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DRUG AND COSMETIC ACT EXAM REVIEW
1. GUIDED BY : DR. RACHANA AKHAND GIRI SUBMITTED BY : M.PHARM. 2ND SEMESTER
ASSISTANT PROFESSOR STEFFI THOMAS
DEPARTMENT OF PHARMACY ANAY PRATAP SINGH
BARKATULLAH UNIVERSITY, BHOPAL KESHAV KUMAR
LOKENDRA SHAKYWAR
M. Pharm 2nd semester (Pharmaceutics)
Sub. – Cosmetics and Cosmeceuticals
Sub. Code – MPH 204T
2. 1. The year in which Drug And Cosmetic Act was enacted
Ans. 1940
2. Full form of BIS
Ans. Bureau of Indian Standards
3. Import of certain cosmetics is prohibited under Drug And
Cosmetic Act rule
Ans. 134A,135,135A
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3. 4. Under which schedule 27 cosmetics are required to
comply with Indian Standards?
Ans. Schedule S
5. Coal tar colour containing Arsenic shouldn’t be more
than
Ans. 2ppm
6. Coal tar colour containing Lead shouldn’t be more than
Ans. 20ppm
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Department of Pharmacy BU Bhopal
4. 7. Area of plant required for Equipment
Ans. 15 square meters
8. Import of cosmetics intended for use on eyebrows , eyelash
containing coal tar is
Ans. Prohibited
9. Major amendments in Drug And Cosmetics Act was made in
Ans. 1982
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5. 9. If the cosmetic contains a colour not prescribed OR If its not
labelled in prescribed manner OR if the label of container bears
any standard which is false or misleading in any particular
Ans. Misbranded drug
10. One of the following form needed for cosmetic manufacturer
Ans. Form 32
11. In order to obtain license the application has to be the form
Ans. Form 31
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6. 12. In order to obtain license application along with license fee
needed
Ans. Rs 2500
13. Under which schedule the Drug And Cosmetic Rule 1945
deals with requirement for factory premises for
manufacturing of cosmetics?
Ans. Schedule M(II)
14. Drug retail sale license are issued by?
Ans. Drug Controller Authority of the State
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7. 15. Which product is specifically excluded from cosmetics in the
FDA act and hence no cosmetic or drug regulation are
applicable to it?
Ans. Soap
16. License is issued from the
Ans. Licensing Authority
17. Pigment colour is made by:
Ans. Filtering a natural product and creating a sulphate from
an about Iron acid mixture which is washed with water which
is then further processed.
7Department of Pharmacy BU Bhopal
8. 18. Name of the person from the register can be removed only by
the order of
Ans. Executive Committee of State PCI
19. Every year the State Pharmacy Council registers are printed
on
Ans. 21st April
20. The Pharmacy Council of India is also known as ?
Ans. Central Pharmacy Council
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9. 21. Which solvent is most useful for bromo acid in lipstick?
Ans. Castor oil.
22. Who keeps a check on whether the manufacturing and sale of
cosmetics along with the drugs through licensing so that these
are manufactured distributed and sold by qualified person?
Ans. Central and State drugs control authority
23. Qualification of Technical staff who supervises the
manufacturing:
Ans. D.Pharma approved by PCI or be registered pharmacist
under the pharmacy act
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10. 24. Anyone who contravenes the act and rules for manufacturing
cosmetic punishable with:
Ans. Imprisonment upto 1 year are fine up to one thousand or
both.
25. Punishment for manufacturing of spurious cosmetic:
Ans. Imprisonment upto 3 years and with fine.
26. What kind of licence is required to import cosmetics and toiletries
into the country?
Ans. Special import licence.
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27. Taxes freight transport charges Commission payable to declare
and the charge towards advertising delivery packing forwarding
and like are included in:
Ans.MRP
28. If cosmeceutical can not be sold as an OTC item and is classified
as Pharmaceutical item the product require approval from:
Ans. office of drug controller of India in Ministry of Health
28. Label contain figure representing the batch number being
proceded by the letter:
Ans. ‘B’
12. 30. Manufacturing license number the number being preceded by
the letter:
Ans. ‘M’
31. Fluoride content in toothpaste shall contain not more than:
Ans.1000ppm
32. Full form of CPSE, CTFA
Ans.1. CPSE-consumer product safety Commission
2.CTFA-cosmetic toiletry and fragrance Association
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13. 34. Which section of FDA states that no person shall sell a
cosmetic product that has in it any substance that may injured
the health of the user?
Ans. Section 16.
35. The federal trade Commission Act was introduced to exercise
control over fear competition in:
Ans.1914
36. Cosmetic colour additives are regulated by the food and drug
administration.(true/ false)
Ans. True
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14. 37. Bismuth oxychloride is approved as cosmetic colour additives
as long as it 85% pure. (True/false)
Ans. False
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