The Drugs and Cosmetics Act, 1940, is a comprehensive legislation in India that regulates the import, manufacture, distribution, and sale of drugs and cosmetics to ensure their safety, efficacy, and quality. Below is an A to Z overview of key terms and concepts from the Act:
A drug that does not meet prescribed standards of strength, quality, or purity.
A statutory body responsible for advising the government on technical matters related to drugs and cosmetics.
The national regulatory authority overseeing drug and cosmetic safety and licensing.
A government-appointed officer responsible for inspecting and ensuring compliance with the Act.
A list of medicines considered essential for public health, regulated under the Act.
Prepared pharmaceutical products containing specific active ingredients in a definite dosage form.
Regulatory guidelines ensuring that drugs and cosmetics are consistently produced and controlled.
Drugs that may cause dependency or addiction, such as narcotics, and are strictly regulated.
The Act regulates the import of drugs to ensure they meet prescribed quality and safety standards.
Defines the authority of central and state regulatory bodies over the enforcement of the Act.
A concept emphasizing consumer awareness regarding drug composition, usage, and side effects.
The government body that issues licenses for the manufacture, sale, and distribution of drugs and cosmetics.
A drug that is misleadingly labeled or does not comply with prescribed labeling standards.
Certain drugs regulated under both the Drugs and Cosmetics Act and the Narcotic Drugs and Psychotropic Substances Act.
Drugs that can be sold without a prescription but are regulated for safe use.
An official publication listing drug standards, such as the Indian Pharmacopoeia (IP).
Standards set for testing and ensuring the efficacy, safety, and purity of drugs.
A process by which defective or harmful drugs are withdrawn from the market.
Different categories of drugs, cosmetics, and regulations grouped under various schedules (e.g., Schedule H, Schedule X).
Government-approved laboratories for drug testing and quality assurance.
Drugs that are not approved by regulatory authorities and are prohibited for sale.
Drugs specifically formulated and regulated for use in animals.
A permit required to sell drugs in bulk to retailers or healthcare providers.
Highly regulated drugs with a high potential for abuse, requiring strict prescription control.
A list of essential or restricted drugs published by the regulatory authorities.
CDSCO’s regional offices responsible for enforcing the Act at various levels.
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A drug that does not meet prescribed standards of strength, quality, or purity, making it harmful or ineffective.
A drug substance used as an active pharmaceutical ingredient (API) in manufacturing formulations.
The national regulatory authority responsible for drug approval and enforcement of the Act.
A government-appointed official responsible for inspecting drug manufacturing, distribution, and sales to ensure compliance.
A list of medicines deemed necessary for public healthcare, regulated under the National List of Essential Medicines (NLEM).
A mandatory application form for new drug approvals in India.
Standards that ensure drugs and cosmetics are consistently produced and controlled according to quality standards.
Drugs that may cause dependency, such as narcotic or psychotropic substances, regulated under the Act.
A drug under clinical trial before receiving regulatory approval.
Defines the scope of authority of central and state drug regulatory agencies in enforcing the Act.
A consumer awareness initiative ensuring people understand drug labels, dosages, and side effects.
The government body that grants licenses for the manufacture, sale, and distribution of drugs and cosmetics.
A drug that is misleadingly labeled or does not comply with prescribed packaging and labeling requirements.
Drugs with potential for abuse, regulated under both the Drugs & Cosmetics Act and the Narcotic Drugs and Psychotropic Substances (NDPS) Act.
Drugs available without a prescription but still regulated for safety.
An official publication listing quality standards for drugs, such as the Indian Pharmacopoeia (IP).
A set of regulations ensuring the efficacy, safety, and purity of drugs and cosmetics.
A regulatory action to withdraw defective, substandard, or unsafe drugs from the market.
Different categories of drugs and cosmetics classified under various schedules, such as Schedule H, Schedule X, and Schedule M.
Government-approved facilities that conduct quality and safety testing of drugs and cosmetics.
Drugs that have not been approved for manufacturing, sale, or distribution, making them illegal.
Drugs specifically formulated and regulated for use in animals.
A permit required for selling drugs in bulk to retailers or healthcare providers.
Highly regulated drugs with a high potential for abuse, requiring strict prescription control and record-keeping.
A regulatory document listing essential or restricted drugs.
Regional offices of the CDSCO, responsible for enforcing drug regulations across different zones in India.
| Dr. Pramod Kumar Singh A to Z of Drugs & Cosmetics Act, 1940 |
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