• It is a set of practice that helps certify a new drug molecule as safe and efficacious before reaching the market. 

Ethical Issues regarding Clinical Trials

• Side Effects: Medical research often entails minor pain, discomfort, or injury from invasive procedures, or potential harm from drug side effects. 
• Lack of Transparency: Some researchers and sponsors may bypass the regulatory framework to expedite trials for increased profit. 
• There also exists a significant challenge of nexus managing the intertwined relationships among sponsors, researchers, regulators, and ethics committees. 
• Targeting Vulnerable Populations: Those in desperate financial situations can become easy targets for unethical clinical trials. 
• Lack of Informed Consent: Complex language in consent forms can make them difficult to understand, particularly for those with low literacy levels. 
• Compensation: Participants sometimes fail to receive compensation when clinical trials do not succeed. This raises questions about the extent to which financial incentives could encourage research subjects to provide misleading or false information.
• Stem Cell Research: Despite the proven therapeutic value of human stem cells, ethical concerns remain around their harvesting, particularly from human embryos. 
• Drug Trials in Neonates: Ethical challenges include the inherent vulnerability of this population, their higher risk of mortality and morbidity, and the difficulties in obtaining informed parental consent.

Way Forward

• Regulatory Approval: The approval process is slow due to new requirements for the submission and review of clinical trials which needs to be streamlined. 
• Patient Recruitment: The recruitment of patients depends on the availability of investigator sites and patient willingness. Increasing the number of investigator sites could help. 
• Ensuring Quality and Compliance: Institutional ethics committees (ECs) should devote time and effort to understanding ethical issues - human protection, independent decision-making, handling conflict of interest, reviewing safety reports and compensation, and overseeing clinical trial conduct. 
• Development of National Clinical Trial Infrastructure: Researchers in low- to middle-income settings need support and training to conduct clinical trials independently or collaboratively. 
• Regulatory Approval: Clear and unambiguous regulatory provisions applicable to diverse situations would enhance the efficiency of trial approval. 
• Education in Ethical Clinical Trials: Different stakeholders, including CDSCO functionaries, IEC members, academicians, CROs, and industry professionals, should be educated on ethical clinical trial practices. 
• Compensation for Trial: Related Death or Injury: Insurance coverage should include all costs associated with investigations and treatments arising from trial participation, the limit and period of insurance coverage, liability per claim, and the aggregate liability.

Regulation of Clinical Trials in India

• Drugs and Cosmetics Act 1940: In India, regulations pertaining to clinical trials are placed in Schedule "Y" of the Drugs and Cosmetics Act 1940, and the rules framed thereunder. 
• New chemical entities cannot be administered to human subjects in a clinical trial without permission from the Drugs Controller General of India.
• The Drugs Controller General of India (DCGI) is an official of the Central Drugs Standard Control Organization (CDSCO) who is the final regulatory authority for the approval of clinical trials in the country. 
• ICMR Ethical Guidelines: It mandates setting up of Ethics Committees (EC's) at the institutional levels, for the purpose of scrutinizing and approving a clinical trial before it begins; and to conduct periodic reviews of the progress of the trial.