Usha Sharma – Mumbai
Three leading industry associations Indian Society of Clinical Research (ISCR), Indian Drug Manufacturers Association (IDMA), Association of Contract Research Organisations (India) (ACRO) came on a common platform and discussed issues related to the clinical research industry at a recently held panel discussion in Mumbai. The Medical Subcommittee of IDMA in collaboration with ACRO and ISCR organised a panel discussion on ‘Clinical Research in India—Where are we heading?
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In his opening remarks, Dr Rashmi Barbhaiya, CEO, Advinus Therapeutics explained the hitches during the approval process in India. To make his point clear he highlighted that the overall time consumption in the different stages of the approval process in India is long than in other developed countries. While showing his concern towards the clinical research industry, he highlighted that in 2008-09, 246 clinical trials were conducted in India whereas in Korea 397 were conducted. The size of the Indian population in 2008-09 was estimated at 1.210 million and Korea had a population of just 48 million. He projected that the number of clinical trials in India from the current year will go further down.
Investigator—Ethics Committee Members, NGO, Industry and Media were part of the panel discussion. Dr VR Joshi, Director of Research, PD Hinduja Hospital chaired the session and Dr Arun Bhatt, President, ClinInvent moderated it.
Panelists who took part in the discussion were Dr Ashok Vaidya, Research Director, Kasturba Health Society Director and Director, Clinical Pharmacology, BSES MG Hospital; Dr Purvish Parikh, VP and MD, AmeriCares India (NGO) and Chairperson Ethics Committee—Wadia Group of Hospitals; Dr Mohandas Mallath, Consultant, Digestive Oncologist and Ex—HOD Digestive Oncology, Tata Memorial Hospital. Industry panelists included Dr Kiran Marthak, Vice Chairman Medical Sub Committee (IDMA) and Head Global Clinical Development – Lambda, Apurva Shah-Chairman, ACRO (India) and Dr Kratish Bopanna, President, ISCR.
The panel discussion started with the existing issues related to the clinical research industry in India and lack of attention from the regulatory body. Heated discussions followed where the role of media was raised and it was accused of showcasing half-baked stories rather than figuring out the root cause.
On the other hand, the media personnel argued that the news provided by them are sourced from authorised persons.
Shah spoke about compensation guidelines like strengthening the link between industry, associations and regulatory bodies, grading the CROs capabilities and judging them on that ground before making an act on it.
Panelists also highlighted that it is wrongly believed that only those clinical trials are being conducted in India, which could not have been conducted in developed countries. They also informed that trials in India have sufficient insurance coverage for negligence and deaths which occur due to the clinical trials and today even the regulation is being put in place with respect to proportion in which compensation is to be paid for any drug-related adverse event/death. The panelists urged that these points needs to be highlighted by the media in a positive way so that the general public, NGOs and the concerned government officials can be updated of these facts. Another point that was emphasised is that no research is initiated unless the patient included is explained the nature of the study and now even the recording of this event is being agreed upon which itself speaks volumes of the earnestness of the research industry.
“If clinical research is not encouraged then even the wonder drug aspirin would not have taken birth.” Bhatt said.
Parikh mentioned that at times we do not follow the given guidelines not because we don’t know it but we believe that if we follow the given or existing guidelines, we might end up losing the person who is part of the trial.
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The discussion was well hooked by both audience as well as panelists. It was a high energy debate between media experts and the industry. Dr Sanjay Agarwal, Head, Medical Department, Corona Remedies said, “It will be good for the industry if they and media work together. As such CRO conditions are very critical in India due to media exposure. We are not able to get subjects (patients) on whom we can conduct the trials. On the other hand, DCGI is not giving requisite permissions for conducting trials, even for the bioequivalance, and not only due to poor infrastructure of DCGI. I personally feel, they are taking more precautions in new drug approval committee (NDAC) as more clinical doctors are involved in the process as compared to the past.
While sharing his view, Shah said, “The challenges faced by the Indian clinical research industry in the form of regulatory stagnation since last year have brought various stakeholders together to collaborate and eliminate all negative perceptions regarding clinical research. I am pleased with the open and candid discussions we had today between the industry, NGOs, academia and the media on the challenges and the possible ways to overcome those challenges. ACRO has already drafted the Code of Conduct for our members as a proactive measure to ensure compliance of the Indian and global ethical and quality standards among its members. Besides this we are working on other measures to ensure safety of the volunteers on a national level. We welcome the government’s initiative to come out with the draft guidelines on compensation and registration of Independent Ethics Committees (IEC). This, along with, better enforcement of the laws by our regulators will help in eliminating a lot of issues and therefore lead to a more positive environment for clinical research in India.” Marthak suggested, “The prospering clinical research industry has suddenly taken a down turn due to various reasons including adverse publicity in media, irrational thinking by regulatory bodies, ad hoc changes in rules and regulations related to clinical research, tremendous delays in getting NOC for the clinical trials has dissuaded the companies to conduct clinical trials in India. There is a disconnect between what the health ministry thinks and the mode of implementation of the rules. If this continues for a long time, clinical research as a science will have a natural death in the country.”
Mallath said, “India has joined the trials much later and hence there is acute shortage of trained investigators, Accredited Ethics Committees, experienced DCGI inspectors, as well as experienced CROs. If we work together and strengthen all the links, India could regain the lost glory. I do not think that the media alone will be able to save the situation.”
While summing up the session, Bopanna said, “Clinical researchers do not want any shortcuts or concessions with respect to ethical or quality standard and are willing to match the best benchmarks that are suitable to the country. The clinical research industry would like to have a clean and transparent regulatory process and balanced reporting that makes scientific sense keeping in mind our social-economic environment. The clinical research industry has always been ready to work with the regulators to strengthen the process and plug the loopholes where applicable.”
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