LSW Interactive Conference - Clinical Research – Regulatory Norms - Current Challenges and the Future of Pharma Industry in India”, The Orchid Hotel, Mumbai, May 27, 2014

An interactive conference by LSW titled "Clinical Research - Regulatory Norms - Current Challenges and the Future of Pharma Industry in India “was held on May 27, 2014 at The Orchid Hotel, Mumbai.

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 / solution consideration of regulatory agencies and wider circulation amongst the clinical trial industry.

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. The Conference was chaired by DR. SURINDER KHER, CEO, Ecron Acunova.

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.

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.

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.

There was an active participation by the representatives of the industry drawn from different areas sharing their view point during session on “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. Prabhash Kumar, Head of Oncology, Tata Memorial Hosp. representing Investigators, Dr. Gururaj Rao, MD 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).

Elaborated session on “COMPENSATION AND RELATED ISSUES, LIABILITIES OF STAKEHOLDERS AND MITIGATION” generated good interest and attraction. DR. 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. 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.

DR. 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 on “BENEFICIARY OF CLINICAL TRIAL”; Dr. Rashmi Hegde, Director-Medical, Abbott “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

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.

Some of the Industry's views/suggestions:

• Expedite resolution of current PIL by enabling ISCR (CLG, Alishan Naqvi), IPA (Abhishek Manu Singhvi), who have filed an impleadment motion against the PIL, to speak. Or appoint an amicus curiae. This case has been dragging for 2 years now. The government has put in place multiple measures to protect patient safety. It's time to let CTAs be approved so that patients in India can at least have a chance of hoping for a better life.
• The gazette notification on compensation is being amended but also needs to be reasonable in the case of outcome or event driven trials where the endpoint is a major CV adverse event. In such trials one wishes to evaluate whether the new drug is able to reduce morbidity and mortality better than standard of care. These are higher risk patients, some of whom will develop these SAEs/endpoints, but sponsors have to compensate for such events in both arms they will never do such trials in India. Also, if the sponsor's adjudication of relatedness is not aligned with that of investigator and/or EC there should be an option of going to an arbitrator or the Expert Committee should allow the sponsor to present its case to the Expert Committee.
• One needs to be able to differentiate between companies who follow strict standardized operating procedures when they conduct CTs all over the world. And companies who flout the law of the land. The former companies' CTs are inspected by US FDA and EMEA and have passed so many such inspections, attesting to the data credibility and patient safety standards. Some of these companies have been doing global CTs in India for 20 years now and have always adhered to the highest standards of patent safety. Treatment of related AEs has always been paid for by the sponsor.
• One needs to understand the value to India of global CTs being conducted in India. Patients have benefited. Some have had a prolonged lease of life and get the drug free of cost for life (e.g., in cancer trials). Hospitals get state of the art equipment which they can use post-trial as well, e.g., 6 DEXA machines were donated to the institutes post a trial on a SERM for osteoporosis. Indian patients get access to the cutting edge research early and free of cost and even when the drug is eventually marketed in India it is at a lower price than elsewhere in the world.
• Operational hurdles need to be looked at rationally. For example, AV recording of the informed consent process should not deny a patient his right to participate if he does not want to be AV recorded. It could be risk-based AV recording, customized to only some patients and some trials which may need this kind of stringency.
• The CDA bill, if passed in its current state, may dissuade investigators from doing CTs, as the penal provisions may be too sweeping. Be balanced and fair, that's all we are asking. The Ranjit Roy Chaudhry seems to be balanced. Let's implement and streamline CT conduct across the country. Industry has always offered to facilitate training of CDSCO onsite inspections, etc. Let's clear the AIR (Academia, Industry, and Regulator) by having more face to face interactions, e.g., NDAC is a good example of AIR.
• In short, we understand why this is happening, although we have always adhered to the highest global standards. We hope that these new regulations will weed out fly by night operators in CR and make India a uniformly clean place to do CTs on par with the best in the world, if not better.
• While there are several new regulations and enforcements that are a huge step in the right direction, there are a couple of areas where the intervention and advice of the DCGI office to the Ministry of Health and Welfare will result in a very beneficial position for the Indian patients.
• Retract the video consenting guidelines since this impinges onpatient confidentiality
• Revoke patient compensation clause for cases of placebo related ADRs or absence of therapeutic effect
• Put in place and enforce stringent timelines for the approval process of New Drugs and CTs for New Drugs
• We need to have a mechanism in place for quick approvals for global trials, clarification on some of the clauses where compensation payments are applicable;
• Clarity in formula used for quantum of compensation and accreditation of study investigators. All of these will not only enhance the quality of clinical data generated but will in still a sense of confidence to sponsors conducting future work in India.

S.G.B. Rao, publisher, LSW opening remarks and Sankar Iyer, LSW, MG. Editor, intorducing the Panel

Dr. Surinder Kher,CEO, Ecron Acunova, Dr. B.M. Gandhi, Dr.Bangarurajan, DDCGI (India), Dr. Rao Vadalmudi, President, IPA, and Dr. Milind Antani, LSW Advisory Board

An interactive conference by LSW titled - Clinical Research–Regulatory Norms-Current Challenges and the Future of Pharma Industry in India” was held on May 27, 2014 at The Orchid Hotel, Mumbai. 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.

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.

Dr. B.M. Gandhi,Former Advisor, GOI, DBT and Dr. Surinder Kher, CEO, Ecron Acunova

The Conference was chaired by Dr. Surinder Kher, CEO, Ecron Acunova. 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.

Dr. K.Bangarurajan, Deputy Drug Controller(India) and Dr. Rao Vadlamudi, President, I. P. A.

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.

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.

Jeroze Dalal, (Glaxo SmithKline ) and Apurva Shah, (Veeda Clinical Research)

Dr. Prabhash Kumar, Head of Oncology, Tata Memorial Hospital, Mumbai. and Dr. Gururaj Rao M.D. International Stem cell Services Ltd, Bengaluru.

There was an active participation by the representatives of the industry drawn from different areas sharing their view point during session on “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. Prabhash Kumar, Head of Oncology, Tata Memorial Hosp. representing Investigators, Dr. Gururaj Rao, MD International Stem Cell Services Ltd on stem cells trials.

Viveka Roy Choudhary, Editor, Express Pharma and Shradha Tawade, G.M., Wockhardt

Viveka Roy Choudhury, Editor, Express Pharma from the media’s perspective and Shradha Tawade, GM, Wockhardt (wife of patient who underwent clinical trial) elaborated session on “Compensation and Related Issues, Liabilities of Stakeholders and Mitigation” generated good interest and attraction.

Dr.Y.K. Gupta, Prof & Head, Dept of Pharmacology, AIIMS, New Delhi and Dr. A. K. Agarwal, Chairman, Compensation Committee Government of India

Dr. 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. 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.

Dr. 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 .

Dr. Y. K. Gupta, Suganthi Iyer, Jeroze Dalal, Dr. A.K. Agarwal, Dr.Rashmi Hegde, Dr.Venu Madhav & Dr. Milind Antani

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.

Yasmin Shenoy, Sanofi and Dr. Rashmi Hegde, Director – Medical, ABBOT

Deepak Gupta, HDFC, ERGO ,Dr. Viraj Suvarna, BoehringerIngelheim & Dr. Prabash Kumar, Tata Memorialal Hospital

Presentations were made by industry professionals comprising Yasmin Shenoy, Sr. Director, Regulatory, Sanofi on “Beneficiary of Clinical Trial”; Dr. Rashmi Hegde, Director-Medical, Abbott “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.

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 .