DANEEN BIOTHERAPEUTICS

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NAMED PATIENT PROGRAME

  • The Named Patient Program (NPP) approval process in India is designed to provide patients with access to investigational drugs that are not yet approved by the Central Drugs Standard Control Organization (CDSCO).
  • The NPP approval process is a valuable tool for patients who have no other treatment options for serious or life-threatening conditions.
  • In India, importation of unapproved new drugs for compassionate use by hospitals or medical institutions in the treatment of patients. India’s regulatory framework for compassionate use allows any medical practitioner or government medical organization to import a new unapproved drug for compassionate use by applying to the Central Drugs Standard Control Organization (CDSCO). For patients suffering from diseases which are life-threatening or may cause serious permanent disability, or patients requiring treatment for an unmet medical need, new drugs which have not been permitted within India but are undergoing a phase 3 clinical trial in any market can be imported exclusively for compassionate use once certified by CDSCO.

CDSCO will review and process these applications within 30 days.

  • The NPP approval process is initiated by a patient’s physician, who can request access to an investigational drug for a patient who has a serious or life-threatening condition and who has exhausted all other treatment options. The physician must submit a request to the CDSCO, along with supporting documentation, including:
  • A description of the patient's condition and why the investigational drug is being requested.
  • A summary of the clinical data on the investigational drug.
  • A risk-benefit analysis of the investigational drug.
  • A plan for monitoring the patient's safety.
  • The CDSCO will review the request and supporting documentation and decide whether to approve the request. The CDSCO will consider the following factors in making its decision:
  • The seriousness of the patient's condition.
  • The availability of other treatment options for the patient's condition.
  • The potential benefits of the investigational drug to the patient.
  • The risks of the investigational drug to the patient.
  • If the CDSCO approves the request, the patient will be able to receive the investigational drug from the physician. The physician will be responsible for monitoring the patient's safety and providing the CDSCO with updates on the patient's progress.
  • The NPP approval process is a valuable tool for patients who have no other treatment options for serious or life-threatening conditions. The process is relatively straightforward and the CDSCO will review the request and supporting documentation within 30 days. If the request is approved, the patient will be able to receive the investigational drug from their physician.
  • Here are some of the key documents that must be submitted as part of the NPP approval process:

Here are some of the key documents that must be submitted as part of the NPP approval process:

  • This document must include information about the patient, the investigational drug, and the clinical evidence supporting the use of the drug.

This document must confirm that the physician has exhausted all other treatment options for the patient and that the patient meets the criteria for NPP.

  • This document must summarize the clinical data on the investigational drug, including its safety and efficacy.
  • This document must assess the risks and benefits of the investigational drug to the patient.
  • This document must describe how the patient's safety will be monitored during NPP.
  • The process is relatively straightforward and the CDSCO will review the request and supporting documentation within 30 days. If the request is approved, the patient will be able to receive the investigational drug from their physician.

We at DANEEN BIOTHERAPEUTICS have the EXPERTISE to help you ACCESS Medicines under NPP .

In addition to the NPP approval process, there are a few other ways that patients in India can access investigational drugs. One way is through the compassionate use program, which is a program that allows patients to receive investigational drugs that are not yet approved for commercial use. Another way is through the clinical trial process, which is a process that allows patients to participate in clinical trials of investigational drugs