Monday, December 18, 2017
Announcements

8th  November’17, Mumbai: With the Indian Pharmaceuticals market growing ever larger, The Economic Times saw the need to cultivate a platform for researchers, pharmaceuticals industries, healthcare professionals and various stakeholders to discuss the latest advances in the space. The Economic Times Pharma & Life Sciences Congress 2017, held today at The Taj Vivanta, Mumbai, saw prominent industry experts deliberate on the ‘Future of Pharma & Life sciences.’

The event convened with opening remarks from Dr. Maruthi Viswanathan, Chief Executive Officer, Rx Prism and later a keynote address delivered by Mr. Ranjit Shahni, Vice Chairman & Managing Director, Novartis. In the keynote address, Mr. Shahani highlighted the key trends, opportunities, challenges that the Indian industry faces, stating, “Demographic trends like increase in population, average life expectancy are putting the healthcare system under pressure.”

Setting the tone for the day, Mr. Deepak Lamba, President – Times Strategic Solutions, said, “The Indian Pharma industry is on the threshold of becoming a major global market by 2020. We at ET believe no global pharmaceutical company can afford to ignore India and its growth. We thus wanted to provide a platform to sustain this growth and bring more positive changes through a talented pool of Pharma experts.”

Dilip G Shah, Secretary General, Indian Pharmaceutical Alliance, expanded further, saying, “The future would be less and less predictable and the disruption would come at a faster rate that we have witnessed and this disruption would come from completely unknown parties, like digital or medical science and my discussion with the other industry shows that we are not prepared for future.” To battle these disruptions, Annaswamy Vaidheesh, Vice President, South Asia & Managing Director, GlaxoSmithKline Pharmaceutical, suggested setting up think tanks within the country.

In the session titled Moving Beyond Generics-Innovation in Pharma-the next up, visionaries , Daara Patel, secretary General, IDMA; Jawed Zia, Country President, Novartis and Kanchana TK, Director General OPPI expounded on the manner in which we should look into working with the government from a policy perspective to actually innovate in Pharma. Mr. Patel added, “Most of the patients are not getting medicines due to poor infrastructure. India has affordability but as far as accessibility is concerned it is far behind than any other country in the world.”

The discussion also highlighted that patent protection is a big challenge in pharma innovations. Speakers suggested that the government should free the Pharma industry from the shackles of price control, there is a lot of competition and the industry is mature enough. Only when there is a drastic difference in the price points should the government intervene. It ended on a positive note, with the statement,‘The value of innovation should be seen as an investment not only for health but also for economy.’

Moving forward in a dialogue between Abhishek Lagvankar, Marketing, Medical Nutrition, Danone; Alap Gandhi, Head Medical Affairs, GlaxoSmithKline Pharmaceuticals; Rinkesh Shah, Digital marketing Strategist, Cipla on Pharma Marketing going digital, it was highlighted that digital marketing in Pharma has low awareness as compared to other industries and 70% of today’s population turns to the internet for medical information. They also said most companies develop apps. However, studies have found that 75% of people don’t use the app after 3 months. Hence what will help in moving forward in digital marketing sphere is to have real time patient data and not just attempt to roll out quarterly marketing initiatives. It ended with an insight that Pharma Industries are way behind in applying digital strategy and that it should pick up.

The day concluded with an enlightening discussion between Mr. Shantanu Mukherjee, Legal Head, Asia Pacific and Japan, Lupin and Sudesh Shetty, Partner and Head, Forensics, Life Sciences, KPMG on manufacturing in India, compliance in manufacturing, making it globally compliant and the road ahead. Mr. Sudesh Shetty ended the session with a remark, “The cost of compliance goes exponentially up when it’s reactive.”

About ET Edge:

Times Strategic Solutions Ltd., functional under the brand name ET Edge, is an Economic Times initiative founded to empower multiple industries and segments by sharing critical business knowledge through focused exhibitions and strategic conferences and summits. Encompassing business vistas, ET Edge strives to bring together visionaries and key leaders on its knowledge platforms to create a social and business environment conducive to the positive changes required by the industry. The main aim of this initiative is to channel global business intelligence through exhibitions, summits and conferences in overarching lectures, hands-on workshops, panels, roundtables, case studies and more.

The Ministry of Health & Family Welfare has recently announced the launch of daily regimen for TB patients
across the country under The Revised National TB Control Programme (RNTCP). The Health Ministry has been
providing the thrice weekly regimen for the treatment of tuberculosis (TB), however it has now decided to
change the treatment strategy for TB patients from thrice weekly to daily drug regimen using fixed dose
combinations (FDC) for treatment. This change will bring transformation in the approach and the intensity to
deal with this disease which accounts for about 4.2 lakh deaths every year.

The daily FDC anti-TB drugs will be made available to private pharmacy or at private practitioners to dispense to TB patients who seek care in private sector, depending upon the convenience of patient and practitioner free of cost. The Health Ministry will take this forward with all major hospitals, IMA, IAP and other professional
medical associations to expand the access to daily FDC to all TB patients.

The salient features of this treatment strategy are use of Ethambutol in continuation phase for all patients, drugs to be given daily (as against only 3 times weekly previously), fixed dose combination (FDC) tablets to be used which will reduce pill burden (as against separate 7 tablets previously), for children, child friendly formulations as dispersible tablets and use of Information Technology (IT) enabled treatment adherence support system.

Current WHO Global TB Report, 2017 has reported that incidence of TB has reduced from 28.2 lakh to 27 lakh and mortality by 60 thousand over the last one year, which is a testimony of anti TB drive by Government of India.

Indian Pharmacovigilance Day 2017 Conference held at Hyderabad on 28-July-2017

The Indian Pharmacovigilance Day 2017 conference was held in Hotel Lemon Tree Premier, Hyderabad on 28 th July 2017, as a part of the series of the ‘Pharmacovigilance Day’ conferences organized in several parts of the world since 2014 and in India in 2016, by Italy-based conference-producing company EasyB srl. Dr J Vijay Venkatraman, Managing Director & CEO of Oviya MedSafe – a Global Pharmacovigilance Consulting & Drug Safety Services providing organization based out of India and the UK, was nominated as the Chair consecutively for the 2nd Indian Pharmacovigilance Day following the success of the three UK Pharmacovigilance Day conferences in London since 2015 and the Indian Pharmacovigilance Day 2016 conference in Mumbai, which he chaired. The agenda was well-crafted to suit the contemporary professional interests of the pharmacovigilance stakeholders in India.

The conference started with a brief welcome address by Mr Enrico Pedroni, Managing Director, EasyB srl, Italy, followed by Dr J Vijay Venkatraman’s address as the Chair to the delegates about the nature and purpose of the conference. The conference started to sail with the perspectives and anecdotes by Dr Ammar Raza S on the topic, “Changing Regulatory Market Landscape in Emerging Countries: Impact on Pharmacovigilance”. This talk was followed by the next speaker Dr Arani Chatterjee, who enthralled the audience with his talk titled “Vaccine Vigilance – An Overview”.

The next session was Higher Functions in Pharmacovigilance, in which professionals from different
verticals in the discipline of pharmacovigilance participated as speakers and shared their thoughts on
specific high-focus areas in pharmacovigilance. The audience were enthralled with the knowledge sharing
by Dr Nitu Sinha on the topic “Drug Safety in Biosimilars” followed by Dr Mamtha B Nair’s seamless
presentation on the operational topic “PADER Vs PBRER – A Comparative Analysis of Aggregate Reports”.
This session ended with the speech by Dr Ankur Arora titled “Safety Signal Detection: Do reporting Biases
Matter in Today’s World?”

The audience were given an overview of the future of pharmacovigilance by Dr Vivek Ahuja, who
deliberated on “Automation in ICSR processing – Is Artificial Intelligence the Paradigm Shift?” a topic that
the audience were eagerly looking forward to. The next speech by Dr S D Sinha showcased the intricacies
and challenges involved in setting up “Global Pharmacovigilance in Indian Multinational Pharmacovigilance
Companies”. Both these speeches generated numerous questions from the audience which were answered
by the speakers, resulting in a participative experience for the audience.

The last session of the day was aimed at unravelling the experiences of Pharmacovigilance
Outsourcing from the viewpoints of a Client and a Service Provider. The colloquium titled “Operational
Excellence in Pharmacovigilance Outsourcing – Pros & Cons” was moderated by Dr J Vijay Venkatraman,
with the speakers being Dr P S Karthik Babu representing the Pharmaceutical Industry &
Mr Soumya Padhy representing the Pharmacovigilance Service Provider industry. Dr P S Karthik Babu
explained the pain points in pharmacovigilance which are expected to be resolved by outsourcing
pharmacovigilance and also about the checks and balances to be maintained when pharmacovigilance
activities are outsourced to a third party. Mr Soumya Padhy highlighted the benefits of outsourcing
pharmacovigilance activities and also went on to emphasize that a service provider could add lots of value
to a client, as a learned partner. The event ended with vote of thanks by Dr J Vijay Venkatraman and the
delegates left with the fulfillment of getting a bird’s eye view of all facets of Pharmacovigilance.

The conference was sponsored by Oviya MedSafe and had Express Pharma, Life Science
World and CIMS as its media partners.

For conference photos see: https://goo.gl/photos/WDJa81aAu9L9PvPn9

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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***Contribution of articles in LSW Guest Desk section. (Articles on new drugs, pharma regulation, R&D or any other topic that the contributor feels suitable)

***Discounted Delegate fee at all LSW conferences/events

***Discounted Tariff plans for Corporate Branding in LSW LifeScienceWorld by way of running Corporate/Product film or Banner advertisement (Refer Cipla film. on our Home Page: www.lifescienceworld.in)

LSW FORUM MEMBERS:

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

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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 jyotrao@gmail.com, mobile 7259028934, 080-65652220

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

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Media Partner

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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.