The Key Developments in BioTechnology and its Socio-Legal Impact – Creation of Techno-Legal Awareness


Biotechnology encompasses a vast field of biology. The word biotechnology essentially refers to using living organisms in the development or manufacture of products or to some other technology-based implementation that utilizes biological mechanisms, living beings, or variants in the manufacture or modification of products and structures for an intended task. Biotechnologists’ newly produced techniques and goods are beneficial in research, farming, commerce, and healthcare. It entails the taming of animals, the optimal cultivation of plants, and the enhancement of all of these systems via modern breeding techniques like genetic manipulation and hybridization.

In other words, biotechnology is a set of techniques for fundamental biological processes and also helps in the development of techniques for conducting comprehensive work in the field of biology. Biotechnology also necessitates adequate scientific research in a lab setting, utilizing biometrics for search, discovery, exploitation, and generation from any living input, as well as biomass as a type of biochemical engineering, allowing for the arranging of strong product lines, as well as predicting, devising, constructing, and production, in order to achieve sustainability and patentability.

Biotech includes bioengineering, which focuses heavily on advanced systems in order to interface with and use humans. This implies using engineering ideas as well as translating natural sciences to body tissue, cells, and molecules. Bioengineering is the use of information and even manipulation of biology in order to create beneficial outcomes that enhance a variety of functions in animals and plants. Biotechnology was formerly employed in the brewing process. This technique was previously used in Mesopotamia, Egypt, China, and India. These nations continue to use this technique to make beer.

Societal Issues with BioTechnology

A negative impact on the environment is likely the most frequently mentioned worry among those averse to GMOs (genetically modified organisms). It is extremely hard to anticipate what would transpire in ecology after the addition of a new creature — genetically engineered or otherwise. Consider weeds. If cultivators insert a herbicide-resistant measure into their crop, it is possible that those qualities will be passed on to weeds, making them herbicide tolerant here too.

Furthermore, the authorities are concerned that terrorists would employ biotech to develop new Viruses and bacteria, contagious infections, and poisons for which there are now no remedies. The Centre for Disease Control and Prevention defines bioterrorism as the deliberate discharge of viruses, bacteria, or any other pathogens with the goal of causing damage to or killing humans, vegetation, or animals.

According to the Central Intelligence Agency, the most probable weapon to be employed in an assault is anthrax – a deadly illness generated by a naturally present bacterium located in soils. Viruses and illnesses have been used as lethal weapons throughout humanity. In the mid-1700s, the British troops sickened Native Americans when they were handed linens out of a smallpox infirmary. During WWII, the Japanese dropped bombs on China with disease-carrying fleas. Bioterrorists may now spread illnesses and viruses through explosions, meals and drinks, and even aerosol propellants. However, the Geneva Convention prohibits the deployment of biotechnology as a warfare tool.

In addition to this, it is challenging to defend oneself when one has no idea what he’s up against. Certain emerging inventions, often non-biological in nature, such as nanotechnology, are commercialized before they’ve been adequately vetted for security. Additionally, there is worry regarding technician protection in labs — in even guarded environments — when dealing with unidentified pathogenicity pathogens. Apart from the dispute about whether gene cloning is blasphemous, several moral difficulties emerge about the propriety of licensing biological discoveries and other intellectual property concerns.

Additionally, the ability to synthesize DNA from scratch implies that we may one day be capable of creating life out of a chemical soup, which would very definitely violate a considerable proportion of people’s moral or religious views. There are additional ethical implications, such as when researchers employ human participants in clinical studies. Activists are opposed to biotechnology’s exploitation of animals as lab rats. Researchers have the ability to modify animal DNA for the betterment of mankind’s life. As a result, the animal is reduced to a particular asset instead of a living organism.

Governance and Regulation of BioTechnology Firms and Corporations

Biotechnology was launched and promoted in India for the 1st time in 1977, as Santha Biotechnics produced an indigenous DNA-based compound called the Hepatitis-B vaccine. Bt cotton was approved as India’s inaugural GM crop in 2002. About 7 distinct varieties of crops are made in India by various firms. Presently, India is cited as a significant participant in the area of biotechnology and therefore is achieving great achievements in this sector as a result of its rapid expansion. When it comes to biotechnology legislation, the DBT or Department of Biotechnology recommended that if we go to the year 1977, there existed a suitable regulatory regime that can be utilized. The 1986 Environment Protection Act now governs corporations.

There are 3 significant components that led to the establishment of the 1989 Biosafety Rules that are in place to ensure the correct study, production, supervision, and delivery of biotech-generated goods. The Biosafety Rules are augmented by the Department of Biotechnology’s 1990 Biotech Safety Guidelines amended in 1998 and 1999. There’s also a Regulatory Committee for Genetic Manipulation that monitors breakthroughs in the area of gene manipulation and recommends improvements. The Institutional Biosafety Committee oversees R&D at a producer of various DNA Products. The primary objective of such a body is to guarantee that the production of all DNA goods proceeds regularly and in compliance with the standards of the Biosafety Rules. The Genetic Engineering Regulatory Committee, which is subordinate to the Ministry of Environment and Forests, is accountable for implementing the massive commercialization of toxic components used by businesses to manufacture their goods without mishap.

BioTechnology and Intellectual Property Rights


Modern advances in biological processes have posed basic cultural and ethical issues and complicated intellectual property rights. Besides the pharmaceutical business, biotech developments and studies are critical to medical systems, agriculture, and the polymeric and material industries, among others. Study and advances in the field take a long time and require a significant cost associated with the said result. To even further these goals, a greater emphasis is placed on patenting ideas in the area and financially supporting the burgeoning research industry.

To assist patent applicants, the Department of Biotechnology (DBT) created the Biotechnology Patent Facilitation Cell in the late 1990s. Provision 3(d) of the Patents Act, of 1970 is a crucial clause that has a key impact on the patent rights of innovations in biotech (and specifically, the pharmaceutical industry). The Ministry of Science and Technology has released “Instructions for Technology Transfer and Intellectual Property Rights”, which will assist in increasing the encouragement of researchers, research centers, and academic institutions working on Department of Biotechnology-funded initiatives.

Regulatory and Legal Concerns

Contemporary advancements in biotechnology in India have facilitated the development of markets for biotechnological goods in order to meet the requirements of the enormous population. Additionally, biotechnology has difficulties generating new goods via the use of dubious technologies. Numerous businesses rely entirely on the creation, packing, and appropriate shipping of commodities. India’s biotech sector is minuscule in comparison to healthcare companies. The majority of biotech businesses are devoted only to agriculture and pharmaceuticals. Numerous businesses are also partnering with one another in order to conduct effective research and expand their businesses. This resulted in the expansion of possibilities in this industry. Handling prospects and difficulties become a concern.

Moreover, the biotech sector has a number of ethical concerns, which are very detrimental to the businesses’ survival. In terms of farming, GM crops provide food for human consumption. Often, such crops are not correctly labeled as authorities believe the food items are comparable to present foodstuffs, have a comparable chemical makeup, and have an identical effect on the digestive tract of animals. If it is discovered that a product contains a chemical that triggers an allergy, it is not labeled in any way. In terms of regional and country statistics on biotechnology, the Us has the most companies, with 5700 businesses or 24.39 percent, while Italy, Sweden, South Korea, Mexico, India, and the Netherlands have had the fewest, with 5.6 percent or 3.2 percent percentages. This says that biotechnology businesses have advanced significantly in industrialized nations, while some nations are still in the early phases of growth.


The methodologies utilized in the biotech business have a lot of space for development, given that biotech is still in its infancy. Numerous pharmaceutical businesses have just lately begun to make significant advancements in order to integrate biotechnology into their research and development processes. We must recognize that this biotechnology-based innovation must target not just human healthcare but also agribusiness and sustainability. We all anticipate that in the foreseeable future, humanity would be capable of creating small amounts of purified, sentient chemicals and would be capable of utilizing all of the substances effectively to achieve new, improved therapies at a lower cost.