The Central Legislative Assembly passed the Drugs and Cosmetics Act 1940 and rules 1945 with an objective to regulate the import, manufacture and distribution, and sale of drugs and cosmetics. It is applicable on Allopathic, Homeopathic, Unani and Siddha drugs as well on contraceptives, mosquitoes repellents, creams, lotions, cosmetics, and devices used for internal and external use for diagnosis. Under this Act, the regulation of manufacture, sale, and distribution of Drugs is primarily the concern of the State authorities while the Central authorities are responsible for approval of New Drugs, Clinical trials in the country, laying down standards for Drugs, control over the quality of imported drugs, co-ordination of the activities of Drug Control Organization and providing expert advice with a view of bringing about uniformity in the enforcement of Drug and Cosmetic Act.
- The Drugs and Cosmetics Act 1940 provides the Central legislation, which regulates the import, manufacture, distribution, and sale of drugs and cosmetics in the country.
- The main objective of the Act is to ensure that the drugs available to the people are safe and efficacious and the cosmetics market is safe for use.
- The D and C Act regulates the manufacture and import of drugs into India so that no substandard or spurious drugs get manufactured and imported in and into India respectively.
- This provides the regulation of the sale and distribution of drugs and cosmetics whereby only qualified and trained persons can undertake their handling, compounding, and distribution.
- This Act also provides the constitution of two boards namely, the Drug Technical Advisory Board (DTAB) and Ayurvedic and Unani Drugs Technical Advisory Board to advise the Central and State governments on technical matters arising out of the administration of this act.
- It also provides the establishment of two Drugs Consultative Committees (DCC), one for allopathic and the other for Ayurvedic, Siddha, Unani drugs to advise the various Governments and Boards on matters tending to secure uniformity throughout the country in the administration of the act.
- All medicines for internal or external use of human beings or animals and 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.
- Such substances (other than food) intend to affect the structure or any function of the human body or are intended to be used for the destruction of vermin or insects which cause disease in human beings or animals.
- All substances intended for use as components of a drug including empty gelatin capsules; and
- Such devices are intended for internal or external use in the diagnosis, treatment, mitigation, or prevention of disease or disorder in human beings or animals.
Ayurvedic, Siddha, or Unani Drug:
It includes all medicines intended for internal or external use of human beings or animals for diagnosis, treatment, mitigation, or prevention of disease or disorder in accordance with the formulae described in the authoritative books of Ayurvedic, Siddha, and Unani Tibb system of medicine, specified in the first schedule.
A drug shall be deemed to be misbranded:
- If it is so colored, 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
- If it is not labeled in a prescribed manner; or
- If 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.
A drug shall be deemed to be adulterated:
- If it consists, in whole or in part, of any filthy, putrid or decomposed substance; or
- If it has been prepared, packed, or stored under insanitary conditions whereby it may have been contaminated with filthy or whereby it may have been rendered injurious to health; or
- If its container is composed in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or
- If it bears or contains, for purposes of coloring only, a color other than one which is prescribed; or
- If it contains any harmful or toxic substance which may render it injurious to health; or
- If any substance has been mixed therewith so as to reduce its quality or strength.
A drug shall be deemed to be spurious:
- If it is manufactured under a name that belongs to another drug; or
- If 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 or conspicuously marked so as to reveal its true character and its lack of identity with such other drug; or
- If 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
- If it has been substituted wholly or in part by another drug or substance., or
- If it purports to be the product of a manufacturer of whom it is not truly a product.
A Drug Inspector appointed by the Central Government or a State Government who is an expert and qualified to monitor the safety, utility, efficacy, and quality of a drug from its manufacturing till its sale at the retail shop.
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.
- A cosmetic shall be deemed to be misbranded: If it contains a color that is not prescribed; or
- If it is not labeled in a prescribed manner; or
- If the label or container or anything accompanying the cosmetic bears any statement which is false or misleading in any particular.
A cosmetic shall be deemed to be spurious:
- If it is imported under a name that belongs to another cosmetic; or
- If it is an imitation of, or is a substitute for, another cosmetic or resembles another cosmetic in a manner likely to deceive or bears upon it or upon its label or container the name of another cosmetic, unless it is plainly and conspicuously marked so as to reveal its true character and its lack of identity with such other cosmetic; or
- If the label or container bears the name of an individual or a company purporting to be the manufacturer of the cosmetic which individual or company is fictitious or does not exist; or
- If it is an imitation of, or is a substitute for, another drug or re-not truly a product.
Licensed premises for the sale of drugs, a retail store that does not require the services of a qualified person and sells both prescription and non-prescription drugs.
Licensed premises for the sale of drugs, which require the services of a qualified person but where the drugs are not compounded against prescriptions.
- He is a person holding a diploma or degree in Pharmacy Pharmaceutical Chemistry; or
- Is a registered pharmacist, (under Pharmacy Act, 1948); or
- Has minimum 4 years experience of dispensing and has been approved by licensing authority as a ‘Qualified Person’ on or before 31st Dec 1969.
A Government Analyst appointed by the Central Government or a State Government who shall analyze or test or cause to be analyzed or tested such samples of drugs as may be sent to him by Inspectors or any other persons or authority authorized by the Central Government or a State Government and shall furnish reports of the results of test or analysis in accordance with these rules.
Further, shall from time to time forward to the Government reports giving the results of analytical work and research with a view to their publication at the discretion of the Government.
In relation to any drug or cosmetic 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 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.
Means to bring into India.
Patent or Proprietary Medicine:
In relation to Ayurvedic, Siddha, or Unani Tibb systems of medicine all formulations containing only such ingredients mentioned in the formulae described in the authoritative books of Ayurveda, Siddha, or Unani Tibb systems of medicine specified in the First Schedule, but does not include a medicine which is administered by the parenteral route and also a formulation included in the authoritative books.
In relation to any other systems of medicine, a drug for internal or external administration of human beings or animals and which is not included in the edition of the Indian Pharmacopoeia or any other Pharmacopoeia or official books.
It includes any drug whose therapeutic efficacy has been established through long clinical experience as recorded in authoritative Homeopathic literature, prepared according to the techniques of Homeopathic pharmacy. It does not include medicines, administered by the parenteral route.
Schedules to the Act and Rules
Schedules to the Act
Schedules to the Rules
Schedule A: Forms and formats of letters for applications of licensing etc.
Schedule B: Fee structure for drug analysis by CDL (Central Drug Laboratory) or by the Govt. Analyst.
Schedule C: Biological and special products for parenteral administration. Examples: Antibiotics, Vitamins, Bacteriophages, Surgical dressings, and Ophthalmic preparations whose import, manufacture, sale, and distribution are governed by special provisions.
Schedule C1: Other special products for non-parenteral administration. Examples: Digitalis drugs, Ergot drugs, Adrenaline, Fish liver oil, Hormonal preparations whose import, manufacture, sale, and distribution are governed by special provisions.
Schedule D: Drugs exempted from the provision of import of drugs.
Schedule E1: Poisonous substances under Ayurvedic, Siddha, and Unani system of medicines.
Schedule F & F1: Special provisions applicable for the production, testing, storage, packing, and labeling of biological and other special products.
Schedule F2: Standards of surgical dressings.
Schedule F3: Standards of sterilized umbilical tapes.
Schedule FF: Standards for ophthalmic preparations.
Schedule G: Various drugs/ substances to be used under medical supervision.
Schedule H: Various drugs to be sold on the prescription of an RMP (Registered Medical Practitioner).
Schedule J: Various ailments (diseases) that cannot be treated by any drug currently on the market.
Schedule K: Various substances and drugs exempted from provisions related to the manufacture of drugs.
Schedule M: Regulations for manufacturing, premises, waste disposal, requirements of plant and equipment (Good Manufacturing Practices).
Schedule M1: Requirements for factory premises, etc. for the manufacture of Homeopathic drugs.
Schedule M2: Requirements for factory premises for the manufacture of cosmetics.
Schedule M3: Requirements for factory premises for the manufacture of medical devices.
Schedule N: Regulations and minimum requirements to run a pharmacy.
Schedule O: Regulations and requirements for disinfectant fluids.
Schedule P: Regulations regarding life period and storage of various drugs.
Schedule P1: Regulations regarding retail package size of various drugs.
Schedule Q: List of permitted dyes and coal tar colors in cosmetics.
Schedule R: Standards for condoms and other mechanical contraceptives.
Schedule R1: Standards for medical devices.
Schedule S: Various cosmetics and toiletries, and directs the manufacturers of cosmetics to conform to the latest BSI (Bureau of Indian Standards) requirements.
Schedule T: Regulations and requirements for factory premises and manufacture of Ayurvedic, Siddha, and Unani products.
Schedule U: Maintenance of manufacturing and analytical records of drugs.
Schedule U1: Maintenance of manufacturing and analytical records of cosmetics.
Schedule V: Standards for patent and proprietary medicines.
Schedule W: List of drugs that can be marketed under generic names only.
Schedule X: List of drugs that are habit-forming, psychotropic, and other drugs likely to be misused for addictive purposes.
Schedule Y: Requirement and guidelines for clinical trials.