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The Trail of clinical drugs on Human beings

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’s”, 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.

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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