1. What ethical criteria should be followed for medical drug promotion?
2. Who is considered an "investigator" under the Drugs (Research) Rules?
3. What is the purpose of the Drugs (Research) Rules, 1978?
4. What labeling requirements apply to drugs manufactured for experimental purposes?
5. What information should be included in the written contract between the contract giver and contract acceptor for contract manufacture?
6. What is the role of the Quality Control Department in the manufacturing process?
7. Which of the following statements about advertisement material is NOT true?
8. What is the maximum allowable retailer's discount for drugs?
9. Who is responsible for carrying out the audit of the Authority's accounts?
10. When can deviations be made from the information submitted during the registration of a drug?
11. What is the purpose of Schedule-III of the DRAP Act?
12. What is the purpose of the Central Research Fund mentioned in the Drugs Licensing, Registering & Advertising Rules 1976?
13. What is the penalty for a person who obstructs an Inspector in the exercise of any power conferred upon him under the Act?
14. In what type of premises should the manufacturing of drugs by way of basic or semi-basic manufacture take place?
15. Which Division is responsible for the evaluation, assessment, and registration of pharmaceutical drugs for human beings and animals?
16. What must be included in the labelling and promotion of a registered drug?
17. How often must records of quarterly production and disposal of a drug be supplied to the Chairman of the Registration Board?
18. What is the consequence of violating the conditions of a license to import drugs or the provisions of the Act?
19. What is the purpose of Form 6?
20. Where should one portion of a sample taken by an Inspector be sent for test and analysis?
21. What is the meaning of "Reference Biotherapeutic Product (RBP)" under ScheduleI?
22. What is the purpose of an "airlock" in pharmaceutical manufacturing?
23. What is the penalty for giving a false warranty in respect of any therapeutic good or applying a warranty given for another therapeutic good?
24. Under Schedule-II, what is allowed in terms of distributing therapeutic goods as samples?
25. What is the tenure of the CEO's appointment, and how many times can it be extended?
26. What is the purpose of the Drug Regulatory Authority of Pakistan Fund?
27. Who can revoke an order passed under Section 32 of the DRAP Act, 2012?
28. Who shall not be liable for a contravention of Section 23 of the Drugs Act 1976?
29. What is the commencement date for the Drugs (Specifications) Rules, 1978?
30. What is the purpose of Schedule-III of the DRAP Act?
31. What is the duration of a license to export drugs?
32. What does an Inspector require from a person during a search or seizure under Schedule-V?
33. Which of the following actions related to therapeutic goods is PROHIBITED under Schedule-II?
34. What is the maximum duration of a licence issued under Drugs Licensing, Registering & Advertising rules 1976?
35. What is the age requirement for the Chief Executive Officer (CEO) of the Authority?
36. What authority is responsible for inspecting and regulaying the manufacturing of drugs under 1976 rules?
37. What is the main duty of a Federal Inspector?
38. What is the penalty for selling a drug in the finished form over and above the maximum retail price fixed by the Federal Government?
39. Under what conditions is contract manufacture permissible?
40. For veterinary drugs, what is the source of specifications if they are not approved by the Registration Board?
41. What is the primary purpose of the Committee of Experts on Drug Research?
42. What is the purpose of The Drug Regulatory Authority of Pakistan Act, 2012?
43. Who has the authority to establish the Drug Regulatory Authority of Pakistan?
44. What substances are NOT included in the definition of "Drug" under Schedule-I?
45. In case an exporter's license is suspended or canceled, what recourse does the licensee have?
46. Within what time frame should the Authority submit its annual report to the Federal Government?
47. Where should one portion of a sample taken by an Inspector be sent for test and analysis?
48. The Central Research Fund fee collected by the Authority will be utilized for:
49. What is the maximum duration for which the approval of an advertisement under sub-rule (1) is valid?
50. What is the purpose of Form 10 in the export of drugs?
51. What substances are NOT included in the definition of "Drug" under Schedule-I?
52. What does the term "batch number (or lot number)" refer to?
53. What is the condition under which printing of labeling for therapeutic goods is allowed under Schedule-II?
54. What kind of offense is non-cognizable under the Drugs Act 1976?
55. Who serves as the ex-officio Chairman of the Appellate Board?
56. What is the penalty for a person who fails to provide information requested by the Authority?
57. Which court shall try an offense punishable under the DRAP Act, 2012, and The Drugs Act, 1976?
58. What is the purpose of the Drug Regulatory Authority of Pakistan Fund?
59. What condition must be met for an application for renewal of a licence to be entertained?
60. What is the Appellate Board's authority to call for the record of a case for review?
61. The Authority may open its accounts with:
62. In which situations may the Registration Board provisionally register a drug for a period of two years?
63. What is the fee for the renewal of registration of a new drug?
64. What are "Medical Devices" under Schedule-I?
65. Which of the following is NOT a source of financing the Drug Regulatory Authority Fund?
66. Which of the following criteria should promotional claims about drugs adhere to?
67. Under what conditions are drug advertisements to the general public generally permitted?
68. Who qualifies as a Federal Inspector according to these rules?
69. What are the types of licences to manufacture drugs under Drugs Licensing, Registering & Advertising rules 1976?
70. When does an Inspector need to divide a sample into three portoons instead of four?
71. What is the penalty for a person who fails to provide information requested by the Authority?
72. What is the term of office for members of the Registration Board?
73. Who has the power to institute a prosecution for a contravention of any provision of the DRAP Act, 2012, and The Drugs Act, 1976?
74. What does the term "Advertise" mean under Schedule-II?
75. What provision allows an exporter to recall issues already made from a batch of drugs that have been found to be in contravention of the Act or rules of 1976?
76. What is the maximum period for which an Inspector can forbid a person in charge of premises from removing or dispensing therapeutic goods?
77. In what circumstances shall a drug not be deemed misbranded or adulterated?
78. In case of inconsistency between the provisions of the DRAP Act and any other law, what takes precedence?
79. What is the punishment for a person who exports, imports, manufactures for sale, or sells any spurious therapeutic good or any unregistered therapeutic good?
80. What is the penalty for a subsequent offense under Clause (1) of Schedule-III?
81. Which authority is responsible for issuing licences to manufacture drugs by way of repacking under section 18 of ordinance in a province?
82. What is the definition of "promotion" for the purposes of Schedule G of 1976 Rules?
83. What is the purpose of an "airlock" in pharmaceutical manufacturing?
84. What is the maximum quantity of a single drug that can be imported for personal use without exceeding the limit?
85. Which term refers to the set of operations that establish the relationship between values indicated by an instrument and known reference standards?
86. The Drugs Act, 1976 extends to which of the following areas?
87. If any difficulty arises in giving effect to any provision of the DRAP Act, who has the authority to remove the difficulty?
88. Who may physically inspect an imported consignment, draw samples, and order the importer not to sell or dispose of the drug for a specific period?
89. Under Schedule-II, what is allowed in terms of distributing therapeutic goods as samples?
90. According to the Drug Licensing, Registering & Advertisement rules 1976, what type of information should advertisements to physicians and health-related professionals be consistent with?
91. Which power of the Inspector requires specific authorization by the Government?
92. Which power of the Inspector requires specific authorization by the Government?
93. The Authority shall levy and collect fees for its functions at rates determined by:
94. What is the purpose of the criteria regarding medical representatives?
95. What is the fee for submitting an appeal to the Appellate Board, as mentioned in the rules?
96. What are "Medicated Cosmetics" under Schedule-I?
97. What does an Inspector require from a person during a search or seizure under Schedule-V?
98. How long do members, other than ex-officio members, of the Appellate Board hold office for initially?
99. Within what time frame should the Authority submit its annual report to the Federal Government?
100. In what situations can a drug or substance be advertised to the medical, pharmaceutical, and allied professions without referring to the Federal Government?
