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Clinical trials in India - a case of trials and errors! 1.0 Regulatory framework.2 1.1 Schedule Y.2 1.2 GCP Guidelines.3 2.0 Loopholes in law and practice.4 Disclaimer – This new sletter is for information purposes and should not be construed as legal advice. Medical science has advanced tremendously Additionally, the Indian Council of Medical over the years. Newer, better and effective drugs are Research (“ICMR”) has issued Ethical Guidelines frequently being introduced to fight the ever- for Biomedical Research on Human Participants and increasing list of prevailing and newly discovered Central Drugs Standard Control Organization has diseases. Interestingly, every new drug that floods the formulated Good Clinical Practices Guidelines market has to undergo a series of tests and a (“GCP Guidelines”) in line with the international considerable study,1 known as clinical trial, before it is guidelines issued by World Health Organization and actually manufactured for use by the population at International Committee on Harmonization (“ICH- large. Clinical trials prove to be a useful way for GCP”), which provide operative guidelines for ethical testing the efficacy and suitability of a drug. Carefully and scientific standards for the designing of a clinical designed and well-conducted clinical studies have the trial protocol3 including conduct, recording, safety potential to yield favorable results for the overall and reporting procedures. It is compulsory for every company undertaking a clinical trial in India to strictly India has become a preferred clinical trial destination for several multi-national pharmaceutical While Schedule Y describes the procedure in terms of the application process for commencing participation in many global clinical trials,2 conducting clinical trials in India, the responsibilities of the clinical trials in India is still a matter of concern due sponsor, investigator and Ethics Committee (“EC”) to several reasons. This newsletter briefly analyses in brief, the GCP Guidelines is more elaborately the basis of this concern, the regulations on clinical drafted. However, the regulations are overlapping and trials in India, and the shortcomings in the present sometimes ambiguous and, consequently, impact the The following sub-sections briefly discuss provisions of Schedule Y and the GCP Guidelines. It The principal legislation governing clinical further tries to analyze the loopholes and the trials, inter alia, is the Drugs and Cosmetics Act, 1940 ambiguous regulations that the authorities should (“Act”) and the principal authority is the Drugs Controller General of India (“DCGI”). Schedule Y (“Schedule Y”) to the Drugs and Cosmetics Rules, 1945 (“Rules”) stipulates the regulations for importing and/or manufacturing new drugs for sale and to undertake clinical trials in India. permission from the DCGI and the respective Ethics 1 Before launchin g a drug, every pha rmaceutical compan y undertakes pre-clinical t rials (tests on animals), Phase I, II, III 3 It is a document that states the background , obje ctives, 2 Drug called Te gaserod b y Novartis, Voriconazole by Pfizer t o rationale , design, methodology and statistical co nsiderations o f Disclaimer – This new sletter is for information purposes and should not be construed as legal advice. Committee (“EC”) of the trial site.4 The document s better assessment of the drug on Indians, their health fundamental to the study, which contain the study and genetic profiles. Moreover, considering that India procedure, details, instructions for conducting clinical is emerging as an important place for conducting trial namely the protocol, case record form, study clinical trials, the amendment wil bring India more in subject’s informed consent form, investigator’s line with global studies and will act as an incentive to undertaking, has to be approved by the DCGI and pharmaceutical companies. However, this will also the EC before commencing the study. The clinical trial process is spread over four phases in humans- implementation thereof to prevent exploitation of Phase I (Non therapeutic) trials, which mark the start of the process, are done for estimation of safety and tolerability of the new drug in a small population of healthy humans to determine the drug’s tolerability, absorption, distribution, metabolism, and Guidelines5 serve as the guiding document for conducting clinical trials in India. It lists the procedures, practices, and methods to be adopted to Phase II (Therapeutic Exploratory) trials are ensure compliance with the international guidelines done to evaluate the effectiveness of the drug for on clinical studies. However, there is still a level of particular indications in patients with the condition ambiguity and lack of comprehensiveness as will be under study, and to determine the common short- evident from the succeeding section. In any clinical term effects and risk associated with the drug. Phase III (Therapeutic confirmatory) trials are done on larger populations of afflicted patients, in institution which initiates, manages and/or finances different stages of disease, to confirm the information gathered in Phase II and to compare the drug’ s effectiveness with an existing drug, if any, in the conducted on subjects by the investigator. Phase IV (Post marketing) trials are done Investigator - A person who is responsible for once the drug is approved to check the safety issues the conduct of the study at the trial and the rights, welfare and health of the study subjects. Where a team of investigators are involved, the designated Based on the existing rules, Phase I clinical leader of the team, the Principal Investigator, has the trial on drugs discovered outside India is allowed only responsibility to co-ordinate between all the upon submission of Phase I results of other countries investigators involved in the study at one site or to the DCGI. Further, Phase II and III trials are permitted only after similar trials have been approved by regulatory authorities of the countries where such drugs have been developed. Thereafter, repeat Phase (“CRO”) - A CRO essentially performs all the tasks, I trial is al owed with the prior permission of the duties, and obligations of the study. A written contract between the sponsor and the CRO defines the scope of responsibility of the CRO. In the Given the varying genetic profiles of people absence of a specific responsibility or obligation in in different parts of the world, the health needs and writing, the same is required to be assumed by the requirements, the regulations should be amended to allow Phase I clinical trials to be done on Indians concurrently with global trials. This will enable a 5 GCP Guidelines are issued by the Central Dru gs Standard Control Organ ization (“CDSCO”) w hich functions under th e 4 Schedule Y, Rule 1. The prescribed app lication form is form Directorate Genera l of Health Services formed by the Ministry Disclaimer – This new sletter is for information purposes and should not be construed as legal advice. these studies is not an easy task. But considering the participates in the clinical study. A study subject number of trials that have been and are taking place cannot be enrolled without obtaining a signed in India, it is essential to remove ambiguities in the existing legislations, plug the gaps by introducing stringent laws to bring the guilty to books and ensure uniformity in the prevailing regulations. As of date, independent review board of the site has an there are many loopholes in and abuses of the important role to play as it monitors the study and regulations. Some of them are discussed below: ensures compliance with the regulations throughout the duration of the study. Though GCP Guidelines The regulations are not categorical and are left are in line with the international practices on clinical to the reader’s interpretation - For instance, rule 3 of trials, there are certain departures. For instance, Schedule Y (responsibility of investigator) states guideline 4.8 indicates that completed subject “Standard Operating Procedures (“SOP”) are identification code list should be in the sponsor’s file. required to be documented by the investigators for This is a potential violation of the subject’s rights to the tasks performed by them”. It has not been confidentiality and privacy. Essential documents are elaborated further. It is not clear what the SOP needed for sponsor’s independent audit function and should contain, in what manner and how they should inspection by the DCGI. The GCP Guidelines also be maintained, who shall maintain them, and who lists essential documents for EC files. This suggests shall review and/or amend them. Similarly, it is not that the sponsor’s auditor can review EC files. This i s clear if the site is also required to maintain a SOP also not in line with ICH-GCP. It is important to independent of the investigators. Whether the SOP eliminate such differences and bring the GCP will be a standard document meant for all the studies Guidelines more in line with the globally applicable or wil it be study-specific? The GCP Guidelines is also silent in these contexts. There needs to be greater Further, it will be interesting to consider if the GCP Guidelines are enforceable in a court of law. By Lack of stringent punishment for defaulters - and large, Indian jurisprudence has confirmed that There is a definite lack of effective deterrence in the guidelines cannot be given effect to in a court of law.6 existing provisions. Several multi-nationals and local All the key participants in a clinical trial have to companies conduct trials in India. There have been comply with the GCP Guidelines. However, in the many adverse events, reported mishaps, death of event of a default (non-compliance, serious adverse subjects, incorrect study procedures etc. but so far the event, death of a subject), due to absence of the DCGI has been unable to take any action against the necessary legislative power under the GCP guilty due to lack of stringent and speedy Guidelines, though it appears that the DCGI has wide enforcement of the laws. Recent media reports7 powers, he can still not take any substantive action suggest that the Health Ministry, DCGI is planning to against the guilty. In such cases, the Act will prevail introduce ten years imprisonment for the persons found guilty of an offence in a clinical study. However, till the law is implemented, there is no protection for the subjects who actually suffer due to the adverse events that occur during such clinical introducing GCP Guidelines, clinical trials have invariably been in the spotlight for wrong reasons. Attribution of definite liability on the sponsor, Owing to the very nature of the study, i.e. CRO, the site, and investigator in case of a serious involvement of humans as the object of study, law adverse event - In case of a foreign sponsor, the GCP and ethics are bound to overlap. Therefore, it is Guidelines clearly state that it has to appoint a local understandable that drafting regulations to monitor representative or CRO and transfer any or all of the 6 Exceptions being w here a direction has been follow ed for long, 7 “Unethical c linical trials may invite painful p enalty ”, Sushmi if they confer a benefit upon individual etc. Dey, Economic Times dated April 15, 2009. Disclaimer – This new sletter is for information purposes and should not be construed as legal advice. study related duties and functions but the ultimate The sites, investigators should be heavily penalized in responsibility for the quality and the integrity of the cases of violation of selection criteria. study data always resides with the sponsor.8 The sponsor being the one who initiates the study, it is reasonable to place this responsibility. However, in investigators - A site involved in a clinical study cases of adverse events at sites, where the engages many investigators and sub-investigators, investigators and the sites are directly involved in who are principally the local doctors or junior doctors conducting the study, it is unfair to hold the sponsor working in the hospitals. Lack of professional completely responsible. The liability and responsibility training, relevant experience, and knowledge can be between the participants should be clearly demarcated disastrous for the subjects and the overall study. There should be a stringent mechanism for selecting, training, and appointing investigators in clinical trials. They should be well apprised with the legal monitoring board - There is no independent data regulations and ethical principles before induction in safety monitoring board established by most of the clinical trial teams, hence adverse drug event or serious adverse events go unnoticed. Consequently, Role of Ethics Committee - In most of the many subjects, who end up with adverse reactions or cases, the committees are headed by the institutional in some cases death, do not get their due in terms of heads, and follow their instructions rather than the EC’s recommendations. At the central level, the central ethics committee at the ICMR issues Lack of regular monitoring by the DCGI - guidelines but has no policing powers. The ECs The existing regulations require prior permission should be monitored closely by a central agency or from the DCGI and EC for initiating the trial. the central ethics committees should be given more However, once the trial is commenced, there is no powers to deal with the ECs at the sites. check on the investigator sites or for that matter on the functioning of the ECs by the DCGI.9 The regulations should have a mechanism to keep a tab on the trials, perhaps, a provision to the effect of One cannot deny the fact that clinical trial is appointing local boards in different areas to conduct the basis for introducing better drugs, medical surprise checks and visits to verify the documents, the practices, and devices. The fact that it involves law methods adopted and the manner in which trials are and ethics makes it a challenge for those framing the conducted at the sites. In case of default, immediate legal provisions. The Ministry of Health and the and strict action should be taken against the guilty. DCGI should leave no room for complacency when it comes to human trials and ensure that the Process of selection of subjects by the sites - loopholes are plugged by ensuring uniformity and Every trial protocol has its own inclusion and removal of ambiguity from the existing regulations. exclusion criteria in order to choose the subjects for However, law can regulate, monitor, and ensure the study. However, it has been observed that the protection of subjects only to a certain extent. economically weaker, il iterate sections of the society Eventual y, it is up to the proponents of clinical trial are sometimes exploited. In effect, it appears that to adopt ethical principles/practices and not exploit many a times the selection criteria tend to be ignored or misuse fellow humans for commercial reasons. and violated by the investigators and sites. And, these discrepancies come to light only in case of adverse events or due to media reports. It is imperative for the sites and investigators to perform the trials in an ethical manner and comply with the ICMR guidelines. 8 Guideline 3.1.17. 9 Though the ICMR has set up the Central Ethics Committee, greater monito ring is required . Disclaimer – This new sletter is for information purposes and should not be construed as legal advice. Disclaimer – This new sletter is for information purposes and should not be construed as legal advice.

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