Kalpana Kamnoore, M P Venkatesh, Balamuralidhara V, T M Pramod Kumar
Kalpana Kamnoore, M P Venkatesh*, Balamuralidhara V, T M Pramod Kumar
Pharmaceutical Regulatory Affairs Group, Dept. of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Mysuru-570015, Karnataka, India.
Volume - 13,
Issue - 3,
Year - 2020
Clinical trial is mandatory for approval of drug to assure safety and efficacy of drug. To safeguard the safety of patient and ethical conduction of clinical trial, India has laid down CT regulations. Compliance with ICH-GCP guideline is mandatory which describes quality assurance and safety of subjects. Clinical trial is regulated under Drug and Cosmetic act 1940 and Rules 1945 which has given Rules to conduct the clinical trial. On March 19, 2019, the Union Ministry for Health and Family Welfare notified New drugs and Clinical Trials Rules, 2019 for promoting clinical research in the country. Central Government notified final rules in Gazette of India vide G.S.R.227(E). The objective of this study is to provide an overview on regulatory requirements to conduct the clinical trials in India and challenges involved in that.
Cite this article:
Kalpana Kamnoore, M P Venkatesh, Balamuralidhara V, T M Pramod Kumar. Regulatory requirements for conducting Clinical Trials in India. Research J. Pharm. and Tech 2020; 13(3):1517-1522. doi: 10.5958/0974-360X.2020.00276.0
Kalpana Kamnoore, M P Venkatesh, Balamuralidhara V, T M Pramod Kumar. Regulatory requirements for conducting Clinical Trials in India. Research J. Pharm. and Tech 2020; 13(3):1517-1522. doi: 10.5958/0974-360X.2020.00276.0 Available on: https://rjptonline.org/AbstractView.aspx?PID=2020-13-3-81
1. Pikee Saxena, Rohit Saxena. Clinical Trials: Changing Regulations in India. Indian J Community Med. 2014 Oct-Dec; 39(4): 197–202.
2. Drug and Cosmetic Act 1940 and Rules 1945. 2016 Available from: URL: https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdfdocuments/acts_rules/2016DrugsandCosmeticsAct1940Rules1945.pdf
3. Rajashree Devarakonda. Current Clinical Trial Scenario of India: Challenges and Solutions. Pharma Bio World. July 2013; Page 16-20.
4. Schedule Y- CDSCO. 2019. Available from: URL: https://rgcb.res.in/documents/Schedule-Y.pdf
5. Aggregating clinical research regulations from around the world. National institute of allergy and infectitious disease. 2019. Available from: URL: https://clinregs.niaid.nih.gov/country/india#labeling_and_packaging
6. Lovely Joylen Castelino, Anoop Narayanan V, Swapnil Dylan Fernandes, Pankaj Kumar, Sandeep D S. Good Clinical Practices: An Indian Perspective. Research J. Pharm. and Tech 2018; 11(7): 3209-3215.
7. Sandeep Lahiry, Rajasree Sinha, Shouvik Choudhury, Ayan Mukherjee, Suparna Chatterjee. Paradigm shift in clinical trial regulations in India. 2018; Volume : 13, Issue : 1, Page : 51-55.
8. Clinical trials in India: Documents requirements. Available from: URL: https://morulaa.com/indian-medical-device-market/clinical-trials-in-india-document-requirements/
9. Bobby George. A New Dawn in the History of Clinical Research for India. IDMA Bulletin. 2019; Volume: 50, Issue : 17, Page: 8-14.
10. India: The New Drugs And Clinical Trial Rules, 2019. Available from: URL: http://www.mondaq.com/india/x/799018/Healthcare/The+New+Drugs+And+Clinical+Trial+Rules+2019
11. Sharma H, Parekh S (2012) Clinical Trials Regulations in India. Pharmaceut Reg Affairs 1:e118. doi:10.4172/2167-7689.1000e118
12. Shrivastava Alankar, Jain R., Agrawal R.K., Ahirwar D.. Clinical Trial of Herbal Drugs and Products in India: Past and Current Status and Critical Issues. Research J. Pharm. and Tech. 1(2) April-June. 2008; Page 69-74.
13. Patil SM, Sapkale GN, Kumbhar PB, Maske AP. Quality Assurance in Clinical Trial. Research J. Pharmacology and Pharmacodynamics. 2010; 2(1):01-04.
14. C. Vijayabanu, R. Renganthan, S H Shahana Hameedha, J. Arokiya Monica4;. Clinical Trials in Digital Era on Pharmaceutical Industry. Research J. Pharm. and Tech 2017; 10(11): 4047-4050.
15. A Review: Indian Pharmaceutical Education and its Regulatory Authorities. S. C. Shivhare, K.G. Malviya, Preeti Srivastav, U.D. Shivhare, Atneriya U.K. Research J. Pharma. Dosage Forms and Tech. 2012; 4(1):14-18.
16. Nilima Kanwar Hada, Mahendra Singh Ashawat. Ethical Conduct of Paediatric Clinical Trials; Issues and Challenges. Res. J. Pharm. Dosage Form. and Tech. 6(3):July- Sept. 2014; Page 156-160.
17. Raghava Ramesh Narayana, KP Shivalinge Gowda, Syed Mansoor Ahamed and S Badami. ICH Guidelines with Special Emphasis on Good Clinical Practice Guidelines (GCP). Research J. Pharmacology and Pharmacodynamics. 2010; 2(1):27-32.
18. Nisreen M. Ibraheem. Controlled Clinical Trials: Comparison The efficacy of some Single Topical Scabies Treatment Modalities versus Combined Topical Modalities. Research J. Pharm. and Tech. 2019; 12(3): 1361-1368.
19. Vasanth Kumar Kunithala, Kiran Kumar Chinthakindi, Paspulati Ravalya, Mahesh K.V.N, Ponala Sowmya, Sandeep Kadaganchi, Manikanta Gandam. Phase -1 Clinical Trials on Formulation and Evaluation of Colon Specific Methylprednisolone Matrix Enteric Coated Tablets. Research J. Pharm. and Tech. 5(7): July 2012; Page 905-911.
20. Ajay Saxena, PK Rai, Ajay Meena, Anupam Srivastava, Kiran Srivastava, Priyanka Pandey. Clinical Trial of Shirodhara in Chittodvega Vis-À-Vis Generalized Anxiety Disorders. Research Journal of Pharmacology and Pharmacodynamics. 2014; 6(3): 141-145.