MARKET
ISCR conducts clinical research conference Indian Society for Clinical Research launches Causality Assessment Portal at 10th Annual Conference THE 10TH Annual Clinical Research Conference was recently held in Mumbai. Launched on the occasion was a Causality Assessment Portal developed by ISCR in collaboration with MRCT Harvard. The portal aims to develop a comprehensive framework for clinical trials case causality assessment that will be relevant globally and within the Indian regulatory context for compen-
make our theme Patients First and Research for India a reality,” said Suneela Thatte, President, Indian Society for Clinical Research (ISCR). A panel discussion on ‘Regulations for Clinical Research – has it led to better protection of patient safety?’, saw lively views from various stakeholders. Dr VG Somani, Joint Drugs Controller iterated the Government of India’s commitment to mak-
Dr Soumya Swaminathan, DG-ICMR felicitating Dr Sudeep Gupta, Deputy Director – ACTREC and Professor of Medical Oncology at Tata Memorial Hospital, with the ISCR Excellence Award for Academia
sation. This becomes particularly significant in light of the recent Indian regulations that directly link trial participant compensation for injury or death to causality assessment. The portal will serve as a tool that provides guidance documents and training materials to enable clinicians and ethics committee members to follow best practice procedures in determining causality for adverse events in a clinical trial. “Clinical research professionals need to take a more proactive role in conducting research for India. A more conducive regulatory framework for the conduct of clinical research will enable this and encourage local innovation, ensuring that Make in India is a reality for drug development and clinical research in India. Such an approach will help
22
EXPRESS PHARMA
March 1-15, 2017
ing India a favoured destination for clinical research. “We are going through a transition phase where we are focussed on bringing about several improvements in the clinical research regulatory environment for the benefit of patients and the society at large,” he said. Delivering the Prof Ranjit Roy Chaudhury Oration on TB: Challenges and Solutions for the 21st century, Dr Soumya Swaminathan, Director General, ICMR said, “It gives me great pleasure to note the many positive changes in the clinical research environment these past few years in India. ISCR has been working relentlessly in this direction. We must continue to invest in capacity building of subject experts, sensitise leadership at the political level, work with ethics committees who are increasingly responsi-
ble for patient safety, and encourage patient representation at various fora.” ISCR presented the Academia Award for Notable Contribution to the Clinical Research Fraternity to Tata Memorial Hospital and the Industry Award for Notable Contribution to the Clinical Research Fraternity to Dr Arun Bhatt who has over thirty years of clinical research experience. A panel discussion witnessed leading industry experts and academia who spoke of the need for improving stakeholder trust in clinical research, creating a more conducive environment for clinical research and further improvement in regulations. They highlighted the need for more investigator and patient testimonials on the benefits of clinical research, and its role in ensuring better health and patient outcomes. “Clinical research drives innovation and it is incumbent on us to do more clinical research to contribute to more drug development in India,” said Naz Haji, SVP and MD, R&D Solutions, QuintilesIMS India. A parallel track was held on data management, medical writing and biostatistics which focused on e-technology advances in clinical operations, oncology trials and NCEs in India. Attending the conference were clinical research professionals from across the stakeholder spectrum. With India operating in a new regulatory environment, Thatte stressed on the key responsibility of each clinical research professional to renew their pledge to quality, patient safety and data integrity and set an example to the rest of the world as to how quality and ethics are not mere tokenism but truly reflect the spirit of the clinical research community in India. EP News Bureau
‘India Pharma 2017’& ‘India Medical Device 2017’ International Conference held in Bengaluru According to Ananthkumar, Union Minister for Chemicals & Fertilizers, Bengaluru will soon become the pharma and Med Tech Zone THE 2ND edition of India Pharma & India Medical Device International Conference was recently inaugurated in Bengaluru by Union Minister for Chemicals & Fertilizers and Parliamentary Affairs, Ananthkumar. The three-day event, with the Vision-‘For Responsible Healthcare’, was organised by the Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers and Federation of Indian Chambers of Commerce & Industry (FICCI). Kumar called the International Conference as a ‘Pharma and Medical Devices Kumbh’. He called upon all the stakeholders present to make India as the ‘Pharmacy of the World’. He said that Bengaluru, being the hub of information technology and skilled manpower, would prove to be the ideal location to set up a pharma and Med Tech Zone and hence the Ministry would work with the state government to establish it soon. Siddaramaiah, Chief Minister, Karnataka said that this is the second time Karnataka is hosting this conference on medical devices and pharma sector, thus giving the state an opportunity to emerge as the desired destination for investments under pharma and medical devices sector and give a boost to Make in India mission in this sector. The India Pharma exhibition, being held as part of the event, covered all the segments of the pharma industry starting from finished formulations, APIs, bio-pharmaceuticals, fine chemicals and intermediates, natural extracts and excipients. India Medical Device exhibition showcased med-tech innovations in India across segments
from preventive to therapeutic care. Leading pharma and medical devices companies showcased their expertise and products to Indian and international healthcare community at the exhibition. Sessions on biopharmaceuticals include, The New Engine of Growth, Scaling MedTech Manufacturing and the Investors Meet, which was a step forward to the ‘Make in India’ mission of the Government of India. The event witnessed over 250 exhibitors from the pharma and medical devices sector. Buyers from over 24 countries, international regulators from eight countries (US FDA-USA, PMDA-Japan, MoH-Malaysia etc), over 29 embassy officials and over 10,000 business visitors took part in the event. Karnataka was the host state while Chhattisgarh was the partner state. Other key dignitaries present during the inauguration function were Nirmala Sitharaman, Minister of State (IC) for Commerce & Industry, DV Sadananda Gowda, Minister for Statistics and Programme Implementation, along with Government of Karnataka Ministers, RV Deshpande, Minister of Industries and Dr Sharanapraksh Rudrappa Patil, Minister of Medical Education. The distinguished gathering also included Jai Priye Prakash, Secretary, Department of Pharmaceuticals, Soumya Swaminathan, Director-General of the Indian Council of Medical Research, Henk Bekedam, WHO Representative to India along with other senior officers of the Ministry and doyens of pharma and medical devices industry. EP News Bureau