India with well trained skilled professionals and vast pharmacy companies offers unique
opportunities for conducting clinical trials. Due to significant cost reduction and increased pace
and productivity of all R&D phases has brought considerable growth and impact to the favorable
regulatory climate for conducting the clinical trials in India. Clinical trials are also known as
clinical studies, test potential treatments in human volunteers to see whether they should be
approved for wider use in the general population. . It is the only way of establishing the safety
and efficacy of any drug before its introduction in the market for human use. A treatment could
be a drug, medical device, or biologic, such as a vaccine, blood product, or gene therapy. Clinical
trials are integral part of new product discovery and development and are required by the food
and drug administration before a new product can be brought to the market. For many years, the
debates on clinical drugs is going on in different parts of the world. Clinical research is a crucial
part of drug discovery and development process. The main debate is associated with the clinical
trials on human beings that have been evolved during the past few years and have been over the
headlines. The research examines how the rights and feelings of the human beings and their
health are bargained to stabilize the industrial clinical market of the developing nation.
Clinical Trials Practice In India
Global clinical research is exploring India. Clinical drug trials in India have grown enormously
over the past decades. India was the second most preferred country to conduct clinical trials
outside US in 2009. “The central drug standard control organization†(CDSCO) is one that help
in strengthening the safe clinical drug trials. Various drug companies are attracted to India due to
work force, low cost and friendly drug-control system and large number of patients available.
Yet it is certainly not the west that is introducing clinical research to India. Two ancient scripts,
Chakra Samhita (a textbook of medicine) and Sushruta Samhita (a textbook of surgery) ,
complied as early as 200B.C. and 200 A.D. respectively, show India’s age-old practice of
clinical trials. At present clinical trials are conducted in a regulatory manner through a proper
guideline that are available in the form of regulations and laws. There are number of laws
governing clinical research in India.
Indian acts /orders related to clinical trials is:
# Medical council of Indian act , 1956(amended in the year 2002)
# Central council for Indian medicine act , 1970
# Guidelines 0 for exchange of biological material (MOH order, 1997)
# Right to information act ,2005
# The biomedical research on human subjects (regulation, control and safeguards)
bill,
2005
# The Indian council for medical research (ICMR) , 1947 (amended in the year
2002).
Global Standards
Clinical studies should be carried out according to guidelines/ recommendations of international
conference on harmonization (ICH) / WHO good clinical practice (GCP). This provides a unified
standards for the European union , Japan, the united states, as well as for Australia, Canada, the
Nordic countries and the World Health Organization (WHO). The international conference on
harmonization of technical requirements for registration of pharmaceuticals for Human Use
(ICH) is a unique project that brings together the regulatory authorities of Europe, Japan and the
US and experts from the pharmaceutical industries in the three regions to discuss scientific and
te 2 chnical aspects of product registration. The objective of such harmonization is a more
economical use of human, animal, material resources, and the elimination of unnecessary delay
in the global development and availability of new medicines whilst maintaining safeguards on
quality, safety, efficacy, and regulatory obligations to protect public health. Currently the global
pharmaceutical market is estimated at US$427 billion with research and development cost
estimated at US$ 60-65 billion annually. Two-thirds of this amount i.e . , approximately US$40
billion, is spent on drug development. Clinical trials involve almost 70% of the time and money
of new drug development as the cost of conducting clinical trials for a new drug is approximately
US$ 200-250 million.
Ethics Committee
The first official guidelines for the formation of ECs were issued by Indian Council for Medical
research (ICMR) in February 1980. These guidelines included recommendations for membership
criteria an ethical standards for review, which laid down the foundation for the establishment if
ECs in India. These guidelines included recommendations for membership criteria and ethical
standards for review, which laid down the foundation for the establishment of EC. This was
followed by release of the ICMR guidelines in bioethics, which was a guidance document for
research in medical, epidemiology, and public health, in the year 2000, which was further revised
in 2006.However, despite the establishment of ethical guidelines since a long time, the ECs in
our country are still grappling with basic issues like, inadequate or no standard operating
procedures (SOPs) and noncompliance with the Schedule Y recommendations. The EC has the
prime responsibility of regulating clinical research and safeguarding the rights and safety of
research participants, however, the institutions and hospitals that focus on enhancing their
research facilities tend to ignore the EC, which approves their research. ECs have to deal with
basic issues such as lack of trained manpower, heavy workload, inadequate space allocated for
EC operations, lack of administrative support, and inadequate remuneration offered to members
serving on EC boards. These issues culminate into relu 3 ctance of trained individuals to serve as
members of the EC.ECs also have to cope with problems such as insufficient space allocated to
them for operations and archival of records, thus posing problems during audit procedures.
Although clinical research in India has increased tremendously in the past years, regulatory
reforms and ethical practices have been unable to keep pace with it. The Drug Controller of India
(DCGI) has released guidelines for inspection of investigator sites, but there are no
recommendations for regulatory inspections to be conducted on ECs. Centralized registration of
ECs is a longtime plan, yet to be implemented. A slew of regulatory reforms led to more than
1000 ECs to be registered with CDSCO although the actual impact o 4 n participants' protection
and safety of these new regulations still remains to be seen.
India A Hotbed For Clinical Trial
Clinical trials are the cornerstone of evidence-based medicine. With a huge population and an
easy access to a wide variety of treatment of native diseases, India forms a hotbed for clinical
trials for both national and international researchers. India is a signatory to the world trade
organization (WTO). As a signatory country, it became fully complaint to the trade related
intellectual property rights in January 2005. Thus, between 2005 and 2009, clinical trials sprung
out like weed throughout the length and breadth of the country. There was an overwhelming
torrent of contract research organizations (CRO) or the sponsors of such trials. During this peak
of trial in India, it was revealed (in 2009) that 24,000 girls were enrolled in the human papilloma
virus (HPV) vaccinations trial which, when investigated, was found to have irregularities in
informed consent, a key component of all clinical trials. It is believed that between 2005 and
2012, about 2,800 patients have died across the country while participating in all clinical trials
conducted by pharmaceutical companies. In fact, there has been a strong skepticism around the
conduct and results of clinical trials in countries like India and China. As the government
prepares to modify the clinical trial policy of the country, it is essential that the subject be
revisited and debated to ensure the efficacy and safety of clinical trials in India, not only from an
ethical, but from all points of view. The patient is the single most important component of a
clinical trial and all efforts should be made to safeguard the interest of the patient. It is shameful
that India harbors a significant quantum of major illness that are not seen in other parts of the
world. In the recent global burden of disease study published in lancet, India ranked 154 th out of
195 countries as far as access to healthcare and quality are concerned. Following the disaster of
2009(HPV vaccinations), it was realized that the compensation to trial subjects was an important
area which need a change. The interests of the patient are sacred in a clinical trial. It is
imperative the state ensures that the concerned CRO should bear all responsibility of harm to a
patient during such trials. This can even be extended to criminal liability in such cases.
Current Drug Regulatory Procedures
In contrast to the drug discovery process, the clinical development process is heavily dependent
on the human element; hence regions of the world with cost competitive human resources are an
attractive alternative efficiency in medical research. With nearly one billion people as potential
patients and a large number of highly skilled investigators, India clearly falls into this category.
There are two major regulatory bodies involved in the drug approval process in India , local
institutional review boards (IRBs) called the independent ethics committee(IEC) and a national
regulatory body, the drug controller general of India (DCGI, India’s version of FDA). Currently
the clinical trials are regulated by schedule y of the drug &cosmetics rules, 1945. Clinical trials
have been defined in rule 122DAA of the D& C Act. After the amendment of the D&C act in
2005, the schedule y was extensively revised to bring the Indian regulations up to par with
internationally accepted definitions and procedures. The central drugs standard control
organization (CDSCO) under ministry of health and family welfare (MOH and FW) prescribes
standards for ensuring safety, efficacy and quality of drugs, cosmetics, diagnostics and devices in
India. Apart from these there are other statutes and ministries that the various aspects
of drugs
such as; 1. the poisons Act, 1919;
2. the pharmacy Act, 1948;
3. the drug and magic remedies Act, 1954;
4. the narcotic drugs and psychotropic substances Act, 1985;
5. the insecticide act, 1968;
6. the
medicinal and toilet preparation (excise duty) Act, 1956 and
7. the Drug (price control) order 9
1995(under the essential commodities Act).
Some more laws having bearing on pharmaceutical
manufacture, distribution and sale in India are The Industries (Development and Regulation) Act,
1951, The Trade and Merchandise Marks Act, 1958. Clinical trials of drugs developed in India
have to undergo all four phases of trials in India. For new drugs discovered in India, the clinical
trials are required to be carried out in India right from phase 1 and data should be submitted as
per the requirement. However for the new drug substances discovered in countries other than
India, phase 1 data will be required from the other country and should be submitted along with
the application. The ministry of health and family welfare has issued the drugs and cosmetics
(sixth amendment) Rules, 2017.By virtue of this amended in ‘schedule H’ of the principal rules,
which prescribes a list of prescription drugs a new entry has been inserted, namely “537. Etizolam†. DGCI has recently issued direction in November 2013 that an audio video of the
informed consent process of an individual subject and his understanding of such content, shall be
maintained by the investigator for record. Another amendment is proposed in the schedule-y
specifying that clinical trials are required to be conducted at sites which have their own ethics
committee. It has been recommended that clinics trials should be carried out in
sites,
investigators and the institutional ethics committee are competent and have been accredited by a
Central Accreditation Council (CAC) to carry on such studies. On October 27, 2017, the ministry
of health and family welfare has published the drugs and cosmetics( Tenth amendment)
Rules,2017 through official gazette, in exercise of the powers conferred by section 12 read with
section 33 of the Drugs and cosmetics (D&C) Act, 1940 (23 of 1940) . The CDSCO has
published interim guidelines to ensure the smooth processing of applications for grant of
manufacturing licenses; and for joint inspection of manufacturing premises.
Government, Legislations And Court Directions
The main question arises that whether the participant who is taking part in the drug trial is
6 well informed about the same? There are instances which show that the pharmaceutical
companies do not follow the government regulations and specific laws which they should
follow for the same. India’s highest court has given the guidelines to the government to
tighten the norms and regulations for the conduct of clinical trials for new drugs. In one of
the petitions filed by a famous NGO has alleged that many patients in India have been used
by pharmaceutical companies as “guinea pigs†for clinical trials of new pharmaceutical
compounds. Supreme Court has asked the government to set up proper norms in relation to
0ensure the safety of the participants who are taking part in the trials. Apart from the topic,
the government has also brought in the various amendments to the clinical trialand various
other regulations are being revised in this respect to make sure the trials are carried out in
the safest way. In an application filled by two Bhopal based NGO’s in the petition had
alleged that the survivors of the deadly poisonous gas leak from Union Carbide factory in
Bhopal 30 years ago and being used as a “guinea pigs†for the clinical trials of new
drug. 5 There were many petition that was filed regarding the clinical trials suggested that
low cost, inadequate and liberal enforcement penalties have made this country an eye
catching destination for the big pharmaceutical houses for the test or the clinical trial. The
Hon’ble Court observed that “uncontrolled clinical trials are causing havoc to human
life’sâ€, laid guidelines for global clinical trial (GCT), including clinical trials of New
Chemical Entities (NCE’s). Clinical drug trials are of utmost importance for the
development of new medicinal molecule in the country and to which India has the capacity
and calibre for drug discovery and research.
Writer’s Opinion
India with a huge variety of benefits like patients, low costs, low literacy rate, etc. have led to the
immense growth of the clinical trial market. However, to achieve its global goal, India will have
to work a lot to supersede the major challenges like unethical trial, lack of good professionalism,
trial investigators and the main one lacks of knowledge. The reason why India has become as a
global hub for clinical trials are no different, but its large number of population and patients who
are in need of treatment and apart from this is the low cost and growing Infrastructure,
development in the field of medical sciences and good medical expertise. For the past few years
the cost of clinical trials in India is reduced up to 60% as compared to the other developing
. ’Bhopal gas victims used as guinea pigs for drug trials’
countries of the world and so on. Investigators cannot bargain the life of innocent people by
simply exposing them into the trial without their consent. The increased compensation every
time that is offered to the participants of the trial is not a just sufficient as it is an inhuman act to
put a human life on sale with a price tag. There is no price payable to the finest masterpiece
created by god. Clinical trials are here to stay. It is important that such trials are better regulated
with the patient or the subject at the centre stage of all policy considerations in this respect.
Safeguarding the interests of the patient in a clinical trial is as holy as the grail. Scientific
advancement and patient safety are two sides of the same coin. We must realize that we cannot
have one at the cost of the other. Adequate regulations which safeguard patient interests and ease
the conduct of clinical trials will go a long way in establishing a “culture†of clinical trials in this
country.
Conclusion
Clinical trials are the key tools in new drug evaluation. India is certainly setting itself to attract
more and more researchers from around the world to carry on their clinical trials studies in India.
The new laws are amended to facilitate and channelize the entry of big pharmaceutical houses.
Recent amendments in the regulatory requirements have shifted the thrust from just safeguarding
the subjects to providing them for access for biomedical innovation. Being the second largest
populated country in the world, India can contribute positively in the global medical researchers
and drug development program, etc. In the last few years we continually see the dramatic
increase in the number of clinical trials. There is a need of a proper structure for regulating the
clinical trials as India lacks a proper mechanism in the clinical trial industry. With experienced
clinical professionals and technological advances, India will be sure to give best as a major
favorite destination for the clinical researchers in the near future. For a flawless conduct of trials,
one need competent, well trained and experienced investigators and resourceful, expertise-
oriented sites. For people who are investigators, monitors, trial designers, statistical analyzers
etc., all need to be formally trained and tested in research methodology, GCP, good laboratory
practice, documentation and regulatory affairs by experienced and expert personnel only.
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