Biotechnology can be described as the use of biological mechanisms in technical applications. Biotechnologists use biological organisms or components of those biological organisms to create a novel product or procedure that benefits the environment and/or human quality of life.
Clinical diagnostic test kits, vaccinations, and biological therapies utilized for scanning and analyzing are examples of advanced biotech medical devices for effective diagnosis and disease prevention purposes.
Because of contagious and infectious diseases, public health has become a major emerging concern around the world, and biotechnology has played a pivotal role in addressing these issues since it has the ability to minimize global health disparities through the development of promising and new technologies.
Biotechnology has improved health, life quality, general well-being, and life expectancy around the world. Biotechnology is about to reshape and restructure the existing healthcare system.
In this article, we examine the existing scenario and evolution of biotechnology in India and the profound impact that it has had on the healthcare sector, and how biotechnology’s new genomics technologies have modernized medicine and reshaped our perception of health and the provision of healthcare services.
Introduction: Introduction of the Area of Study
Since the post-traditional modern age, a lot of technological progress has taken place in every field of science, and biotechnological science also did not remain untouched. It has made a significant contribution to the expanding public and global health requirements. Since its inception, it has transformed mankind.
Karl Ereky, a Hungarian engineer, introduced the term “biotechnology.” Existing medications can be manufactured more conveniently and economically using advanced biotechnology. Medicines meant to combat human ailments were the first genetically modified products with the use of biotech.
Besides that, a wide range of gene therapy techniques has been developed to treat inherited disorders such as Parkinson’s disease, influenza, HIV, cancer, and hepatitis.
Biotechnology means the practice that involves the procedure of controlling and deliberately manipulating biological systems (typically living cells or cell components) or their associated products in order to create, modify, improve, or efficaciously manufacture or process useful products and cost-effective solutions.1 Medicine, as well as its availability and accessibility, are a crucial aspect of a country’s healthcare system, and biotechnology helps to ameliorate the quality of this important resource to provide better and affordable medical aid.2 Affordable healthcare solutions have the ability to meet the needs of all the general people, particularly those with lower incomes.3 Such innovation-driven efforts not only enhance the living standard of the masses but also establish domestic enterprises which provide economic gains in the global market.
The Indian constitution guarantees free healthcare services to all its citizens, and so all government hospitals are required to provide everyone with free healthcare facilities.
However, in practice, the private healthcare sector is in sole control of the majority of healthcare services in India, and most healthcare costs are borne by patients and their family members.4 Therefore, new innovations in the field of biotechnology become a considerable necessity to achieve and provide a better living standard however, India is already on the verge of developing its health biotech sector but still lacking due to its limited financial means and redundant policies to bolster this sector.
Literature Review
To analyze the effect of biotechnology on the healthcare system in India, academic research has been done by studying the relevant kinds of literature that helped in understanding the situation adequately.
Biotechnological advancement is very crucial for progress in the healthcare sector, especiaiotechnology in the Healthcare Industry, Amit A. Charan, S. Morya, and A. Danquah-Amoah). A biotechnological revolution in India can lead to the formation and establishment of pharmaceutical-based multinational corporate giants
that can turn out to be tremendous economic potential for the country (Health Biotechnology in India, L.M. Srivastava). The government must frame policies with a primary focus on wellbeing (Biotechnology Policy in India, Alok C. Samal & Piyal Bhattacharya).
Improvement of biotechnology can contribute to modern molecular diagnostics, better quality of medicines, the development of vaccines for infectious diseases, nutrients rich food, and a clean environment through proper treatment of waste, all of this can promote better health. (Role of Biotechnology in Improving Human Health, Hina Afzal, Khadija Zahid, Qurban Ali, et al.).
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Indian biotech is failing to meet the country’s substantial health requirements, and it is also failing to position itself to benefit from the much more potentially profitable international market. The country’s health biotech enterprises work in close proximity to the alarming health disparities due to a lack of financial and political support (India’s health biotech sector at a crossroads, Sarah E Frew, Rahim Rezaei, Stephen M Sammut et al).
1 Archibald, Amit A. Charan et al, “The Impact of Biotechnology in the Healthcare Industry” 10(19) Tends in
Biosciences 3358 (2017).
2
Id. at 3359.
3 K. Vijayaraghavan and Mark A. Dutz, “Biotechnology Innovation for Inclusive Growth: A Study of Indian
Policies to Foster Accelerated Technology Adaptation for Affordable Development” PRWP 2 (2012).
4 The Growth of Healthcare and Hospital System in India, available at: https://aihms.in/blog/the-growth-ofhealthcare-and-hospital-system-in-india/ (Last visited on May 16, 2022).
Research Methodology
This research is based on a combined approach of qualitative, doctrinal, and non-doctrinal research methods. The idea is supported by various journals, articles, newspaper articles, thesis, and judicial rulings gathered from various legal databases and websites. The qualitative method of research has been used to understand the existing situation of the biotechnological setup in India and to adopt measures to cope with the situation.
Hypothesis
The hypothesis on which this research proceeds is that “From a public health point of view, a systematical approach backed with financial and political aid is necessary to enhance and establish the biotechnology to provide better medical facilities and healthcare in India.”
Research Question
The research aims to assess and analyze the change in biotechnology from the earlier periods to the contemporary times with respect to healthcare in India. The significance of the advance in biotech and its impact on healthcare and wellness of the people. And the problems arising during the implementation of the policies regarding the improvement of biotech in India. Then,
attempts are made to find out reasonable solutions and suggestions to upgrade the existing structure of biotechnology with reference to medical assistance and health care services.
Citation
The citation style has been followed in this article is ILI Rules of Footnoting.
Characterization
This article has been divided into five chapters.
Chapter I is the introduction, it introduces the area of study i.e. biotechnology and its impact on the healthcare system that exists, and also includes the literature reviewed, research methodology, objective, and hypothesis of the topic.
Chapter II deals with the history and evolution of the healthcare system pertaining to biotechnology in India and the different facets of traditional knowledge.
Chapter III contextualizes the evolution and development of biotechnology by the time across the country and its dynamic nature.
Chapter IV studies and analyses the effect of biotech advancement in enhancing the medico-healthcare
services across India.
Chapter V presents the conclusion and puts forth suggestions for the up-gradation of biotech to improve healthcare facilities.
Evolution of Right to Healthcare & Biotechnology in India
The Supreme law which promises to ensure everyone with the right to healthcare as a fundamental right in India is the Constitution. Under Articles 39, 41, 42, and 47 in the Directive
Principles of state policy5
it is the responsibility of the state in ensuring basic nutrition, basic standard of living, public health, protection of workers, special provisions for disabled persons, and other health standards. Further, Article 21 of the Indian Constitution6 provides for the right to life and personal liberty as a fundamental right and within its purview, it covers the right to healthcare as a fundamental right to everyone. However, this cannot be termed as the establishment of the right to healthcare in India, rather, since ancient times there were traces of healthcare facilities provided to the people in India.
5 The Constitution of India, arts. 39, 41, 42, 47.
6 The Constitution of India, art 21
The Ancient Indian medical system was more a kind of holistic treatment approach where we found traces of healthcare way back to 5000 BCE in the Vedic Period, where we came across the description of the Dhanwanthari, the Hindu god of medicine. Further, we also found to have developed the concept of ‘Ayurveda’ under Atharvaveda.
There were also compilations like “Charaka Samhita”, the famous treatise on Medicine compiled by Charaka, and the surgical skill enunciated by Sushrutha, who is known as the father of Indian surgery.7 However, the construction of the most outstanding hospitals was recorded during the period of King Ashoka from 273-232 BCE. Also, the Universities of Taxila and Nalanda use to teach certain Indian medicine principles to the students.
During the 17th and 18th centuries, there was a slow and steady growth of the modern system of medicine in India, and moving on to the British era, the development of new trends in medical systems and a transition from surveys to microscopic studies in medicine was recorded in 19th and early 20th century in India.
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Additionally, the first hospital in India that was established in 1679 under British Rule was the Madras General Hospital after which the Presidency General Hospital in Calcutta was formed in 1796 and about four hospitals were formed in Madras between 1800 to 1820.
The main aim of establishing these hospitals was to fulfill the growing need for health professionals and thereby, Calcutta Medical College was established by an order in February 1835, which was the first institute of western medicine in Asia.8 Alongside healthcare, India, being an ancient civilization, is also one of the countries with traditional knowledge of biotechnology.
As Indians were familiar with the vast knowledge of the environment and properties of plants and animals. And so, processes like fermentation were used to produce a variety of foods, traditional medicines, etc., and were also widely used in agricultural activities. Moreover, modern biotechnology was developed around the mid-eighteenth century across the world with the emergence of modern technology, machines, and devices.
And after all these developments, India became the first country to create a separate Department for Biotechnology, within the Ministry of Science and Technology in March, 1986.9 It was opined by the legislature that India would not progress to the desired extent if we don’t recognize the importance of biotechnology & its scope in the Indian context.
This step is also relevant, as it has subsumed many of our macro-economic issues of growth within that science’s development and ensuring a good medical healthcare system in India. Hence, the concept of biotechnology is not so old, but the traces of health infrastructure in ancient India reflects the vigilant instinct of the people in safeguarding and ensuring the rights of healthcare in India, since time immemorial.
Therefore, it is relevant to note that India possesses its traditional knowledge of health as well as of biotechnology and when merged with present-day science, biotech can significantly improve the healthcare standards in the country and can serve the purpose of betterment of medical facilities across the world.
7 Dr. S. K. Jawahar, “Healthcare Scenario in India”, ICU Management & Practice, ICU Volume 6 – Issue 4 – Winter
2006/2007, available at: https://healthmanagement.org/c/icu/issuearticle/healthcare-scenario-in-india. (Last visited
on May 17, 2022).
8 Muhammad Umair Mushtaq, “Public Health in British India: A Brief Account of the History of Medical Services
and Disease Prevention in Colonial India”, Indian J Community Med. 2009 Jan; 34(1): 6–14, available at:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2763662/. (Last visited on May 17, 2022)
India’s Biotechnological Landscape
India’s biotechnology industries have reached exceptional levels as a result of the recent economic expansion. The country could reorganize the biopharma and medical services industries. India’s biotech industry is among the country’s fastest-growing industries.
Given the rising private investment in Research and development and the sector’s low starting point, there is enormous potential for future rapid expansion, particularly in biopharmaceuticals, bio-Agri, and bio-services. India, as a significantly growing economy with a developing biotech sector, is highly interested in global biotech patterns.
Given the country’s existing wealth of biodiversity, indigenous peoples’ traditional knowledge, appropriate policy measures to foster the sector, and the arrival of private sector companies driving the growth of the sector, and so biotechnology can best be considered as a breakthrough industry with a lot of room for growth in India.10
The companies are focusing on the development of novel techniques and their implementation by collaborating with the other participants11 and Global Biotechnology Market is estimated to reach $726.8 billion by 2025 growing at a CAGR of 8.1 percent from 2017 to 2025.12
Among all, the biopharmaceutical sector dominates the biotechnology market, accounting for 55 percent of total revenues in 2018, followed by the bio-agriculture sector with 23 percent of the market share.13 With a 3 percent market share in the global biotech sector, India is one of the top 12 destinations for biotechnology worldwide.
India is also the world’s largest supplier of DPT, BCG, and measles vaccinations. The Indian biotech sector now has around 3000 biotech budding companies and is expected to expand to above 10,000 by 2024. In India, there are about 2800 biotech industries, and around 60 percent of the total biotechnology items available in the marketplace are healthcare products.14
The biopharmaceutical industry of India, specifically, offers huge development potential. This seems to be due to the country’s huge population and the significant income increase expected from healthcare and medical tourism.15 The sector counts vaccines, diagnostics, and recombinant therapeutics among its major drivers of growth.16 This sector has generated worldwide best-known Indian enterprises such as the Serum Institute of India, Biocon, and Shantha Biotechnics moreover, dating back to the early 1900s when the Haffkine Institute in Mumbai and the Pasteur The Institute of India were producing vaccinations.
Furthermore, India assists in the distribution of vaccines to international organizations such as the World Health Organization and the United Nations International Children’s Emergency Fund. Indian biopharmaceutical companies have also made considerable progress in the past years.
While major corporations such as Sanofi and Takeda are working to produce a vaccine for the Zika virus, an Indian company, Bharat Biotech, has become the first to file for a relevant patent.17
The Indian biotechnology sector is experiencing exponential growth, requiring the development of biotechnology policy and regulation, and also some structural changes. The Report advocated the establishment of an autonomous, statutory, and professionally-led ‘National Biotechnology Regulatory Authority’ (henceforth NBRA), (2004) as the first national biotechnology authority of India.
The proposed NBRA was designed to have two separate wings−one addressing food and Agri-biotech, while the other dealing with medical and pharmaceutical biotechnology.18 The Department of Biotechnology (hence referred to as DBT) established the ‘National Biotechnology Development Strategy’ in 2005, which outlined a ten-year visionary action plan for biotechnology in India.
To achieve its goals, the Strategy would include multi-stakeholder discussions, addressing all pertinent concerns in the biotech sector. In addition, there are other authorities to manage the biotech sector in particular Indian states.
Some Indian states are eager to embrace the benefits of biotechnology applications, while others are suspicious of this cutting-edge technology.19 As a result, each state’s biotechnology policy and laws differ from each other.
Therefore, there is an urgent necessity for drafting as well as implementing a well-defined ‘Biotechnology Policy’ at the national and international levels. For our country’s socio-economic well-being to achieve its utmost potential, the aforesaid policy framework should be the outcome of the broad discussion with all stakeholders in the field of biotechnology, including researchers, educators, regulatory agencies, and policymakers.
9 Department of Biotechnology, Ministry of Science & Technology, Government of India, available at:
https://dbtindia.gov.in/about-us/introduction.
10 A. Padmanabhan, R. Shashank Reddy et al., Modern Biotechnology and India’s governance Imperatives 7
(Carnegie India, New Delhi, 2017
11 Supra note 8 at 4529.
12 Global Biotechnology Market Global Scenario, Market Size, available at:
https://www.giiresearch.com/report/var642080-global-biotechnology-market-global-scenariomarket.html (Last
visited on May 17, 2022).
13 India- a Biotech Growth Catalyst, BioTech Times, available at: https://biotechtimes.org/2020/03/02/india-abiotech-growth-catalyst/ (Last visited on May 17, 2022).
14 Supra note 8 at 4529.
15 Supra note 9 at 8.
16 Id. at 9.
17 “An Indian Biotech Company Has Been Developing Zika Vaccines for Over a Year,” Quartz India, available at:
https://qz.com/609291/this-indian-biotech-firm-is-the-worlds-first-to-ready-a-zika-vaccine-for-testing/ (Last visited
on May 17, 2022)
18 Alok C. Samal and Piyal Bhattacharya, “Biotechnology Policy in India” available at:
https://www.researchgate.net/publication/316989089 (Last visited on May 17, 2022).
19 Ibid
4 Biotechnological Advancement and its Scope under Indian Healthcare System
In India, about 28% of the total population does not have access to any kind of healthcare facilities, which constitutes a huge number in a country having the world’s second-largest population.
The cost of hospitalization, diagnosis, treatment and surgical procedures is majorly borne by the patients and only a few employees in the public and private sectors get the costs reimbursed in developing countries.
As a result of its high cost and scarce availability, the majority of patients use and have access to only the minimum medical facility. Thus, with the enhancement of science & technology, we can overcome the gap between developed and developing nations like India.
Biotechnology is known to be for the utilization of biological processes, organisms, or systems to produce products that are anticipated to improve human lives hence, with the enhancement of biotechnology we can ensure a dignified life under Article 21 of the Indian Constitution.
In developing countries there are still millions of people to whom the benefits of modern medicines have not been reached but, through new science and technology, we can effectively enhance the efficacy of public healthcare in these countries.
Further, in the fight to improve global health needs and in addition to implement effective public health measures, there is a requirement for rapid and efficient diagnostic tools like new vaccines and drugs, efficient delivery methods and novel approaches to therapeutics, and low-cost restoration of water, soil and other natural resources.20 Therefore, with the introduction of biotechnology there will be a significant reduction in the prices of vaccines and their smooth distribution.
Modern biotechnology can be used to manufacture existing drugs more easily and cheaply. Also, the economic developments of the healthcare industry depend on the healthcare system of a country, but in India, it is still available to a very small fragment of society.
There are various kinds of vaccines developed by the tremendous use of biotechnological approaches which have been used globally to cure human health challenges. Additionally, there are several Indian biotechnological firms that have focused their businesses on the development, manufacturing, and marketing of vaccines.
The principal use of these vaccines is to simply stimulate the patient’s immune system against infectious agents like viruses or bacteria without causing any disease itself.
The Indian-based company, Shantha Biotechnics21 now supplies nearly 40% of the United Nations Children’s Fund’s (UNICEF) global requirement for the Hep-B vaccine, which is being distributed globally, including countries of Africa and Latin America.22 Further, the Serum Institute of India (Pune) is not only the largest vaccine supplier to the government of India’s expanded program on immunization (EPI), but it is also India’s largest exporter of vaccines with a 138-country distribution network.23 Likewise, a New Delhi, based company named, Panacea Biotech supplies its oral polio vaccine to India’s expanded program on immunization and to UNICEF.
Very recently, in Covid times the Apex court has also observed the importance of providing vaccines at affordable prices in the Indian healthcare sector. In the case of In Re-Distribution of Essential Supplies and Services During Pandemic,24 the Supreme Court has clearly specified that the end use of the vaccines, whether purchased by the Centre or the remaining 50%, is the same,
thus the vaccinations being provided to citizens constitute a valuable public good.
Discrimination cannot be made between different classes of citizens who are similarly circumstanced on the ground that the Central Government will carry the burden of providing free vaccines to a certain particular group of society only.
Although, a 2004 report by the United Nations Development Program (UNDP) argued that a strong private sector contributes to economic growth and reduces poverty.25 However, the UNDP report did not focus on health issues, and more research is needed to understand how the domestic private sector can best be harnessed to address local health needs in developing countries.
Further, International recognition of vaccines’ impact and increased global demand for vaccines have stressed the need for global strategies to assure the timely provision of low-price vaccines through policies supporting free and universal access.26 But, this transition in the Indian medical and healthcare sector of generating vaccines by using biotechnology will render the right of people to be vaccinated equality27 and at affordable prices irrespective of the private and public vaccine providers.
It is thus essential to invest efforts to develop broad manufacturing capabilities to expand their capabilities for scale-up and
large production of low-cost vaccines.
Further, it can also help in enriching the Nutrients by way of producing genetically modified food. Genetically modified foods are made by inserting genes of other species into their DNA.
These foods are useful in controlling and preventing the occurrence of certain diseases. By modifying the DNA system of these foods, the properties causing allergies are eliminated and help in the faster growth of the foods that are grown traditionally.
Subsequently, the increased productivity will provide the population with more food and can help in enriching the nutrition
level and living standard of the people in India. Genetically engineered foods are reported to be high in nutrients and contain more minerals and vitamins than those found in traditionally grown foods.
Other than this, these foods are known to taste better. Another reason for people opting for genetically engineered foods is that they have an increased shelf life and hence there is less fear of foods getting spoiled quickly.28 However, in a developing country like India it is very difficult to inculcate the new evolving biotechnology process, hence, the following are the major challenges to further the growth of biotechnology in India:
• Dearth of financial resources– Indian biotechnological firms are highly dependent on foreign sources to sustain funding for their research programs because domestic funding from both public and private sources remains very low. Further, being a
developing country, it has emerged as a most challenging part to ensure sufficient financial resources.
Further, a large majority of equipment necessary for the research facility is generally imported, and customs duties were imposed as high as 45% on certain goods, by domestically producing the required equipment we can significantly reduce the cost of biotechnology in India.29
• Shortage of advanced training programs and scarcity of qualified personnel- The concept of biotechnology can be very effective only if it is implemented in the right way with proper awareness and training programs among the people. Indian biotechnological firm lacks the highly qualified people to improve national and global competitiveness and enhance the firm’s in-house expertise and capabilities required to access a pool of highly trained personnel.
• Public-private collaborations lack overall effectiveness- Although there is a number of linkages between private and public institutions in India, still various firms expressed dissatisfaction in collaborating with Indian research institutes and universities majorly because of “a difference in expectations”. Thus, to effectively implement biotechnology there is essential to have collaboration and coordination among the two major healthcare providers in India i.e., Public and Private Healthcare distributors.
Hence, the development of biotechnology in India is not as easy, as it is in developed countries but if we inculcate certain measures it can turn out to be a boon for enhancing the dignified life and increasing the nutrition level with an increase in living standards of people in India and consequently, we can effectively ensure the right to healthcare under Article 21 of the Indian Constitution.
But, the inculcation of this new biotechnology has to be handled with care so that it will not suffer the other sections of society just for the sake of certain new developments which may in coming times affect the surroundings of living organisms.
20 Tara Acharya, Robyn Kennedy, et.al., “Biotechnology to improve health in developing countries: a review”
available at: https://doi.org/10.1590/S0074-02762004000400001. (Last visited on May 19, 2022).
21 Justin Chakma, Hassan Masum, et.al., “Indian vaccine innovation: the case of Shantha Biotechnics”, Global
Health available at:https://globalizationandhealth.biomedcentral.com/articles/10.1186/1744-8603-7-9. (Last visited
on May 19, 2022).
22Sarah E Frew, Rahim Rezaei, et.al., “India’s health biotech sector at a crossroads”, Nature Publishing Group
(2007), available at: https://www.nature.com/articles/nbt0407-403.pdf. (Last visited on May 19, 2022).
23 Ibid.
24 Suo Moto Writ Petition (Civil) No. 3/2021.
25 UNDP Commission on Private Sector and Development, Unleashing Entrepreneurship: Making Business Work
for the Poor, United Nations Development Program, New York, (2004).
26 H Cody Meissner, “Immunization policy and the importance of sustainable vaccine pricing”, 315 (10) J Am Med
Assoc., 981–982 (2016).
27 In Re Distribution of Essential Supplies and Services During Pandemic, Suo Moto Writ Petition (Civil) No.
3/2021
28 A. S. Bawa & K. R. Anilakumar, “Genetically modified foods: safety, risks and public concerns—a review”,
50(6) J Food Sci Technol 1035–1046 (2013).
29 Supra note 22.
5 – Conclusion
Overall, India is a potential hub for biotechnology, especially in the healthcare sector. In recent times, it has already made headway to flourish health biotechnology. However, the efforts are inadequate and it is still lacking in certain respects due to which it is unable to transform its potential into a breakthrough.
In India, the major population did not have access to a doctor or proper medical facilities. In rural and underserved areas, the availability of the proper medical and healthcare facilities is still a major challenge. As people in these areas have lower incomes so, doctors migrate from rural areas to bigger cities. So there is a need for a better healthcare model between the public and the private, which is affordable for the common people.
The role of biotechnology is fundamental to achieving this model, as a doctor, being a human, can be expected to remember every critical aspect of healthcare every time. Therefore, there is a need for innovation with a proper R&D program to find a better solution in biotech.
Following are the suggestions and recommendations regarding the proper functioning of the biotechnology under healthcare system in India: –
• There is a need to build a skilled workforce and trained paramedical professionals to cater to the need for managing the biotech efficiently.16
• Government must focus on investing in research and development to develop indigenous biotech to provide affordable solutions for proper healthcare and should lay down policies in this regard.
• With the establishment of public sector initiatives like the Biotechnology Industry Research Assistance Council (BIRAC), India should nurture its start-ups and domestic pharma companies so that the country can not only produce novel & affordable medicines but also can import them to other countries.
Moreover, the advancement of biotech will provide a growth trajectory for medical tourism which will further boost the economy.
• A good healthcare system is including an accurate diagnosis of disease in order to cure it properly, with help of biotech, cost-effective diagnostic lab tests will facilitate a better diagnosis and a lower-cost treatment for lower-income people.
• And above all, India must harmonize its medical care standards with international benchmarks so that the quality of biotech in healthcare must not be compromised.
Any developing country like India should be determined to develop and enhance its potential for health biotech to ensure better health and well-being to the people and export its services for
economic advantage
