Friday, April 28, 2017

8th Annual Clinical Trials Summit 2017

“A critical guide for successfully conducting clinical trials”
24th May 2017, Kohinoor Continental Hotel, Mumbai, India

Media Partner LSW LifeScienceWorld


Hope all is well

I am happy to invite you and your colleagues to be a sponsor/ delegate for our upcoming “8th Annual Clinical Trials Summit 2017”. The conference will be held on 24th May 2017, Kohinoor Continental Hotel, Mumbai, India.


  • K. BANGARURAJAN, Deputy Drugs Controller (India), CDSCO
  • RAJENDRA H. JANI, Advisor/ Independent Subject Expert, Zydus Cadila
  • ARUN BHATT, Consultant – Clinical Research & Development
  • SUMIT MUNJAL, Medical Director Lead, Global Medical Safety, Head of Mature Established products, Takeda Pharmaceuticals (UK)
  • VIVEK GUPTA, Worldwide VP, Acceliant
  • MANMOHAN SINGH, APAC Regional Medical Director, Pfizer
  • YASMIN SHENOY, Director-Regulatory Affairs, Sanofi
  • SRIRUPA DAS, Associate Director-Medical Affairs, Abbott
  • CHIRAG TRIVEDI, Director & Head of Clinical Study Unit, Sanofi
  • TAPANKUMAR M. SHAH, Country Head-Site Management & Monitoring, AstraZeneca
  • EMRAN KHAN, Head-R&D Outsourcing Services Procurement, Cipla
  • MUKESH KUMAR, Global Head-Clinical Management, Dr. Reddy’s Laboratories
  • SHILPA RAUT, Regional Training Head-Asia, Middle East and Africa Cluster, Novartis
  • NARESH TONDARE, Head-India and Nepal Regulatory Affairs, Glenmark Pharmaceuticals
  • ARUNKUMAR S, Functional Lead, Acceliant
  • MILIND ANTANI, Partner In-Charge-Pharma LifeSciences, Nishith Desai Associates
  • JYOTSNA PATWARDHAN, Head Development QA, Novartis
  • ABHAY PHANSALKAR, Head Clinical Trials, Cipla
  • PRAVIN GHADGE, Head-Medical Writing & Pharmacovigilance, Reliance Life Sciences

Plus Many More..


CEO’s, CTO’s, CIO’s, Presidents, Vice Presidents, Directors Heads & Managers of:

Clinical Research & Development, Clinical Research Services, Clinical Operations, Clinical Data Management, Clinical IT, Clinical Trials, Medical Affairs, Regulatory Affairs, Compliance, Quality control / Assurance/GCP, Clinical Study Design, Safety Surveillance, Subject Recruitment, E-Clinical Systems.


  • Standard Price – 1 or 2 Delegates – (INR 8,000 + Tax (15%) per delegate)
  • Group Discounts – 3 or 4 Delegates – (INR 7,000 + Tax (15%) per delegate)
  • Group Discounts – 5 and above Delegates – (INR 6,000 + Tax (15%) per delegate)
  • Conference Sponsor & Exhibition Stall – We also have sponsorship opportunities available for the event which gives you an opportunity to speak/exhibit and create brand awareness. In addition, the networking opportunities in focused and relevant industry gathering provide the personal contact necessary for business development efforts. So kindly let me know if you would be interested in sponsorship packages for speaking opportunity or exhibiting at the conference, you can simply email your interest and queries to TEL: +91 44 65515695, +91 9940043915 or


In order to register you can simply email me your invoice details in the below mentioned format;

Company Name & Address:

Attendee Name:

Job Title:

Contact Number:

Should you and your colleagues wish to participate as our delegate kindly let me know on the same and I can help you with the same.

If you require any further information then please do let me know. I look forward to hearing back from you soon.


Thanks & Regards,

R. Swetha
Sr. Marketing Manager
Virtue Insight

Tel – + 91 44 65515695; Mobile – +91 (0) 9940043915
E-Mail –

Date : 4th.Feb. 2017

Place : Bangalore

Address : Royal Orchid, Allalasandra, Yelahanka, Bangalore.

The above mentioned meeting will be jointly held between Society for Regenerative Medicine and Tissue Engineering  and School of Regenerative Medicine,University of Manipal. The joint Conveners will be Dr.S.G.A.Rao,Stem Foundation and Dr. Gopal Pande,Dean,  SORM. The meeting is supported by the Stem Foundation,Bangalore and SORM. The tentative program is as follows :

  1. Inaugural session
  2. Key note address
  3. Padma shri Dr. C.M. Habibullah Memorial Symposium
  4. .Students Session
  5. Valedictory

Contact Dr. Jyothsna A. Rao, Secretary, SRMTE at, mobile 7259028934, 080-65652220

LSW Conference titled ““Holistic approach to Cancer –An Integrated Therapy” was held on February 6, 2016 in Mumbai at The Orchid


This conference held in Mumbai on February 6, 2016 was endorsed by the Ministry of Ayush, Govt. of India. Mr.Jitendra Sharma, Joint Secretary and Dr. D.C.Katoch, Advisor, Ministry of Ayush, provided the leadership for organizing the meeting. All the different directorates under Ayush were involved and the directors participated. Eminent doctors of all the disciplines and prominent cancer researchers made presentations. Dr.Milind Antani, LSW Advisory Board Member was the Moderator for the entire proceedings.


Dr. Milind Antani starting the proceedings

Inaugural Session: Fm. L-R (Seated) Dr. D C Katoch, Advisor, Ministry of Ayush, Jitendra Sharma, Joint Secretary, Ministry of Ayush
Inaugural Session: Fm. L-R (Seated) Dr. D C Katoch, Advisor, Ministry of Ayush, Jitendra Sharma, Joint Secretary, Ministry of Ayush

The opening remarks were given by Dr.S.G.A.Rao, LSW Advisory Board member and Cancer Research Scientist. He focused on the need to approach cancer therapy in a holistic manner. The futility of treating cancer patients using a single modality such as chemotherapy was well illustrated by two cases presented by him. He advocated an integrated approach involving different systems of medicine to achieve health. He was of the opinion that eradication of disease is not the primary objective, but it is restoration of health.

IMG_6129Opening Remark by Dr. S G A Rao

Dr. Katoch, gave a detailed account of the various ayurvedic preparation available for treating cancer. He also described the contributions made by several Ayush institutions carrying out research and their contributions. His presentation was remarkable for being comprehensive and up-to-date. He described in detail the efforts put by the Ministry of Ayush in *modernizing the approach of Ayush institutions towards cancer therapies.


IMG_6136Dr. D C Katoch rendering Overview

Dr. K M Madhu
Dr. K M Madhu

The Arya Vaidya Sala, Kottakkal was represented by Dr. Madhu, Sr. Physician at the Clinical Research Department. He gave an excellent exposition of the Ayurvedic view of Cancer and described the various formulations available for its treatment.

Dr. G Sivaraman
Dr. G Sivaraman

Dr. Sivaraman, is the chief Siddha physician at the Arogya Siddha Hospital, Chennai. He gave a lucid talk on the medicine available in Siddha System for the treatment of Cancer. He made a significant point when he informed the participants that, in Western countries such as United States of America and China, an integrated approach involving traditional systems of medicine and modern system were already prevalent for treatment of cancer.

Dr. Govind Reddy
Dr. Govind Reddy

Dr. Govind Reddy, Research Officer, Podar Ayuveda Cancer Research Institute, Mumbai gave a comprehensive report on the various research programs on cancer at the Institute.

Dr. Khalid Siddiqui
Dr. Khalid Siddiqui

Dr. Khalid Mahmood Siddiqui,  Dy. Director General of Central Council for Research in Unani in his talk, detailed the research on cancer being carried out in various Unani  laboratories. He stressed the fact that in Unani system it was important to restore health.

Dr. Kumar Prabhash
Dr. Kumar Prabhash

Dr.Kumar Prabhash, Assistant Professor of Medical Oncology at the Tata Memorial Hospital, Mumbai gave an informative presentation on the evidenced based medicine for treatment of cancers. He stressed on clinical trials in the discovery process. When he was asked why he did not use an integrative approach, he made it clear that for him to use medicine from non conventional systems, there should be evidence which stands scientific scrutiny. Such evidence is possible only when controlled clinical trials are carried out and the results are subjected to statistical analysis.

Dr. Nisha Manikantan
Dr. Nisha Manikantan

Dr. Nisha Manikantan, Founder Director Sri Sri Ayurveda and head of Cancer Care Department gave an interesting and illuminating discourse on the yoga in cancer. She explained that ‘Sudershana Kriya’ is powerful means of restoring health which led to cancer cure. She recounted several cases to illustrate this point. She went on to state that, even in cases where cancer could not be cured, the quality of life was substantial.

Dr. Jyothsna Rao
Dr. Jyothsna Rao

Dr. Jyothsna Rao, Research Director, International Stem Cell Services Ltd., Bangaluru, gave a clear disposition on the immune status in Cancer. She explained the mechanisms by which cancer cells escape immune surveillance and established itself in the body of the patient and then spread to different sites. She explained the various forms of immunity which play a part in cancer. She then explained that there was enough evidence to show that surgery, radiation and chemotherapy which are the three main modalities for the treatment of cancer always resulted in substantial immunosupression. She then described methods for boosting specific and non specific immunity.

Dr. Deepali Rao
Dr. Deepali Rao

Dr. Deepali Rao, Clinical Psychologist, practicing in VIMHANS, made a very lucid presentation on the various psychological aspects which affect Cancer patients. The most asked question is, ‘Why me’. The feeling of ‘Victimhood’ is very strong in these patients, leading to severe depression. In addition several cancers are known to secrete cortisols which depress immunity and cause mental depression. Another prominent psychological trauma is caused by disfigurement due to chemotherapy or surgery. These patients need constant counseling and family support to preserve a good quality of life.

Dr. Roma Antani
Dr. Roma Antani
Dr. Anwar Amir Ansari
Dr. Anwar Amir Ansari

Dr. Roma Antani and Dr. Anwar Amir Ansari, practicing homeopathic doctors from Mumbai, gave excellent presentations to explain the importance of restoring health rather than merely eradicating the disease. They described several cases where cancer patients were cured by Homoeopathic remedies.

Dr. Zubin Phiroze Marolia
Dr. Zubin Phiroze Marolia

Dr. Zubin Marolia, a practicing Homoeopath from Mumbai, gave a presentation on the Homoeopathic use of a semi parasitic plant, viz. Loranthus, commonly known as Mistletoe in the treatment of cancer.

Mrs. Malathi A Rao
Mrs. Malathi A Rao

Mrs. Malathi Rao, a Reiki Grand Master and Emotional Freedom technique expert practicing in Hyderabad, gave a lucid presentation assisted by her daughter, who very ably gave a demonstration of the energy points in the human body. Mrs. Malati explained that disease was nothing but disturbance in the energy field, which when corrected resulted in restoration of health and cure from disease. She frankly admitted that she is unable to provide scientific explanation for the cures and would be glad collaborate with scientific experts for finding the scientific reasons.

Shri Virendra Kumar Jain
Shri Virendra Kumar Jain

Shri Virendra Kumar Jain, from Indore made an excellent exposition on the use of cow urine as a therapy for treating several diseases including cancer. He claimed that in his centre many hopeless cases including that of his mother had been cured completely.

The presentations were followed by a panel discussion Chaired by Shri Jitendra Sharma, Joint Secretary, Ministry of Ayush – distinguished panelists being the Director Generals of the 4 Central Council of Research streams, viz., Prof. Vaidya. K.S.Dhiman, Prof. Ishwara N Acharya, Prof. Ishwara Acharya, Yoga and Naturopathy, Dr. Rais Ur Rahman, Unani, Prof. R.S. Ramaswamy, Siddha, and Dr. Praveen Oberoi, Scientist,Central Council of Research, Homeopathy along with Shri Virendra KumarJain.

Below line: (From L-R) Shri Virendra Kumar Jain, Dr. Rais Ur Rahman, Prof. R S Ramaswamy, Prof. Vd. K S Dhiman, Shri. Jitendra Sharma, Dr. Ishwara N Acharya and Dr. Praveen Oberai.
(From L-R) Shri Virendra Kumar Jain, Dr. Rais Ur Rahman, Prof. R S Ramaswamy, Prof. Vd. K S Dhiman, Shri. Jitendra Sharma, Dr. Ishwara N Acharya and Dr. Praveen Oberai.

At the outset, Shri Sharma, invited questions from the audience. In response, he was asked whether Ayush had any plans of bringing together a multi specialty group consisting of conventional therapist and others to evolve a holistic approach to Cancer Therapy. In reply, Shri Sharma was candid in accepting the difficulty of getting such group together. He however, promised to do his best.

Shri. Jitendra Sharma flanked by Prof. Dhiman(L) and Dr. Acharya(R)
Shri. Jitendra Sharma flanked by Prof. Dhiman(L) and Dr. Acharya(R)

Following this discussion the panelists made their presentation, which described the progress made by each Directorate.

Prof. (Dr) R S Ramaswamy, DG, Central Council for Research in Siddha
Prof. (Dr) R S Ramaswamy, DG, Central Council for Research in Siddha
Dr. Ishwara N Acharya, DG, Central Council for Research in Yoga & Naturotherapy
Dr. Ishwara N Acharya, DG, Central Council for Research in Yoga & Naturotherapy
Dr. Praveen Oberai, Scientist, Central Council for Research in Homeopathy
Dr. Praveen Oberai, Scientist, Central Council for Research in Homeopathy

The meeting concluded with vote of thanks proposed by Dr. Antani.

**Membership Registration Form**

LSW LifeScienceWorld

Regd.Office: 716, Block 2, Express Garden, Vaibhav Khand, 6,Indirapuram –201010, Ghaziabad, Delhi NCR

LSW FORUM: Objectives

Take up issues concerning the industry to government agencies like DCGI, ICMR, DBT, MCI, Dept. of Pharmaceuticals and the Ministry of Health & Family Welfare through LSW’s Advisory Board of eminent personalities like Dr. A K Agarwal, Dr. Y K Gupta, Dr. B.M. Gandhi and others and help in resolving issues affecting the growth of the Industry.

Events:  Roundtables and Conferences are organized under LSW Forum.

Events Held:
  • LSW Interactive Conference titled “Clinical Research–Regulatory Norms-Current Challenges and the Future of Pharma Industry in India”, May 27, 2014, The Orchid Hotel, Mumbai.
  • LSW Roundtable 1st Edition with Prof. Ranjit Roy Chaudhury, November 5, 2014, The Orchid Hotel, Mumbai
  • LSW Roundtable 2nd Edition with K L Sharma, Joint Secretary, Ministry of Health & Family Welfare, Dr. G N Singh,DCGI and A K Pradhan, DDCI, May 30, 2015, The Orchid Hotel, Mumbai
  • LSW Interactive Conference titled “ Holistic Approach to Cancer-An Integrated Therapy” in association with Ministry of Ayush, February 6, 2016, The Orchid Hotel, Mumbai
  • LSW Roundtable 3rd Edition with Jai Priye Prakash, Secretary, Department of Pharmaceuticals, July 1, 2016, The Orchid Hotel, Mumbai
LSW Online Discussion Forum:

LSW Forum Members can post issues affecting the Industry besides discussing Subjects related to pharma, biotech and life sciences; exchange views/opinion etc. This will also enable each of the LSW Forum members to interact and build their network.

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GlaxoSmithKline, Johnson & Johnson, Sanofi, Wockhardt, Cipla, Takeda, Hinduja Hospital, MSD India, Bayer Pharmaceuticals, Veeda Clinical Research, Abbott



Research Institute/Academia


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LSW’s conference titled “Clinical Research–Regulatory Norms-Current Challenges and the Future of Parma industry in India” was held on May 27, 2014 at The Orchid Hotel, Mumbai.

logo LSW Conference: “Clinical Research – Regulatory Norms-Current Challenges and the Future of Pharma industry in India”, May 27, 2014, The Orchid Hotel, Mumbai.

Conference Support Partner


Media Partner


The objective of this conference was to bring together the regulator and the clinical trial industry to focus on issues related to clinical research/trials area, identify the gap areas, if any in view of the new guidelines released by DCGI office, CDSCO and the Health Ministry and highlight the suggestions / recommendations / solutions consideration of regulatory agencies and wider circulation amongst the clinical trial industry.

Inaugural Session - (From Left to Right: Dr. Surinder Kher, Dr. B M Gandhi, Dr. K Bangarurajan, Dr. Rao Vadlamudi, Dr. Milind Antani)
Inaugural Session –
(From Left to Right: Dr. Surinder Kher, Dr. B M Gandhi, Dr. K Bangarurajan, Dr. Rao Vadlamudi, Dr. Milind Antani)

The Conference provided an opportunity to clinical trial industry to interact directly with the regulator, policy makers, legal experts, experts in the field associated with the health ministry and the experts from the industry to discuss recent amendments in Schedule Y; challenges to bring new drugs to global market; perspectives on clinical trial sector in India; compensation and related issues; liabilities of stakeholders and mitigation; other related issues.

There was a good response to the conference and representatives from more than fifteen industries directly involved with clinical trials and more than 30 potential beneficiaries participated in the meeting.

Proceedings :

summary-2Dr. Surinder Kher, CEO, Ecron Acunova- Conference Chairperson
The conference was chaired by Dr. Surinder Kher, CEO, Ecron Acunova, who conducted the day long proceedings so beautifully, that despite long sessions and short lunch break and almost without tea break, the audience stayed put on their seats and interacted with the speakers, panelist and the regulator.

summary-3Dr. B M Gandhi, Former Advisor, DBT, Govt. of India addressing the Conference Overview
Dr. B M Gandhi, Former Adviser, Government of India, Department of Biotechnology introduced the conference to the delegates in light of recent amendments to the schedule y of the Drugs and Cosmetics Act, report of the Ranjit Rai Chaudhry, mandatory audio-visual recording of the consent, serious adverse reactions and compensation and registration of ethics committees linked to the topics of the agenda.

summary-4Dr. K Bangarurajan, Deputy Drug Controller of India, West Zone rendering the Inaugural Address
Dr. K. Bangarurajan, Deputy Drug Controller (India) gave the inaugural address highlighting the “Regulations-Past, Present & future Scenario” highlighting the implications of the recent amendments in schedule Y, monitoring the clinical trials, NDACs, Ethics Committee registration and related issues.

summary-5Dr. Rao Vadlamudi, President, Indian Pharmaceutical Association rendering the Keynote Address
Dr. Rao Vadlamudi , President, Indian Pharmaceuticals Association in his keynote address highlighted the challenges to bring new drugs to global market in present scenario of clinical research in India and advocated for GCPs in clinical research, enough number of sites, adequate regulatory support, sufficient resources and timely clearances by the regulatory bodies, responsive media for educating public and politicians and political will.

This was followed by “View Point” a session titled “My Perspective on Clinical Trials sector in India-Where are we? Where are we going? Where we should be going?” Significant contributions were made by :

Jeroze Dalal (Glaxo SmithKline), Apurva Shah (Veeda Clinical Research, CRO),
Dr. Kumar Prabhash, Head of Oncology, Tata Memorial Hospital, . representing Investigators,
Dr. Gururaj Rao, Managing Director, International Stem Cell Services Ltd on stem cells trials,
Viveka Roy Choudhury, Editor, Express Pharma from the media’s perspective and
Shradha Tawade, GM, Wockhardt (wife of patient who underwent clinical trial).

Jeroze. J Dalal
Jeroze. J Dalal
Apurva Shah
Apurva Shah
Dr. Kumar Prabhash
Dr. Kumar Prabhash
Dr. Gururaj Rao
Dr. Gururaj Rao
Viveka Roy Choudhury
Viveka Roy Choudhury
Shradha Tawade
Shradha Tawade
Elaborated session on “Compensation and Related Issues, Liabilities of Stakeholders and Mitigation” generated good interest and attraction.
Panelists of Session titled “Compensation and Related Issues, Liabilities of Stakeholders and Mitigation”. From L-R: Dr. Y K Gupta, Dr. suganthi Iyer, jeroze Dalal, Dr. A K Agarwal, Yasmin Shenoy and Dr. Venu Madhav
Panelists of Session titled “Compensation and Related Issues, Liabilities of Stakeholders and Mitigation”.
(From L-R: Dr. Y K Gupta, Dr. suganthi Iyer, jeroze Dalal, Dr. A K Agarwal, Yasmin Shenoy and Dr. Venu Madhav)

Dr. Y K GuptaDr. Y. K. Gupta, Professor and Head, Department of Pharmacology, AIIMS discussed detailed information on recent amendments and post-scenario implications on compensation and related issues like basis of calculation of compensation and factors which entitles quantum of compensation. He informed that a Committee is already compiling the suggestions and recommendations in this regard and further suggestions, if any received, would also be considered.

Dr. A K AgarwalDr. A. K. Agarwal, Chairman, Compensation Committee, Government of India also informed that suggestions are open for debate and change. He further observed that about 50-60 cases of death are being reported in clinical trials besides subjects reporting permanent or partial damage/disability.


summary-15Dr. Milind Antani highlighted the importance of contract with the Project Investigator, Institute and Sponsors; role of CROs and Insurance Package for trial related injuries. Mitigation strategy should deal with liability and project Investigators should also get indemnified under the Professional Negligence Policy.

Other speakers included Dr. Suganthi Iyer of Hinduja Hospital, Jeroze Dalal from GSK, Dr. Venu Madhav, COO, Veeda Clinical Research and Dr. Prabhash Kumar as Panelists.

Presentations were made by industry professionals comprising Yasmin Shenoy, Sr. Director, Regulatory, Sanofi India on “Beneficiary of Clinical Trial”; Dr. Rashmi Hegde, Director-Medical, Abbott India on “Liabilities of Stakeholders”; Deepak Gupta, Asst. Vice President, HDFC ERGO “on New areas of Clinical Trials That Can Be Covered by Insurance “Dr Viraj Suvarna, Medical Director, Boehringer Ingelheim India” Impact on Sponsor Company”; Milind Antani “Contracts” and Prabhash Kumar “Practical Issues and Concerns” These presentations were followed by in-depth discussions

Yasmin Shenoy
Yasmin Shenoy
Dr. Rashmi Hegde
Dr. Rashmi Hegde
Deepak Gupta
Deepak Gupta
Dr. Viraj Suvarna
Dr. Viraj Suvarna
Dr. Milind Antani
Dr. Milind Antani

(Some of the other panelists: L- R: Dr. Viraj Suvarna, Dr. Rashmi Hegde, Dr. Kumar Prabhash, Deepak Gupta, Dr. Venu Madhav and Dr. Milind Antani)
(Some of the other panelists: L- R: Dr. Viraj Suvarna, Dr. Rashmi Hegde, Dr. Kumar Prabhash, Deepak Gupta, Dr. Venu Madhav and Dr. Milind Antani)

The highlight of the conference was the presence of Dr. K Bangarurajan, Deputy Drug Controller of India, West Zone representing DCGI during the entire course of discussions at the conference and actively interacting with the participants. He addressed to all their queries on implications of the new guidance media perceptions. In his closing remarks, he assured the participants that he would carry forward all the discussion points and the suggestions made at the conference to the notice of CDSCO, DCGI and the Health Ministry.

Closing Remarks by Dr. K Bangarurajan, Deputy Drug Controller (3rd from left). Others in the pic. (From L-R) Dr. Milind Antani, Dr. Surinder Kher and Dr. B M Gandhi
Closing Remarks by Dr. K Bangarurajan, Deputy Drug Controller (3rd from left).
Others in the pic. (From L-R) Dr. Milind Antani, Dr. Surinder Kher and Dr. B M Gandhi

The details of the discussions and the recommendations made at the conferences and comments would be available on this site soon.

Minutes of LSW Round Table Meeting on Clinical Trial, November 5, 2014, Mumbai Meeting

Title: LSW Round Table Meeting with Dr. Ranjit Roy Chaudhury
Meeting Called by: LSW LifeScienceWorld
Type of Meeting: Round Table
Purpose of the Meeting: To revive Clinical Trial Operations in India Meeting Date: November 5, 2014
Venue: The Orchid, Mumbai Chair: Prof. Dr. Ranjit Roy Chaudhury, Adviser to Minister of Health, Govt. of India
Note Taker: Dr. Milind Antani, Advisory Board Member, LSW and Partner, Nishith Desai Associates


  • Dr. Shailesh Ayyangar, Managing Director, Sanofi India
  • Jitendra Tyagi, Managing Director, Bristol – Myers Squibb
  • Dr. Murtaza Khorakiwala, Managing Director, Wockhardt
  • Aman Bajaaj, Managing Director, Takeda Pharma
  • Dr. Santosh Jha, Director-Medical & Regulatory, Takeda
  • Sudharshan Jain, Managing Director, Abbott Healthcare.
  • Dr.Arun Mishra, Director-Regulatory Affairs, Abbott India
  • Dr. Chandrashekhar Potkar,Director-Medical & Regulatory Affairs, Pfizer
  • Dr. Suresh Menon, CSO, Novartis
  • Jeroze J Dalal, Head-Clinical Operations, India & Pakistan, Gsk
  • Dr. Anish Desai, Director-Medical Affairs, Johnson & Johnson
  • Nandita Chopra, India Representative, NIH, USA
  • Dr. Milind Antani, Partner, Nishith Desai Associates
  • D G Shah, Secretary-General, Indian Pharmaceutical Alliance
  • Dr. Rashmi Hegde, Director- Medical Affairs,Abbott
  • Dr. Veena Jagutse, Director-Development Operations, Amgen
  • Sankar Iyer, Editor & Managing Partner, Lsw Lifescienceworld

Discussion: 6 points of the policy pertaining to Clinical Trials

Stress on Accreditation:

  • Centre which will carry out clinical trials will be accredited
  • Principal Investigator will be accredited
  • Ethics Committee will be accredited


Industry’s views, future plans and suggestions to the government with regards to the revival of clinical trials as before and on other core issues pertaining to the pharma industry, and what industry can expect from the government.

Summary of Discussion:
Following recommendations were put forth:

  1. To form a committee representing industry, government and NGO to discuss and handle various issues
  2. To have clarity in the language of notifications/office orders and to give clarification that the regulations notified are applicable to prospective trials and not ongoing trials
  3. New Drug Advisory Committee (NDAC)
    a. To have only one layer of committee approval
    b. NDAC must act very fast and ethically
    c. Proper training program for NDAC members
    d. Regular evaluation of performance of NDAC members should be done
    e. There should be clarity on the process of functioning of the committee
    f. An experience industry expert should be involved in the committee
    g. All the minutes of meeting should be published on website
    h. Committee must have an able leader, should give adequate time in the meeting and decisions in meeting must be communicated immediately
    i. Composition of committee needs to change
    j. Professional project management training should be done
    k. High level committee should be formed regarding formation
  4. To create a platform at government level to connect with all the stake holders
  5. While finalizing the notifications/office order, DCGI office should invite industry representative to sit with them as many a times outcome of meeting is not interpreted correctly
  6. Correspondence regarding invitation to be committee should happen from office of ministers and properly as it is an honor
  7. To study and compare global practices and implement
  8. In reporting of SAE, language should change from “occurrence” to “awareness”
  9. To issue clarification on post marketing surveillance and phase 4 clinical trials
  10. To tacked medical device issues and expedite pending bills

Action Points for Industry:

  1. To provide relevant examples of issues they have faced so that proper representation can be made before the minister
  2. To provide global practices and what best can / should be implemented in India 3. To discuss and provide guidance on Project Management expertise 4. To give composition of NDAC