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New Drugs and Clinical Trial Rules (2023)


Syllabus: Application of Ethics/ Government Policies and Related Issues


Source: TH, BBC

Context: The government of India recently passed an amendment to the New Drugs and Clinical Trial Rules (2023) that permits researchers to utilize non-animal and human-relevant methods for testing the safety and effectiveness of new drugs.


  • It will amend the Drugs and Clinical Trials Rules, 2019

Alternative methods proposed are 3D organoids, 3D bioprinter, organs-on-chip, and advanced computational methods.

 To know the process of Clinical Trials in India: Click Here


The use of animals in drug testing has limitations:  

LimitationsDescription Example
Limited predictability for human responseAnimals may respond differently to drugs compared to humans due to differences in biological processes, genetics, and other factors.The drug Thalidomide caused severe birth defects in humans but did not produce the same effects in animal tests, leading to tragic consequences.
Ethical Concerns and animal welfareAnimal testing involves the use of sentient beings and raises ethical concerns regarding the suffering and harm caused to animals. This includes procedures such as force-feeding, injections, and euthanasia.The Draize test, which involves applying substances to animals’ eyes, has been criticized for causing severe pain and distress.
The high failure rate in translating to human efficacyDespite passing animal testing, many drugs fail during human clinical trials, leading to wasted resources and potential harm to human participants.For instance, a study published in the British Medical Journal found that over 90% of drugs tested on animals fail to translate into safe and effective treatments for humans.
Inadequate representation of human diversityAnimals used in testing may not accurately represent the diversity of human populations in terms of age, sex, genetic variations, and underlying health conditions.For example, the drug Ximelagatran showed promise in animal studies but caused liver damage in humans, highlighting the need for more accurate models.
Regulatory and legal considerationsThe use of animals in testing is subject to regulatory requirements and ethical considerations, which can lead to delays, increased costs, and challenges in obtaining approvals.The European Union has implemented a ban on animal testing for cosmetics.


Ethical Issues Related to the Use of Animals in drug testing:

Ethical DilemmaDescription
Animal SufferingAnimal experimentation often involves causing pain, distress, or harm to the animals, raising concerns about their welfare and the ethics of inflicting suffering on them.
Moral Status of AnimalsThe debate centres around the moral consideration and rights of animals. Some argue that animals have inherent value and should not be subjected to experimentation, while others believe that human benefits justify their use.
Balancing Human BenefitsThe dilemma arises when weighing the potential benefits to human health and well-being against the harm caused to animals. Ethical considerations involve determining if the benefits are significant enough to justify the use of animals in experiments.
Informed Consent and Voluntary ParticipationUnlike human clinical trials where participants can provide informed consent, animals have no agency or ability to voluntarily participate in experiments, raising questions about the ethics of subjecting them to testing without their consent.


Steps by Other Countries:

  • In 2021, the European Unionpassed a resolution on an action plan to facilitate the transition towards technologies that don’t use animals in research, regulatory testing, and education. The U.S. passed the FDA Modernization Act 2.0 in December 2022, allowing researchers to use these systems to test the safety and efficacy of new drugs.
  • Also, in 2022, South Korea introduced a Bill called ‘Vitalization of Development, Dissemination, and Use of Alternatives to Animal Testing Methods’.
  • In June 2023, Canada amended its Environmental Protection Act to replace, reduce or refine the use of vertebrate animals in toxicity testing.



Thus the use of non-animal methods is significant for avoiding these ethical dilemmas. However, India faces challenges in terms of interdisciplinary expertise and the availability of resources for research in this area. Efforts are being made to establish centres of excellence and develop an end-to-end ecosystem in India to support the implementation of these new technologies.


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Clinical Trials


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 Case Study: One of the scientists working in the R&D laboratory of a major pharmaceutical company discovers that one of the company’s bestselling veterinary drugs has the potential to cure a currently incurable liver disease which is prevalent in tribal areas. However, developing a variant of the drug suitable for human beings entailed a lot of research and development having a huge expenditure to the extent of Rs. 50 crores. It was unlikely that the company would recover the cost as the disease was rampant only in poverty-stricken areas having very little market otherwise. (250 Words)

If you were the CEO, then;

(a) Identify the various actions that you could take

(b) Evaluate the pros and cons of each of your actions