Jurisprudence Flashcards
Patent Act
1970
Drugs and Magic Remedies Act
1954
Drugs and Cosmetics Act
1940
Pharmacy Act
1948
Poison Act
1919
Narcotics and Psychotropics Act
1985
All India Council for Technical Education
1994
Medical Termination of Pregnancy
1971
The Factories Act
1949
Drug Price Control Order
1995
Schedule A
Performa for the application of licences, issue and renewal of licences
Schedule B
Fees to the paid to the CDL and other labs for the analysis of drugs and cosmetics
Schedule C
List of drugs obtained from biological origin (hormones, vitamins, alkaloids and antibiotics)
Schedule D
Exceptions and conditions for the import of drugs
Schedule E
List of drugs or poisons that should be labelled
Schedule E (I)
List of poisonous drugs under Ayurveda, Sidha and Unani
Schedule F
Manufacturing, labelling and testing of biological products intended for human use
Schedule F (I)
Manufacturing, labelling and testing of biological products intended for veterinary use
Schedule F (II)
Standards for surgical dressing
Schedule F (III)
Standards for umbilical tapes
Schedule FF
Standards for ophthalmic preparations
Schedule G
List of drugs that should not be taken without medical supervision and should be labelled accordingly
Schedule H
List of prescribed drugs
Schedule J
Drugs that do not prevent or cure diseases/ailments
Schedule K
Drugs exempted from certain provisions of drug manufacture
Schedule M
GMP requirements for premises, factories and plants
Schedule M (I)
GMP requirements for the preparation of homeopathic medications
Schedule M (II)
GMP requirements for the prep of cosmetics
Schedule M (III)
GMP requirements for the prep of Medical Devices
Schedule N
Minimum requirements for the efficient running of a pharmacy
Schedule O
Standards for Disinfectant fluids
Schedule P
Life period of drugs
Schedule P (I)
Pack size of drugs
Schedule Q, part 1
Lost of dyes, colours and pigments for cosmetics and soaps
Schedule Q part 2
List of colours for soaps
Schedule R
Standards for condoms for one time use and other mechanical contraceptives
Schedule R (I)
Standards for medical devices
Schedule S
Standards for cosmetics
Schedule V
Standards for patented and proprietary medicines
Schedule W
Drugs marketed under generic names onlg
Schedule X
List of narcotic and Psychotropic drugs
Schedule Y
Requirements and guidelines for the clinical trial of new drugs and their manufacture and import
What is Schedule 1 in the D&C Act about?
Names of the books under Ayurveda, Sidha and Unani systems
What is Schedule 2 under the D&C Act about?
Standards to be complied by the drugs for import, distribution and exhibit for sale
Appendix 1
Data to be submitted for the marketing of a new drug
Appendix 2
Format for the submission of Clinical trial reports
Appendix 3
Animal toxicity levels during clinical trials that are acceptable for the marketing of a new drug
Appendix 4
No. of animals that can be used for the long term toxicity studies of a drug
Appendix 5
Patient consent form for participating in Phase I trials
Appendix 6
4 groups of fixed dose combinations and their data requirements
How should vitamins be stored?
In a well-closed container, away from light
Drugs that should be stored in a “cold place”
Biologicals
Drugs that should not be stored at a temperature >5degree celsius
Carbencillin, Nystatin
Drugs that should be stored in a “cool place”
Anti-biotics and heparin injection
Under what section does the definition of “Drug” fall?
Section 3(b)
Under what section does the definition of
“Government analyst” fall?
Section 3(c)
Under what section does the definition of a “Drug Inspector” fall?
Section 3(e)
What section includes Misbranded drugs?
Section 17
What section talks about Adulterated Drugs?
Section 17(a)
What section talks about Spurious drugs?
Section 17(b)
What sections describes a Drug Store
Rule 65 [15(e)]
What section talks about a Pharmacy?
Rule 65 [15(c)]
What section involves the definition of Chemists and Druggists?
Rule 65 [15(b)]
Forms involving cosmetics
31, 32, 33, 31A, 32A, 33A
Forms involving import licences
8-12A
Forms involving sales of drugs
19, 20 and 21
Forms for Homeopathic medications
19B, 20C, 20D, 20E, 24C, 25C, 26C
Forms for Ayurveda, Sidha and Unani drugs
24D, 24E, 25, 26
Form 19
Application for the grant/renewal of the state licence by retail or wholesale by the state licensing authority
Form 20
Licence granted to sell by retail drugs (except away schedule c and c1)
Form 20B
Licence granted to sell by wholesale (other than in Schedule C and C1)
Form 21
Licence granted to sell retail drugs (specified in Schedule C and C1)
Form 21B
Licence granted to sell wholesale and distribute the drugs specified in Schedule C and C1
Form 24
Application for the grant/renewal for the licence to manufacture (other than the drugs included in Schedule C and C1)