Why India Needs Nanotechnology Regulation Before it is Too Late

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“For us (India) to fully harness the advances made in nanotechnology and consolidate our leadership in the field, we must work towards building a regulatory framework encompassing public safety.” – Prateek Sibal

India ranks third in the number of research publications in nanotechnology, only after China and the US. This significant share in global nanotech research is a result of sharp focus by the Department of Science and Technology (DST) to research in the field in the country. The unprecedented funding of Rs 1,000 crore for the Nano Mission was clearly dictated by the fact that India had missed the bus on the micro-electronic revolution of the 1970s and its attendant economic benefits that countries like China, Taiwan and South Korea continue to enjoy to this day.

At the same time, the success of the Nano Mission is not limited to research but also involves training the required human resource for further advancement in the field. An ASSOCHAM and TechSci Research study reported in 2014: “From 2015 onwards, global nanotechnology industry would require about two million professionals and India is expected to contribute about 25% professionals in the coming years.”

A missing element in India’s march towards becoming a nanotechnology powerhouse is the lack of focus on risk analysis and regulation. A survey of Indian practitioners working in the area of nano-science and nanotechnology research showed that 95% of the practitioners recognised ethical issues in nanotech research. Some of these concerns relate to the possibly adverse effects of nanotechnology on the environment and humans, their use as undetectable weapon in warfare, and the incorporation of nano-devices as performance enhancers in human beings.

One reason for lack of debate around ethical, and public-health and -safety, concerns around new technologies could be the exalted status that science and its practitioners enjoy in the country. A very successful space program and a largely indigenous nuclear program has ensured that policymakers spend much of their time feting achievements of Indian science than discussing the risks associated with new technologies or improving regulation.

It is not surprising then that products like silver-nano washing machines or insecticides with nanoparticles continue to be sold in the Indian market without any analysis of the risk associated with their use. This – despite the fact that the government itself has acknowledged that nanoparticles of sizes comparable to that of human cells can be deposited in lungs and “may cause damage by acting directly at the site of deposition by translocating to other organs or by being absorbed through the blood.”

A study by the Massachusetts Institute of Technology, Boston, on the toxicity of nano-materials found that carbon nanoparticles inhaled by rats “reached the olfactory bulb and also the cerebrum and cerebellum, suggesting that translocation to the brain occurred through the nasal mucosa along the olfactory nerve to the brain.” This ability to translocate opens up questions about the effect different types of nanoparticles could have on human health.

Many commonly used products have nanoparticles; for instance, titanium dioxide nanoparticles are widely used in sunscreens and cosmetics as sun-protection. In the US, the National Institute of Occupational Safety and Health has issued safe occupational exposure limit of 0.1 mg/m3 for nanoscale titanium dioxide. This was after reports of incidences of lung cancer in rats at doses of 10 mg/m3 and above surfaced. There is also a concern that nano-scale titanium dioxide particles have higher photo-reactivity than coarser particles, and may generate free radicals that can damage cells.

The challenge that remains in front of policymakers is that of regulating a field where vast areas of knowledge are still being investigated and are unknown. In this situation, over-regulation may end up stifling further development while under-regulation could expose the public to adverse health effects. Further, India’s lack of investment in risk studies only sustains the lull in the policy establishment when it comes to nanotech regulations.

The Energy and Resources Institute has extensively studied regulatory challenges posed by nanotechnology and advocates that an “incremental approach holds out some promise and offers a reconciliation between the two schools- one advocating no regulation at present given the uncertainty and the other propounding a stand-alone regulation for nanotechnology.”

Kesineni Srinivas, the Member of Parliament from Vijayawada, has taken cognisance of the need for incremental regulation in nanotechnology from the view point of public health and safety. (Disclosure: The author worked with the Vijayawada MP on drafting the legislation on nanotechnology regulation, introduced in the winter session of Parliament, 2015.)

In December 2015, Srinivas introduced the Insecticides (Amendment) Bill in the Lok Sabha to grant only a provisional registration to insecticides containing nanoparticles with a condition that “it shall be mandatory for the manufacturer or importer to report any adverse impact of the insecticide on humans and environment in a manner specified by the Registration Committee.” This is an improvement over the earlier process of granting permanent registration to insecticides. However, the fate of the bill remains uncertain as only 14 private member bills have been passed in Parliament since the first Lok Sabha in 1952.

More recently, the DST released the ‘Guidelines and best practices for safe handling of nano-materials in research laboratories and industries’. The guidelines which are precautionary in nature lay out methods for safe handling and disposal of nanoparticles by researchers and the industry. Though much delayed, it is a welcome step towards safer nanotechnology research in India.

For us to fully harness the advances made in nanotechnology and consolidate our leadership in the field, we must work towards building a regulatory framework encompassing public safety. Without such a provision, any mishap or catastrophe precipitated by the use of nanotechnology could leave a great opportunity out of our reach.

Prateek Sibal will be joining Sciences Po (the Paris Institute of Political Sciences), Paris, as a Charpak Scholar in 2016.