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Published : April 13, 2013 | Author : aditisingh@legalserviceindia.com
Category : Human Rights laws | Total Views : 10592 | Rating :

aditi singh pursuing L.L.M from Indian Law Institute

Science and Technology in human rights: An Indian perspective

THE myth of the technology fix is currently in the making. Corruption, inefficiency and ‘leakages’ are persuasive reasons for replacing the human element with technology. In a milieu where there are many users of technology, but remarkably few who understand it, or its consequences, or its application, technology is easily perceived as value-neutral and not sharing the traits and frailties of the human, social condition.

The depths to which public morality has sunk evokes desperation, which seeks answers somewhere other than where the problem now abides, viz. in the human person. Technology and the machine can in the land of desperate optimism seem relatively incorruptible. The potential intrusiveness of technology is shielded by the extent to which the temptations of technology have upended ideas of privacy, confidentiality, personal security and fraud. This seems to have prepared the ground for a technology fix.

Amongst a wide array of topics that deal with science and technology, this paper specifically deals with only three areas viz
A. Clinical trials in India
B. Efficacy of UIDAI in India
C. Impact of Biotechnology on Environment

A. Clinical trials in India
India has recently been recognized as an attractive country for clinical trials. But the country's journey in clinical research field has a long history. India has a rich heritage of traditional medicine – Ayurveda. The classic texts contain detailed observations on diseases and in-depth guidance on remedies. It is likely that these descriptions are based on direct observations made by the ancient ayurveda experts. However, there is no recorded documentation in the ancient texts of any clinical experiments. Hence, one has to fall back on current history of medical research in India.

Brief History
The major historic milestones of the Indian Council of Medical Research reflect, in many ways, the growth and development of medical research in the country over the last nine decades. First meeting of the Governing Body of the Indian Research Fund Association (IRFA) was held on November 15, 1911 at the Plague Laboratory, Bombay, under the Chairmanship of Sir Harcourt Butler. At the 2nd meeting of the Governing Body in 1912, a historic decision was taken to start a journal for Indian Medical research. Between 1918--20, several projects on beriberi, malaria, kala azar and indigenous drugs were initiated. In 1945, a Clinical Research Unit – the first research unit of IRFA attached to a medical institution- was established at the Indian Cancer Research Centre, Bombay. In 1949, IRFA was re-designated as the Indian Council of Medical Research. Over next 60 years, ICMR established many national research centers in the fields of nutrition, tuberculosis, leprosy, viral disease, cholera, enteric disease, reproductive disorders, toxicology, cancer, traditional medicine, gas disaster, genetics, AIDS etc.

The Central Ethical Committee of ICMR on Human Research constituted under the Chairmanship of Hon'ble Justice (Retired) M.N. Venkatachaliah held its first meeting on September 10, 1996. Several subcommittees were constituted to consider ethical issues in specific areas e.g., Epidemiological Research; Clinical Evaluation of Products to be used on Humans; Organ Transplantation; Human Genetics, etc. The committee released Ethical Guidelines for Biomedical Research on Human Participants in 2000 which were revised in 2006.

Schedule Y of Drugs and Cosmetics Act came into force in 1988 and established the regulatory guidelines for clinical trial (CT) permission. The schedule did force the industry to conduct Phase III clinical trials for registration of a new drug and supported growth of a predominantly generic Indian pharmaceutical industry. However, this schedule only permitted clinical trials at a phase lower than its global status. This phase lag obstructed integration of India in global clinical development.

The next major step has been revision of Schedule Y in Jan 2005. As compared to Schedule Y 1988, which had narrow and restrictive definitions of clinical trial phases, the amended Schedule Y 2005 provided pragmatic definitions for Phase I to IV. The definitions and guidelines for clinical trial phases are broad and rational. The earlier restrictions on number of patients and centers in early phases stipulated in Schedule Y of 1988 were removed allowing the sponsor company freedom to decide these in relation to protocol requirements. The phase lag requirements gave way to acceptance of concurrent Phase II-III as part of global clinical trials.

Schedule Y 2005also legalized Indian GCP guidelines of 2001. It stipulated GCP responsibilities of ethics committee (EC), investigator and sponsor and suggested formats for critical documents e.g. consent, report, EC approval, reporting of serious adverse event. These amendments in Schedule Y have been a major step forward in direction of GCP compliant trials and have provided the much-needed regulatory support to GCP guidelines.

Though the basic ethical guidelines for performing clinical trials are the Declaration of Helsinki issued by the World Medical Association. But in India, guidelines have been set by the Indian Council of Medical Research (ICMR), and there is no law that makes the guidelines binding on those involved in conducting trials. Trials must also adhere to Good Clinical Practice guidelines of the International Conference on harmonization drafted in 1996.

A need was, however, felt to develop our own Indian Guidelines to ensure uniform quality of clinical research throughout the country and to generate data for registration for new drugs before use in the Indian population. An Expert Committee set up by Central Drugs Standard Control Organisation (CDSCO) in consultation with clinical expert has formulated this GCP (Good Clinical Practices) guideline for generation of clinical data on drugs.

The Procedure of trials
The drugs go through several stages of development prior to human trials. The trials themselves are approved and regulated by government agencies and undertaken only after animal experiments prove their safety beyond any evidentiary doubt. Dr Bhatt, ISCR, said, “Drug development is a long, complex and expensive process and it takes on an average around 12-15 years for a new medicine to be developed for human use. Only those medicines that are safe and effective after tests in the laboratory reach the stage of clinical testing. Of 10,000 substances identified as potential drugs, only about 10 make it to the human testing stage and out of these, only one may finally be launched in the market.”

Clinical trials are conducted in four phases. It is the third phase which is most expensive. Conducted on 1,000-3,000 patients, it confirms the therapeutic benefits of a new drug. Multinational drug companies, therefore, outsource the third phase of trials to non-traditional research areas where cost is much less.

In short when a new drug is discovered, the office of the Drugs Controller General of India (DCGI), the regulatory authority, grants permission to conduct clinical trials in India. An ethics committee gives its stamp (A body of at least seven members comprising professionals like pharmacologists, lawyers and sociologists, it can be institutional or independent. It is this body’s responsibility to safeguard the rights, safety and well-being of a trial subject. It should also check the trial design, ensure insurance cover and review informed consent forms.) The Clinical Trial Registry of India (CTRI) registers it as a drug being tested in India. The trial is conducted by investigation agencies, which could be CROs or non-profits. Data from trial sites is submitted to DCGI after which marketing licenses are issued.

At present, there is no specific provision under the Drugs and Cosmetics Rules for payment of compensation in case of clinical trial-related injury or death. However, the Good Clinical Practice (GCP) Guidelines for Clinical Trials of India state that the research subject who suffers physical injury as a result of his participation in clinical trials is entitled to financial or other assistance to compensate him equitably for any temporary or permanent impairment or disability, subject to confirmation from the Ethics Committee. In case of death, the subject’s dependents are entitled to compensation.

Blame it on lack of credible regulation. The fact is that our current legal framework is strong enough to ensure transparency and ethical practices during the conduct of clinical trials. There can of course be improvements.

The answer is not in shackling clinical trials - it will only result in denying better and cheaper drugs to millions of Indian patients. All drugs need to be tested on ethnic populations to ensure their efficacy; so Indian patients must have representation in trials. Genetic variations can result in different levels of drug efficacy and hence the need for local clinical trials. For e.g. the cancer drug Iressa worked well in Japanese population but not so in Caucasians, which led to the identification of a gene mutation that determined response. Moreover, some diseases are more prevalent in India. These range from malaria and chikunguniya to tuberculosis, kala azar and head and neck cancer. Drugs for such diseases can be best tested in India.

B. Efficacy of UIDAI in India
In 2006, the need to identify those belonging to BPL category was felt strongly by the government and various social groups. Finally in 2009 the Unique Identification Authority of India (UIDAI) was set up under the Planning Commission by an executive order on January 28, 2009.

The project, first called the UID Authority of India and then renamed AADHAAR, aims to create a database with a unique identity number for every resident of the country, authenticated by fingerprints and iris scans. Its supporters, led by UIDAI chairman Nandan Nilekani, claim it will benefit the poor and bring inclusivity and efficiency to government schemes and will help the poor and homeless to associate with the state.

The UID project, the national project of the Government of India, aims to give a unique 12-digit number called ‘Aadhaar’ to every citizen of the country, a random number that is generated and linked to a person's demographic and biometric information. The advocates of the project believe that this will eliminate the multiple bureaucratic layers that the people of the country, particularly the rural poor, are confronted with and the multiplicity of documents that they have to present in order to access their legitimate entitlements, and the channels of corruption that these have bred over the years. After authentication by a centralized database of biometric and demographic information to which service providers will be linked, this unique identification number alone will enable every individual to access services and entitlements anywhere in the country and at any time. The centralized database, Central ID Repository (CIDR), will be maintained and regulated by the UIDAI.

Though at the outset it seemed like a very good project but it has also come with its fair share of fallacy which has strongly been propagated by a socio- legal activist Ms. Usha Ranganathan. This paper mainly deals with that.

She stated three adjectives that reflect the target goal of the Unique Identification Authority of India (UIDAI): unique, ubiquitous and universal. She demonstrated how their initial objectives and claims have been drastically altered in many ways:-
• The UIDAI claimed that enrolment is voluntary, not mandatory, and hence, inclusive. Yet, Nandan Nilekani has consistently maintained that other agencies may make it compulsory. UID is becoming ubiquitous and is a prerequisite for access to a wide variety of welfare schemes and services such as PDS, MGNREGS, banks, public health, etc. it is thus clear that this could actually exclude those who do not have a number or whose biometrics doesn't work. Therefore, this undermines the inclusive nature of the project.

• The UIDAI claimed that the UID would enable inclusive growth. Instead of facilitating inclusion, around two to five per cent of the Indian population would be excluded from the current process of authentication and potentially from having a UID number, as they do not have viable biometric data. Physical or visual impairments such as corneal blindness, corneal scars, and malnourishment induced cataracts or ‘low-quality’ fingerprints from a lifetime of hard labour inhibit those from providing valid fingerprints or iris scans. Hence, estimated failure of biometrics is expected to be as high as 15% due to a large chunk of population being dependent on manual labour.

• The promise of inclusiveness is belied by the ‘approved’ introducers i.e., where the poor are unable to provide any supporting documents to prove their identity, a network of approved introducers are to “introduce and vouch for the validity of a resident’s information”. So, those who have no documents to vouch for them would be threatened with exclusion. Where being a legal resident is to be closely tied in with having a UID number, it could render the poor vulnerable to having the legitimacy of their staying in the country being placed in the shadowy terrain of illegality and exclusion.

• Each individual’s identity would be decided by a third person. An Advaasi’s existence and how he is known to the state depends on how he is introduced as by a third body such as the UID. Today we have our own identity but tomorrow we are known to the world as how we are projected by UID which is an unknown, alien, distant third body.

• The citizen’s of this state are given a false sense of security. UID claims that they shall be the sole holder of all information. But UID cannot collect all information from such a diverse vast population because of which they have signed MOU’s with other organisations and agencies such as banks, gas distributors and the like. These enrollers will collect the desired information and a will then send the matter to UID. UID is to duplicate the information. In the second stage the information is de- duplicated wherein UID confirms that, no two people share the same card. A registrar is given each person’s ID number. The registrar can collect any additional information he/she desires. The kind of information to be collected is left to the discretion of the registrar. Thus this information passes through many hands and will be retained by several others.

• The National Identification Authority India Bill,2010 prohibits sharing data, except by
# the consent of the resident,
# by a court order or
# for national security.
However, UID information is being directly fed into the National Intelligence Grid (NATGRID) who will then provide information about people that is in 21 databases, to eleven security agencies, including the RAW and IB over which there is no superintendence or oversight. She discussed the high likelihood of a breach of privacy as there are insufficient standards protecting an individual from unlawful invasion. Additionally, the UIDAI does not have mechanisms in place for an individual to be notified if there is a data breach.

Lastly, Ms. Ramanathan discussed the international experience of a universal identity system. In the United Kingdom, their universal system of identification was labeled as ‘intrusive bullying’ as well as ‘an assault on personal liberties’. The United States and the United Kingdom both abandoned a universal identity system, as it was impractical, unjustified and dangerous. While in India also the Parliamentary Standing Committee on Finance finds the UID project to be “conceptualized with no clarity” and “directionless”.

C. Biotechnology and Environment
In its most simple form, biotechnology is the use of living systems (organisms) by people to make products. It uses many different sciences, such as biology, chemistry, physics, engineering, computers, and information technology to develop tools and products. It basically changes genes of organisms for specific purposes. Genetically modified food (GM food) has made a big splash in the news lately. The term GM foods or GMOs (genetically modified organisms) is used to refer to the crop plants created for animal as well as human consumption using latest molecular biology techniques. According to this technique the plants have been modified in the laboratory to improve nutritional content and resistance to herbicides. These foods have the potential to solve many of the world's hunger problems. Yet there are many challenges ahead for governments, especially in the areas of safety testing, regulation, international policy and food labeling.
The transgenic plants and animals not only help in increasing the production but also transfer photochemical, vitamins, essential amino acids, etc. For instance, the advent of the golden rice tackled vitamin A deficiency, or the advent of green and white revolution in India led to its self sufficiency in the same.

Some common examples of Biotech use are -
# Medicine
1. Some new developments delve into the hereditary material of humans known as gene therapy
2. Therapeutant - product used to maintain health or prevent disease.
3. Biopharmaceuticals – drug or vaccine developed through biotechnology called designer drugs.
4. Biopharming – production of pharmaceuticals in cultured organisms, combination of the agriculture and pharmaceutical industries

# Agriculture and Forestry
a) Plant biotech
1. Improve plants and the products produced from them.
2. Insect and disease resistant plants.
3. Plants engineered to have desired characteristics.
4. Corn plant produced with high levels of the amino acid Lysine.

b) Animal biotech
1. Improve animals or the products they produce.
2. Animals may be used to produce products that promote human health.
3. Increase productivity or life span.
4. Pigs engineered to produce human hemoglobin.
5. Some new developments delve into the hereditary material of humans known as gene therapy.

# Food and beverage processing
1. Use of technology in producing and processing
2. Some biotech principles have been employed for hundreds of years like Yeast in baking bread
3. Genetically altered crops like rBGH milk

# Environment
It is the solving of environmental problems through the application of biotechnology. It is needed to:
# eliminate the hazardous wastes produced by our other technologies.
# distinguish between similar species and ensure species are not at risk of extinction.
# create alternative energy sources (i.e. Biofuel)

Currently it is being used in various fields-
1. Molecular Ecology
Using biological techniques (i.e. DNA fingerprinting) to better understand aspects of nature. This is done to look at the biodiversity of different populations to ensure they are not at risk of going extinct (cheetahs and polar bears currently).It can be used to determine if a new species has emerged and also better map the evolutionary development of different families of animals (horses and whales currently).examples are reading a DNA fingerprint, biofuel exaggeration etc.

2. Bioremediation
Bioremediation is the use of bacteria (or fungi) to clean up hazardous environmental wastes. The bacteria essentially turn the dangerous waste products into less hazardous, easy to dispose of, waste. Plants are also being tested in some areas to do this job (Sunflowers at Chernobyl removed Cesium and Strontium). Also it has been used to clean up after oil spills, currently this science can “engineer” bacteria to break down hazardous waste right at the workplace to avoid transport and storage.

3. Biosensors
A biosensor uses a biological entity (i.e. bacteria) to monitor levels of certain chemicals or uses chemicals to monitor levels of certain biological entities (i.e. pathogens). Current uses of biosensors include:
# Detecting levels of toxins in an ecosystem
# Detecting airborne pathogens (i.e. anthrax)
# Monitoring blood glucose levels

4. Biofuels
A biofuel is a plant derived fuel that is deemed more environmentally friendly that current fuel sources as they all release less carbon dioxide into the atmosphere. Like -
# Ethanol from corn is placed in many gasoline varieties in North America.
# Biodiesel is fuel made from used cooking oil.
# Biogas is made from gases released by compost or a landfill.
# The current project of many biofuel scientists is aptly nicknamed “A Journey to Forever”, creating a self-sustaining biofuel cell that gives off no greenhouse gas emissions. Many different bacterial strains can produce lots of hydrogen under anaerobic conditions. This hydrogen can be used as a fuel source with the only waste product being oxidized hydrogen… water. Though this technology has not been perfected yet.

Biotechnology has been described as "Janus-faced." This implies that there are two sides. On one, techniques allow DNA to be manipulated to move genes from one organism to another. On the other, it involves relatively new technologies whose consequences are untested and should be met with caution. Many traditional biotechnologies are uncontroversial, such as the fermentation of microorganisms to produce wine, beer, and cheese. But genetic engineering, a powerful new technology that involves the artificial transfer of genes across species lines, has provoked intense public interest and scrutiny. Despite its many benefits, genetic engineering has caused concern among some people. Some oppose genetic engineering because they fear that harmful, uncontrollable bacteria might be produced accidentally. Others worry about possible environmental damage by the deliberate introduction of organisms whose heredity has been altered. In addition, some people question the morality of manipulating the genetic material of living creatures.

Since the Scurvy trial, clinical trials have evolved into a standardized procedure, focusing on scientific assessment of efficacy and guarding the patient safety. As the discipline of drug development is enriched by novel therapies and technologies, there will always be a continuing need to balance medical progress and patient safety. As the scientific advances continue to occur, there will be new ethical and regulatory challenges requiring dynamic updates in ethical and legal framework of clinical trials.

With all his scientific discoveries and technology, man has proved his superiority over the other beings in nature. His thoughtless act has caused irreparable damage to his own self as well as to the environment. Science made man civilized but in the process he has abused and ignored nature. Even though with genetic engineering we might develop new powers but will it be used for the benefit of mankind and for the earth at large. There is a great need to use science scrupulously to have a positive impact. It is very important to watch your next step, but before you take the next step, make sure that you have a long vision which gives a direction to that step. It’s time that we should use science with a good conscience and prudence.
Our universe is not just an object, it is a very intelligent force. Our body is a perfect example of order, a million activities occurs with a perfect order within our body and that too without any conscious voluntary effort on our part but we have not discovered order in our consciousness. The entire successful scientific quest has been successful because the order already exists in universe. Though Newton discovered gravitation but it was always there, even a million years before. The laws of nature are independent of the scientist. Technology is a by- product of science, but science itself is the quest for truth about nature. History is witness to the fact that man has used it and is still using it primarily for destruction rather than for construction, bringing our planet and our lives to a level of danger which never existed before. A deeper understanding of life and of our self is the need of the hour. Scientific knowledge is supposed to be value neutral and humanity needs to discover what is called as the scientific spirit as the spirit is always more important than the technique, the knowledge or the method in any activity.

Web sources
• Dr Arun Bhatt, Evolution of Clinical Research: A History Before and Beyond James Lind available at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3149409/ (visited October 25th, 2012)
• Daniel Cressey, India shakes up rules on clinical trials available at http://www.nature.com/news/india-shakes-up-rules-on-clinical-trials-1.11223 ( visited October 27th 2012)
• Kalyan Ray, Clinical trial norms made harsher available at http://www.deccanherald.com/content/288304/clinical-trial-norms-made-harsher.html (visited October 27th 2012)
• Aarti Dhar, Health activists oppose clinical trial compensation guidelines available at http://www.thehindu.com/news/national/article3766148.ece ( visited October 21st,2012)
• Dr. Reeja Tharu, Clinical Trials in India - Boon or Bane available at http://www.medindia.net/news/healthwatch/Clinical-Trials-in-India-Boon-or-Bane-41419-1.htm (visited November 5th, 2012)
• Subir Roy, Clinical research set to mine data for gold available at http://www.business-standard.com/india/news/clinical-research-set-to-mine-data-for-gold/488990/ (visited October 29th, 2012)
• Sushmi Dey, Pharma majors named in clinical trial death list available at http://www.business-standard.com/india/news/pharma-majors-named-in-clinical-trial-death-list/481274/ (visited October 26th, 2012)
• Kiran Mazumdar-Shaw, Need a rational view on clinical trials available at http://articles.economictimes.indiatimes.com/2012-09-13/news/33817062_1_clinical-trials-iscr-human-trials (visited October 29th, 2012)
• Usha Ramanathan, The myth of the technology fix available at http://www.india-seminar.com/2011/617/617_usha_ramanathan.htm (visited November 2nd, 2012)
• Food biotechnology boon or bane? available at http://2011iard6020.wordpress.com/2011/01/08/food-biotechnology-boon-or-bane/ (visited November 2nd,2012)
• http://www.fao.org/sd/EPdirect/EPre0040.htm.

# Sewlikar S. Bhatt, India Steps towards Globalization-Reforms to Schedule Y Regulations (CR Focus. 2007 at 26).
# Usha Ramanathan, , Implications of registering, tracking, profiling (The Hindu Monday, Apr 05, 2010)
# Usha Ramanathan “A Unique Identity Bill” Vol - XLV No. 30 (July 24, 2010)
# R. RAMACHANDRAN, “How reliable is UID?” Frontline Volume 28 Issue 24, 2011
# USHA RAMANATHAN, “UID is an Identity Crisis in the Making”, Tehelka Magazine, Vol 7, Issue 38 (September 25, 2010)

 Standing Committee 42 report on Finance on NIDAI Bill (Dec 2011)

*** Submitted by: Aditi Singh,3rd Semester LLM (2 year) - Under the Able Supervision of Dr. Jyoti Dogra Sood

Authors contact info - articles The  author can be reached at: aditisingh@legalserviceindia.com

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