India is home to 2.68 crore persons with disabilities comprising 2.21 per cent of its population (2011 Census). However, less than 16 per cent of persons with disabilities have any assistive aids and appliances. In general, Indian innovators in assistive device technology lack crucial understanding of the market realities and possess a sketchy understanding of issues that have important implications for the disability sector. This has resulted in poor research and engineering of assistive devices, directly affecting the quality of support given to the disabled.Some of the issues that have not been fully understood by Indian innovators are: ‘freedom-to-operate’ and consequent infringement of Intellectual Property Rights (IPR), the necessity to comply with regulatory and industry standards, and the need for robustness, precision, accuracy, and reliability. As cost-effective environmental interventions have not been effectively implemented in India, and because distribution of aids and assistive devices are not effectively funded by the government, almost two thirds of those using assistive devices and rehabilitation technology have purchased the devices themselves from private sources.Those left without assistive devices, or with old-fashioned and inefficient devices are the target for those who enter the market with ‘low cost’ devices, of dubious scientific or medical value, and poor regulatory compliance. As an under-served and under-supported sector, the assistive devices sector only benefits from innovations by those innovators who have spotted the niche funding opportunity and lack of robust competition in the so-called low cost indigenous market.Three recent legal instruments have the potential to significantly improve the access of good quality assistive devices for the disabled India. The instruments, arriving nearly together, set up formidable barriers to poor research and engineering, and non-standard assistive devices being distributed to unwary persons with disability who are in want and discomfort. These are The Rights of Persons with Disability Act, 2016, The Medical Devices Rules, 2017 and The National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, 2017.This Policy Report takes stock of the compliance and regulatory environment in India, critically examines the legal ecosystem relating to research and ethics of clinical trials for assistive devices. It also analyses the gaps in the ethical conduct of research and concludes by highlighting the need to streamline research protocols in order to serve the disability sector in an effective manner. [ The title of this Policy Report was corrected on December 26, 2018. ] [PDF 1.55 MB]

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