The biotechnology industry has grown immensely in the 21st century and is likely to continue on this upward slope. Asia has significantly contributed to the expansion of this industry, and India in particular, has experienced this growth. An article from Asia Times Online reported that between 2005 and 2006, India's biotechnology revenues were US$2 billion, and the annual growth rate averaged 30-35 per cent. According to the Hindu Business Line, revenues are predicted to reach US$13-16 billion (Rs10,273 crore) by 2015. The biotech industry in India has enormous potential and is becoming a leader in the areas of pharmaceuticals, vaccine, and agricultural research and development. However, there are numerous concerns associated with increased biotechnology despite the plethora of benefits that it can provide.

The progress made in the life sciences and biotechnology, while beneficial for humanity and required in the fight against the spread of global diseases and food insecurity, provides more opportunities for exploitation by terrorists. Biotechnology has dual-use potential, meaning technology with positive applications has the potential to be subverted for malicious use. For example, scientific breakthroughs with DNA synthesis and genetic manipulation have allowed researchers to create viruses just by stringing together the genetic code, as seen in 2002 when a team at Stony Brook University in New York, USA assembled the poliovirus genome. While DNA synthesis can greatly avail public health, it could also be utilized to harm human health since it has the potential of enhancing the virulence of a pathogen or making a vaccine ineffective.

Another important and more recently addressed biotechnology issue in India is that of Genetically Modified Organisms (GMOs) and their impact on animal and human health. This is a particularly important issue because India has significantly invested in agricultural biotechnology research and has been severely affected by the global food crisis. GMOs refer to organisms whose genetic material has been altered due to genetic engineering. Investment in GMOs has been hindered by the controversy surrounding the potential harm they could cause, leading many countries to refuse the use of genetically modified crops. However, due to a growing demand and limited supply of farm commodities, innovative and sustainable agricultural methods are being pursued. According to the International Food Policy Research Institute (IFPRI), cotton is the only GM crop India has approved thus far.

In order to deal with old and emerging issues in biotechnology, the Government of India spent two years consulting relevant institutions and experts on the regulation of biotechnology. Previously, the Environmental Protection Act of 1986 was the primary act that regulated GM products. The Department of Biotechnology recently proposed setting up the National Biotechnology Regulatory Authority (NBRA) which would essentially replace the Genetic Engineering Approval Committee (GEAC), the agency that currently regulates GM products. The authority of the NBRA may also extend to food and recombinant drugs, which would streamline some of the regulations of these from the Food Safety and Standards Authority (FSSA) and the Drug Controller General of India (DCGI). The NBRA will be an autonomous body that serves as a "single window mechanism for biosafety clearance of genetically modified products and processes," according to the draft released by the Department of Biotechnology.

The creation of the NBRA has spurred some debate concerning its necessity and whether or not it is the best solution to biotechnology regulation. Some argue that the GEAC has been negligent in abiding by biosafety norms and has been too quick in its approval of products like Bt cotton. There are proponents of the NBRA who feel it is a step in the right direction for biotech regulation. RK Sinha, Executive Director of the All India Crop Biotechnology Association (AICBA), believes that the draft of the NBRA shows "exemplary commitment and sagacity" for biotechnology regulation and that having a single point of contact with clout is a good move. The Task Force on the Application of Agricultural Biotechnology released reports in both 2004 and 2005 that endorsed the creation of the NBRA. However, according to Krishan Bir Chaudhary, President of the Indian Farmers Organisation, the answer does not lie in creating the NBRA; rather the GEAC should be scrutinized and held more accountable for not being thorough enough in its regulation. Another key argument revolves around the vague boundaries of the NBRA and whether certain products will still fall under the jurisdiction of the FSSA and other agencies. According to the Hindu Business Line, the NBR Act has the potential to "set off regulatory turf wars."

The extensive amount of opposition to the NBRA indicates that there are still many blemishes in the draft and it should be further examined and modified according to expert opinion and outside examples of successful biotechnology regulation. The ever-increasing investment in biotechnology and the changing nature of biotechnology research, demands increased efforts to monitor GMOs and potentially harmful research. Whether the issue is the safety of GM crops or the danger of dual-use technology, biotechnology must be thoroughly monitored and regulated in order to ensure that India and all nations benefit from biotech research and development while diminishing the potential negative consequences.