INTRODUCTION
Drugs & Cosmetic Act: The Drugs & Cosmetic Act was passed in 1940 (10th April), with the main object to regulate the import, manufacture, distribution and sale of drugs and
cosmetics.
OBJECTIVES
1. The D&C Act 1940 provides the Central legislation, which regulates
import, manufacture, distribution and sale of drugs and cosmetics in the country.
2. To ensure that the drugs available to the people are safe and efficacious and the cosmetics marketed are safe for use.
3. The D&C Act regulates the manufacture and import of drugs into India so that no substandard or spurious drugs get manufactured and imported in and into India
respectively.
4. This provides the regulation of sale and distribution of drugs and cosmetics whereby only qualified and trained persons can undertake their handling, compounding and
distribution.
5. This Act provides the constitution of two boards namely, the Drug Technical Advisory Board (DTAB) and Ayurvedic and Unani Drugs Technical Advisory Board to advise the Central and State governments on technical matters arising out of the administration of this act.
6. It also provides the establishment of two Drugs Consultative Committees (DCC), one for allopathic and the other for Ayurvedic, Siddha, Unani drugs.
DEFINITIONS
Misbranded Drugs:
(i) If it is so colored, coated, powdered or polished that damage is concealed or if it is
made to appear of better or greater therapeutic value than it really is; or
(ii) If it is not labelled in the prescribed manner;
(iii) If its label or container or anything accompanying the drug bears any statement,
design or device which makes any false claim for the drug or which is false or misleading in any particular.
Adulterated Drugs:
(i) If it consists, in whole or in part, of any filthy, putrid or decomposed substance; or
(ii) If it has been prepared, packed or stored under insanitary conditions whereby it may have been contaminated with filthy or whereby it may have been rendered injurious to health.
(iii) If its container is composed in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health.
(iv) If it bears or contains, for purposes of coloring only, a colour other than one which is prescribed.
(v) If it contains any harmful or toxic substance which may render it injurious to health.
(vi) If any substance has been mixed therewith so as to reduce its quality or strength.
Spurious Drugs:
(i) If it is manufactured under a name which belongs to another drug.
(ii) If it is an imitation of, or is a substitute for, another drug or resembles another drug in a manner likely to deceive or bears upon it or upon its label or container the name of another drug unless it is plainly or conspicuously marked so as to reveal its true character and its lack of identity with such other drug.
(iii) If the label or container bears the name of an individual or company purporting to be the manufacturer of the drug, which individual or company is fictitious or does not exist.
(iv) If it has been substituted wholly or in part by another drug or substance.
(v) If it purports to be the product of a manufacturer of whom it is not truly a product.
SCHEDULES TO THE ACT AND RULES
First Schedule: Names of books under Ayurvedic and Siddha systems.
Second Schedule: Standard to be compiled with by imported drugs and by drugs manufactured for sale, stocked, or exhibited for sale or distributed.
A- List of forms used for making applications for issuing licenses, granting license, sending memorandums.
B- Fees for test or analysis by the Central drug laboratory or Government analyst.
C- Biological and special product.
C (1) – Other special products (the import, manufacture and sale of Schedule C & C (1) drugs Governed by special provisions)
D- List of drugs exempted from the provisions of import of drugs.
E- (1) List of poisonous substances under the ayurvedic (including siddha) and unani systems of medicine.
F- & F1- Provision applicable to the production, testing, storage, packaging and labeling
of Biological & special product.
F2- Standards for surgical dressings.
F3- Standards for sterilized umbilical tapes.
FF- Standards of ophthalmic preparations.
G- List of the substances that are required to be used only under medical supervision & which are to be labeled accordingly.
H- List of prescription drugs.
J - Diseases or ailments which a drug may not purport to prevent or cure.
K- Drugs exempted from certain provisions relating to manufacture of the drugs.
M- GMP requirements of factory premises, plant and equipment’s.
M1- Requirements of factory premises etc., for manufacture of homeopathic preparations.
M2- Requirements of factory premises for manufacture of cosmetics.
N- List of minimum equipment’s for efficient running of pharmacy.
O- Standards for disinfectant fluids.
P- Life periods of drugs.
Q- List of coal tar colors permitted to be used in cosmetics.
R- Standards for mechanical contraceptives.
S- Standards for cosmetics.
T- Requirements of factory premises and hygienic conditions for ayurvedic (including siddha) and unani drugs.
U- Particulars to be shown in manufacturing, raw material and analytical records of drugs.
U1- Particulars to be shown in manufacturing, raw material and analytical records of cosmetics.
V- Standards for patent or proprietary medicines.
W- List of drugs which shall be marketed under generic name only.
X- List of habit forming, psychotropic and other such drugs.
Y- Requirements and guidelines on clinical trial for import and manufacture of new drugs.