Context– The Government of India recently approved the New Drugs and Clinical Trial Rules (2023), with the objective of substituting animal experimentation, particularly in the field of pharmaceutical testing.
Key-highlights of the Amendment:
- The amendment grants researchers the authority to use alternative techniques that do not include animals and are more applicable to humans.
- These methods encompass technology such as 3D organoids, organs-on-chip, and sophisticated computational approaches, which are utilized to assess the safety and effectiveness of novel pharmaceuticals.
- The aforementioned regulations provide that any Contract Research Organization (CRO) doing a clinical trial or bioavailability/bioequivalence research involving novel or experimental medications in human participants must get registration from the Central Licensing Authority prior to commencing such investigations.
Clinical Trials module in India:
- Each pharmaceutical undergoes a comprehensive series of evaluations aimed at assessing its efficacy in treating the specific ailment it was developed for, as well as its potential adverse effects.
- The first stage of the drug testing procedure is evaluating the candidate molecule in a minimum of two animal species, namely rodents (mice or rats) and non-rodents, such as dogs and primates.
- Nevertheless, it is important to acknowledge the intricacies of human physiology, as biological mechanisms and their reactions frequently exhibit individual variations.
- These variations can be attributed to various factors including age, gender, existing medical conditions, genetic makeup, and dietary patterns. Consequently, relying solely on laboratory-bred animal species raised under controlled environments may not provide a comprehensive understanding of the human response to a particular drug.
Need for new regulations:
- In spite of the escalating allocation of resources in the pharmaceutical industry, a substantial proportion of medications that successfully pass the animal-testing phase encounter failure throughout the subsequent stage of human clinical trials.
- The constraints associated with the traditional testing procedure, which starts with animal experimentation, have prompted a growing cohort of academics to prioritize the development of alternative systems that more effectively emulate the complexities of human biology and enhance the ability to forecast human reactions.
Status of regulations worldwide
- In the year 2021, the European Union enacted a resolution outlining an action plan aimed at expediting the shift towards non-animal-based technology in the domains of research, regulatory testing, and teaching.
- In the year 2022, the United States enacted the FDA Modernization Act 2.0, which granted researchers the authorization to use these systems for the purpose of assessing the safety and effectiveness of novel pharmaceuticals.
- The Republic of Korea implemented a legislative proposal known as the ‘Vitalization of Development, Dissemination, and Use of Alternatives to Animal Testing Methods Bill’.
- In the year 2023, the Environmental Protection Act of Canada underwent an amendment with the objective of substituting, decreasing, or improving the use of vertebrate animals in toxicity testing.
- In March 2023, the Indian government made modifications to the New Drugs and Clinical Trials Rules 2019, including these systems into the drug-development pipeline.
New Drugs and Clinical Trial Rules (2019)
- The aim of this study is to modify the existing regulatory framework pertaining to the authorization process for novel pharmaceuticals and the implementation of clinical trials inside the nation.
- This set of regulations will be applicable to a wide range of pharmaceutical products, including newly developed medications, experimental pharmaceuticals intended for human use, clinical trials, bioequivalence studies, and the activities of Ethics Committees.
- The period required for approving applications has been decreased to 30 days for pharmaceuticals produced in India and 90 days for drugs generated outside the nation.
- If there is a lack of contact from the Drugs Controller General of India (DCGI), it might be assumed that the application has been granted.
- The need of conducting a clinical trial at a local level might be exempted in the process of approving a novel pharmaceutical product, provided that it has already received authorisation and is being sold in certain countries designated by the Drugs Controller General, subject to government consent.
- Safety in clinical trials is of paramount importance, since it guarantees the well-being and protection of patients who voluntarily participate in these studies after providing informed permission.
- The oversight committee responsible for ethical considerations will oversee the clinical trials and determine the appropriate level of compensation in instances of adverse occurrences.
Technologies suggested as alternatives:
In order to circumvent the use of animals in clinical studies, the implementation of various technologies might prove to be very successful.
- Technologies using human cells or stem cells include the creation of three-dimensional cellular constructs, referred to as “organoids” or “mini-organs,” which replicate distinct bodily organs on a millimeter scale.
- The ‘organ-on-a-chip’ technology refers to the use of AA-battery-sized chips that are coated with human cells and interconnected with microchannels. This configuration is designed to replicate the circulation of blood inside the human body.
- These systems include several facets of human physiology, including interactions between different tissues as well as the analysis of physical and chemical signals occurring inside the body.
- The use of 3D bioprinters involves the fabrication of biological tissues by the deposition of human cells and fluids, which serve as the bio-ink.
- Given their ability to be constructed using cells that are distinct to individual patients, these structures may also be used to customize drug testing procedures.
There are several obstacles associated with clinical trials that have been alleviated by the use of technology.
- The aforementioned factors include expedited recruiting and enhanced retention, enhancement of the patient experience, optimization of patient data collection, availability of non-conventional data sources, and remote monitoring of patients.
- Moreover, the decentralization of trials and the implementation of a patient-centric strategy might be considered.
- Furthermore, the obstacles encountered by trials in the current paradigm shift resulting from the COVID-19 pandemic may be effectively addressed by the use of innovative technology.
- The use of mobile devices, smartphone-based applications, and wearable medical technology has considerable promise in enhancing the process of patient data collection. The use of patient data plays a vital role in clinical trials as it serves to shape the trajectory of research and ultimately influences the final therapeutic results.
- The COVID-19 pandemic and the need of social separation to mitigate disease transmission have led to a heightened emphasis on remote monitoring in clinical trials. Researchers are increasingly using remote site access and monitoring capabilities.
- Clinical trials face various barriers, including challenges related to decentralized trials such as patient compliance and participants’ technological proficiency. Nevertheless, this form of clinical trial effectively addresses obstacles like logistical constraints, transportation limitations, and the difficulty of reaching remote populations, which otherwise impede the global expansion of trials.
- India’s drug development law change reduces animal experimentation and promotes ethical principles for safer and more effective pharmaceuticals.
- India establishes a foundation for responsible drug development by promoting alternative approaches, animal welfare, and international criteria.
- This innovative technique is intended to progress science, helping the pharmaceutical industry and people worldwide.