1. Who is responsible for carrying out the audit of the Authority's accounts?
2. Who has the authority to establish the Drug Regulatory Authority of Pakistan?
3. Under Schedule-II, what is allowed in terms of distributing therapeutic goods as samples?
4. What is the penalty for a person who obstructs an Inspector in the exercise of any power conferred upon him under the Act?
5. Which of the following is NOT included in the definition of "Biologicals" under Schedule-I?
6. What is the penalty for a person who fails to provide information requested by the Authority?
7. What is the term of office for members of the Registration Board?
8. For veterinary drugs, what is the source of specifications if they are not approved by the Registration Board?
9. What are "Medicated Cosmetics" under Schedule-I?
10. What is the Appellate Board's authority to call for the record of a case for review?
11. In what circumstances shall a drug not be deemed misbranded or adulterated?
12. What kind of offense is non-cognizable under the Drugs Act 1976?
13. Who has the authority to physically inspect consignments of exported drugs and draw samples for testing?
14. Which of the following is NOT considered as "Therapeutic goods" under the Act?
15. What should an Inspector do if he finds that the therapeutic good does not contravene any provisions of the Act?
16. The Drugs Act, 1976 extends to which of the following areas?
17. What does an Inspector require from a person during a search or seizure under Schedule-V?
18. What is the purpose of the criteria regarding medical representatives?
19. What is the tenure of the CEO's appointment, and how many times can it be extended?
20. What is the consequence of violating the conditions of a license to import drugs or the provisions of the Act?
21. Which of the following substances would NOT be considered a "Medicated Cosmetic"?
22. Which authority may authorize a Federal Inspector to disclose information acquired during official duties?
23. Under what conditions is contract manufacture permissible?
24. Which of the following criteria should promotional claims about drugs adhere to?
25. In which circumstances may the Registration Board register a drug on its own motion?
26. What is the primary function of the Federal Drug Laboratory as stated in the rules?
27. What is the penalty for selling a drug in the finished form over and above the maximum retail price fixed by the Federal Government?
28. Who serves as the ex-officio Chairman of the Appellate Board?
29. 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?
30. What is the penalty for a person who fails to provide information requested by the Authority?
31. Who qualifies as a Federal Inspector according to these rules?
32. What is the purpose of The Drug Regulatory Authority of Pakistan Act, 2012?
33. What authority is responsible for inspecting and regulaying the manufacturing of drugs under 1976 rules?
34. 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?
35. What is the main duty of a Federal Inspector?
36. How many members does the Policy Board consist of?
37. In what type of premises should the manufacturing of drugs by way of basic or semi-basic manufacture take place?
38. Within what time frame should the Authority submit its annual report to the Federal Government?
39. For drugs other than those falling under specific categories, whose approval is required for the specifications?
40. What is the penalty for selling a drug in the finished form over and above the maximum retail price fixed by the Federal Government?
41. What does the term "batch number (or lot number)" refer to?
42. In case of an appeal against the decision of the Registration Board rejecting an application for registration of a drug, what statement is required to be submitted?
43. When does an Inspector need to divide a sample into three portoons instead of four?
44. Which of the following actions related to therapeutic goods is PROHIBITED under Schedule-II?
45. The Authority may open its accounts with:
46. What is the short title of the rules that govern the Drugs Appellate Board?
47. What is the penalty for a person who obstructs an Inspector in the exercise of any power conferred upon him under the Act?
48. What information should be included in the written contract between the contract giver and contract acceptor for contract manufacture?
49. Where should one portion of a sample taken by an Inspector be sent for test and analysis?
50. Under what condition can finished drugs be imported?
51. Who has the power to institute a prosecution for a contravention of any provision of the DRAP Act, 2012, and The Drugs Act, 1976?
52. If any difficulty arises in giving effect to any provision of the DRAP Act, who has the authority to remove the difficulty?
53. Which term refers to the set of operations that establish the relationship between values indicated by an instrument and known reference standards?
54. Under Schedule-II, what is allowed in terms of distributing therapeutic goods as samples?
55. What is the purpose of the Drug Regulatory Authority of Pakistan Fund?
56. When can deviations be made from the information submitted during the registration of a drug?
57. What is the purpose of an "airlock" in pharmaceutical manufacturing?
58. Who shall not be liable for a contravention of Section 23 of the Drugs Act 1976?
59. What condition must be met for an application for renewal of a licence to be entertained?
60. What ethical criteria should be followed for medical drug promotion?
61. In case of inconsistency between the provisions of the DRAP Act and any other law, what takes precedence?
62. Which of the following is NOT included in the definition of "Biologicals" under Schedule-I?
63. What does the term "Advertise" mean under Schedule-II?
64. What is the maximum duration for which the approval of an advertisement under sub-rule (1) is valid?
65. What is the definition of "Biological Drugs (Ready-to-fill form)" under Schedule-I?
66. What is the maximum period for which an Inspector can forbid a person in charge of premises from removing or dispensing therapeutic goods?
67. What is the fee for submitting an appeal to the Appellate Board, as mentioned in the rules?
68. Which of the following actions related to therapeutic goods is PROHIBITED under Schedule-II?
69. What are the types of licences to manufacture drugs under Drugs Licensing, Registering & Advertising rules 1976?
70. What is the condition under which printing of labeling for therapeutic goods is allowed under Schedule-II?
71. What is the role of the Quality Control Department in the manufacturing process?
72. What is the punishment for a person who exports, imports, manufactures for sale, or sells any spurious therapeutic good or any unregistered therapeutic good?
73. What is the purpose of Form 10 in the export of drugs?
74. In case an exporter's license is suspended or canceled, what recourse does the licensee have?
75. Which of the following is NOT a source of financing the Drug Regulatory Authority Fund?
76. What does the term "Advertise" mean under Schedule-II?
77. When does an Inspector need to divide a sample into three portoons instead of four?
78. What is the primary focus of basic research in the context of the Drugs (Research) Rules?
79. What is the role of the Appellate Board under The Drug Regulatory Authority of Pakistan Act, 2012?
80. Who can revoke an order passed under Section 32 of the DRAP Act, 2012?
81. What is the purpose of Form 6?
82. According to the schedule in the Drugs (Specifications) Rules, what specifications should drugs bear that reference publications specified under sub-clause (ii) of clause (z) of Section 3?
83. What is the duration of a license to import drugs, unless suspended or canceled?
84. What is the definition of "promotion" for the purposes of Schedule G of 1976 Rules?
85. Who has the authority to make rules for carrying out the purposes of the DRAP Act 2012?
86. How often must records of quarterly production and disposal of a drug be supplied to the Chairman of the Registration Board?
87. Where should one portion of a sample taken by an Inspector be sent for test and analysis?
88. What condition must be met for a drug or substance to be advertised through press without reference to the Federal Government?
89. Which power of the Inspector requires specific authorization by the Government?
90. Which type of ophthalmic preparations is allowed to have a preservative?
91. Who is responsible for maintaining records of quarterly production and disposal of a drug?
92. What is the fee for the renewal of registration of a new drug?
93. What form should be used for applying for the grant or renewal of a licence to manufacture drugs?
94. Which of the following offenses punishable under Schedule-III is non-cognizable?
95. What is the meaning of "Reference Biotherapeutic Product (RBP)" under ScheduleI?
96. What action should the Authority take in response to objections raised by the Auditor-General?
97. What is the duration of a license to export drugs?
98. Under what circumstance can an exporter withdraw a batch of drugs from export after being informed by the licensing authority?
99. What is the purpose of an "airlock" in pharmaceutical manufacturing?
100. What are the conditions that the Central Licensing Board must ensure are complied with before granting or renewing a licence to manufacture drugs by way of basic or semi-basic manufacture?
