The year 2020 has emphasised the need to pay attention to health and life sciences in India. There is an urgent requirement to increase public funding and facilitate private sector funding in both fundamental and translational research. However, along with this funding, it is important that right policies and laws are formulated to utilise the infrastructure and expertise. Below is my wish list of Bills India needs to debate, strengthen and pass in 2021 to form the bedrock of the transformation to a life science leader.
The National Health Bill, 2009: An overhaul of public health legislation has been long overdue in India. The COVID-19 outbreak has brought attention to this underfunded and fragmented system. It will not be surprising if there is some form of new legislation brought in for future pandemic preparedness. Pandemic preparedness is rooted in effective public health services; hence it is important that any legislation caters to all aspects of improving public health. Any new legislation has to embrace three core principles: proportionality (response measures have to be proportionate with the severity of disease), clarity (separation of duties between various departments with no conflict of interest or overlapping functions) and transparency of decision-making. The National Health Bill from 2009 was a great start and debating and passing the bill this year will be a step in the right direction for improving public health.
The Biotechnology Regulatory Authority of India Bill, 2013: The Bill proposed to promote the safe use of modern biotechnology by enhancing the effectiveness and efficiency of regulatory procedures and provide for establishment of the Biotechnology Regulatory Authority of India to regulate the research, transport, import, manufacture and use of organisms and products of modern biotechnology. Currently, biotechnology products are regulated by various governmental agencies depending on the product and technology used. Various committees have suggested streamlining this process by introducing a single statutory body which can assess and approve products in an evidence-based manner. Clarity in the approval mechanism and the presence of a central authority can certainly ease the regulatory pathway for new products and emerging technologies. This is required if India intends to promote more translational research in this field.
DNA Technology (Use and Application) Bill, 2019: This Bill has been presented in Parliament in various iterations and is currently under examination by a Rajya Sabha Committee. The current Bill does two things – creates a DNA Regulatory Board to set standards for DNA profiling and sets up a database to house DNA profiles for forensic use. The effectiveness of this latter objective in India is doubtful, but there is a broader need to set standards for laboratories that offer genetic services. The Bill needs to be revisited in this context. Over the next decade, personalised medicine based on individual genetic profile is expected to revolutionise the healthcare industry. It is essential that the laboratories which lay the groundwork of this genetic sequencing are of adequate standard and follow set protocols to safeguard patient interests.
Biobanking Law and Personal Data Protection Bill: There is a growing demand to collect and maintain human samples for data analysis and retrieval. Large datasets are being created to understand the Indian genome or disease epidemiology. India currently has no explicit laws that govern aspects of biobanking such as regulating access, consent for future research and benefit sharing with donors. A biobanking law is needed to regulate the use of human samples within India and globally. The National Ethical Guidelines For Biomedical and Health Research Involving Human Participants provides guidance on how biobanking can proceed, but stronger and more comprehensive legislation is required. In conjunction with laws to regulate the actual collection and analysis of the data, India also needs to the pass the personal data protection bill to safeguard the privacy of those contributing their data.
Biodiversity Act, 2002: The Biodiversity Act, 2002 was implemented with the purpose of sustainably using and sharing the benefits of use of biological resources present in the country. However, it is fraught with many issues that has led to stalling of research projects. A reworking of this Act is in the works, and will be necessary to ensure India’s biological diversity can be optimally used for further development.
The Agricultural Biosecurity Bill, 2013: The COVID-19 outbreak has shown us the havoc a new disease can wreck on society. While strengthening public health can prevent future catastrophes, measures have also to be taken to protect India’s agriculture. The Agricultural Biosecurity Bill was introduced to “to provide for establishment of an Authority for prevention, control, eradication and management of pests and diseases of plants and animals and unwanted organisms for ensuring agricultural biosecurity and to meet international obligations of India for facilitating imports and exports of plants, plant products, animals, animal products, aquatic organisms and regulation of agriculturally important microorganisms and for matters connected therewith or incidental thereto.” Agricultural biosecurity is as essential as public health security and needs to be revisited in 2021.
India has to heavily invest in developing expertise and infrastructure to become a science leader. However, this investment needs enabling policies to realise its potential. It is critical that India passes regulation that facilitates the development of scientific technologies that can drive the economy, improve health outcomes and support India’s ascent to science leadership.