1. What is the purpose of The Drug Regulatory Authority of Pakistan Act, 2012?
2. What is the purpose of The Drug Regulatory Authority of Pakistan Act, 2012?
3. What is the commencement date for the Drugs (Specifications) Rules, 1978?
4. If any difficulty arises in giving effect to any provision of the DRAP Act, who has the authority to remove the difficulty?
5. What is the purpose of the Drug Regulatory Authority of Pakistan Fund?
6. What does an Inspector require from a person during a search or seizure under Schedule-V?
7. When does an Inspector need to divide a sample into three portoons instead of four?
8. What is the punishment for violating any prohibitions specified in Schedule-II of the DRAP Act?
9. What does the term "batch number (or lot number)" refer to?
10. 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?
11. How often must records of quarterly production and disposal of a drug be supplied to the Chairman of the Registration Board?
12. In what circumstances shall a drug not be deemed misbranded or adulterated?
13. Who has the authority to establish the Drug Regulatory Authority of Pakistan?
14. In which situations may the Registration Board provisionally register a drug for a period of two years?
15. Which authority may authorize a Federal Inspector to disclose information acquired during official duties?
16. In what type of premises should the manufacturing of drugs by way of basic or semi-basic manufacture take place?
17. What does an Inspector require from a person during a search or seizure under Schedule-V?
18. Which of the following is NOT included in the definition of "Biologicals" under Schedule-I?
19. Which type of ophthalmic preparations is allowed to have a preservative?
20. Which power of the Inspector requires specific authorization by the Government?
21. If any difficulty arises in giving effect to any provision of the DRAP Act, who has the authority to remove the difficulty?
22. What substances are NOT included in the definition of "Drug" under Schedule-I?
23. What condition must be met for an application for renewal of a licence to be entertained?
24. What are the types of licences to manufacture drugs under Drugs Licensing, Registering & Advertising rules 1976?
25. What is the short title of the rules that govern the Drugs Appellate Board?
26. What labeling requirements apply to drugs manufactured for experimental purposes?
27. What is the meaning of "Reference Biotherapeutic Product (RBP)" under ScheduleI?
28. What is the purpose of the Drugs (Research) Rules, 1978?
29. What is the penalty for giving a false warranty in respect of any therapeutic good or applying a warranty given for another therapeutic good?
30. Which of the following actions related to therapeutic goods is PROHIBITED under Schedule-II?
31. What is the purpose of Schedule-III of the DRAP Act?
32. Under what circumstance can an exporter withdraw a batch of drugs from export after being informed by the licensing authority?
33. What type of containers are ophthalmic solutions and suspensions required to be contained in?
34. 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?
35. What form should be used for applying for the grant or renewal of a licence to manufacture drugs?
36. What is the penalty for selling a drug in the finished form over and above the maximum retail price fixed by the Federal Government?
37. Which of the following substances would NOT be considered a "Medicated Cosmetic"?
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. What substances are NOT included in the definition of "Drug" under Schedule-I?
40. What is the main duty of a Federal Inspector?
41. Within what time frame should the Authority submit its annual report to the Federal Government?
42. What should an Inspector do if he finds that the therapeutic good does not contravene any provisions of the Act?
43. Which of the following offenses punishable under Schedule-III is non-cognizable?
44. What is the procedure for appealing the suspension or cancellation of a license under Drugs Import & Export Rules 1976?
45. Where should one portion of a sample taken by an Inspector be sent for test and analysis?
46. According to the Drug Licensing, Registering & Advertisement rules 1976, what type of information should advertisements to physicians and health-related professionals be consistent with?
47. What is the Appellate Board's authority to call for the record of a case for review?
48. What must be included in the labelling and promotion of a registered drug?
49. Which of the following offenses punishable under Schedule-III is non-cognizable?
50. What condition must be met for a drug or substance to be advertised through press without reference to the Federal Government?
51. What is the penalty for a person who fails to provide information requested by the Authority?
52. What is the purpose of the Central Research Fund mentioned in the Drugs Licensing, Registering & Advertising Rules 1976?
53. What is the maximum period for which an Inspector can forbid a person in charge of premises from removing or dispensing therapeutic goods?
54. What is the purpose of an "airlock" in pharmaceutical manufacturing?
55. According to the Drugs (Specifications) Rules, 1978, what is the requirement for ophthalmic ointments?
56. What is the role of the Quality Control Department in the manufacturing process?
57. In which circumstances may the Registration Board register a drug on its own motion?
58. What is the punishment for violating any prohibitions specified in Schedule-II of the DRAP Act?
59. What is the purpose of an "airlock" in pharmaceutical manufacturing?
60. What is the maximum duration of a licence issued under Drugs Licensing, Registering & Advertising rules 1976?
61. What kind of offense is non-cognizable under the Drugs Act 1976?
62. Which authority is responsible for issuing licences to manufacture drugs by way of repacking under section 18 of ordinance in a province?
63. Under what conditions can the aid from the research fund be withdrawn and a clinical trial terminated?
64. What are "Medicated Cosmetics" under Schedule-I?
65. What is the meaning of "Reference Biotherapeutic Product (RBP)" under ScheduleI?
66. What does the term "Advertise" mean under Schedule-II?
67. The Drugs Act, 1976 extends to which of the following areas?
68. What ethical criteria should be followed for medical drug promotion?
69. What is the meaning of "sponsor" in the context of the Drugs (Research) Rules?
70. 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?
71. What is the purpose of Schedule-III of the DRAP Act?
72. Which of the following criteria should promotional claims about drugs adhere to?
73. Under Schedule-II, what is allowed in terms of distributing therapeutic goods as samples?
74. What is the purpose of the Committee on Drugs Evaluation?
75. Who has the authority to physically inspect consignments of exported drugs and draw samples for testing?
76. Within what time frame should the Authority submit its annual report to the Federal Government?
77. What is the penalty for a person who fails to provide information requested by the Authority?
78. Who is considered an "investigator" under the Drugs (Research) Rules?
79. What is the fee for submitting an appeal to the Appellate Board, as mentioned in the rules?
80. What is the penalty for a person who obstructs an Inspector in the exercise of any power conferred upon him under the Act?
81. Which type of research involves intervention, treatment, or medication programs using human subjects?
82. What is the purpose of Form 10 in the export of drugs?
83. What is the primary focus of basic research in the context of the Drugs (Research) Rules?
84. What is the purpose of a separate application for manufacturing drugs on more than one set of premises?
85. What is the penalty for a person who obstructs an Inspector in the exercise of any power conferred upon him under the Act?
86. What is the purpose of the criteria regarding medical representatives?
87. What is the condition under which printing of labeling for therapeutic goods is allowed under Schedule-II?
88. Who shall not be liable for a contravention of Section 23 of the Drugs Act 1976?
89. What is the age requirement for the Chief Executive Officer (CEO) of the Authority?
90. For veterinary drugs, what is the source of specifications if they are not approved by the Registration Board?
91. How long do members, other than ex-officio members, of the Appellate Board hold office for initially?
92. What degree qualifications are required for the competent technical staff involved in the manufacture of drugs by way of basic or semi-basic manufacture?
93. What is the role of the Appellate Board under The Drug Regulatory Authority of Pakistan Act, 2012?
94. What are "Medical Devices" under Schedule-I?
95. Who has the authority to make rules for carrying out the purposes of the DRAP Act 2012?
96. What is the punishment for a person who exports, imports, manufactures for sale, or sells any spurious therapeutic good or any unregistered therapeutic good?
97. Who serves as the ex-officio Chairman of the Appellate Board?
98. Under what conditions are drug advertisements to the general public generally permitted?
99. What is the purpose of the Drug Regulatory Authority of Pakistan Fund?
100. In case of inconsistency between the provisions of the DRAP Act and any other law, what takes precedence?
