The Drugs and Cosmetics Act,1940 has sought to regulate the import, production, distribution and sale of drugs and cosmetics in India. In accordance to the laws of land, it has sought to ban certain types of drugs from import, manufacture and distribution in the country. However, such clause is saved if the drugs are imported in small quantities for the purpose of examination, analysis, test or for personal use.
It is also subjected to further amendments by the Central Government, if required. Central government may regulate, prohibit manufacture or restrict the sale or distribution if any drug if it is satisfied on any relevant material that such drug is likely to be injurious to human beings. For the same, it doesn’t require prior consultation with Drugs Technical Advisory Board.[1]
PROHIBITION OF IMPORT:
According to S.10, The Drugs and Cosmetics Act, no person is allowed to import the following categories of drugs, i.e.,
- Drugs which don’t fulfill standard quality
- Misbranded drugs
- Spurious cosmetics
- Adulterated drugs
- Drugs which require a license is prescribed for import
- Patent or proprietary medicine, unless it is presented in the prescribed manner on the label or container.
- Drug which, by any manner of statement, design or device accompanying it which claims to cure any disease or infirmity.
- Any other drug the sale of which is banned under the act
- Cosmetic comprising ingredients which might be harmful if used in accordance to the directions provided on label.
Nothing prevents the Central Government, in lieu of public interest, to prohibit the import, sale, manufacture of any drug which is likely to pose threat on human beings or animals or doesn’t have any therapeutic values as it claims to be.
What are misbranded drugs?
According to S.9 of the Act, any drug which fulfills either of the below mentioned conditions, is treated as a misbranded drug.
- If it is coloured, coated, polished, powdered so as to conceal the damage
- If it is made to appear better or of higher therapeutic value than it apparently is.
- If not labelled appropriately.
- If the labels or container or anything associated with the drugs represent statement, design or device which makes false assertions and are misleading in nature.
What are adulterated drugs?
According to S.9A of the Act, any drug which fulfills either of the below mentioned conditions, is treated as an adulterated drug.
- If the drug contains, wholly or partly, any filthy, putrid or decomposed substance.
- If it has been formulated, packed, and stored in unsanitary conditions which might have caused contamination or is potentially injurious to health.
- If the container comprises, wholly or partly, any poisonous or deleterious substance which may be harmful to the consumer’s health.
- If it comprises, for the purpose of coloring, a color other than one which is recommended
- If it contains toxic or any harmful substances which might be harmful to health.
- If the substance of the drug has been mixed in order to dilute its strength or quality.
What are spurious drugs?
According to S.9B of the Act, any drug which fulfills either of the below mentioned conditions, is treated as a spurious drug.
- If the drug is imported under a name which belongs to other drug.
- If it is a reproduction of, or a substitute for, another drug or bear a resemblance to another drug so as to deceive the consumer or conceal the true character of the drug.
- If the label on the drug contains the name of an individual or company showing itself to be the manufacturer, whereas such company doesn’t exist at all and is a fictitious entity.
- If it claims to be the product of a manufacturer whereas in reality it isn’t.
- If it has been replaced wholly or partly by another drug or substance.
What are misbranded cosmetics?
According to S.9 of the Act, any cosmetics which fulfills either of the below mentioned conditions, is treated as a misbranded cosmetic.
- If the cosmetic contains any color other than what is prescribed.
- If the cosmetic isn’t labelled in the suggested manner.
- If the label or the container or anything in addition to the cosmetic contains any statement which is false or misleading.
What are misbranded cosmetics?
According to S.9D of the Act, any cosmetics which fulfills either of the below mentioned conditions, is treated as a spurious cosmetic.
- If the cosmetic is imported under the name of another cosmetics.
- If the label claims to be the product of a manufacturer whereas in reality it isn’t.
- If the label on the cosmetics contains the name of an individual or company showing itself to be the manufacturer, whereas such company doesn’t exist at all and is a fictitious entity.
- If it is a reproduction of, or a substitute for, another cosmetics or bear a resemblance to another drug so as to deceive the consumer or conceal the true character of the cosmetics.
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