1. What is the punishment for a person who exports, imports, manufactures for sale, or sells any spurious therapeutic good or any unregistered therapeutic good?
2. What is the role of the Quality Control Department in the manufacturing process?
3. What is the role of the Quality Control Department in the manufacturing process?
4. Who is considered an "investigator" under the Drugs (Research) Rules?
5. What does an Inspector require from a person during a search or seizure under Schedule-V?
6. Which of the following offenses punishable under Schedule-III is non-cognizable?
7. What is the punishment for violating any prohibitions specified in Schedule-II of the DRAP Act?
8. What information should be included in the written contract between the contract giver and contract acceptor for contract manufacture?
9. What is the punishment for violating any prohibitions specified in Schedule-II of the DRAP Act?
10. What action should the Authority take in response to objections raised by the Auditor-General?
11. What is the purpose of the criteria regarding medical representatives?
12. What is the purpose of The Drug Regulatory Authority of Pakistan Act, 2012?
13. Under what condition can finished drugs be imported?
14. What are "Medical Devices" under Schedule-I?
15. When a Federal Inspector is not competent to take action under Schedule-IV, what should he do?
16. What is the role of the Appellate Board under The Drug Regulatory Authority of Pakistan Act, 2012?
17. According to the Drugs (Specifications) Rules, 1978, what is the requirement for ophthalmic ointments?
18. Which power of the Inspector requires specific authorization by the Government?
19. 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?
20. What is the penalty for giving a false warranty in respect of any therapeutic good or applying a warranty given for another therapeutic good?
21. Which of the following offenses punishable under Schedule-III is non-cognizable?
22. In case an exporter's license is suspended or canceled, what recourse does the licensee have?
23. Which of the following actions related to therapeutic goods is PROHIBITED under Schedule-II?
24. What authority is responsible for inspecting and regulaying the manufacturing of drugs under 1976 rules?
25. How many members does the Policy Board consist of?
26. Who is responsible for carrying out the audit of the Authority's accounts?
27. The Drugs Act, 1976 extends to which of the following areas?
28. In which circumstances may the Registration Board register a drug on its own motion?
29. What stage of investigation on human beings involves determining safety, effectiveness, and common side effects of a drug?
30. What is the purpose of 'the Drugs (Federal Inspectors, Federal Drug Laboratory and Federal Government Analysts) Rules, 1976'?
31. The Authority may open its accounts with:
32. What is the maximum time limit for submieng an appeal to the Appellate Board after receiving a decision?
33. How long do members, other than ex-officio members, of the Appellate Board hold office for initially?
34. What is the definition of "promotion" for the purposes of Schedule G of 1976 Rules?
35. Which Division is responsible for the evaluation, assessment, and registration of pharmaceutical drugs for human beings and animals?
36. What type of containers are ophthalmic solutions and suspensions required to be contained in?
37. What is the penalty for selling a drug in the finished form over and above the maximum retail price fixed by the Federal Government?
38. What are "Medicated Cosmetics" under Schedule-I?
39. What is the main duty of a Federal Inspector?
40. What is the duration of a license to export drugs?
41. What is the fee for submitting an appeal to the Appellate Board, as mentioned in the rules?
42. What degree qualifications are required for the competent technical staff involved in the manufacture of drugs by way of basic or semi-basic manufacture?
43. Which of the following statements about advertisement material is NOT true?
44. What is the fee for the renewal of registration of a new drug?
45. What is the Appellate Board's authority to call for the record of a case for review?
46. What are "Medicated Cosmetics" under Schedule-I?
47. The Central Research Fund fee collected by the Authority will be utilized for:
48. Under Schedule-II, what is allowed in terms of distributing therapeutic goods as samples?
49. Under what circumstance can an exporter withdraw a batch of drugs from export after being informed by the licensing authority?
50. Under Schedule-II, what is allowed in terms of distributing therapeutic goods as samples?
51. Where should one portion of a sample taken by an Inspector be sent for test and analysis?
52. Who has the authority to establish the Drug Regulatory Authority of Pakistan?
53. What is the consequence of violating the conditions of a license to import drugs or the provisions of the Act?
54. Which term refers to the set of operations that establish the relationship between values indicated by an instrument and known reference standards?
55. Which power of the Inspector requires specific authorization by the Government?
56. What is the primary function of the Federal Drug Laboratory as stated in the rules?
57. In what circumstances shall a drug not be deemed misbranded or adulterated?
58. 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?
59. When does an Inspector need to divide a sample into three portoons instead of four?
60. Which type of ophthalmic preparations is allowed to have a preservative?
61. Under what conditions can the aid from the research fund be withdrawn and a clinical trial terminated?
62. What is the maximum quantity of a single drug that can be imported for personal use without exceeding the limit?
63. In case of inconsistency between the provisions of the DRAP Act and any other law, what takes precedence?
64. For drugs other than those falling under specific categories, whose approval is required for the specifications?
65. What are the types of licences to manufacture drugs under Drugs Licensing, Registering & Advertising rules 1976?
66. What ethical criteria should be followed for medical drug promotion?
67. What is the age requirement for the Chief Executive Officer (CEO) of the Authority?
68. Who is responsible for maintaining records of quarterly production and disposal of a drug?
69. When can deviations be made from the information submitted during the registration of a drug?
70. In what situations can a drug or substance be advertised to the medical, pharmaceutical, and allied professions without referring to the Federal Government?
71. Which court shall try an offense punishable under the DRAP Act, 2012, and The Drugs Act, 1976?
72. What is the penalty for a person who obstructs an Inspector in the exercise of any power conferred upon him under the Act?
73. What is the meaning of "sponsor" in the context of the Drugs (Research) Rules?
74. What is the purpose of Schedule-III of the DRAP Act?
75. What is the commencement date for the Drugs (Specifications) Rules, 1978?
76. Which of the following substances would NOT be considered a "Medicated Cosmetic"?
77. What is the procedure for appealing the suspension or cancellation of a license under Drugs Import & Export Rules 1976?
78. What is the purpose of an "airlock" in pharmaceutical manufacturing?
79. What is the primary focus of basic research in the context of the Drugs (Research) Rules?
80. What is the meaning of "Reference Biotherapeutic Product (RBP)" under ScheduleI?
81. What is the purpose of Schedule-III of the DRAP Act?
82. What is the primary purpose of the Committee of Experts on Drug Research?
83. What is the meaning of "Reference Biotherapeutic Product (RBP)" under ScheduleI?
84. What is the term of office for members of the Registration Board?
85. What is the punishment for a person who exports, imports, manufactures for sale, or sells any spurious therapeutic good or any unregistered therapeutic good?
86. Who serves as the ex-officio Chairman of the Appellate Board?
87. What is the penalty for a person who fails to provide information requested by the Authority?
88. Who has the authority to make rules for carrying out the purposes of the DRAP Act 2012?
89. Who has the power to institute a prosecution for a contravention of any provision of the DRAP Act, 2012, and The Drugs Act, 1976?
90. What form should be used for applying for the grant or renewal of a licence to manufacture drugs?
91. 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?
92. Within what time frame should the Authority submit its annual report to the Federal Government?
93. The Authority shall levy and collect fees for its functions at rates determined by:
94. What are "Medical Devices" under Schedule-I?
95. How often must records of quarterly production and disposal of a drug be supplied to the Chairman of the Registration Board?
96. Which of the following is NOT included in the definition of "Biologicals" under Schedule-I?
97. Which type of research involves intervention, treatment, or medication programs using human subjects?
98. What substances are NOT included in the definition of "Drug" under Schedule-I?
99. What is the tenure of the CEO's appointment, and how many times can it be extended?
100. If any difficulty arises in giving effect to any provision of the DRAP Act, who has the authority to remove the difficulty?
