The Importance Of Implementing Nanotechnology Regulations In India
The Nano Mission is a comprehensive capacity-building program launched in India in 2007 to boost research and development in the field of nanotechnology. The program aims to provide support for basic research, human resource development, research infrastructure development, international collaborations, and related activities, targeting scientists, institutions, and industries throughout the country. The Department of Science and Technology anchors the program, overseen by a Nano Mission Council chaired by a distinguished scientist.
Nanotechnology is an emerging field with vast potential in various significant sectors such as agriculture, healthcare services, and the fertilizer industry. The Indian government has demonstrated its commitment to nanotechnology since 2001, with the launch of the Nano Science and Technology Initiative and more recently the Nano Mission, both supported by the Department of Science and Technology (DST).
Despite robust public investment in nanotechnology research and development for almost a decade, the regulatory and legal framework concerning nanotechnology in India is still in its infancy. India has faced similar challenges in creating effective regulatory and legal frameworks for other emerging and high-technology sectors such as outer space and biotechnology. The need for regulatory clarity is essential for private investment and participation in the market, as well as for creating a platform for innovation and commercialization. It is imperative to address the risks that emerging nanotechnology poses to the environment and human health from a legal and regulatory perspective.
Nanotechnology involves the manipulation of materials at the nano-scale level, where materials exhibit unique physicochemical properties. Leveraging these properties can be significant for commercialization, such as silver’s antimicrobial properties and silicon becoming a good conductor at the nano-scale. The potential for commercialization of nano-materials by utilizing these distinctive properties is significant. The growing use of nanotechnology in drug delivery mechanisms and as nano-biosensors provides a compelling rationale for promoting research and development in this field.
Table of Contents
Comprehensive Regulatory Framework To Manage Potential Risks Of Nanotechnology
The regulatory framework in India for managing the potential risks associated with nanotechnology is not yet fully developed. While there are guidelines in place for the safe handling of nanomaterials in research and industry, there are no specific regulations for nanotechnology. However, existing environmental and waste management laws, such as the Environment Protection Act, of 1986[1], and the Hazardous Waste (Management, Handling, and Transboundary Movement) Rules, of 2008[2], provide a basis for regulating nanotechnology waste and identifying nanotechnology as a hazardous substance.
The existing chemical regulations, such as the Manufacture, Storage, and Import of Hazardous Chemical Rules, 1989[3], and the Chemical Accidents (Emergency Planning, Preparedness, and Response) Rules, 1996[4], may also be applicable to nano-materials, but there is a need for further clarity and definition in this area. The current institutional mechanism for monitoring and implementing environmental laws is overseen by the Central Pollution Control Board and respective State Pollution Control Boards, but they may not be equipped to handle risks associated with nanomaterials.
Different product applications of nanotechnology may also fall under various regulations, such as the Drug and Cosmetics Act, of 1940[5], the Insecticide Act, of 1968[6], and the Food Safety and Standards (Contaminants, Toxins, and Residues) Regulations, of 2011[7]. However, these regulations do not currently address the potential risks posed by nanoparticles.
Occupational health and safety regulations, such as the ‘Guidelines and Best Practices for Safe Handling of Nanomaterials in Research Laboratories and Industries’, are crucial for ensuring the safe handling and disposal of nanoparticles in industrial and research settings. Overall, there is a need for a comprehensive regulatory framework that specifically addresses the potential risks associated with nanotechnology in India.
Outcomes And Significance Of The Mission
The Nano Mission has played a significant role in India’s achievements in nanoscience and technology, with the country now ranking among the top five nations for scientific publications in this field. The Mission has enabled the publication of approximately 5,000 research papers and supported the completion of around 900 Ph.D. degrees. Additionally, it has led to the creation of several practical products, such as nano hydrogel-based eye drops, water filters for arsenic and fluoride removal, pesticide removal technology for drinking water, and nano silver-based antimicrobial textile coating.
Overall, the Nano Mission has helped to establish an ecosystem in India that encourages both fundamental research and application-oriented R&D, with a focus on developing practical technologies and products.
Conclusion
In conclusion, it is imperative for India to establish a robust regulatory framework for nanotechnology that incorporates the strong precautionary principle of the European Union and the weak precautionary approach of the United States. This can be achieved through a dialogue involving multiple stakeholders and by anchoring the critical institutional mechanism for regulation within the Nano Mission. The Food Safety and Standards Authority of India should oversee the regulation of nanomaterials from a food safety perspective, and a coordinated approach between the Nano Mission and the Central Pollution Control Board is required for environmental risk regulation.
To achieve this goal, the Nano Mission could adapt the regulatory tools utilized by the European Union, such as pre-market review and authorization, post-market monitoring and labeling, product recalls, and adverse event reporting. In the long-term, comprehensive legislation is needed to enable incremental regulations based on evidence. Developing a nanotechnology regulatory policy is crucial for India to become a preferred destination for commercial product development using nanotechnology. It will also serve as a model for other emerging technology regulations in India, promoting the safe integration of new technologies while safeguarding the health and well-being of Indian citizens.
However, India’s investment in nanotechnology is significantly lower compared to other countries such as the USA, China, and Japan. Additionally, the quality of research needs to be improved, and the private sector’s involvement in this field is minimal, despite its vast potential. There is a shortage of students pursuing nanotechnology, despite the Ministry of HRD setting a target of 10,000 PhDs per year. Despite these challenges, there is potential for significant growth in nanotechnology in India, with examples of successful practical applications such as the removal of arsenic from contaminated water and self-cleaning technology for the textile industry developed by teams from IIT Madras and IIT Delhi.
In summary, addressing the challenges in investment, research quality, and private sector involvement while developing a robust regulatory framework for nanotechnology will be essential for India to fully leverage the potential of this emerging field. However, with the commitment of various stakeholders and a focus on developing practical applications, India can become a leading player in nanotechnology research and development.
FAQs
What is nanotechnology and how is it being used in various sectors?
Nanotechnology is the manipulation of materials at the nanoscale level, which is typically between 1 to 100 nanometres (nm) in size. At this scale, materials exhibit unique physicochemical properties that can be harnessed for various applications in different sectors. The applications of nanotechnology are extensive, including healthcare, agriculture, energy, and electronics. For example, in healthcare, nanotechnology is utilized for drug delivery, disease detection, and personalized medicine. In agriculture, nanotechnology can be used for crop protection, nutrient delivery, and soil remediation. In the energy sector, nanotechnology has the potential to develop efficient solar cells and energy storage devices. In electronics, it can be used for the development of faster and more efficient computing devices, high-density storage, and sensors. Overall, nanotechnology offers many possibilities for advancing science and technology in various fields.
What is the Nano Mission, and what is its significance in India?
The Nano Mission is an Indian government initiative that aims to promote research and development in the field of nanotechnology. Since its launch in 2007, it has played a significant role in advancing India’s position in the global nanotechnology market. One of the key objectives of the mission is to foster collaboration between academia and industry, with a focus on promoting entrepreneurship in the field. The Nano Mission’s significance lies in its contribution to the development of cutting-edge technologies, which in turn creates job opportunities and drives economic growth in the country.
What are the challenges associated with them?
One of the significant challenges associated with nanotechnology in India is the absence of specific regulations and guidelines that address the unique properties and potential risks of nanomaterials. This has resulted in uncertainty among both researchers and regulators about how to assess and manage the potential risks associated with nanotechnology. Furthermore, there is a lack of standardization in the testing and characterization of nanomaterials, which makes it challenging to compare results across different studies and ensure consistency in regulatory decisions. Finally, there is a need for greater public awareness and engagement on the potential risks and benefits of nanotechnology.
[1]Environment Protection Act, of 1986,<https://cpcb.nic.in/displaypdf.php?id=aG9tZS9lcGEvZXByb3RlY3RfYWN0XzE5ODYucGRm> as accessed in 26th April 2023.
[2]Hazardous Waste (Management, Handling, and Transboundary Movement) Rules, of 2008<https://thc.nic.in/Central%20Governmental%20Rules/Hazardous%20Waste%20(%20Management,%20Handling%20and%20Transboundary%20Movement)%20Rules,%202008.pdf> as accessed in 25th April.
[3]Manufacture, Storage, and Import of Hazardous Chemical Rules, 1989<https://dish.tn.gov.in/assets/pdf/HAZARDOUS%20CHEMICAL%20RULES.pdf> as accessed in 26th April
[4]Chemical Accidents (Emergency Planning, Preparedness, and Response) Rules, 1996<https://dste.py.gov.in/ppcc/pdf/act/THE%20CHEMICAL%20ACCIDENTS%20RULES-1996.pdf> as accessed in 26th April.
[5]Drug and Cosmetics Act, of 1940<https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf documents/acts rules/2016DrugsandCosmeticsAct1940Rules1945.pdf> as accessed in 25th April 2023.
[6]Insecticide Act, of 1968<https://agricoop.gov.in/Documents/46%20of%201968.pdf> as accessed in 25thApril 2023.
Food Safety and Standards (Contaminants, Toxins, and Residues) Regulations, of 2011[7]<https://www.fssai.gov.in/upload/uploadfiles/files/Compendium_Contaminants_Regulations_20_08_2020.pdf> as accessed in 26th April 2023.
King Stubb & Kasiva,
Advocates & Attorneys
New Delhi | Mumbai | Bangalore | Chennai | Hyderabad | Mangalore | Pune | Kochi | Kolkata
Tel: +91 11 41032969 | Email: info@ksandk.com
By entering the email address you agree to our Privacy Policy.