Academic CTs must follow the\nEC-approved CT procedure and the ethical guidelines outlined in the ICMR\nGuidelines for Biomedical Research on Human Participants.<\/li><\/ul>\n\n\n\nThe Ministry of Health & Family\nWelfare has changed the guidelines. In a notice dated August 31, 2021, the\nMinistry published the New Drugs and Clinical Trials (Amendment) Rules, 2021.\nThe definitions of bioavailability and a bioequivalence research centre are\naltered by the Rules, which update the New Drugs & Clinical Trials Rules,\n2019, respectively. The following is the updated definition under Rule 2(1)(g):<\/p>\n\n\n\n
Bioavailability\n& bioequivalence study centre means a centre created\/established to\nundertake bioavailability study or bioequivalence study of a drug for either\nclinical part or analytical part or for both clinical and analytical part of\nsuch study.<\/em><\/p>\n\n\n\nThe\nfollowing rules under the New\nDrugs and Clinical Trials Rules of 2019 should be understood:<\/p>\n\n\n\n
- Rule 2(1)(a) talks about – academic clinical trial<\/li>
- Rule 2(1)(k) talks about – clinical trial protocol<\/li>
- Rule 2(1)(l) talks about – clinical trial site<\/li>
- Rule 2(1)(o) talks about – Ethics Committee<\/li>
- Rule 2(1)(p) talks about – Good Clinical Practices Guidelines<\/li>
- Rule 2(1)(q) talks about – global clinical tria<\/li>
- Rule 3 talks about – Central Licencing Authority<\/li>
- Rule 6 talks about – Requirement of the Ethics Committee<\/li>
- Rule 7 talks about – Constitution of Ethics Committee for clinical trial<\/li>
- Rule 8 talks about – Registration of Ethics Committee relating to\nclinical trial, bioavailability & bioequivalence study.\u2015<\/li>
- Rule 9 talks about – Validity period of registration of Ethics Committee\nfor clinical trial<\/li>
- Rule 10 talks about – Renewal of registration of Ethics Committee for\nclinical trial<\/li>
- Rule 12 talks about – Proceedings of Ethics Committee for clinical trial<\/li>
- Rule 13 talks about – Maintenance of records by Ethics Committee for\nclinical trial<\/li>
- Rule 14 talks about – Suspension\/cancellation of registration of Ethics\nCommittee for clinical trial<\/li>
- Rule 19 talks about – Clinical trial of new drug or investigational new\ndrug<\/li>
- Rule 20 talks about – Oversight of clinical trial site<\/li>
- Rule 21 talks about – Application for permission to conduct clinical\ntrial of a new drug\/investigational new drug<\/li>
- Rule 22 talks about – Grant of permission to conduct clinical trial<\/li>
- Rule 23 talks about – Permission to conduct clinical trial of a new\ndrug\/investigational new drug as part of discovery, research & manufacture\nin India<\/li>
- Rule 24 talks about – Permission to conduct clinical trial of a new drug\nalready approved outside India<\/li>
- Rule 25 talks about – Conditions of permission for conduct of clinical\ntrial<\/li>
- Rule 26 talks about – Validity period of permission to initiate a\nclinical trial.<\/li>
- Rule 27 talks about – Post-trial access of investigational new drug or\nnew drug<\/li>
- Rule 28 talks about – Academic clinical trial<\/li>
- Rule 29 talks about – Inspection of premises relating to clinical trial<\/li>
- Rule 30 talks about – Suspension or cancellation of permission to conduct\nclinical trial.<\/li>
- Rule 39 talks about – Compensation in case of injury or death in clinical\ntrial or bioavailability\/bioequivalence study of new drug or investigational\nnew drug.<\/li>
- Rule 40 talks about – Medical Management in clinical trial or\nbioavailability & bioequivalence study of new drug\/investigational new\ndrug.<\/li>
- Rule 41 talks about – Consideration of injury\/death\/permanent disability\nto be related to clinical trial\/bioavailability and bioequivalence study.\u2015<\/li>
- Rule 42 talks about – Procedure for compensation in case of injury\/death\nduring clinical trial, bioavailability & bioequivalence study.<\/li>
- Rule 43 talks about – Medical management & compensation for injury\nor death relating to biomedical & health research overseen by an Ethics\nCommittee for biomedical & health research as referred to in Chapter IV<\/li>
- Rule 52 talks about – Application for permission to manufacture of new\ndrug\/investigational new drug for clinical trial or bioavailability and\nbioequivalence study\/for examination, test and analysis<\/li>
- Rule 53 talks about – Grant of permission to manufacture new drugs or\ninvestigational new drugs for clinical trial or bioavailability\/bioequivalence\nstudy, or for examination, test and analysis.<\/li>
- Rule 54 talks about – Validity period of permission to manufacture of\nnew drug\/investigational new drugs for clinical trial or bioavailability &\nbioequivalence study, or for examination, test and analysis.<\/li>
- Rule 56 talks about – Licence to manufacture new drugs\/investigational\nnew drugs for clinical trial or bioavailability\/bioequivalence study\/for\nexamination, test & analysis under the Drugs and Cosmetics Rules, 1945<\/li>
- Rule 57 talks about – Inspection of new drugs\/investigational new drugs\nmanufactured for clinical trial\/bioavailability & bioequivalence study\/for\nexamination, test and analysis.<\/li>
- Rule 59 talks about – Application for permission to manufacture\nunapproved active pharmaceutical ingredient for development of pharmaceutical\nformulation for test\/analysis or clinical trial or bioavailability and\nbioequivalence study.<\/li>
- Rule 60 talks about – Grant of permission to manufacture an unapproved\nactive pharmaceutical ingredient for development of pharmaceutical formulation\nfor test\/analysis or clinical trial or bioavailability and bioequivalence study<\/li>
- Rule 61. Validity period of the permission to\nmanufacture an unapproved active pharmaceutical ingredient & its\nformulation for test\/analysis\/clinical trial or bioavailability and\nbioequivalence study.\u2015<\/li>
- Rule 62 talks about – Suspension\/cancellation of permission to\nmanufacture an unapproved active pharmaceutical ingredient for development of\nformulation for test\/analysis or clinical trial or bioavailability and\nbioequivalence study.<\/li>
- Rule 64 talks about – Licence to manufacture an unapproved active\npharmaceutical ingredient for the development of formulation for\ntest\/analysis\/clinical trial\/bioavailability & bioequivalence study under\nthe Drugs & Cosmetics Rules, 1945<\/li>
- Rule 65 talks about – Inspection of manufacturer of an unapproved active\npharmaceutical ingredient for development of formulation for test or\nanalysis\/clinical trial or bioavailability and bioequivalence study.<\/li>
- Rule 67 talks about – Application for import of new drug\/investigational\nnew drug for clinical trial\/bioavailability or bioequivalence study\/for\nexamination, test and analysis.<\/li>
- Rule 68 talks about – Grant of licence for import of new\ndrug\/investigational new drug for clinical trial\/bioavailability\/bioequivalence\nstudy or for examination, test and analysis.<\/li>
- Rule 69 talks about – Validity period of licence for import of new drugs\nfor clinical trial\/bioavailability\/bioequivalence study or for examination,\ntest and analysis.<\/li>
- Rule 91 talks about – Application for permission to manufacture an\nunapproved new drug but under clinical trial, for treatment of patient of life\nthreatening disease.\u2015<\/li>
- Rule 92 talks about – Grant of permission to manufacture an unapproved new drug but under clinical trial,\nfor treatment of patient of life threatening disease.<\/li>
- Rule 94 talks about – Inspection of unapproved new drug but under\nclinical trial manufactured for patient of life threatening disease.<\/em><\/li><\/ul>\n\n\n\n
<\/span>Stages of\nRegulatory Approvals in the Process of Drug Development<\/span><\/h2>\n\n\n\nThe following is the stage wise regulatory\napproval for clinical trials in India:<\/p>\n\n\n\n
Stage 1: Drug Discovery<\/p>\n\n\n\n
Stage 2: Pre-Clinical Testing <\/p>\n\n\n\n
Stage 3: Permission to Conduct Clinical Trial<\/p>\n\n\n\n
Stage 4: Launch of New Drug<\/p>\n\n\n\n
Stage 5: Registration of New Drug<\/p>\n\n\n\n
Stage 6: Human Clinical Trial<\/p>\n\n\n\n
Stage7: Post Marketing Surveillance<\/p>\n\n\n\n
<\/span>What Are The Legal Issues Involved In Making A Human\nSubject To Clinical Trials In India?<\/span><\/h2>\n\n\n\nSchedule\nY of the Drugs & Cosmetics Rules states:<\/p>\n\n\n\n
Without\nthe Drugs Controller General of India’s approval, new chemical entities cannot\nbe given to volunteers in clinical research (DCGI). You can get this approval\nby submitting a clinical study application to the DCGI.<\/strong><\/p>\n\n\n\nThe application must\ninclude:<\/strong> <\/strong><\/p>\n\n\n\n- A plan\nfor the investigation,<\/li>
- The\nInformed Consent Document’s draught,<\/li>
- A list\nof potential researchers who have consented to take part in the study, and according\nto Schedule Y of the Drugs & Cosmetics Rules, background information\nregarding the substance is required.<\/li><\/ol>\n\n\n\n
For the majority of investigatory\nmedications, getting approval for a clinical study takes close to 12 weeks. For\nmedications that are particularly important to the nation’s healthcare needs or\nthose that can be viewed as contentious, the time frame may be extended since\nthese are likely to be sent to the Indian Council of Medical Research for\nopinions. A “Test-Import License” must also be requested in order to\nimport clinical materials. Regulations 33 and 34 as well as the clauses in Part\nX-A of the rules control the import and manufacturing of clinical trial\nsupplies.<\/p>\n\n\n\n
The process for requesting marketing\nauthorisation is determined by the new drug’s status, which generally falls\ninto one of three categories:<\/p>\n\n\n\n
- If\nphase III<\/strong> or confirmatory trials are carried out to gather data about\nthe efficacy and safety of the drug in a sufficient number of patients, in\ncomparison with a standard drug or a placebo, in order to confirm efficacy and\nsafety claims made in the product monograph, that is sufficient for newly\ndiscovered drug substances that are already approved\/marketed in other\ncountries. <\/li>
- New\npharmacological compounds that have been identified but have not been licenced\nor commercialised in other nations are given “phase lag<\/strong>” approval\nfor clinical studies. This implies that a phase I<\/strong> trial can only be\napproved if the medicine has already passed phase I<\/strong> and entered phase\nII<\/strong> in other nations. Similar to other nations, phase II<\/strong> in India is\nonly permitted if phase II<\/strong> there has ended and phase III<\/strong> has\nstarted.<\/li><\/ol>\n\n\n\n
<\/span>What Are The Consequences If A Human Subject Dies Under Clinical Trials?<\/span><\/h2>\n\n\n\nCompensation\nin case of damage or death during a clinical experiment, under 122-DAB<\/strong> \u2013<\/p>\n\n\n\n- If the subject sustains a harm while participating in the clinical study, free medical care will be provided for as long as necessary or until it is determined that the injury is unrelated to the experiment, whichever comes first.<\/li>
- If a trial subject sustains an injury that is connected to the clinical trial, the subject will also be entitled to financial compensation, as per the order of the licencing authority described in clause (b) of Rule 21, which will be in addition to any costs associated with the subject’s medical care. If there is no lasting damage, the amount of compensation must be proportionate to the subject’s non-permanent damage and salary loss. <\/li>
- According to the Licensing Authority’s order, which is defined in clause (b) of Rule 21, in the event that a subject involved in a clinical trial passes away, his or her nominee(s) would be entitled to financial compensation, which would be in addition to any costs associated with the subject’s medical care.<\/li>
- The sponsor of the clinical trial is responsible for covering the costs of medical care and monetary compensation in the event that a trial participant is injured or dies during the course of the study.<\/li>
- The following conditions shall be deemed to constitute clinical trial-related injuries or deaths, and the subject or his\/her nominee(s), as applicable, shall be entitled to financial compensation for such injuries or deaths:
- Adverse impacts of the product(s) under examination. <\/li>
- Violation of the approved protocol, carelessness on the part of the sponsor, his agent, or the investigator, as well as a violation of Drugs and Cosmetics Rules of 1945. <\/strong><\/li>
- Failure of the experimental product to have the desired therapeutic impact when, despite the availability of conventional treatment, the patient did not get it in accordance with the clinical study protocol.<\/li>
- Using a placebo in an experiment where the individual was eligible for conventional care but it wasn’t given to them in accordance with the protocol for the clinical trial;<\/li>
- Adverse drug interactions that prevent the need for routine care yet are necessary for following a procedure that has been approved;<\/li>
- If a parent’s involvement in a clinical trial causes harm to an unborn child; <\/li>
- If any clinical trial methods are used in the research.<\/li><\/ul><\/li>
- A promise to pay compensation in the event of injury or death resulting from a clinical trial for which subjects are entitled to compensation must be provided by the sponsor, whether it be a pharmaceutical company or an institution, along with the application for permission to conduct a clinical trial to the Licensing Authority as defined in clause (b) of Rule 21.<\/li>
- The licencing authority may, after giving the sponsor a chance to demonstrate why such an order should not be passed, suspend or cancel the clinical trial if the sponsor fails to provide medical management for the subject’s injury, financial compensation for the trial subject for injury related to the clinical trial, or financial compensation to the subject’s nominee(s) in case of clinical trial related death of the subject.<\/li><\/ol>\n\n\n\n