall be deemed to be misbranded if:
- it is so coloured, coated, powdered or polished that damage is concealed or if it is made to appear of better or greater therapeutic value than it really is; or
- it is not labelled in the prescribed manner; or
- its label or container or anything accompanying the drug bears any statement, design or device which makes any false claim for the drug or which is false or misleading in any particular.
- Adulterated Drug: A drug shall be deemed to be adulterated if:
- it consists, in whole or in part, of any filthy, putrid or decomposed substance; or
- it has been prepared, packed or stored under insanitary conditions whereby it may have been contaminated with filth or whereby it may have been rendered injurious to health; or
- its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or
- it bears or contains, for purposes of colouring only, a colour other than one which is prescribed; or
- it contains any harmful or toxic substance which may render it injurious to health; or
- any substance has been mixed therewith so as to reduce its quality or strength.
- Spurious Drug: A drug shall be deemed to be spurious if:
- it is imported under a name which belongs to another drug; or
- it is an imitation of, or is a substitute for, another drug or resembles another drug in a manner likely to deceive or bears upon it or upon its label or container the name of another drug unless it is plainly and conspicuously marked so as to reveal its true character and its lack of identity with such other drug; or
- the label or container bears the name of an individual or company purporting to be the manufacturer of the drug, which individual or company is fictitious or does not exist; or
- it has been substituted wholly or in part by another drug or substance; or
- it purports to be the product of a manufacturer of whom it is not truly a product.
- Manufacture: In relation to any drug or cosmetic, includes any process or part of a process for making, altering, ornamenting, 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, or the packing of any drug or cosmetic, in the ordinary course of retail business.
- Patent or Proprietary Medicine: Means 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 authorised in this behalf by the Central Government after consultation with the Drugs Technical Advisory Board.
Schedules to the Act and Rules
The Drugs and Cosmetics Act, 1940, has two schedules (First and Second Schedule). However, the bulk of the operational details, standards, and requirements are contained within the Schedules to the Drugs and Cosmetics Rules, 1945. These schedules are numerous and cover a wide range of topics. Here are some of the prominent ones:
Schedules to the Act:
- First Schedule: Lists authoritative books of Ayurvedic, Siddha, and Unani Tibb systems of medicine.
- Second Schedule: Specifies standards to be complied with by imported drugs and by drugs manufactured for sale, sold, stocked or exhibited for sale or distributed. It refers to standards like those in the Indian Pharmacopoeia (IP).
Selected Important Schedules to the Rules:
- Schedule A: Specifies various forms for applications for licenses, issue of licenses, renewal of licenses, etc.
- Schedule B: Rates of fee for test or analysis by the Central Drugs Laboratories or State Drugs Laboratories.
- Schedule C & C(1): List of biological and special products (e.g., sera, vaccines, hormones, antibiotics) whose import, sale, distribution, and manufacture require special provisions and licensing.
- Schedule D: Information and undertaking required to be submitted by a manufacturer or his authorized agent with the application form for an import license. Also lists drugs exempted from certain import provisions.
- Schedule E(1): List of poisonous substances under the Ayurvedic (including Siddha) and Unani systems of medicine.
- Schedule F: Deals with provisions applicable to blood banking, blood components, and transfusion services. Part XII B specifies requirements for a blood bank. Part XII C for blood products.
- Schedule F-I: Provisions applicable to the production of bacterial vaccines, viral vaccines, antisera, diagnostic antigens, etc.
- Schedule F-II: Standards for surgical dressings.
- Schedule F-III: Standards for umbilical tapes.
- Schedule FF: Standards for ophthalmic preparations.
- Schedule G: List of substances that are required to be used only under medical supervision and which are to be labelled accordingly. (Caution: "It is dangerous to take this preparation except under medical supervision").
- Schedule H: List of prescription drugs which can be sold by retail only on the prescription of a Registered Medical Practitioner. Now includes Schedule H1 drugs as well, which have additional requirements like maintaining a separate register.
- Schedule H1: Contains certain antibiotics, anti-TB drugs, and habit-forming psychotropic drugs. Requires stricter sale records and specific labeling.
- Schedule J: List of diseases and ailments (by whatever name described) which a drug may not purport or claim to prevent or cure or make claims to prevent or cure.
- Schedule K: Class of drugs exempted from certain provisions relating to manufacture, sale or distribution.
- Schedule M: Good Manufacturing Practices (GMP) and Requirements of Premises, Plant and Equipment for pharmaceutical products. It has different parts like M-I (Homoeopathic preparations), M-II (Cosmetics), M-III (Medical Devices). This is fundamental for quality assurance in manufacturing.
- 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 (expiry dates). Schedule P1 specifies pack sizes of drugs.
- Schedule Q: List of dyes, colours, and pigments permitted to be used in cosmetics and soaps.
- Schedule R: Standards for condoms made of rubber latex and other mechanical contraceptives. Schedule R1 for medical devices.
- Schedule S: Standards for cosmetics.
- Schedule T: Good Manufacturing Practices (GMP) for Ayurvedic, Siddha, and Unani medicines.
- Schedule U: Particulars to be shown in manufacturing, raw material, and analytical records of drugs. Schedule U1 for cosmetics.
- Schedule V: Standards for patent or proprietary medicines.
- Schedule X: List of psychotropic and habit-forming drugs (e.g., narcotics, certain tranquilizers) whose import, manufacture, sale, and distribution are subject to very strict controls and licensing. Requires detailed record-keeping.
- Schedule Y: Requirements and guidelines on clinical trials for import and manufacture of new drugs.
These definitions and schedules are dynamic and can be amended by the government based on recommendations from the Drugs Technical Advisory Board (DTAB) and the Drugs Consultative Committee (DCC) to keep pace with scientific advancements and public health needs. A thorough understanding of these is essential for compliance and for ensuring the safety and quality of drugs and cosmetics in the Indian market.
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