Schedule Y is a schedule in the Drugs and Cosmetics Act of India that provides guidelines for the conduct of clinical trials of new drugs in India. Schedule Y was first introduced in 1983 and has since been amended several times to align with the latest scientific and regulatory requirements.
The primary objectives of Schedule Y are to ensure the safety and efficacy of new drugs before they are approved for use in India, and to protect the rights and welfare of participants in clinical trials. Schedule Y covers all aspects of clinical trial conduct, including study design, ethical review, informed consent, data management, and reporting.
Some of the key provisions of Schedule Y include:
- Approval of clinical trials: Clinical trials of new drugs in India must be approved by the Central Drugs Standard Control Organization (CDSCO) prior to initiation. The CDSCO assesses the safety and efficacy of the new drug, as well as the study design and ethical review process, before granting approval.
- Ethical review: Clinical trials of new drugs in India must be reviewed and approved by an independent ethics committee. The ethics committee assesses the potential risks and benefits of the study, as well as the informed consent process, to ensure that the rights and welfare of the participants are protected.
- Informed consent: Participants in clinical trials of new drugs in India must provide informed consent prior to participating in the study. The informed consent process must be approved by the ethics committee and must include a detailed explanation of the study, its purpose, procedures, risks, benefits, and alternatives.
- Data management: Clinical trial data must be managed in accordance with international standards for data quality and accuracy. The data must be kept confidential and should only be used for the purpose of the study.
- Reporting: The results of clinical trials of new drugs in India must be reported to the CDSCO and the ethics committee. The results must be made publicly available to ensure transparency and accountability in the clinical trial process.
Schedule Y plays a crucial role in ensuring the safety and efficacy of new drugs in India and protecting the rights and welfare of participants in clinical trials. The provisions of Schedule Y help to ensure that clinical trials of new drugs in India are conducted in a scientifically rigorous and ethically responsible manner.
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