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Delegates during the event
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Usha Sharma – Mumbai
Updating the industry about the global regulatory requirements of pharmacovigilance, DIA a neutral, global, non-profit association, recently organised a two-day conference in Mumbai on Pharmacovigilance & Drug Safety – A New Era. The conference provided a platform to discuss and share insights about the global clinical research industry.
Ganesh Parkar, Cluster Head of Pharma and Manufacturing, TCS welcomed all the delegates and participants and also delivered the keynote speech. The conference registered a large number of participants from the industry and their active participation during the Q&A session created an inquisitive environment. The Q&A session raised various industry related issues, which were later discussed by different speakers.
Key speakers during the event were Professor Andy Stegachis, University of Washington, Prof YK Gupta and Head, Department of Pharmacology, All India Institute of Medical Sciences; Jyoti Joshi Jain, Senior Advisor, Immunisation Safety Surveillance Immunisation Technical Support Unit, MoHFW Public Health Foundation of India; Sudhakar Bangera- Programme Director, Clinical Development Services Agency (CDSA), an Extramural unit of THSTI, Department of Biotechnology Government of India; Ute Hoeffner- EU QPVV, Novartis Consumer Healthcare, Germany; Seema Jaitly, Chief Executive Officer, Essjay Solutions; Stewart Geary, Chief Medical Officer, Eisai Pharmaceuticals; CL Baklaji, Managing Director, Accenture Lifesciences; Aparna Patkar, Lead PV offering, TCS; Rajesh Kuppuswamy, Life Sciences Consulting Head, APAC; Dinesh Kasthuril, Director Service Delivery, Sciformix Corporation; Vineet Kacker, Managing Director and Global Technical Head, APCER Pharma Europe; Anish Desai, Director, Medical Affairs, Johnson and Johnson; Vishwas Sowani, Country Manager, Revogenex; Milind Sardesai, Assistant Director, Lupin and Mangesh Kulkarni-Group Head, DS&E, Novartis.
Commenting on the recent direction on compensation in clinical trials in India, Gupta, stressed on the questions which were raised in the Parliament relating to clinical trial (CT) deaths. He emphasised that it is not necessary that the deaths have taken place due to the trials but it happened during the CT.
Gupta highlighted various issues like compensation, ‘who is the sponsor’, ‘what is called injury and its definition’, ‘who will give the compensation for negligence by sponsor or investigators?’ and shared his perspective on the same. He also discussed quantum compensation formula and mentioned that till the new formula arrives into the system this (For less than 16 years `73.59 lakhs is maximum compensation paid to for clinical trials related deaths) will remain as it is. He ended his speech with a message, ‘Clarity evolves as we go along.’
Bangera talked about the importance of reporting adverse drug reactions (ADRs) and explained why there have been less number of ADRs reported. He said that less number of reported ADRs in India that doesn’t mean that ADRs are not happening in the country. When we have 2000+ pharmacy colleges, en numbers of nursing homes and various centres, it means that ADRs are happening but it is not being reported.
Bangera felt that the challenges in the public health programmes are basically disease management by the public health providers, not always well diagnosed clinically. Treatments are often initiated in the absence of an adequate diagnosis and there are many insufficient follow ups of patients.
Highlighting on fake drugs monitorisation, which can also play an important role in ADRs, Bangera said, “I feel if we monitor adverse events at the bottom level or grass root level, we will be able to gain more reports accurately and also gain confidence from various channels. We need to encourage patients to report the smallest side effects. Also 2D barcode, quick response codes and scratch off labels on medicines should be encouraged to stop counterfeit drugs.”
Dr Manoj Swaminathan, Global Safety Lead Global Pharmacovigilance Department, Sun Pharma said, “I was amongst the few participants who attended the two-day conference. This was my first ever participation at a DIA event. I was sceptical whether this would turn-out to be another networking platform with little or no learning.
However, I realised that my understanding was incorrect. There were a lot of opportunities for networking. The best session on Day-one was the question and answer session with two EU-QPPVs and on Day-two was the panel discussion with big-five KPOs in India. These two sessions were the first-of-its-kind in the pharmacovigilance arena and these sessions were well accepted by the audience as well.”