Drug Registration and Approval

1. Comparative analysis of the Indian drug approval process versus the US FDA with a focus on regulatory timelines.
2. Impact of recent amendments to Schedule Y on the drug registration process for biosimilars in India.
3. Regulatory challenges in introducing new drug delivery systems in the Indian pharmaceutical market.
4. Study on accelerated drug approval pathways in India for life-threatening conditions: A regulatory perspective.
5. Role of the Subject Expert Committee (SEC) in expediting drug approvals in India.
6. Comparative study of dossier submission requirements for ANDA in India versus EMA.
7. Impact of Schedule M amendments on pharmaceutical manufacturing processes in India.
8. Evaluation of drug pricing regulations under the Drug Price Control Order (DPCO) and their implications for industry and patients.
9. Challenges faced by Indian companies in registering orphan drugs under the current regulatory framework.
10. Regulatory hurdles in the approval of herbal medicines and traditional formulations in India.
11. A study on the regulatory framework for complex generics in India.
12. Impact of Indian pharmacopoeia standards on drug approval processes for generics.
13. Evaluation of the post-approval change requirements for pharmaceuticals in India.
14. Role of pharmacovigilance data in regulatory decision-making for drug approvals in India.
15. Challenges in implementing regulatory harmonization under SAARC guidelines for drug approvals.

Clinical Trials

16. A critical evaluation of the 2019 Clinical Trial Regulations and their impact on trial timelines in India.
17. Study on patient recruitment challenges for clinical trials in India and their regulatory implications.
18. Ethical concerns in clinical trials conducted in India: An analysis of recent cases.
19. The role of Institutional Ethics Committees in ensuring regulatory compliance for clinical trials in India.
20. Impact of the CDSCO’s regulatory framework on clinical trial monitoring in India.
21. Regulatory challenges in conducting bioequivalence studies in India for export markets.
22. Comparative analysis of Phase I clinical trial requirements in India versus other global regulatory agencies.
23. Regulatory framework for adaptive clinical trials in India: Challenges and future prospects.
24. Role of patient-reported outcomes in clinical trial approvals in India.
25. Challenges in implementing virtual or decentralized clinical trials in India.
26. Regulatory oversight on the use of placebo-controlled trials in India: Ethical and practical concerns.
27. The impact of the New Drugs and Clinical Trial Rules (2019) on contract research organizations (CROs) in India.
28. Role of e-consent in improving regulatory compliance for clinical trials in India.
29. Comparative study of data safety monitoring board (DSMB) practices in Indian clinical trials versus global standards.
30. Study on the regulatory requirements for pediatric clinical trials in India.

Good Manufacturing Practices (GMP) and Quality Assurance

31. Implementation challenges of WHO-GMP standards in Indian small-scale pharmaceutical companies.
32. Comparative study of India’s Schedule M versus WHO-GMP guidelines for pharmaceutical manufacturing.
33. Regulatory implications of data integrity issues in Indian pharmaceutical manufacturing.
34. The role of the CDSCO in ensuring GMP compliance in Indian pharmaceutical facilities.
35. Challenges in meeting international GMP standards for exporting pharmaceuticals from India.
36. Role of quality risk management (QRM) in achieving GMP compliance in Indian pharmaceutical plants.
37. A case study analysis of GMP compliance lapses in Indian manufacturing units and their regulatory impact.
38. Study on the regulatory requirements for facility inspections under CDSCO guidelines.
39. Role of process validation in ensuring regulatory compliance for Indian pharmaceutical manufacturers.
40. Comparative analysis of GMP compliance requirements for nutraceuticals versus pharmaceuticals in India.
41. Study on the implementation of Good Distribution Practices (GDP) in the Indian pharmaceutical supply chain.
42. Challenges in meeting stability testing requirements for pharmaceutical products under Indian regulations.
43. Study on the use of technology transfer protocols for regulatory compliance in India.
44. Role of the National Institute of Biologicals in ensuring GMP compliance for vaccines manufactured in India.
45. Evaluation of regulatory requirements for temperature-sensitive pharmaceutical products in India.

Emerging Regulatory Areas

46. Study on the regulatory framework for biosimilars in India: Challenges and opportunities.
47. Regulatory requirements for gene therapy products in India: Current status and future needs.
48. Evaluation of the Medical Devices Rules (2017) and their impact on device registration in India.
49. Regulatory challenges in introducing personalized medicines in India.
50. Study on the classification and registration process for medical devices in India.
51. Comparative analysis of regulatory requirements for combination products in India versus the US FDA.
52. Challenges in the regulation of in-vitro diagnostic (IVD) devices in India.
53. Study on the regulatory framework for advanced therapy medicinal products (ATMPs) in India.
54. Role of CDSCO in monitoring the safety of mobile health applications and digital therapeutics in India.
55. Study on the regulatory challenges in approving stem cell-based products in India.
56. Evaluation of the nutraceutical regulatory framework in India: Challenges and gaps.
57. Study on the safety and efficacy requirements for Ayurveda-based nutraceuticals in India.
58. Impact of recent amendments to the Drugs and Cosmetics Act on the regulation of veterinary drugs in India.
59. Study on the role of Artificial Intelligence (AI) in regulatory decision-making in India.
60. Regulatory challenges in approving nanomedicine products in India.

Drug Pricing and Access

61. Impact of the National Pharmaceutical Pricing Authority (NPPA) on drug affordability in India.
62. Regulatory challenges in implementing price control for essential medicines under DPCO.
63. Study on the role of generic drugs in improving patient access to affordable medicines in India.
64. Analysis of the impact of price control regulations on innovation in the Indian pharmaceutical industry.
65. Regulatory framework for anti-cancer drugs in India: A focus on pricing and access.
66. Challenges in balancing drug affordability and pharmaceutical profitability in India.
67. Impact of government schemes like Jan Aushadhi on drug pricing and access in India.
68. Study on the effectiveness of trade margin rationalization in reducing drug prices in India.
69. Regulatory analysis of compulsory licensing provisions under Indian patent law.
70. Study on the impact of price regulation on high-cost therapies like biologics in India.

Regulatory Compliance and Harmonization

71. Study on India’s participation in international harmonization initiatives like ICH.
72. Role of the CDSCO in harmonizing Indian drug regulations with global standards.
73. Challenges in aligning Indian pharmacopoeial standards with USP and EP.
74. Study on the regulatory framework for export of generic medicines from India.
75. Role of prequalification programs by WHO in enhancing India’s pharmaceutical exports.
76. Comparative study of regulatory requirements for veterinary medicines in India and other countries.
77. Challenges faced by Indian pharmaceutical companies in meeting global serialization requirements.
78. Study on the role of eCTD submissions in expediting drug approvals in India.
79. Evaluation of India’s regulatory requirements for import of APIs.
80. Challenges in adopting real-time release testing (RTRT) for pharmaceuticals in India.

Case Studies and Policy Analysis

81. Case study on the regulatory approval process for India’s first COVID-19 vaccine.
82. Analysis of the regulatory challenges faced during the introduction of generic insulin in India.
83. Case study on the implementation of the FDC ban in India and its impact on the pharmaceutical industry.
84. Regulatory review of nutraceutical products manufactured under the Ayush Ministry.
85. Analysis of India’s drug recall processes and their effectiveness in ensuring patient safety.
86. Study on the regulatory challenges faced by Indian CROs in conducting global clinical trials.
87. Policy analysis of India’s patent waiver proposal during the COVID-19 pandemic.
88. Case study on India’s regulatory framework for the approval of herbal cosmetics.
89. Role of regulatory policies in curbing antimicrobial resistance in India.
90. Analysis of India’s drug recall processes and challenges in implementation.

Specialized Studies

91. Regulatory challenges in implementing blockchain technology in the Indian pharmaceutical supply chain.
92. Evaluation of India’s pharmacovigilance program and its impact on patient safety.
93. Study on the regulatory requirements for vaccine manufacturing in India.
94. Analysis of India’s rare disease policy and its impact on orphan drug development.
95. Role of digital platforms in streamlining regulatory submissions in India.
96. Study on regulatory policies for traditional medicine exports from India.
97. Regulatory challenges in implementing serialization and traceability in the Indian pharmaceutical industry.
98. Study on the role of public-private partnerships in shaping drug regulatory policies in India.
99. Evaluation of India’s regulatory framework for over-the-counter (OTC) drugs.
100. Comparative study of pharmacovigilance practices in India versus developed countries.
101. Study on the regulatory requirements for API intermediates in India.