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Drugs and Cosmetics Act, 1940
 Is an Act of the Parliament of India
 Regulates the import, manufacture and distribution
of drugs in India
 Obj- to ensure that the drugs and comestics sold in
India are safe, effective and conform to state the
quality standards
 Contains provisions for classification of drugs under
given schedules and there are guidelines for the
storage, sale, display and prescription of each
schedule
 The term "drug" as defined in the act includes a
wide variety of substance, diagonstic and
medical devices.
 "cosmetic" as any product that is meant to be
applied to the human body for the purpose of
beautifying or cleansing.
 In 1964, the act was amended to
include Ayurveda and Unani drugs
 The Section 16 of the act defines the standards of
quality for drugs.
 The Section 17 defines "misbranding". A drug is
considered misbranded if it claims to be of more
therapeutic value than it actually is.
 The manufacturer of such a drug may be asked to
suspend manufacture of the drug under Section 18.
 Section 27 deals with fake and adulterated drugs.
The act requires that ingredients of the drugs
should be printed on the label
 Spurious drugs- if it is manufactured under a name
which belongs to another drug, if it is an imitation
of, or is a substitute for, another drug
 The Section 22 defines the powers of the drug
inspectors and Section 23 defines the strict
procedure which should be followed by the
inspectors during any raids

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Regulating Drugs & Cosmetics in India: Key Provisions of 1940 Act

  • 1. Drugs and Cosmetics Act, 1940  Is an Act of the Parliament of India  Regulates the import, manufacture and distribution of drugs in India  Obj- to ensure that the drugs and comestics sold in India are safe, effective and conform to state the quality standards  Contains provisions for classification of drugs under given schedules and there are guidelines for the storage, sale, display and prescription of each schedule
  • 2.  The term "drug" as defined in the act includes a wide variety of substance, diagonstic and medical devices.  "cosmetic" as any product that is meant to be applied to the human body for the purpose of beautifying or cleansing.  In 1964, the act was amended to include Ayurveda and Unani drugs
  • 3.  The Section 16 of the act defines the standards of quality for drugs.  The Section 17 defines "misbranding". A drug is considered misbranded if it claims to be of more therapeutic value than it actually is.  The manufacturer of such a drug may be asked to suspend manufacture of the drug under Section 18.  Section 27 deals with fake and adulterated drugs. The act requires that ingredients of the drugs should be printed on the label
  • 4.  Spurious drugs- if it is manufactured under a name which belongs to another drug, if it is an imitation of, or is a substitute for, another drug
  • 5.  The Section 22 defines the powers of the drug inspectors and Section 23 defines the strict procedure which should be followed by the inspectors during any raids