The Drug and cosmetic Act, 1940 is an act to regulate import, manufacture, distribution & sale of drug and cosmetics. The Drug and Cosmetic rules, 1945 made under the act prescribe statuary requirements for grant of license to manufacture for sale and distribution of drug to ensure safety, efficacy and quality of drugs manufactured and sold in country.
In 1964, the act was amended to include Ayurveda and Unani drugs.
The primary objective of the Act is to ensure that the drugs and cosmetics sold in India are safe, effective and conform to prescribed quality standards. The Drugs Act was formulated in 1940 in pursuance of recommendations of Chopra Committee constituted in 1930 by Government of India.
The Drugs Act, as enacted in1940, has since been amended several times and is now titled as “The Drugs and Cosmetics Act, 1940”.
Download: Drug and Cosmetic Act, 1940 and rules, 1945 as amended upto 31st December 2016.
Drug includes
- 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 human body for the purpose of repelling insects like mosquitoes;
- such 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 6[vermin] or insects which cause disease in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette;
- All substances intended for use as components of a drug including empty gelatin capsules; and
- 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 Board;]
Cosmetic
Means 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 except soaps.
Drug and Cosmetic Act, 1940:
Drug and Cosmetic Act is divided into five chapters and two schedules.
Chapter i: Introductory
Chapter ii: The drugs technical advisory board, the central drugs laboratory and the drugs consultative committee
Chapter iii: Import of drugs and cosmetics
Chapter iv: Manufacture, sale and distribution of drugs and cosmetics
Chapter iv a: Provisions relating to ayurvedic siddha and unani drugs
Chapter v: Miscellaneous
The first schedule:
a. Ayurvedic and siddha systems
b. Unani tibb system
The second schedule:
Standards to be complied with by imported drugs and by drugs manufactured for sale, sold, stocked or exhibited for sale or distributed
Drug and Cosmetic Rules, 1945:
Drug and Cosmetic rules contains following parts and schedules:
Parts:
Part i: Preliminary
Part ii: The central drugs laboratory
Part iii: Rules 9 to 20- omitted
Part iv: Import and registration
Part v: Government analysts, inspectors, licensing authorities and controlling authorities
Part vi: Sale of drugs other than homoeopathic medicines
Part via: Sale of homoeopathic medicines
Part vii: Manufacture for sale or for distribution of drugs other than homoeopathic medicines
Part viia: Manufacture for sale or for distribution of homoeopathic medicines
Part viii: Manufacture for examination, test or analysis
Part ix: Labeling and packing of drugs other than homoeopathic medicines
Part ixa: Labeling and packing of homoeopathic medicines
Part x: Special provisions relating to biological and other special products
Part x a: Import of manufacture of new drug for clinical trials or marketing
Part xb: Requirements for the collection, storage, processing and distribution of whole human blood, human blood components by blood banks and manufacture of blood products
Part xi: Exemptions
Part xii: Standards
Part xiii: Import and registration of cosmetics
Part xiv: Manufacture of cosmetic for sale or for distribution
Part xv: Labelling, packing and standards of cosmetics
Part xv (a): Approval of institutions for carrying out tests on drugs, cosmetics and raw materials used in their manufacture on behalf of licensees for manufacture for sale of drugs / cosmetics
Part xvi: Manufacture for sale of ayurvedic (including siddha) or unani drugs
Part xvi (a): Approval of institutions for carrying out tests on ayurvedic, siddha and unani drugs and raw materials used in their manufacture on behalf of licensees for manufacture for sale of ayurvedic, siddha and unani drugs
Part xvii: Labelling, packing and limit of alcohol in ayurvedic (including siddha) or unani drugs
Part xviii: Government analysts and inspectors for ayurvedic (including siddha) or unani drugs
Part xix: Standards of ayurvedic, siddha and unani drugs
Schedules:
Schedule A: Schedule A describes the format of form used for various licenses and approvals under Drug and Cosmetic Act & Rules.
Schedule B: Schedule B Describe the Fees required to pay 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: Schedule D describes the requirement and formalities to import medicinal substances in India.
Schedule D (II): Schedule D (II) covers 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.
Schedule E and E1: Schedule E was omitted in 1982.Schedule E(1) contains the list of poisonous substances under Ayurvedic (including Siddha) and Unani System of Medicines
Schedule F: Part I to Part XII-A– Omitted
Part XII B: Part XII-B describes the requirements for the functioning and operation of a Blood Bank and/or for preparation of Blood components.
Schedule G: Most of these drugs are hormonal preparations. Products or Substances that are included in this list should mention below lines at label:
Caution: It is dangerous to take this preparation except under medical supervision’ – conspicuously printed and surrounded by a line within which there shall be no other words;
Schedule H: Schedule H includes drugs that shall be sold by retailer on prescription of the registered medical practitioners.
If product contains a substance specified in Schedule H be labelled with the symbol Rx and conspicuously displayed on the left top corner of the label and be also labelled with the following words in Red color base:
‘Schedule H drug – Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only’
Schedule H1: Schedule H1 also includes prescription drugs but antibiotics, anti-TB drugs and habit forming that was fall under schedule H category was moved to a new sub category that is known as Schedule H1. “SCHEDULE H1 DRUG – WARNING:
-It is Dangerous to take this preparation except in accordance with the Medical Advice
-Not to be Sold by retail without the prescription of a Registered Medical Practitioner.”
Schedule J: List of diseases which a drug may not purport to prevent or cure
Schedule K: Schedule K describe the exempted drugs, conditions and extent of exemption from all the provisions of Chapter IV of the Act and the Rules there under subject to the conditions
Schedule L (Omitted)
Schedule M: Schedule M describes Good Manufacturing Practices and Requirements of Premises.
Schedule M-1: Schedule M-1 describes the Good Manufacturing Practice requirements of factory premises for manufacture of Homoeopathic preparations:
Schedule M-2: Schedule M-2 describes the requirements of factory premises for manufacture of cosmetics
Schedule M-3: Schedule M-3 describes the requirements of factory premises for manufacture of medical devices
Schedule N: List of Minimum Equipment for the Efficient Running of Pharmacy
Schedule O describes the standards for Disinfectant Fluids.
Schedule P: Schedule P describes the life period of drugs in months (unless otherwise specified)
Schedule P1: Schedule P1 describes the Pack size of drugs. Schedule P1 contains Name of drug, their dosage form and pack size of listed drugs.
Schedule Q: Schedule Q describes the list of Dyes, Colors and Pigments permitted to be used in Cosmetics and Soaps.
Schedule R: Schedule R describes the standards for condoms made of rubber latex intended for single use and other mechanical contraceptives
Schedule R1: Schedule R1 describes the following medical devices shall conform to the Indian Standards specifications laid down from time to time by the Bureau of Indian Standards
Schedule S: Schedule S describes standards for cosmetics in finished form
Schedule T: Schedule T describes the Good Manufacturing Practice for Ayurvedic, Siddha and Unani Medicines.
Schedule U: Schedule U describes the particulars to be shown in manufacturing record
Schedule V: Schedule V describes the standards for patent or proprietary medicines
Schedule W omitted
Schedule X: Schedule X describes the list of drugs that covered in schedule. Generally habit forming and narcotic drugs are covered under schedule X
Schedule Y: Schedule Y describes requirements and guidelines for permission to import and/or manufacture of new drugs for sale or to undertake clinical trials.
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