It was the year 2001, and on joining the Indian Council of Medical Research (ICMR), I was posted directly under Dr Vasantha Muthuswamy, Senior Deputy Director General and Head, Division of Basic Medical Sciences (BMS). She offered me a seat in her own office and a place in her heart, and this was the beginning of the most extraordinary and warm relationship with the outstanding human being she was. I watched her closely, in awe, day by day discovering more about her. She was kind, loving and thoughtful like a mother. With her brilliant mind and fluency in several languages, I also found her super interactive and loads of fun. Time would fly when she spoke, there would never be a dull moment and one could admire her unique style and ability to analyse complexities and present them in a manner for anyone to understand. Her command and grasp of the subjects dealt with in the BMS Division was enormous, her arguments absolutely wonderful, and she so loved to talk. I observed that she remained unbiased, fair, and fearless despite the undue pressures common at her level. She seemed to know automatically what was right, and I found myself taking mental notes on her amazing persona.
She respected one and all equally, with no preference according to status or rank, and was very approachable. No wonder people entered her room freely, coming for personal, professional, and financial advice or help, and she obliged them all. She loved her office — her room always bursting with energy, full of people, and phone constantly ringing; she would happily always say “Yes” to every kind of work. Her room was flooded with piles of files as she was a member of dozens of committees, never hesitating to travel at the shortest notice, and delivering innumerable lectures. Her Division was like her family, and the internal meetings went on till late in the evenings, as she enjoyed chatting about the day’s proceedings or planning things to be taken up next. Her portfolio included basic sciences and her main interests revolved around Drug development, Traditional Medicine, Reproductive Health and Nutrition, Genetics, Genomics and Biomedical Ethics (human and animal experimentation) and Short Term Studentship Program for Undergraduate medical students. She contributed to a number of guidelines, policies and reports, such as the National Guidelines for Stem Cell Research, Guidelines for Care and Use of Animals in Scientific Research, Guidelines on Animal Experimentation by the Committee for Control and Supervision of Experiments on Animals, Guidelines for the Safety Assessment of Foods Derived from Genetically Engineered Plants, the Guidelines for Good Clinical Laboratory Practices, Guidelines for Accreditation, Supervision and Regulation of ART [Assisted Reproductive Technology] Clinics, the Report of the Dr Ranjit Roy Chaudhury Committee and many other such instruments. Under her guidance, I spent many happy and productive years in ICMR, and during this time, she made sure that each scientist in the Division as well as from several other institutions across the country received a formal training in bioethics.
She was a Founder member of the Forum for Ethical Review Committees in the Asian and Western Pacific Region (FERCAP) in 2000 and of Strategic Initiative for Developing Capacity in Ethical Review (SIDCER), and President of the Forum for Ethics Review Committees in India (FERCI). She remained a member of the Steering Committee of FERCAP for many more years. She was part of several international initiatives involving the development of guidelines, reports, white papers on a variety of topics pertaining to ethics, and also collaborated with the World Health Organization, United Nations Educational, Scientific and Cultural Organization, Joint United Nations Programme on HIV/AIDS, the Nuffield Council, The Drugs for Neglected Diseases Initiative, National Institutes of Health and many others. She made friends easily and had an enormous network with associations from across the world.
Dr Vasantha’s retirement in 2008 seemed to be too early, as she was bubbly and energetic as any youngster, putting in extra hours every day. Her visits to ICMR gradually became infrequent as she moved to Chennai and then to Coimbatore and during Covid-19 pandemic, to join her family in Mumbai. As Head of the Division, she was responsible for more than 18 subject areas but once retired, she decided to focus mainly on Ethics. Between 2010 and 2014, she closely helped ICMR in the preparation of The Biomedical and Health Research Regulation Bill in order to set up a mechanism for regulation of biomedical research in India. Though the Bill could not be approved, it paved the way to incorporation of relevant clauses in the New Drugs and Clinical Trial Rules, 2019, with the creation of a new Chapter IV which required ethics committees to register on the Naitik portal. Her happiness knew no bounds when the ICMR Ethical Guidelines became legally binding for every biomedical research study in India and the National Ethics Committee Registry for Biomedical and Health Research was set up on the Naitik Portal at the Department of Health Research. Her dedicated efforts and far sightedness had made this possible.
In 2015, under the direction of the Director General, ICMR, it was decided to revise the ICMR National Ethical Guidelines and she was appointed as Chairperson of the Ethics Advisory Committee to guide this revision. She had vast experience having led earlier revisions in the year 2000 and 2006 and she made the process comprehensive by appointing sub committees which extensively worked on various sections of the guidelines. Meanwhile, in 2016, the ICMR Bioethics Unit was set up as an independent unit in Bengaluru, and activities in ethics received an enormous boost. It was decided that all activities undertaken by it would be under her leadership, which she happily accepted. In a matter of two years, this extensive work on revision of the guidelines was completed. She devoted many hours to review, line by line, each section of the National Guidelines to achieve perfection. The document was released in October 2017 and as it turns out, this document was found to be extensive, of robust quality, and was recognised globally [1]. Meanwhile, she also contributed to an ethics guidelines for research involving children which was also released on the same day. Following the release, she joined the various dissemination meetings that were conducted across the country reaching out to more than 8000 persons to sensitise them about the newly released ICMR National Ethical Guidelines.
She further guided the creation of several tools and instruments focussing on ethics committee functioning, such as the creation of the “Common Forms for Ethics Committee Reviews” and “The Handbook on ICMR Ethical Guidelines”. During this time, she contributed to the development of an online course for ethics committee members being coordinated by ICMR-National Institute of Epidemiology, and it was a unique model to build capacity in ethics review in India. Dr Vasantha was also member of the committee to develop End-of-Life Care definitions, and the ICMR Consensus Guidelines on “Do Not Attempt Resuscitation”. Her command of ethics, helped India root itself firmly in bioethics and set a benchmark for the rest of the world.
She wanted ICMR to also come up with a “Reference book on Research Ethics” as there is an acute paucity of writings from an Indian standpoint on research ethics. She was determined to publish a book to cover a variety of topics to help researchers and ethics committees. There were numerous meetings of the Editorial group to finalise the topics, speakers, peer review processes being a new type of work. However, the work got delayed due to the pandemic. Despite challenges, the book could be finalised and released on April 7, 2022 [2]. She was happy as this was a dream come true, something that she had always wanted to do.
When Covid-19 struck, ICMR came under enormous pressure to undertake research and deliver, and time was of the essence. Under Dr Vasantha’s chairmanship, ICMR came up with the National Guidelines for Ethics Committees Reviewing Research during Covid-19 and India was among the first few countries to prepare a guidance as early as April 2020, soon after the pandemic struck [3]. She was excited and happy, like a child, when she saw the number of downloads of the guidelines across the world. During this period, ICMR undertook extensive research related to therapeutics, basic sciences, diagnostics, socio-behavioural science and surveillance. The Central Ethics Committee on Human Research was called to action to undertake ethics reviews mostly for the very large multicentric research studies being coordinated by the ICMR Headquarters. The committee was reconstituted under her chairmanship to undertake robust reviews in a time bound manner. This involved huge time commitments and in the position of Chairperson her work load was enormous. She totally dedicated herself to the need of the hour, facilitated time bound reviews, whether full committee meetings, expedited reviews, or exemptions from reviews, working day and night, including on weekends and odd hours, to help ICMR achieve its goal. She encouraged scientific research requiring several rounds of revisions, if the protocols happened to be sketchy and always remained open to all perspectives. The multidisciplinary committee set an exemplary precedent of quality and timeliness that would be hard to follow, since her clear mind and thought processes never gave in to pressure and ensured decision making was methodical.
Her disease came as a huge setback, however despite being under treatment, she continued to work. She surprised us, as she continued to attend online webinars — many of which being international, happened at odd hours of day and night — but she remained a keen learner, always hungry for more knowledge. Her qualities never failed to impress anyone who came in contact with her. She has showered love on and guided the lives of hundreds, and was always easy to reach, encouraging and supportive. Her positive energies, clear thoughts and untiring attitude made her very special. Losing her, we have lost a wonderful human being who was as lovable as a mother, and sharp and insightful as a guide. She was a true ethicist in every sense, unbiased, true to herself and to the nation. I have been very privileged and honoured to have been closely connected with her, “The Mother of Bioethics in India”.
Rest in Eternal Peace, Dr Muthuswamy, you will be dearly missed.