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Indian Regulations with specific reference to Schedule Y

Indian Regulations with specific reference to Schedule Y

In India, Schedule Y is a set of regulations that outline the requirements for the conduct of clinical trials for new drugs or investigational new drugs (INDs) in the country. Schedule Y is a part of the Drugs and Cosmetics Act and Rules, which are the primary laws governing the manufacturing, sale, and distribution of drugs and cosmetics in India.

The key provisions of Indian Regulations with specific reference to Schedule Y include the following:

  1. Ethics Committee Approval: All clinical trials must be approved by an independent ethics committee, which is responsible for ensuring that the trial is conducted in an ethical and safe manner.
  2. Investigational New Drug (IND) Requirements: Any new drug that is not approved for marketing in India must first be tested in clinical trials, and an IND application must be submitted to the Drug Controller General of India (DCGI) for approval.
  3. Clinical Trial Approval: The DCGI must approve all clinical trials before they can be conducted in India. The application for approval must include detailed information on the study design, patient selection criteria, endpoints, and safety monitoring procedures.
  4. Informed Consent: Patients who participate in clinical trials must provide informed consent, which includes a full explanation of the risks and benefits of participating in the study.
  5. Adverse Event Reporting: Any adverse events that occur during a clinical trial must be reported to the ethics committee and the DCGI in a timely manner.
  6. Quality Assurance: All clinical trials must be conducted in accordance with Good Clinical Practice (GCP) guidelines, which are a set of international standards for the design, conduct, and reporting of clinical trials.
  7. Post-Marketing Surveillance: After a drug is approved for marketing in India, post-marketing surveillance must be conducted to monitor its safety and efficacy.

Schedule Y is intended to ensure that clinical trials are conducted in a safe and ethical manner, and that the drugs that are approved for marketing in India are safe and effective. The regulations outlined in Schedule Y are regularly updated to reflect changes in international standards and best practices.

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