Policy Report No. 26

Bridging Multiple Gaps: Strengthening India’s Research Protocols for Assistive Aids

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]

Post a Comment
  1. Comments will be moderated.
  2. Comments that are abusive, personal, incendiary or irrelevant cannot be published.
  3. Please write complete sentences. Do not type comments in all capital letters, or in all lower case letters, or using abbreviated text. (example: u cannot substitute for you, d is not 'the', n is not 'and').
  4. We may remove hyperlinks within comments.
  5. Please use a genuine email ID and provide your name, to avoid rejection.

Policy Report

Farmer Producer Companies: Preliminary Studies on Efficiency and Equity from Maharashtra

Bridging Multiple Gaps: Strengthening India’s Research Protocols for Assistive Aids

The Phenomenon of Political Dynasties Among the Muslim Legislators of Uttar Pradesh

‘Nobody's Children, Owners of Nothing’: Analysing the Indian State’s Policy Response to the Rohingya Refugee Crisis

Living with Pain: Women’s Everyday Lives and Health in Rural Bihar

The Politics and Governance of Social Policies in Delhi: Comparing Cash and In-kind Transfers

Enabling Social Accountability: The Community Health Worker Programmes of Chhattisgarh and Jharkhand

At the City’s Margins: Coal, Land and Livelihoods in Chennai

Rural India on the National Optic Fibre Network: What Happens Next?

Modern Day Slavery: A Study of Tribals and Dalits as Bonded Labour in Brick Kilns

Narratives of Dalit Inclusion and Exclusion in Formulating and Implementing the Forest Rights Act, 2006

The Plight of Kashmiri Half-Widows

Enabling Reporting of Rape in India: An Exploratory Study

Youth Activism and Democratic Politics in India’s Northeast: 2014 Election in Perspective

Dholera Smart City: Urban Infrastructure or Rentier Growth?

Communicating Caste and Gender: Understanding Narratives on Systemic Discrimination in Textbooks from CBSE, TN and UP Boards

Pradhan Mantri Jan Dhan Yojana: An Analysis of Policy Design and Implementation Gaps

Caste, Urban Spaces and the State: Dalits in Telangana

Crisis of Urban Governance in India

The Future of Post Offices as Banking Institutions in India

Intra-party Democracy and Indian Political Parties

Gujarat, Rajasthan and Punjab: The Need for a Border States Group

The Puzzle of the BJP's Muslim Supporters in Gujarat

Web Freedom and Criminal Libel in India

Why Intelligence Fails

Ethics of Disobedience

Decisional Analysis and the Role of the Speaker