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    BlogLegal issues in regulating the Clinical Drug Trials on  human beings in...

    Legal issues in regulating the Clinical Drug Trials on  human beings in India

    -Vidhanshi Bhardwaj

    Balancing economic opportunities with public health 

    In general, when a person hears the term ‘drug’ a very negative picture comes to the mind, i.e., of something hallucinogenic, narcotic, or stimulating in nature, that causes addiction, violence, or other sorts of things. The drug is a neutral term that covers all sorts of substances in its ambit, whether for a  medicinal purpose or narcotic. The key to remember is all medicines are drugs, but not all drugs are medicines. A ‘drug’ can be defined as any chemical substance that can cause a change in an 

    organism’s physiology, psychology, or biology when consumed. Such substances in limited amounts for a limited duration are required for human medication to treat, cure, prevent, or diagnose a disease or to promote well-being and are called ‘medicines’. 

    What is a Clinical Trial? 

    According to 122DA (5) (a) of Import of Manufacture of New Drug for Clinical Trials or Marketing: 

    Clinical Trial” means a systematic study of any new drug(s) in the human subject(s) to generate data for discovering and/or verifying the clinical, pharmacological (including pharmacodynamic and pharmacokinetic), and/or adverse effects with the objective of determining safety and/or efficacy of the new drug. 

    A clinical trial can be defined as a set of practice or laboratory experiments that helps to certify a new drug molecule, made by a pharmaceutical agency, as safe and efficacious to a human being before reaching the market for consumption. Hence, when a drug is made by a Pharma, they need to have a  certification, that they have the requisite safety standard for human consumption, by certain authorities. Those “certain authorities” in India is CDSCO, whose compliance with issued GCP  guidelines is recommended.  

    Human Rights Violations:– 

    Informed consent is an essential requirement of medical trials, which denotes that the patient undergoing treatment as part of the study should be made aware of the trial being conducted, the drugs being administered to him, and its possible side effects. 

    However, the country has, in several instances witnessed gross violations of human rights and ethical values while conducting trials on volunteers enrolled in studies. In 1999, without obtaining the consent of the patients who were under treatment in the government-run Regional Cancer Centre in Trivandrum,  

    An experimental drug tetraglycinyl nor-dihydro-guaiaretic acid was administered to them. Though there was an established treatment for their condition, they were not informed that they were taking part in an experiment or that they were being denied an established treatment. 

    Similarly, in 2002, the pharma giant Novo Nordisk conducted multi-center phase III clinical trials of a  diabetes drug even before receiving the results of animal studies. The study report found that the drug,  ragaglitazar, caused urinary bladder tumors in rats; this should have been known before the drug went for phase I trials. The trials were conducted on 650 people from North America, 200 from Latin  America, 100 from Australia / New Zealand, 800 from the European Union, 200 from non-EU Europe; and 550 from Asia. 

    In 2003, Mumbai-based Sun Pharmaceutical Industries Ltd. launched a promotional-cum-research program by getting private doctors to prescribe the anti-cancer drug Letrozole to more than 400  women as a fertility drug for ovulation induction. The company then publicized the doctors’ reports to other doctors as “research”, using their network of medical representatives. The drug was prescribed despite the fact that it was known to be toxic to embryos. 

    These are only a few of the numerous shocking human rights violations that have been exposed in the area of clinical trials. These instances throw light on the lacunae in the Indian legal system for penalizing drug companies that violate norms and mess up while conducting global clinical trials. 

    Another flaw in the Indian healthcare regulation is the lack of consistency in the licensing procedure.  Currently, the interpretation and enforcement procedure varies from one state to another. This variation in procedures creates little accountability, in case an issue arises. At the same time, attempts by the  Central government to create a Central Drug Authority are highly appreciable. Such a move gains significance in the context that the US and European drug giants are increasingly outsourcing their clinical testing to rapidly developing economies like China, India, and Africa. 

    What are the LEGAL ISSUES involved in making a HUMAN subject to Clinical Trials? 

    According to Schedule Y of the Drugs & Cosmetics Rules: 

    New chemical entities cannot be administered to human subjects in a clinical trial without permission from the Drugs Controller General of India (DCGI). Such permission may be obtained by submitting to the DCGI an application for a clinical trial.  

    The application must include: 

    A. a protocol for the study,  

    B. a draft of the Informed Consent Document,  

    C. a list of proposed investigators who have agreed to participate in the study, and  D. background information about the drug in accordance with Schedule Y of the Drugs &  Cosmetics Rules. 

    It takes almost 12 weeks to obtain permission for a clinical trial for most investigatory drugs. The duration may be longer for medicines with special significance to the healthcare concerns of the country or those that may be considered controversial since these are liable to be referred to the Indian Council of Medical Research for comments. If clinical supplies are to be imported, a “Test-Import License”  must also be applied for. Import and manufacture of clinical trial supplies are governed by Rules 33 & 34 and provisions contained in Part X-A of the rules. 

    The procedure for applying for marketing approval depends on the status of the new drug, which  broadly falls within three categories: 

    (i) new drug substances discovered that are already approved/marketed in other countries, for which it is sufficient if phase III or confirmatory trials are conducted to obtain data about the efficacy and safety of the drug in a sufficient number of patients, in comparison with a standard drug or a placebo,  to confirm efficacy and safety claims made in the product monograph. 

    (ii) new drug substances discovered but are not approved/marketed in other countries, for which permission for clinical trials is granted with a “phase lag”. It means that permission to conduct a phase I  trial is allowed only if the drug has completed phase I and moved to phase II in other countries.  Likewise, phase II is allowed in India only after completion of phase II in other countries and phase  III has commenced. 

    What are the consequences if a human subject dies under a clinical trial? According to 122-DAB (Compensation in case of injury or death during a clinical trial) – 

    (1) In case of an injury occurring to the subject during the clinical trial, free medical management shall be given as long as required or till such time it is established that the injury is not related to the clinical trial, whichever is earlier. 

    (2) In case, the injury occurring to the trial subject is related to the clinical trial, such subject shall also be entitled to financial compensation as per the order of the Licensing Authority defined under clause (b) of Rule 21, and the financial compensation will be over and above any expenses incurred on the medical management of the subject.  

    (2A) In case, there is no permanent injury, the quantum of compensation shall be commensurate with the nature of the non-permanent injury and loss of wages of the subject. 

    (3) In the case of a clinical trial related death of the subject, his / her nominee(s) would be entitled for financial compensation, as per the order of the Licensing Authority defined under clause (b) of Rule 21 and the financial compensation will be over and above any expenses incurred on the medical management of such subject.  

    (4) The expenses of medical management and financial compensation in the case of clinical  trial injury or death of the trial subject shall be borne by the sponsor of the clinical trial.  

    (5) Any injury or death of the subject occurring in clinical trial due to following reasons shall  be considered as clinical trial related injury or death and the subject or his/her nominees(s), as  the case may be, are entitled for financial compensation for such injury or death:  

    • (a) Adverse effect of investigational product(s);  
    • (b) Violation of the approved protocol, scientific misconduct or negligence by the sponsor or  his representative or the investigator; Drugs and Cosmetics Rules 1945 145 
    • (c) Failure of investigational product to provide intended therapeutic effect, where, the  standard care, though available, was not provided to the subject as per the clinical trial  protocol;  
    • (d) Use of placebo in a placebo-controlled trial where, the standard care, though available,  was not provided to the subject as per the clinical trial protocol;  
    • (e) Adverse effects due to concomitant medication excluding standard care, necessitated as  part of approved protocol;  
    • (f) For injury to a child in-utero because of the participation of parent in clinical trial; (g) Any  clinical trial procedures involved in the study.  

    (6) The sponsor, whether a pharmaceutical company or an institution shall give an  undertaking along with the application for clinical trial permission to the Licensing Authority  defined in clause (b) of Rule 21, to provide compensation in the case of clinical trial related  injury or death for which subjects are entitled to compensation.  

    (7) In case, the sponsor fails to provide medical management for the injury to the subject and  / or financial compensation to the trial subject for clinical trial related injury or financial  compensation to the subject‘s nominee(s) in case of clinical trial related death of the subject,  the Licensing Authority may after giving an opportunity to show cause why such an order  should not be passed, by an order in writing, stating the reasons thereof, suspend or cancel the  clinical trial and / or restrict Sponsor including his representative(s) to conduct any further  clinical trials in the country or take any other action deemed fit under the rules. 


    India is pulling in an ever-increasing number of scientists from around the globe to carry on  their clinical preliminary investigations in India. The new laws are being revised to encourage  and channelize the passage of the large pharmaceutical houses. However, there is a need to  modify and execute the current scholarly laws with high moral norms that will lead the  clinical preliminary of India to the following level in the global market.  

    Being the second biggest populated nation on the planet, India can contribute decidedly in the  worldwide clinical investigates and medication improvement program, and so forth. Over a  couple of years, there has been a consistent observation of the emotional increment in the  number of clinical preliminaries. There is a strict need for a legitimate structure for  controlling the clinical preliminaries as India comes up short on an appropriate instrument in  the clinical preliminary industry. With set of experienced clinical experts and innovative  advances, India will certainly give the world its best as a significant most loved goal for the  clinical explore sooner rather than later. 

    References: documents/acts_rules/2016DrugsandCosmeticsAct1940Rules1945.pdf,, 


    se%20is%20different%20from%20that%20of%20medicine, issues-regulating-the-clinical-drug-trials-on-human-beings-in-india/.

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