Centre of Excellence in Regulatory Sciences (CEReS)

Overview

Establishment Year: 30th November 2022.

Need for Establishment: To bridge the gap between SME's, Regulators and academics, the Centre of Excellence in Regulatory Sciences at JSS College of Pharmacy, Mysuru was established to address the regulatory issues and propel research in regulatory sciences.

The Centre of Excellence in Regulatory Sciences has made significant strides through eCTD training, workshops, and webinars, while fostering valuable collaborations with IKP and Biocon Academy. Our initiatives also include robust support to SMEs, reflecting our commitment to advancing regulatory science and supporting the broader industry ecosystem.

Area of Research Focus

  • Development support to SMEs in collaboration with regulators
  • Nurture regulatory science / educational programs
  • Impart training to create and support regulatory submissions

Vision and Mission

  • Vision: To improve and enhance skill set in regulatory science and utilize its resources to propel regulatory profession.
  • Mission: To make available a pool of competent professionals in Pharmaceutical Regulatory Affairs with fundamental knowledge.

Key Objectives

  • To create opportunities for budding regulatory professionals
  • To build collaborative interactions to foster regulatory science communications
  • To impart training to create and submit regulatory dossiers
  • To provide a focal point for knowledge management, with the ability to capture new knowledge and best practices from the healthcare sector

Inaguration

  • Date: 30th November 2022
  • Institution/Department: Dept. of Pharmaceutics, JSS College of Pharmacy, Mysuru
  • Reporting Period: 30th November 2022 - 11th September 2024

US-FDA India Office team

Dr. Sarah McMullen, Country Director – India Office

Mr. Gregory Smith, International Relation Specialist – Drugs

Dr. Sudheendra Kulkarni, Medical Product Safety Coordinator – BIMO, Devices

Mr. Dhruv Shah Medical Product Safety Coordinator – Drugs

Key Activities and Achievements

Collaborations

  • National: IKP Knowledge Park, Bengaluru
  • National: Biocon Academy, Bengaluru
  • International: CyVidia, Chicago, USA

Number of publications in peer-reviewed journals: 140 and Conference presentations: 46

Infrastructure and Resources

Infrastructure facilities: Regulatory Studio

  • Regulatory Affairs Lab with 54 workstations, IT enabled facilities
  • PharmaReady® Software for eCTD submissions
  • 14 desktop computers with high-speed internet

Advisors

Dr. B Suresh

Pro-Chancellor
JSS AHER, Mysuru

Dr. Surinder Singh

Vice Chancellor
Ex-DCGI, Govt. of India
Ex-Director, NIB
JSS AHER, Mysuru

Dr. Bangaru Rajan

Professor
Reg. Affairs & Ex-JDC, CDSCO, New Delhi
JSS AHER, Mysuru

Faculty

Dr. T M Pramod Kumar
Principal and Professor
Dr. Bangaru Rajan
Professor
Dr. Balamuralidhara V
Associate Prof & HoD
Dr. M P Venkatesh
Associate Professor
Dr. G S Meghana
Lecturer

Centre of Excellence in Regulatory Affairs (CEReS) Expert Panel

Following drug regulatory officers from CDSCO and state regulatory officers are on the rolls as Expert in the Panel to support CEReS and its activities.

Sl. No Name of the Expert Affiliation
1 Dr. G. Selvaraj Director of Drugs control TN (Retd.)
2 Mr. M.Bhaskaran Director of Drugs control TN (Retd.)
3 Dr. Sateesh Director of Drugs control Kerala (Retd.)
4 Mr. M.N.Sridhar Joint Director of Drugs Control, TN
5 Dr. Jagashetty Drugs Controller, Karnataka (Retd.)
6 Dr. Amaresh Tumbagi Additional Drugs Controller, Karnataka (Retd.)
7 Mr. Om Prakash Sadwani Joint Commissioner FDA Maharashtra (Retd.)
8 Mr. Ananda Das Drugs controller, Odisha (Retd.)
9 Dr. Mandal Deputy Drugs Controller, West Bengal (Retd.)
10 Mr. Lalith Goel Deputy Drugs Controller, Haryana
11 Mr. Arivzhagan Deputy Drugs Controller, Delhi (Retd.)
12 Dr. Atul Nasa Drugs Controller, Delhi (Retd.)
13 Dr. Goswami Drugs controller Tiripura (Retd.)
14 Mrs. Lotika Drugs Controller, J&K
15 Mr. Salem Veljee Commissioner FDA Goa (Retd.)
16 Mrs. Jothi Sardesai CommissionerFDA, Goa
17 Mr. Mahapatra Drugs controller Odisha (Retd.)
18 Mr. Lalsawma Pachuau Drug controller Mizoram
19 Dr. Vijay Joint Commissioner, FDA Gujarat (Retd.)
20 Dr. Sella Senthil, Assistant Drugs Controller, CDSCO, New Delhi
21 Mr. R.K.Sinha Drugs Controller, Bihar
22 Mr. A.K.Jain Drugs Controller, UP
23 Dr. Ananthakrishnan Deputy drugs Controller, Puduchery
24 Mr. Hridyananda Mahanta Ex. Drug Controller, Assam
25 Mrs. Shanthy Gunasekaran JDC (I) (Retd.) CDSCO
26 Dr. Manivannan Deputy Drugs Controller, CDSCO, Bangalore Zone
27 Dr. D.Roy Deputy Drugs controller (I),CDSCO (Retd.)
28 Dr. Ramkishan Deputy Drugs Controller (I), Hyderabad
29 Dr. Adeshra EX Commissioner, FDA, Gujarat

The board of Expert committee of CEReS will give their advice/expertise in taking forward the purpose of CEReS

  • By identifying the upcoming newer areas in Pharmaceutical sciences to initiate the research in those areas
  • By giving solutions to the problems encountered by the SMEs to comply with the current GXPs
  • By collaborating with the team members of Industry and Institutions to start the Newer projects
  • Be an expert/resource person in the Training Programs / workshops/ seminars/ conferences organized for the benefit of Students, staffs and SMEs
  • To help in the preparation in Simplified Language through descriptive documents, the current Regulatory Requirements for manufacture of APIs, Finished Formulations, Biologicals, Medical Devices, IVDs and other New Drug Delivery Systems

Global Regulatory Affairs (GRA) Certificate program with Biocon Academy, Bengaluru [JSS AHER, Mysuru is the Knowledge Partner]

Biocon Academy, Bengaluru offers high quality innovative programs focussed on the Business of Biosciences with the aim to empower experienced professionals from the field of Life sciences and to develop fresh biotech graduates into Biosciences and other related professionals. They have partnered with JSS Academy of Higher Education and Research (JSS AHER) as a Knowledge Partner for conduct and delivery of Global Regulatory Affairs (GRA) program.

JSS College of Pharmacy, Mysuru, a constituent college of JSS AHER is collaborating partner with Biocon Academy (BA) for the Joint Certificate Program in Global Regulatory Affairs (GRA) titled “Biocon-JSSAHER Certificate program in Global Regulatory Affairs”. For the GRA program, JSS AHER, Mysuru is the knowledge partner and the faculty of JSS College of Pharmacy, Mysuru would deliver didactic lectures online (for 16 weeks) and impart hands-on- training (5 days) at JSSCP Mysuru to the enrolled candidates. After the successful completion of the program, candidates are awarded joint certificates from Biocon Academy and JSS AHER.

The GRA program is a 16-weeks course with 6 subject areas [Introductory/ Preparatory Regulatory Affairs, Small Molecule Regulatory Affairs (Drugs), Large Molecule Regulatory Affairs (Biologics), Clinical Regulatory Affairs, Medical Devices Regulatory Affairs, Documentation and Regulatory Approvals] relevant to global/ industrial regulatory requirements. The syllabus and content were proposed by JSSAHER, reviewed, and accepted by both parties.

Monitoring of the program: The GRA program was monitored regularly by means of monthly meetings between coordinators of Biocon Academy and JSSCP, Mysuru. Updates of the program was discussed, and any issues related was also discussed for the smooth conduct of the program. The assessment scores of the evaluation were promptly shared with Biocon Academy which gave them a platform to follow up with the students.

Hands on Training: 5 days Hands on training will be conducted at the end of the program

The following activities were conducted during the training at JSSCP Mysuru.

  1. eCTD compilation and submission
  2. electronic submissions by employee shadowing
  3. filling 356h forms
  4. CDSCO SUGAM portal
  5. training on pharmacovigilance and clinical trial activities

Evidence of Success: It is clearly evident that GRA students of all 3 batches were successfully placed in reputed pharmaceutical/ biopharmaceutical organizations in good roles.

Sl. No. Batch Number Activity dates No. of students
1. GRA Batch 1 Program: 30th Aug 2021 to 24th Dec 2021
Hands-on-training: 3rd Jan to 7th Jan 2022 		19
2. GRA Batch 2 Program: 10th Feb to 26th May 2023
Hands-on-training: 29th May to 2nd June 2023 		18
3. GRA Batch 3 Program: 12th February to 29th May 2024
Hands-on-training: 2nd June to 7th June 2024 		19

Faculty of JSS College of Pharmacy, Mysuru for Global Regulatory Affairs Program:

Sl. No. Faculty Designation
1. Dr K Bangarurajan Professor
2. Dr Balamuralidhara V Associate Professor
3. Dr H V Gangadharappa Associate Professor
4. Dr. M.P. Venkatesh Associate Professor & Coordinator - GRA
5. Dr Gowrav M P Assistant Professor
6. Dr Hemant Kumar S Assistant Professor
7. Dr Shailesh T Lecturer
8. Dr. G.S. Meghana Lecturer
Read about Course

Challenges and Opportunities

Challenges

Regulatory sciences, which encompass the development, implementation, and evaluation of policies and procedures to ensure the safety and efficacy of medical products face variety of challenges like

  • Keeping up with Rapid Technological Advances
  • Global Harmonization
  • Complexity of Data
  • Resource Constraints
  • Regulatory Flexibility and Adaptability

Addressing these challenges requires a collaborative approach, involving regulators, industry experts, researchers, academia and other stakeholders to ensure that regulatory practices evolve in line with scientific advancements and public health needs.

Opportunities

Regulatory sciences offer several opportunities to enhance public health, facilitate innovation, and improve the efficiency and effectiveness of regulatory processes.

  • Regulatory Science Education and Training: Expanding educational and training programs in regulatory sciences can build a skilled workforce capable of addressing current and future challenges. These programs can also promote interdisciplinary collaboration and innovation in regulatory practices.
  • Adaptive Regulatory Pathways: Developing and implementing adaptive regulatory pathways can accelerate the approval of innovative products
  • Integration of Advanced Technologies: The incorporation of technologies such as artificial intelligence (AI), machine learning, and big data analytics can significantly enhance the ability to predict safety issues, streamline regulatory processes, and analyze complex data sets.

Future Directions

Upcoming Projects/Initiatives

  • Centre of Excellence in Regulatory Sciences is actively engaged in organizing seminars/ symposium/ workshop/ training programs in regulatory sciences.
  • As a part of continuing educational activities, CEReS is planning to conduct 2 webinars/ seminars/ workshops in this calendar year.

Collaborative Efforts Planned

Collaborations with National and International Regulatory Agencies:

  • CEReS is actively working to collaborate with United States -Food and Drug Administration (US-FDA) to have an MoU/ MoI.
  • CEReS is focusing on strengthening our collaboration efforts with CDSCO, New Delhi to enhance regulatory processes and advance our mutual goals.
  • Centre of Excellence in Regulatory Sciences (CEReS) is expanding its collaborative activities with SMEs (Medical devices, drugs and cosmetic industries) to foster research and regulatory submissions.
  • Establishment of a robust industry-academia collaborations can bridge the gap existing in regulatory sciences and make available talented pool of regulatory professionals.

Capacity Building Programs:

  • Establishment of a robust industry-academia collaborations can bridge the gap existing in regulatory sciences and make available talented pool of regulatory professionals.
  • Centre of Excellence in Regulatory Sciences (CEReS) is expanding its collaborative activities with SMEs (Medical devices, drugs and cosmetic industries) to foster research and regulatory submissions.

Anticipated Funding Applications:

Given our plans for significant expansion in our activities, we wish to seek funding from national and international agencies to support our efforts.

Activities

IGRF (IKP Global Regulatory Forum)

Over the last 23 years, IKP Knowledge Park (IKP) has supported innovation in a multifaceted manner through more than 25 different initiatives. One of the most recent initiatives launched is the IKP Global Regulatory Forum (IGRF), which recognizes the need for regulatory support for startups. IKP established IGRF in partnership with former regulatory officials and experts to address the regulatory challenges faced by start-ups and MSMEs.

IGRF aims to assist entrepreneurs in accelerating the development and commercialisation of innovative products and technologies by reducing regulatory hurdles through effective support.

The initiative was launched on February 16, 2023, in Bengaluru, in the presence of representatives from the MSME sector, academia, startups, regulators, and government officials. At the launch event, the discussion centered around the challenges faced by regulators and business owners and how IGRF will help close those gaps.

The IKP Knowledge Park and JSS AHER agreement to promote entrepreneurs that was signed few months earlier served as the catalyst for the creation of IGRF.

The core expert committee, which will guide the activities of IGRF, was announced at the launch. The Core Experts Committee members, headed by Chairperson Dr Surinder Singh, Vice-Chancellor, JSS Academy of Higher Education & Research, and Former Drug Controller General of India, include Dr D. Roy, Ex-DDC (I), CDSCO, Govt. of India, and ex-members of state and zonal regulatory bodies, as well as experts from industry.

Objectives of IGRF

  • Support the start-ups in regulatory hurdles
  • Addressing the queries of the start-ups and providing solutions
  • Guiding abut regulatory procedures for obtaining permissions, licences etc
  • Expert Group under CEReS consisting of Serving and retired Drug control officers from State and CDSCO to support IGRF initiatives
Sl. No. Dates Activity Venue
1. 5th January 2023 Partnering with IKP Knowledge Park & JSSAHER, Mysuru Board Room, JSS AHER, Mysuru
2. 16th February 2023 Committee of experts formed to guide the Startups in Drug Regulations Launch of IKP Global Regulatory Forum (IGRF), Bengaluru Chairman: Dr. Surinder Singh, Vice Chancellor, JSS AHER Member: Dr. K. Bangarurajan, Professor, JSSCP, Mysuru Vivanta, Residency Road, Bengaluru
3. 7th July 2023 Exploratory Visit to IKP, Bengaluru by Dr. K. Bangarurajan and Dr. M. P. Venkatesh - Discussion on various collaborative aspects Read More
4. 8th July 2023 Mr. Raj Joshi, Founder and CEO, CyVydia Chicago USA, expert in Cybersecurity technologies – Discussion with JSS AHER leadership – Collaborative activities Read More
5. 23rd September 2023 CEReS Expert Committee Meeting: Online discussion/ interaction with the expert committee members JSS College of Pharmacy, Mysuru
6. 19th June 2024 Exploratory visit to “Wifiltronics and Glowtronics” Mysuru forRegulatory support and collaborative activities Read More
7. 29th July 2024 Exploratory visit: Biological E Limited, Hyderabad for Capacity building and continuing education activities Read More
8. 30th July 2024 Exploratory visit: IKP Knowledge Park, Hyderabad for Regulatory support and collaborative activities IKP Knowledge Park, Hyderabad

Association with universities Abroad

Title: Knowledge, Education and Training in Regulatory/Compendial Science Advisory Group

Introduction: United States Pharmacopoeia (USP) along with US universities and JSS University has come out with the idea of offering knowledge, education and training in Regulatory/Compendial Sciences.

Objectives: The purpose of the Consortium is to advance global approaches to facilitate education and training in regulatory and compendial sciences. These approaches will necessarily require understanding and maintenance of a strong and rapidly evolving knowledge base. Beneficiaries of the Consortium will include but not be limited to members and their institutions, students of regulatory and compendia sciences in academia, regulatory agencies, pharmaceuticals manufacturers, and allied bodies.

Context: The Consortium is a volunteer, consensus-based group of member organizations who work to advance their own interests in cooperation with mutually beneficial interests of the Consortium. There is no intent to incorporate or to build governance/ legal responsibilities. Instead, the Consortium is advanced as a forum to promote information exchange and collaborative activities that are mutually beneficial to members and to stakeholders with interest in the general topics. Specifically, the Consortium will not interfere with or otherwise disturb any individual mandates, requirements, or responsibilities of participating members. Information and materials coming into the Consortium will be freely given with the expectation that it will appear publicly and thus should not intrude in member intellectual, academic, or other interests.

Practice: The Consortium will meet typically by phone/Webex at quarterly intervals and/or face to face, or more often as needed. These meetings can occur in advance of a Webex seminar with featured speakers with allied instructional materials provided or recommended by the Consortium. The seminars will form the primary offering of the Consortium. No plans exist now to confer degrees or certificates, although the latter may be contemplated, beginning possible with certificates of attendance. The Consortium can work as a Steering Committee with Working Groups, depending on member interest and capability to provide volunteer support, which is expected to be minimal. Each meeting of the Consortium and associated Seminar will be led by a chair on a rotating basis.

Member Universities / Associations:

  • Albany Medical College
  • American Association of Colleges of Pharmacy
  • American Association of Pharmaceutical Scientists
  • Drug Information Association
  • International Pharmaceutical Association
  • Johns Hopkins University
  • JSS University (India) [now JSS AHER, Mysuru]
  • Keck Graduate Institute
  • Massachusetts College of Pharmacy
  • Northeastern University
  • St. John's University
  • Temple University
  • University of Florida
  • University of Georgia
  • University of Pittsburgh
  • University of Southern California
  • University of Virginia
  • U.S. Pharmacopeial Convention

Capacity building of Regulatory Officers

Capacity building of Indian Drug Regulatory Officers

JSS AHER provided a platform for Drug Regulatory Officers serving the Central and State Governments to further enrich their Knowledge by enrolling in Regulatory Affairs programs offered by the University.

M. Pharm extended program was devised specially for Regulatory Officers

2 years M. Pharm RA program is offered as 3-years program for regulatory officers

First batch of Regulatory Officers joined the program in 2012

Every academic year 2-3 officers took part in the program

Regulatory officers also pursued PhD program at JSS AHER

State-wise mapping of Regulatory Officers who have pursued their higher studies at JSS College of Pharmacy, Mysuru

Drug Regulatory Officers with M. Pharm Programme

Sl.no Name of the Student Designation Status
1. Mr. Amaresh Tumbagi Deputy Drug Controller, Karnataka Awarded
2. Mr. Ravi S Menon Drugs Controller, Kerala Awarded
3. Mr. John K J Assistant Drug Controller, Kerala Awarded
4. Mr. Jayant Kumar Zonal Head, CDSCO, Ahmedabad Awarded
5. Mr. Dharmesh Bigoniya Assistant Drug Controller, Madhya Pradesh Awarded
6. Mr. Saju John Assistant Drug Controller, Kerala Awarded
7. Mr. Jayan P M Assistant Drug Controller, Kerala Awarded
8. Mr. Krishna Kumar Baradwaj Drug Inspector, New Delhi Awarded
9. Mr. Prakash Babu Deputy Drug Controller, Kerala Awarded
10. Mr. Martin joseph Drugs Controller, Kerala Awarded
11. Mr. K. Narendran Assistant Drug Controller, Chennai Awarded
12. Mr. Yogesh Shelar Assistant Drug Controller, New Delhi Awarded
13. Mr. Sidarth Sahai Malhotra Drug Inspector, New Delhi Awarded
14. Mr. Parag Bhushan Gautam Drug Inspector, New Delhi Awarded
15. Mr. Shashi Paul Drug Inspector, New Delhi Awarded
16. Mr. Sanjay Kumar Agarwal Drug Inspector, New Delhi Awarded
17. Mr. Manmohan Taneja Drugs Controller, Haryana Awarded
18. Mr. Satya Naryan Saini Drug Inspector, Assam Awarded
19. Mr. Guru Charan Singh Assistant Drugs Inspector, Ahmedabad Awarded
20. Mr. Biswajeet Dasgupta Assistant Drugs Inspector, Patna Awarded
21. Mr. Mukesh Kumar Assistant Drugs Inspector, CDSCO, NewDelhi Awarded
22. Mr. Ravindra Kumar Sinha Drugs Controller, Bihar Awarded
23. Mr. Sandeep Hooda Drug Inspector, Ahmedabad Awarded
24. Mr. SPN Singh Assistant Drugs Inspector, CDSCO, New Delhi Awarded
25. Mr. Sunil Chaudhary Assistant Drugs Controller, Chandigarh Awarded
26. Mr. Virendra Singh Drug Inspector, New Delhi Awarded
27. Mr. Sandeep Sah Drug Inspector, Bihar Awarded
28. Mr. Ashok Kumar Yadav Drug Inspector, New Delhi Awarded

Drug Regulatory Officers enrolled for Ph.D.

Sl.no Name of the Student Designation Status
1. Mr. Suresha M Assistant Drug Controller, Karnataka Awarded
2. Mr. Nagaraja Assistant Drug Controller, Karnataka Awarded
3. Mr. Umesha Deputy Drug Controller, Karnataka Awarded
4. Mr. Sreekumar K Deputy Drug Controller, Karnataka Awarded
5. Mr. Kempaiah Suresh Assistant Drug Controller, Karnataka Awarded
6. Mr. Bhaskaran Assistant Drug Controller, Karnataka Awarded
7. Mr. Mallikarjun Nagar Drug Inspector, Karnataka Ongoing
8. Ms. Mahalakshmy. R Drug Inspector, Karnataka Awarded
9. Ms. Moni Veena G Drug Inspector, Kerala Awarded
10. Mr. Nishith M C Drug Inspector, Kerala Awarded
11. Mr. Amaresh Tumbagi Deputy Drug Controller, Karnataka Awarded
12. Mr. Jayanth Deputy Drugs Controller, CDSCO, New Delhi Awarded
13. Ms. Mahalakshmi Drugs Inspector, Kerala Awarded

Training program for Ethiopian Food and Drugs Authority / International Regulators:

Sl. No. Dates Activity
1. 9th to 21st December 2023 10 days training program for Ethiopian Food and Drugs Authority (EFDA) officers on “Medical Device Regulations and Quality Control of IVDs and Analysis of PCR and ELISA system to evaluate RDT performances” Read more
2. 3rd to 11th June 2024 10 days training program for Ethiopian Food and Drugs Authority (EFDA) officers on “Pharmaceutical and Vaccine Manufacturing” Read more

Collaboration with NAM S&T

NAM S&T Centre Monograph on "Generic Drugs"

The Centre for Science and Technology of the Non-Aligned and Other Developing Countries (NAM S&T Centre) is an Inter-governmental Organization which was set up in 1989 in New Delhi, India in pursuance of the recommendations in various NAM Summits. It is a diplomatic entity and presently has 47 Member Countries from the African, Middle Eastern, Asian, Latin American and European Regions.

In order to accomplish its objectives, the Centre holds several International Workshops, Training Programmes and Training Courses on various S&T subjects, undertakes bilateral and multilateral collaborative projects and offers short-term fellowship programmes in partnership with S&T institutions/agencies and Centres of Excellence (CoE) in various countries. Also, the Centre has brought out 94 publications, including 77 technical books, 10 workshop proceedings, 3 Monographs and 4 other publications.

The NAM S&T Centre has recently initiated a programme of publishing a series of Monographs on selected S&T areas that are of significant importance and relevance to the developing world. The main idea is to bring out comprehensive scientific documents written by experts in the respective fields that would be of use to the scientists, technologists, government officials and policymakers in the Member Countries of the NAM S&T Centre as well as other stakeholders from the developing world.

As a part of this initiative, NAM S&T have recently started the process of publishing a Monograph on "Generic Drugs".

  • Dr. K. Bangarurajan, Professor (Regulatory Affairs), JSS College of Pharmacy, JSS AHER, Mysuru; and Former Joint Drugs Controller (India), CDSCO, New Delhi, India Corresponding Editor for this Monograph Project.
  • Dr. Subhash Malghan, Ex-Deputy Director, CDRH, US-FDA as the Co-editor
  • Dr M P Venkatesh, Associate Professor, JSS College of Pharmacy, Mysuru as Co-editor

The NAM S&T Centre will take the responsibility of getting the book published through one of the leading international publication houses.

The details of the Monograph and authors are tabulated:

Sl. No. Author’s Name and affiliation Title of Chapter
Section 1: Science, Technology and Innovation
01 Dr. Shashi Bala Singh,
Former Director,
NIPER, Hyderabad, India 		Science of Generic Drugs
02 Dr. V. Ravichandran,
Director,
NIPER, Kolkata, India 		Technologies for manufacturing Generic Drugs – Biosimilars
03 Dr. Bobby George,
Vice President & Group Head,
Regulatory Affairs at Reliance
Life Sciences Pvt. Ltd., Mumbai,
Maharashtra, India 		Bio Similar Concepts
04 Dr. Vikas Jain,
Associate Professor,
JSSCP, Mysuru,
Karnataka, India 		Innovations in Generic Drugs Manufacturing
05 Dr. M P Gowrav/
Mr. Manohar SK
JSS College of Pharmacy (JSS CP),
JSS AHER, Mysuru,
Karnataka, India 		Technologies for manufacturing Generic Drug Industries
06 Dr. Rafik Karaman,
Pharmaceutical Sciences Department,
Faculty of Pharmacy,
AI- Quds University,
Jerusalem, Palestine 		Commonly used Generic Antibiotics- Uses, Mechanism of Action and Bacterial Resistance
07 Dr. Sanjay Kumar Dey,
Laboratory of Structural Biology of Membrane Proteins,
Dr B R Ambedkar Center for Biomedical Research, University of Delhi, India 		Biochemical research driving generic Drug discoveries
Section II: Globalization and Generic DrugMarket
08 Dr. Bindu Ajit,
Program Dean,
Biocon Academy, Bengaluru, Karnataka, India 		Generic drugs: Status and Perspectives from Developing Countries for Non- aligned Movement Science &Technology(NAMS&T)
09 Dr. B S Keenoo,
Lecturer, Department of Medicine, Faculty of Medicine and Health Sciences, University of Mauritius, Réduit, Mauritius 		Enhancing Cost- Effective Health Delivery Systems in Developing Countries through the Utilization ofGenericDrugs
10 Dr. D Roy,
Ex.DDC(I), CDSCO,
New Delhi, India 		India - The Pharmacy of the World: Status of Generic Drugs IndustryinIndia
Section III: Regulations, Policies and Socio-economicImpacts
11 Dr. Subhas Malghan,
Former Deputy Director,
Office of Science & EngineeringLabs,
Center for Devices and Radiological Health (CDRH)
U.S. FoodandDrug Administration, Washington, D.C., USA 		Impact Of Generic Drugs in Medical Insurance and Government Policies in the USA
12 Dr. Ramkishan,
DDC(I),
CDSCO, Hyderabad Zone,
Hyderabad, India 		Policies and Regulatory Frameworks for
Development, Clinical Trials and Approvals of Generic Drugs in India
13 Mr. Sadeck Vawda,
Unicorn,
Mauritius 		Generic Drugs- Regulatory Perspective in Mauritius
14 Dr. Gopakumar Nair,
Founder,
Nair Associates,
Mumbai, India 		Implications of Current Patent Regime under TRIPS on Generic Drug Industry
15 Dr. Vidushi S Neergheen,
Director of Doctoral School,
University of Mauritius,
Réduit, Mauritius 		The Role of Biosimilars in Enhancing Healthcare Affordability
Section IV: Quality Control and Standardization
16 Dr. S. Ravisankar,
Vice President,
CPB Wockhardt Ltd.,
Aurangabad, India 		Methods for Evaluating Bioequivalence of Generic Drugs vis-a-vis Original Drugs
17 Dr. K Bangarurajan, Dr. Subhas K Malgan and Dr. M P Venkatesh
(Editors) 		Epilogue
18 Prof. Dulal Panda,
Director, National Institute of
Pharmaceutical Education and
Research (NIPER),
Mohali, Punjab, India 		Contribution of NIPER towards growth of generic pharmaceutical industry in India
19 Prof. Dr. Ashish D Wadhwani,
Head, Faculty of HealthSciences& Dean, School of Pharmacy, JSS Academy of Higher Education and Research, Mauritius 		Generic Drugs: Effectiveness,
Utilizationand Future in Global South

The proposed Book chapter is scheduled to be released by the end of 2024.

Activities

Outreach and Community Engagement

Detail any outreach activities conducted by the CEReS that contribute to societal impact or collaborations with industry, academia, or the public sector.

Workshops/Seminars/Conferences

Sl. No. Dates Activity Venue
1. 3rd March 2023 Seminar on “Medical Devices Rules 2017 and Software as medical Device” Read More
2. 6th March 2023 Invited talk from Dr Subash Malghan, Ex-Deputy Director CDRH, USFDA Read More
3. 19th April 2023 Seminar on ‘Licensing procedure of Fixed Dose Combinations & Need for FDC’s in Patients Health care’ Read More
4. 20th April 2023 Seminar on “Regulatory Pathway for software as Medical device (SaMD)” In association with IGRF, Bengaluru IKP Knowledge Park, Bengaluru
5. 18th May 2023 Expert talk by Dr Jagashetty, Core Committee member of Expert Panel of CEReS JSS College of Pharmacy, Mysuru
6. 24th May 2023 Expert talk by Dr. Gerald Dal Pan, Director of the Office of Surveillance and Epidemiology, CDER, US-FDA on “Overview of post marketing drug safety” Read More
7. 5th August 2023 Webinar titled “Recent updates on IVD Regulation and Business and Employment Opportunities in IVD’s” Read More
8. 26th August 2023 Webinar titled "Global Medical Device Regulations & Health Care Application of medical devices" Read More
9. 11th September 2023 Expert lecture by Mr. A Dhavaraj Soloman Head – International Regulatory Affairs, Himalaya Wellness Company, Bengaluru “Emergence of Regulatory Affairs as a powerful function in the modern Pharmaceutical Industry” Read More
10. 22nd March 2024 Expert lecture by Dr. Jayant Kumar, Deputy Drugs Controller (India) CDSCO, West Zone, Mumbai on “Regulatory Expectations for Quality Compliance - Proposed Revision Of Schedule M” Read more
11. 6th April 2024 One-day symposium on “GMP Compliances and export/import opportunities – Regulator’s View” Read more
12. 31st August 2024 Webinar on “Indian Drug Regulations and Regulatory Compliance” Read more

International Conference of Drug Regulatory Authorities

The International Conference of Drug Regulatory Authorities (ICDRA) has brought together regulatory authorities from WHO Member States to strengthen collaboration and develop international consensus on regulatory priorities. ICDRA provides a unique forum to support and guide regulatory authorities, WHO and international stakeholders in confronting the challenges and highlighting the opportunities of today’s dynamic and innovative regulatory sector.

Delegates from regulatory authorities around the world will participate in an event programme designed to evoke ideas and discussion on the current key priorities in the regulatory environment while also ensuring valuable engagement with leading stakeholders across industry, research as well as healthcare professionals in the open pre-ICDRA conference.

ICDRA will facilitate focused discussions on quality issues, regulatory reforms and strengthening regulatory systems, safety of medical products, detection, prevention and response to substandard and falsified medical products, access to quality medical products, smart regulation of clinical trials, regulatory collaboration, harmonization, rationalization and reliance, access to new and novel technologies, regulation of novel medical products, regulation of herbal medicines.

30-01-2025

The theme for this year’s ICDRA conference: “Smart Regulation: Delivering Quality Assured Medical Products for All” scheduled from 14th to 18th October 2024 at New Delhi.

Faculty from JSS College of Pharmacy, Mysuru will be participating in the said event to showcase about the institution and the university to the delegates and interested parties. Aim is to network and collaborate with national and international agencies/ industries to further propel the objectives of CEReS.

Read More

Important Visitors to CEReS

Dr. Thomas Mathew, USFDA India Office Director visited CEReS and interacted with the faculty and students at JSS College of Pharmacy, Mysuru during Dec 2015