Drugs and Cosmetics Act, 1940 and its rules 1945:

Objectives, Definitions, Legal definitions of schedules to the Act and Rules

Drug is an essential commodity and is required to be regulated in terms of

its import, manufacture, sale and distribution.
The Central Government and State Government are charged
with the responsibility of providing the drugs of desired quality to the
needy patients and in order
to ensure this primary obligation of the Government,
the network is required to be developed to
root out adulterated,
misbranded and
spurious drugs from the society.
 • Objectives
1. For preventing substandard in drugs, probably for treatment and
preserving high medical standards.
2. For controlling the import, manufacture, distribution, and sale of drugs and
cosmetics by licensing.
3. For ensuring that manufacture, distribution, and sale of drugs and
cosmetics is done by qualified persons only.
4. For controlling the manufacture, and sale of Ayurvedic, Siddha, and Unani
drugs.
5. Establishment of Drugs Technical Advisory Board (DTAB) and Drugs
Consultaive Committees (DCC) for Allopathic and Allied drugs and
Cosmetics
 Important definitions
• 1. Drug
It
Include
s:
• All medicines for internal or external use of human beings or animals and
substances used for or in the
• diagnosis,
• treatment,
• mitigation or prevention of any disease or disorder in human beings or
animals including, preparations applied on human body for the purpose of
repelling insects like mosquitoes.
• (ii) The substances other than food which may affect the structure or any
function of the human body or used for the destruction of insects or
vermin which cause disease in human beings
• 2. Cosmetic
• It means any article intended to be sprayed, poured, rubbed or sprinkled
on, or introduced into, or applied to the human body or its any part for
• cleansing,
• beautifying,
• promoting attractiveness
• or altering the appearance
• 3. Ayurvedic, Siddha or Unani Drugs
• These include all medicines used for internal or external purposes or used
in the diagnosis, treatment, mitigation or prevention of disease or
disorder in human beings or animals and
• manufactured exclusively in accordance with the formulae described in
the authoritative books
• of Ayurvedic, Siddha and Unani Tibby Systems of Medicines specified in
the First Schedule to the Drugs and Cosmetics Act, 1940.
• Misbranded Drug
• A drug is considered as a misbranded drug:
• (i) if it is not labeled in the prescribed manner,
• or
• (ii) if it is so coloured, coated, powdered or polished that damage is
concealed or it is made to
• appear of better or greater therapeutic value than it really is,
• or
• (iii) if the label or container or anything accompanying the drug bears any
statement, design or
• device which makes any false claim for the drug or gives misleading
information.
• Adulterated Drug
• A drug is considered to be adulterated:
• (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 poor sanitary conditions
whereby, it may have been contaminated with filth and rendered injurious to
health,
• or
• (iii) if container of the drug is composed in whole or in part of any poisonous
substance which may render the contents injurious to health,
• or
• (iv) if it contains a colour other than one which is prescribed,
• or
• (v) if the drug contains any harmful or toxic substance which may render it
injurious to health,
• or
• (vi) if the drug is admixed with any substance so as to reduce its quality or
strength
• Spurious Drug
• A drug is deemed to be a spurious drug:
• (i) if it is imported under a name which belongs to another drug,
• or
• (ii) if it is an imitation of or a substitute for another drug or if it resembles
another drug in a manner likely to deceive or bears upon it or its label or
container the name of another drug,
• or
• (iii) if it has been substituted wholely or in part by another drug substance,
• or
• (iv) if it claims to be the product of a manufacturer or company of whom it
is not truly a product

• Adulterated cosmetic and spurious cosmetic

 Schedules to the Act and Rules

There are two Schedules to the Act and 35 Schedules to the Rules.
1. First Schedule: It comprises the list of books of references for Ayurvedic,
Siddha and Unani medicines
2. Second Schedule: It comprises of the standards to be complied with for
imported drugs, manufacture of drugs, their sale, stocking and storage
etc.
• The Schedules to the Rules
• Schedule A: Different Forms for application to procure licence, renewal of
licence, and for all other activities.
• Schedule B: Rates of fees charged for analysis by COL or State Drugs
Laboratories.
• Schedule C: List of biological and other special products governed by
special provisions
• Schedule D: Class of drugs: extent and conditions of exemption
• Schedule E (I): List of poisonous substance under Ayurvedic , Siddha and
Unani medicines
• Schedule F: Requirement for operation of blood bank and / or preparation
of blood components. Provisions for bacterial vaccines, viral vaccines,
antisera, diagnostic antigens,
• Schedule FF: Standards for ophthalmic preparations
• Schedule G: Drugs required to be taken under medical supervision.
• Schedule H: List of prescription drugs
• Schedule J: List of diseases or ailments which a drug may not purport to
prevent or cure.
• Schedule K: Drugs exempted from certain provisions related to
manufacturer.
• Schedule M: GMP (Good Manufacturing Practices) comprising
requirements of factory premises, plant and equipment
• Schedule N: List of minimum equipment of running a pharmacy
• Schedule O: Standards for disinfectant fluids
• Schedule P: Life period of drugs
• Schedule P-l: Pack sizes of drugs
• Schedule Q: List of colours, dyes and pigments permitted in cosmetics and
soaps, list of colours permitted in soaps
• Schedule R: Standards for condoms of rubber latex and other mechanical
contraceptives
• Schedule R-I: Standards for medical devices
• Schedules S: Standards for Cosmetics
• Schedules T: GMP (Good Manufacturing Practices) for manufacture of
Ayurvedic, Siddha and
• Unani medicines, G.M.P., machinery, equipment minimum manufacturing
premises, etc.
• Schedules U: Particulars required to be shown in manufacturing records;
raw material and analytical records
• Schedules V: Standards for patent or proprietary medicines
• Schedules X: Psychotropic substances
• Schedules Y: Requirements and guidelines on clinical trials for import and
manufacture of new drug

• Import of drugs and cosmetics

• The import of drugs and cosmetics is regulated by the provisions of this
Act.
• Classes of drugs and cosmetics prohibited from import
• The following categories of drugs and cosmetics are prohibited from
import
1. Drugs or cosmetics which are not of standard qualities.
2. Drugs or cosmetics which are misbranded, spurious and adulterated.
3. Drugs or cosmetics for import of which license is required.
4. Any patent or proprietary medicine without true formula or list of active
ingredients and their quantities.
5. Any drug or formulation which claims to prevent or cure diseases
mentioned schedule J.
6. Any drug or cosmetic for which manufacture, sale or distribution is
prohibited in country of its origin.
7. Any drug which is not packed or not labeled in conformity with the Rules of
the Act.
8. Any cosmetic containing an ingredient which may render it unsafe or
harmful.
9. Any drug or cosmetic the import of which is prohibited by Act.
• Import under license or permit.
• The licensing authority grants a license for the import
of following classes of drugs
• A. Drugs specified in schedule C and C1 excluding those
specified in schedule X
• B. Drugs specified in schedule X
• C. Small quantities of drugs imported for examination, test or
analysis
• D. Drugs for personal use prescribed by a Registered Medical
Practitioner
• E. Any new drug
 Manufacture of Drugs
• The following categories of drugs and cosmetics are prohibited to be
manufactured or sold in our country.
• 1. Any drug or cosmetic which is substandard, misbranded, adulterated or
spurious.
• 2. Any patent or proprietory medicine without clear indication of ingredients.
• 3. Any drug claiming for accurate cure or prevention of diseases listed in
Schedule J.
• 4. Any manufacturing of formulation containing drug or cosmetic which has
been imported into our country in contravention to the provisions of the Act
and Rules.
• 5. Manufacturing for sale of any drug or cosmetic containing any harmful
ingredient.
• 6. Manufacturing for sale of any drug or cosmetic in contravention to the
provisions of the Act and Rules, provided that manufacture of small quantities
of any drug for the purpose of examination, test or analysis is permitted, subject
to prescribed conditions

• . Separate applications for separate licences for more than one premises of
manufacture are required to be made.
• The types of licenses are granted are
• 1. Manufacturing of drugs for examination, test or analysis
• 2. Manufacture of new drug
• 3. Manufacturing under Loan licences
• 4. Licence for Repacking
• 5. Licence to Manufacture of drugs other than Schedule C, C(1), and
Schedule X
• 6. Licence to Manufacture of Biologicals and Special Products in Schedules
C and C (1)
• 7. Manufacturing of drugs belonging to Schedule X
 Manufacturing of drugs for examination, test or analysis
• 1. The manufactured drugs should be kept in containers bearing
appropriate label indicating the purpose of test or analysis.
• 2. The drugs should be used for the purpose for which they are
manufactured.
• 3. When the material is supplied to other manufacturer, the label stating
the name and address of manufacturer, scientific name of the drug,
licence number, date of manufacture etc., should be provided.
• 4. The manufacturer should allow the Inspector to inspect the premises,
manufacturing, and analytical records and withdraw the samples if
required for analysis.
• 5. The manufacturer should maintain an Inspection Book and the same be
shown to the Inspector.
• 6. The licensee should comply with other requirements for which a notice
has been given to him one month before by the Licensing Authority.
 Licence to Manufacture of drugs other than Schedule C, C(1), and Schedule X
1. The factory premises shall comply with conditions laid down in the Schedule M.
2. The manufacture shall be conducted under active supervision of
Competent Technical Staff.
3. Adequate facilities for testing should be provided and it should be separate
from manufacturing unit.
4. Adequate facilities for storage of drugs.
5. Licensee must allow an Inspector to inspect the premises, check the record and
to take the sample.
6. Licensee must display the licence on the premises and produce it when asked for.
7. Licensee must pay fees and get endorsement on the licence if the licensee
wishes to manufacture any additional product.
8. Record of testing and manufacture (Schedule U) should be maintained at least
for 2 years from the date of expiry of drugs and for 5 years in case of other
drugs.
9. Licensee must provide samples to the Authority.
10. Licensee must furnish the data of stability of drug if demanded.
• Special conditions for Biologicals
• 1. All Schedule C drugs must be issued in previously sterilized, sealed glass
of other suitable containers.
• 2. All containers should comply with Schedule F/F1.
• 3. The drug must comply with standards specified in Schedule F.
• 4. Serum should be tested for freedom from abnormal toxicity.
• 5. Multidose containers for liquids should contain preservatives to prevent
growth of microorganism.
• 6. Sterility testing should be done.
• 7. Some classes of substances should be tested for the absence of aerobic
and anaerobic microorganisms like bacterial vaccines, dry preparation of
insulin, sera etc.
• 8. Solution for parenteral administration in dose of 10 ml or more should
be tested for freedom from pyrogens.
• 9. There should be separate laboratories culture and manipulation of
spore bearing pathogens.
 Manufacturing of drugs belonging to Schedule X
.
• A licence is obtained from licensing authority on the application in
prescribed Form No. 27B with prescribed fees.
• If conditions are fulfilled then licence is issued in prescribed Form
No. 28B.
• Special conditions
• 1. Account of all transactions regarding manufacture should be
maintained in a serially bound and paged register as follows. This should
be prescribed for 5 years.
• ? Accounts of drug used in manufacture ( Date of issue, Name of the drug,
Opening balance, Quantity received, Quantity used, Balance quantity,
Sign.
• Account of production (Date of manufacturer, Name of drug, Batch No.,
Quantity of raw material, Wastage, Quantity of manufactured drug)
• ? Amount of manufactured drug (Date of manufacturer, Name of drug,
Batch No., Opening balance, Quantity manufactured, Quantity sold, Name
of purchaser, Balance quantity)
• 2. Manufacturer is required to send the copies of invoice of sale of drugs
to licensing authority every 3 months.
• 3. Preparations should be labeled as XRX (red ink).
• 4. No Schedule X drugs should be supplied by the way of physician sample.
• 5. Drugs specified in Schedule X drugs shall be marketed in packaging not
exceeding 100 Units dose- Tablets/Capsule, 300 ml –Oral liquid and 5 ml
–Injection.