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Drugs and cosmetics act of 1940 and it’s rule, 1945
The Drugs and Cosmetics Act of 1940, along with its accompanying rules of 1945, has played a crucial role in regulating the manufacturing, sale, and distribution of drugs and cosmetics in India. This comprehensive legislation provides a framework for ensuring the safety, efficacy, and quality of these products.
Under the Drugs and Cosmetics Act of 1940, strict guidelines are set to ensure that drugs and cosmetics meet certain standards before they can be made available to the public. These standards cover various aspects such as labelling requirements, prohibited ingredients, product registration, clinical trials, manufacturing practices, and more.
This act also verify that the drugs and cosmetics should be manufactured, distributed and sold only by qualified persons having a license for this purpose.
Objectives of drugs and cosmetics act
1. It is basically used for controlling the import, manufacture, distribution and sale of drugs and cosmetics by licensing and also by qualified persons only.
2. To verify the standards and quality of drugs manufactured in India and to regulate their manufacture, sale & distribution.
3. To maintain the high standards of medical treatments by avoiding sub-standard in drugs.
4. It is useful in control the manufacture and sale of Ayurvedic, Siddha and Unani drugs.
5. For establish DTAB and DCC.
Understand the drugs
1. All medicine for internal or external use of human beings or animals and all substances intended to be used for or in the diagnosis, treatment and prevention of any disease or disorder in human being or animals, including preparation applied on human body.
2. Such substance (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 watch 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.
3. All substances intended for use as components of drug including empty gelatine capsules.
4. Such devices intended for internal or external use in the diagnosis, treatment or prevention of diseases 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 drug technical advisory board (DTAB).
Understand the cosmetics
Any product intended to be rubbed, poured, sprinkled or sprayed on, or introduced into human body for cleaning, beautifying, promoting attractiveness or altering the appearance and includes any article intended for use as components of cosmetics.
What do you mean by “manufacture”
Any progress or part of process for making, altering, finishing, packing, labelling, breaking up or otherwise treating or adopting any drugs or cosmetic with a view to its sale or distributions but does not include the compounding or dispensing of any drugs, or the packing of any drugs or cosmetic in the ordinary course of retail business.
What do you mean by “patent or proprietary medicines”
It refers to a remedy whose formula is owned exclusively by the manufacturer and which is marketed usually under a name registered as a trademark.
In tension to Ayurvedic, Siddha and Unani system of medicine all formulations containing such ingredients mentioned in the formulae described in the authoritative books of Ayurvedic, Siddha, Unani or Tibbs system of medicine specified in the first schedule to the act but does not include the medicine administered by the parenteral routes.
In relation to any other systems of medicines including allopathic, a drug presented in the form ready for internal or external administered of human being or animals and which is not included for the time being in the edition of Indian pharmacopeia.
What do you mean by “misbranded drug”
It any drugs label or container or anything accompanying the drugs bear any statement, design or devices which makes any false claim for the drugs or which is false or misleading in any particular, then it’s called misbranded drug.
What do you mean by “spurious drugs”
1. If it is imported (manufactured in relation to manufacture, sale and distribution of drugs and cosmetics) under a name which belongs to another drugs.
2. If any drug is an imitation of or is a substitute for another drugs or resembles another drug in a manner likely to deceive or bears upon it or upon its label container the name of another drug/cosmetic.
3. If the label or container bears the name of an individual or company purporting to be the manufacture of the drug, which individual or company is fictitious or does not exist.
4. If it has been substituted wholly or in part by another drug or substances.
5. If it claims to be the product of a manufacturer or company of whom it is not truly a product.