NOC | Current regulatory requirements for conducting clinical trials in India

Course abstract

Demonstration of safety and efficacy of the drug product for use in human being is essential before the drug can be approved for import or manufacturing and marketing in the country. The Rules 122A, 122B and 122D, 122 DA, 122DB, 122DAA, 122 DAB, 122 DD, and 122E of Drugs and Cosmetics Rules and Appendix I, IA and VI of Schedule Y, describe the information/data required for approval of clinical trial and/or to import or manufacture of new drug for marketing in the country. Recently, there are few amendments made related to the new drug rules. and â€œ New Drugs and Clinical Trial Rules, 2018. (Draft) published by the CDSCO. This course will make the participant aware about all the current regulatory and ethical requirements for conducting clinical trials in India. Enjoy the course!

Course Instructor

Prof.A.B.Ramteke

Shri. Arunkumar B. Ramteke retired as a senior drugs regulatory officer (Joint Drugs Controller, India, CDSCO) with 31 years of experience in drug regulatory aspects in the office of the Drugs Controller General of India (DCGI). He has in-depth knowledge of Indian Drugs & Cosmetics Act, Rules and of regulations of Global Drug Regulatory Norms. He started his career at Central Research Institute, Kasauli, as Deputy Assistant Director, BSQC Division and faculty for B.Sc. (Microbiology) H.P. University. As Drug Regulator he has extensive experience with new drugs, vaccines and biotech products/pharmaceuticals, medical devices regulatory approvals and development experience. He also has experience in review and evaluation of product dossier for pre-clinical, toxicological, pharmacological, CMC, and quality control, clinical trial data of new drugs, biological and medical devices (IND, ANDAs).
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Prof.Sucheta Banerjee Kurundkar

r. Sucheta Banerjee Kurundkar joined CDSA as Director Training in 2012. She has 20+ years of experience in research and CRO Industry. Prior to this, she was Chief Scientific Officer at a multinational Clinical Research Organization. She is involved in training, quality assurance (pre-clinical, clinical & medical labs) and regulatory affairs at CDSA. She is a GLP Trainer (WHO); GCP & GCLP Trainer; Auditor for NABL (ISO 15189, ISO 17025), ISO 9001:2015 & NABH standards. She is a NABH Assessor (Ethics Committee under clinical trial accreditation program) & SIDCER (WHO) Survey, Trainee. Sucheta is a Visiting Faculty to Bureau of Indian Standards & National Institute of Training for Standardization. Sucheta obtained her Ph.D. in Biochemistry from the University of Pune. Her doctoral work on a novel inhibitor received recognition at the World Congress on Insulin Resistance Diabetes & Cardiovascular Research, USA (2010). She is a recipient of CSIR International Travel Award. She has a MBA with specialization in Total Quality Management from Sikkim Manipal University and Management Development Programme from IIM, Ahmedabad (IIMA).
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Prof.Nandini K Kumar

Dr. Nandini K. KumarÂ completed her MBBS and Post Graduate Diploma in Clinical Pathology from GMC, Trivandrum, and is a Fogarty Fellow graduate in Bioethics from the University of Toronto. She worked as a researcher in the Gastroenterology Dept. of GMC, Trivandrum and in the Liver Clinic of Madras Medical College, Chennai.Â She retired as Deputy Director General, Senior Grade from ICMR, where she was Program Officer for bioethics, traditional medicine research, pharmacology, summer studentship for medical undergraduates. She was closely involved in the formulation of several ethical guidelines in India under the aegis of ICMR, Dept. of AYUSH & NACO. She is national & international surveyor for ethics committee for SIDCER recognition program. She has pioneered Bioethics Education in India and has been instrumental in initiating the first online PG Diploma course in bioethics in India under ICMR-IGNOU joint initiative sponsored by the NIH, USA.
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