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Swayam Central

Current regulatory requirements for conducting clinical trials in India for investigational new drug/new drug (Version 2.0)

By Prof. Arun B.Ramteke, Prof. Sucheta Banerjee Kurundkar, Prof. Nandini K Kumar, Prof. Y. K. Gupta, Prof. D. K. Sable, Prof. Rubina Bose, Prof. Vishnu Rao   |   Consultant Regulatory Affairs, CDSA, THSTI, DBT; Former Joint Drugs Controller, CDSCO, Director Training, CDSA, THSTI, DBT, Former Deputy Director General (Senior Grade), ICMR; Adjunct Faculty, CDSA, THSTI, DBT, CDSA,THSTI,DBT, Assistant Drugs Controller of India at Central Drugs Standard Control Organisation (CDSCO), Ministry of Health & Family Welfare, Government of India., Deputy Drugs Controller of India, West Zone, Central Drugs Standard Control Organisation (CDSCO), Ministry of Health & Family Welfare, Government of India., Director, CTRI, NIMS, ICMR
As prescribed by the Drugs and Cosmetics Act 1940 and thereunder, it is pre-requisite for anyone to know about the current regulatory requirements prior to carrying out any clinical trial or before getting involved in new drug development or research for the purpose of seeking regulatory approval in India. In recent years there have been many changes/amendments in the clinical trial/new drug approval rules and regulations in India. It is important to know the right information as regulations can be misinterpreted. This knowledge when disseminated by the regulators themselves along with subject experts and experienced trainers, will have profound impact. Being an online course, it will address a larger section of public. Making it a ‘free course’ will allow many to acquire the knowledge at the comfort of their home without paying any money. 

Version 1.0 of this online course was launched in early 2019 with 12 lectures as a four-week course. This online course (version 1.0) was attended by 1047 participants (Jan - Mar 2019). The release of the New Drugs and Clinical Trials (NDCT) Rules, 2019 on March 19, 2019 has steered a need to revise this online course as version 2.0 so that it can be updated with the recent advancements in regulatory knowledge. A series of brainstorming sessions were conducted by CDSA with CDSCO for incorporating the new updates, the feedback received (version 1.0 participants). Also, the deliberations from various face-to-face programs that were conducted by CDSA and inputs from the interactive session on NDCT Rules conducted by CDSA with CDSCO were incorporated to decide upon the contents of version 2.0. This course now has 24 lectures spread over a period of 8 weeks. This course also involves 8 weekly assignments and a final exit assessment. The exit assessment and weekly assignments are optional in nature. Only those who are willing to take certification exam by paying fees, can opt for this. 

The course like version 1.0 is developed under the guidance of Shri A. B. Ramteke, Former Joint Drugs Controller (India) and presently Consultant, Regulatory Affairs at CDSA, THSTI, DBT along with CDSCO and subject experts. Few subject experts and trainers are invited to take 3-4 lectures to enrich the course. For example, CTRI lecture was taken by CTRI, ICMR. This course attempts to explain in simple language the fundamentals of current regulatory requirements for conducting clinical trials in India for investigational new drug (IND)/new drug.

TARGET AUDIENCE  : The course is suitable for those involved in:
Clinical trial and new drug development (R & D/manufacture/import) including investigators, regulatory affairs personnel, human ethics committee members, clinical trial team members/researchers, and any other person interested in this area;
Industry (pharma, biotech, contract research organization, etc.); Academia

PRE-REQUISITES Indian nationals working in this area are encouraged. There is no pre-requisite to undertake this course. It is suitable for personnel with scientific/medical background (BSc/MSc/PhD/B Pharm/M Pharm/BAMS/BHMS/BDS/MDS/MBBS/MD/DM). Personnel working in the area of drug development/clinical trials/research may benefit from this course.

INDUSTRY SUPPORT :Pharmaceutical companies, Research/Academic Institutions, Biomedical research organizations, Regulatory authorities, Medical colleges, Contract research organizations



Learners enrolled: 447

SUMMARY

Course Status : Upcoming
Course Type : Elective
Duration : 8 weeks
Start Date : 27 Jan 2020
End Date : 20 Mar 2020
Exam Date : 29 Mar 2020
Enrollment Ends : 03 Feb 2020
Category :
  • Multidisciplinary
  • Level : Undergraduate/Postgraduate
    This is an AICTE approved FDP course

    COURSE LAYOUT

    Week 1 :  Lecture 1: Introduction to Indian regulatory system
    Lecture 2: Introduction to D & C Act and Rules thereunder 
    Lecture 3: Brief about NDCT Rules 2019 

    Week 2 :  Lecture 4: Pre-clinical data requirements
    Lecture 5: Rules governing clinical trials
    Lecture 6A: Phases of clinical trial, forms and fees 
    Lecture 6B: Regulatory pathway & data requirements for NDCT, 2019

    Week 3 :  Lecture 7: BA/BE study and study centres
    Lecture 8: BA/BE guidelines
      Lecture 9: EC registration /re-registration

    Week 4 :  Lecture 10: Ethical considerations
    Lecture 11: Good Clinical Practice Guidelines
      Lecture 12: Requirements for import/manufacture of new drug/IND

    Week 5 :  Lecture 13: Important issues
    Lecture 14: Special concern
    Lecture 15: Clinical trial related Guidelines

    Week 6 :  Lecture 16: Content of proposed protocol 
      Lecture 17: Content of CT report
    Lecture 18: Post-marketing assessment and clinical trial compensation 

    Week 7 :  Lecture 19: Common observations during submission of CT protocol
    Lecture 20: Common observations during CT /EC site
    Lecture 21: New Drug development & discovery

    Week 8 :  Lecture 22: Salient feature of NDCT 2019 (What's new in NDCT)
      Lecture 23: Online submission [Part-1: SUGAM and Part-2: CTRI]
    Lecture 24: Tables given in NDCT and its content

    BOOKS AND REFERENCES

    Drugs & Cosmetics Act and Rules, New Drugs and Clinical Trial Rules, 2019, Related Guidance documents available at CDSCO and ICMR websites.

    INSTRUCTOR BIO

    Prof. Arun B.Ramteke

    Consultant Regulatory Affairs, CDSA, THSTI, DBT; Former Joint Drugs Controller, CDSCO
    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 (INDs, ANDAs). He has strong skills in quality assurance management, regulatory oversight of clinical trials, development of SOPs and guidelines and involvement in drug rules amendments. As an expert he has attended various national and international training workshops and meetings on drug regulations. He has contributed to preparation and implementation of Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and Good Manufacturing Practice. He works as an Expert to the Pharmacovigilance Program, GCP Training and Inspections of CROs in India. He has been working as Consultant and Faculty at Clinical Development Service Agency (CDSA), Department of Biotechnology, Govt. of India since April 2012. He is primarily involved in training workshops of GCP, Ethics Committee and other regulatory topics.


    Prof. Sucheta Banerjee Kurundkar

    Director Training, CDSA, THSTI, DBT
    Dr Sucheta Banerjee Kurundkar has joined CDSA as Director Training in 2012. She has 21+ years of experience in research and CRO Industry. She is involved in training, quality assurance (pre-clinical, clinical & medical labs) & regulatory affairs. She is a GLP Trainer (WHO); GCP Trainer; GCLP Trainer; Auditor for NABL (ISO 15189, ISO 17025), ISO 9001:2015 and NABH standards. Sucheta is NABL Assessor (ISO 17025) and NABH Assessor (Ethics Committee under clinical trial accreditation program) & SIDCER (WHO) Survey Trainee. She is a Visiting Faculty to Bureau of Indian Standards & National Institute of Training for Standardization. Sucheta obtained her PhD in Biochemistry from 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 the recipient of CSIR International Travel Award. She has MBA with a specialization in Total Quality Management from Sikkim Manipal University and Management Development Programme from IIM, Ahmedabad (IIMA). She was an International Program Committee member of IIMA (2015-18). Professionally trained in ‘Management of Training’ from Institute of Secretariat Training and Management, she has steered >130 training programs with national experts, DBT, DST, CDSCO, ICMR & QCI across 50+ Indian cities covering >12000+ participants, >2000+ institutions at CDSA. She is a reviewer of 11 international journals of repute. Sucheta is working to develop e-learning programs on regulations, GCP and ethics. She is an Advisory Group Member to WHO-ICMR-NIE e-course for Indian Ethics Committees (e4IEC). She was involved in India’s first Comprehensive National Nutrition Survey by UNICEF as a Team Leader for monitoring of biological samples at CDSA (2016-18). She is involved in the revision of GCLP guidelines (ICMR, DHR) and is a visiting faculty to ICMR, DHR; NABH, QCI and CDTL, CDSCO. She is presently engaged with National Medicines Regulatory Authority, Sri Lanka and NABL, International for Laboratory quality management and lab accreditation respectively.


    Prof. Nandini K Kumar

    Former Deputy Director General (Senior Grade), ICMR; Adjunct Faculty, CDSA, THSTI, DBT
    Dr. Nandini K. Kumar completed her MBBS and Post Graduate Diploma in Clinical Pathology from GMC, Trivandrum, and is a Fogarty Fellow graduate in Bioethics from 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. 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. She is a member of international panel of ‘President Obama's Commission for the Study of Bioethical Issues’, Advisory Council of Drug Information Association, India, and other nationally important committees. Presently, she is Dr. TMA Pai Endowment Chair and Adjunct Professor in Bioethics, KMC, Manipal University, and consultant for bioethical issues and traditional medicine research in India and abroad. She has publications in these areas and is also a reviewer for national and international journals for the same. She is an Adjunct Faculty at CDSA and PSG Institute of Medical Sciences and Research. She is the recipient of ISCR Lifetime Achievement Award 2015.


    Prof Y. K. Gupta retired as the Dean (Academics) of All India Institute of Medical Sciences (AIIMS), New Delhi in May 2018. He was also the Professor and Head, Department of Pharmacology at AIIMS, New Delhi. Dr. Gupta is now the Principle Adviser (Projects) at THSTI, DBT where he mentors and steers many activities at CDSA. He is also the CG Pandit National Chair at ICMR. Dr. Gupta chairs the expert committee, which is revising GCP Guideline for CDSCO presently. Dr. Gupta completed his M.B.B.S & M.D Pharmacology from KMC, Lucknow. He earlier served as Sub Dean, A.I.I.M.S (1996 – 2001) & Director, Indian Institute of Toxicology Research (IITR, CSIR) (2003-05). He was In charge of National Poison Information Centre & National Scientific Co-coordinator of Pharmacovigilance Program of India (PvPI). He has been honoured with Fellowships of 8 National Scientific bodies (FAMS, FNASc, FIPS, FNASc, FIAN, FST, FAEB, FIACS). He has more than 230 publications in International & National journals with total impact factor of over 780, among which 50 publications are on herbal drugs. He has several chapters in books to his credit. Dr Gupta is recipient of several awards. He is currently President of Society of Toxicology; Dean, Indian Society for Rational Pharmacotherapeutics; IPS President (2005-06); Editor of Indian Journal of Physiology & Pharmacology (1999-2011); Editorial Board member of several International & Indian Journals. He is Chairman of National Committee of IUPS-IUPHAR of INSA; Member, IUPHAR – IOSP Committee; Ex-member of ACSoMP of WHO (2009-12); Chairman of Equivalence Committee & Member of Ethics Committee of MCI (2011-13). He has been member of Project Advisory Committee; Research Council; Scientific Advisory Committee & Task force Member of CSIR, ICMR, DST & DBT; Chairman, SAC of NIOH-ICMR. He is Chairman of National GLP Technical Committee, Member, Scientific Body of Indian Pharmacopoeia (IP); Chairman of Expert Committee on Clinical Medicine & Pharmacology of IP. He was Governing Body member of IGPIMER, Patna; Chairman of National Essential Medicine List Committee (2011); Chairman of the working group of Inter-Ministerial Coordination Committee to look into the matters of implementation Government commitment to provide quality medicine at affordable prices.


    Dr Dhananjay Sable is presently working as Assistant Drugs Controller of India at Central Drugs Standard Control Organisation (CDSCO), Ministry of Health & Family Welfare, Government of India. He obtained M. Pharm from KMK College, (Mumbai University) and PhD from RK University (Gujarat). Dr Sable worked in various private industries as Assistant chemist/chemist. He also worked in the capacity of Principal of Pharmacy College at Nanded (Maharashtra). He Joined CDSCO as Drugs Inspector (in 2010). He qualified two times in MPSC (Maharashtra Public Service Commission) exams and selected for the post of Drugs Inspector and for the post of Assistant Commissioner, FDA, Maharashtra. He also qualified twice in UPSC for the post of central Government as Drugs Inspector and as Assistant Drugs Controller of India. As an Inspector he audited more than 150 national/multinational pharmaceutical industries many of Blood banks, CROs, Ethics committee, clinical trial sites across the India. He has been involved in reviewing application which pertains to medical devices, clinical trial, new drugs, IND, GCT, SND, and FDC for its approval. Dr Sable participated in more than 100 meetings of NDAC/SEC (new drug advisory committee/SEC) for approval of clinical Trials/New Drug/Medical Devices. He also attended more than 50 GCP/GLP/GMP workshops, training, and seminars. He was appointed as a member of, New Drug and Clinical Trial Rules, 2019 drafting committee by Govt. of India. He attended world conferences related to Clinical trials at International level such at Geneva, Tokyo. Dr Sable delivered lectures at many of the colleges and universities at Mumbai, Delhi, Gujarat, Hyderabad and in national workshops organized by CDSA.


    Prof. Rubina Bose

    Deputy Drugs Controller of India, West Zone, Central Drugs Standard Control Organisation (CDSCO), Ministry of Health & Family Welfare, Government of India.
    Dr Rubina Bose, Doctor of Pharmacy from Jadavpur University has more than 20 years of experience in regulation of medical products in Central Drugs Standard Control Organisation, MHFW, GOI and is presently working as Deputy Drugs Controller (India) . She has worked in areas of new drugs, clinical trial, import registration, vaccines, GMP, GCP, GLP inspections, QMS in CDSCO. Worked as technical officer in the vaccine prequalification team of WHO in Geneva and has been part of various national and international workshops as trainer of WHO within the country and abroad.


    Dr. M. Vishnu Vardhana Rao is the director of the National Institute of Medical Statistics (NIMS), Indian Council of Medical Research, New Delhi. He is basically a trained mathematical statistician and data scientist.

    COURSE CERTIFICATE

    • The course is free to enroll and learn from. But if you want a certificate, you have to register and write the proctored exam conducted by us in person at any of the designated exam centres.
    • The exam is optional for a fee of Rs 1000/- (Rupees one thousand only).
    Date and Time of Exams: 29th March 2020, Morning session 9am to 12 noon; Afternoon Session 2pm to 5pm.
    • Registration url: Announcements will be made when the registration form is open for registrations.
    • The online registration form has to be filled and the certification exam fee needs to be paid. More details will be made available when the exam registration form is published. If there are any changes, it will be mentioned then.
    • Please check the form for more details on the cities where the exams will be held, the conditions you agree to when you fill the form etc.

    CRITERIA TO GET A CERTIFICATE:
    • Average assignment score = 25% of average of best 6 assignments out of the total 8 assignments
     given in the course. 
    • Exam score = 75% of the proctored certification exam score out of 100
    • Final score = Average assignment score + Exam score

    YOU WILL BE ELIGIBLE FOR A CERTIFICATE ONLY IF AVERAGE ASSIGNMENT SCORE >=10/25 AND EXAM SCORE >= 30/75. 
    • If one of the 2 criteria is not met, you will not get the certificate even if the Final score >= 40/100.
    • Certificate will have your name, photograph and the score in the final exam with the breakup.It will have the logos of NPTEL and IIT Madras. It will be e-verifiable at nptel.ac.in/noc.
    • Only the e-certificate will be made available. Hard copies will not be dispatched.

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