This Article is written by Akanksha Chowdhury from Amity University, Kolkata. The article talks about the legal aspects of the biotech industry and also the regulatory issues faced by them. It also talks about the advantages and disadvantages along with recommendations which have to be implemented by these industries for a better future ahead.

Introduction

Biotechnology is a very wide area of Biology. In the late 20th and 21st centuries, the Biotech Industry has progressed a lot and has included various types of new sciences such as genomics, combined gene techniques, immunology and advancement in pharmaceutical therapies and pathological tests. The term “Biotech” or “Biotechnology” contains a wide range of procedures so as to turn living beings as per the prospect of human beings, then going back to animal domestication, proper plant cultivation and improving all such systems with the help of advanced breeding methods that comprises artificial selection and hybridization. If we talk about the cultures in Modern Approach, it involves a method known as Genetic Engineering along with cultures of cell and tissue. Biotechnology system consists of approaches on basic biological approaches and also contributes in providing methods for having systematic research in the field of Biology. 

The biotech also involves proper research and development in a laboratory using Biometrics for exploration, exploring, exploiting and production from any of the living source and also biomass as a means of biochemical engineering where the planning of high valued products can be done nicely along with forecasting, formulating, developing and manufacturing in order to have sustainable development and also patented. Biotech conversely involves bioengineering which emphasises on higher systems so as to interface and utilise human beings. It means applying the principles of engineering and also converting natural sciences to tissues, cells and molecules. Bioengineering involves usage of knowledge and even manipulating biology in order to achieve positive results which can improve a lot of functions in the animals and plants. Biotechnology was earlier used in the process of brewing. This method was earlier introduced in countries like Mesopotamia, Egypt, China and India. These countries still practice this method in order to produce beer. In the brewing process, malted grains convert the starch from the grains into sugar and then by adding yeasts, beer is finally produced for drinking. 

Biotechnology has even contributed a lot in the field of antibiotics. In the year 1928, Alexander Flemming had discovered a type of mould which is known as penicillium. His well-discovered mould had led to the purification of antibiotic compounds which was produced by Howard Florey, Ernst Boris Chain and Norman Heatley. Penicillium became the first-ever popular and sold drug which helps in the cure of bacterial infections in humans in the year 1940. There were many great discoveries and research made in the field of biotech and thus, the commercial validity of a biotech industry was made in the year 1980 when the US court had ruled out a statement saying that even genetically produced microorganisms could also be patented. This matter came up in the case of Diamond v. Chakravarty. In this case, Ananda Chakravarty, who was born Indian used to work in the Genetic Engineering Industry. He had produced a genetic particle which had the capability to break crude oil which had the capability of treating oil spills.

Meaning of biotechnology regulatory effect

There has been a lot of controversy regarding GMOs or Genetically Modified Organisms with respect to our food which we eat and also the farming patterns that we have adopted. Our country India is recognised to be a part of Convention of Biological Diversity, 1992 and they have also ratified the Cartagena Protocol on Biosafety in order to protect our entire diversity from dangerous and hazardous GMOs in January, 2003. The Genetic Engineering Approvals Committee, which we have presently and governed under the Ministry of Environment and Forests Association is responsible to approve Genetically Engineered Products in India. India does not have a proper statue or provision or law in order to regulate Genetic Industry fully. The conflicts which are happening in the field of GM are an exact example of conflicts in the country. The violation of rules, regulations and norms are taking place continuously each and every time because there is no proper law or bill which can govern this situation. After proper analysis and clear set of provisions, finally a new bill was introduced by the Government in the year 2013. This bill is called Biotechnology Regulatory Authority of India bill or BRAI. 

This bill came into the Lok Sabha by Mr. Jaypal Reddy, Minister for Science and Technology. Talking about this bill, this bill was formed in order to promote a safer use of Modern Biotech. As per the statements in the bill, there will be one chairman followed by two full time and two part time members who will be fully responsible for handling proper operations in the successful working of the committee as a whole. These committee members should have knowledge in the field of biology, life sciences, health care and botany. The regulatory body will be fully recognised as an autonomous and statutory body that will be responsible for transporting, importing and manufacturing of genetic products. The body will also help in clinical trials for certain drugs or medicines. The body will be responsible for managing the biodiversity of the entire country and promote safer operations for the goodwill of the entire country as whole. It will also ensure safety to the human and animal environment for a better tomorrow. 

How are biotechnological companies regulated

Biotechnology was first introduced and popularised in India in the year 1977, when an indigenous DNA technology-based product known as Hepatitis-B vaccine was developed by Santha Biotechnics. The permission for the first ever GM crop in India was given for Bt cotton in 2002. There are around seven types of crops manufactured in India by various companies. Today, India is recognised as one of the key players in the field of biotechnology and is making a lot of progress in this field by having immense growth. Talking about regulation of Biotech Companies, there was a recommendation given by DBT or Department of Biotechnology that if we look back in the year 1977, there was a proper regulatory system which could be adopted. Now, the companies are regulated as per Environment Protection Act, 1986. 

There are three important provisions which contributed in the formation of Biosafety Rules, 1989, which are there for proper research, manufacture, regulation and proper supply of biotech generated products. The Biosafety Rules were supplemented by Biotech Safety Guidelines which were issued by the Department of Biotechnology in the year 1990 and then it was revised in the years 1998 and 1999 respectively. There is a Regulatory Committee on Genetic Manipulation, which looks in the developments happening in the field of genetic manipulation and provides better ways for advancements. The Institutional Biosafety Committee (IBC) is responsible for research and developments happening in the manufacturer of several DNA Products. The main motive of this committee is to ensure that the manufacturing of all the DNA products are going on normally as per the provisions mentioned under Biosafety Rules. The Genetic Engineering Regulatory Committee which is governed under the Ministry of Environment and Forests is responsible for approval of large-scale commercialisation of Hazardous substances used by the companies in order to produce the products without any problem. 

Legal and regulatory issues in biotechnology

There are around three issues which are legal and regulatory under Biotechnology. These issues are as follows: –

Managing the opportunities and challenges

The recent developments in the field of biotech in India and around the world has given immense gains in the field of agriculture, food, pharmaceuticals etc. It has created an opportunity for markets selling biotechnological products in order to cater the needs of the huge population. Also, biotech is facing challenges in developing new products by using sceptical technologies. Many companies are fully dependent on manufacture, packaging and proper transportation of the materials. India’s biotechnology industry is really very small compared to the pharmaceutical industry. Most of the biotech industries carry out activities which are only focused on agriculture and pharma. Many industries are also collaborating with other industries in order to have a proper R&D and also diversify their business. This had led to opening of wider opportunities in this field.

Overview of issues for discussion

Talking about the issues, the biotech industry has certain ethical issues which is really very harmful for the industries to survive. Talking on the basis of agriculture, GM crops are the source of food for people. Many times, those crops are not labelled properly because agencies think that the food products are based on similarity to existing foods, its chemical composition and effect on the digestive system of animals. If a food is found to contain a chemical which causes allergies, is not at all labelled. 

Regional and country reports

Talking about reports on biotech based on regions and countries, the highest number of industries are located in the USA i.e. 5700 companies or 24.39% and the countries which have the lowest companies are Italy, Sweden, South Korea, Mexico, India and the Netherlands which represent 5.6% or 3.2% shares. These states determine that the biotech industries are developed a lot in the developed countries like Western Europe and Brazil. While there are some countries which are under the initial stages of development like China or Brazil.

Issues and challenges

The major issues and challenges that the biotech industry faces are as follows: –

High Level of Risk

Many Biotech companies are given patents for their products that are produced by them so that they can recover all the expenses that they have invested in the process of Research & Development. Once their patent expires, the products have a wider popularity in the market as compared to their competitors. The main problem which arises over here is that the investors have to weigh a factor that this period leads to a huge risk due to delayed results through Research & Development. 

Level of Affordability

The second big challenge faced by biotech industries is the level of affordability. Many drugs require a huge scale of amount and also many firms do not trust the R&D methods used by these industries in order to make a proper product for the use of the public at large. 

Problem of Privacy

Another main issue which we face in this industry is the problem of privacy. Many data are stolen by the rival industry and hence they use it in their product in order to gain huge profits in the markets. This is also a huge challenge for the industries and thus they need to protect it really very strictly.

Advantages and Disadvantages

Talking about Advantages and Disadvantages, some think that this industry is good and some think that it is dangerous. The advantages and disadvantages of Biotech are described as follows:

Advantages

1. It can help a lot in the improvement of health and hunger of people.
2. It creates a sense of flexibility in the food chain.
3. It provides opportunities in the field of medical advancements.
4. It allows us to preserve all the resources.
5. It helps in elimination or minimising of waste resources.
6. It can even reduce the rates of infectious diseases.

Disadvantages

1. It creates an environment on all or nothing approach.
2. It can also ruin a lot of croplands.
3. It is a field which consists of many unknown areas.
4. It is so dangerous that it can be used for destruction.

Conclusion

In the biotech industry, the methods which are used have an opportunity in a huge room in order to get improvements for considering the fact that biotech is currently undergoing an early stage. Many pharma companies have started very recently making some bigger breakthroughs in order to incorporate biotech into the R & D process. We have to understand the fact that it is not only human health but also there is agriculture and sustainability which has to be addressed by this biotech technology which is based on biology. We all believe that in the coming future we will have the capacity to produce minimal quantities on the basis of pure, compounds that are human-derived and will be able to use all the compounds nicely in order to attain new and improvised therapeutics at a lesser price.

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