Introduction

The term “Managed Access Programs” (“MAPs”) covers various types of programs, in particular, “Compassionate Use,” “Expanded Access,” “Named Patient Supply,” “Named Patient Program,” “Special Access Schemes/Programs,” “Autorisations temporaires d’utilisation (ATU)” and others.

“Named-patient basis” is another way of obtaining medicine before authorization where a doctor requests a supply of an unauthorized medicine directly from the manufacturer to treat an individual patient under the doctor’s direct responsibility.

Named Patient Program in India

The Named Patient Program approval process in India is designed to provide patients access to investigational drugs not yet approved by the Central Drug Standard Control Organization (CDSCO).

The NPP approval process is initiated by a patient’s physician, who can request access to an investigational drug for a patient with a serious or life-threatening condition and has exhausted all other therapy options. The physician must submit a request to the CDSCO, along with other essential documents 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.
• This is exactly where we help the patient and physician ease their work accessing such medications. Here are some steps on how you can make a request:
• To make the request, the treating physicians can click the link: https://www.ikrispharmanetwork.com/contact-us. Ikris’s receipt of the request will be acknowledged by email within 1 business day.
• Ikris will assess the request in consideration of its internal rules and under the applicable local rules and regulations.

Why should you choose Ikris?

Ikris believes that “access is a right, not a privilege,” and we help patients access unregistered medicines irrespective of geographical boundaries. 

• Helping Patients/HCPs to access Life Saving medications not available or registered in their home country
• Major Therapeutic Area Covered: Oncology, Hepatology, Neurology, Transplant, Hematology, Immunology, Nephrology
• Ikris Team is well-trained in pharmacovigilance, ABAC, Patient & Data privacy, and Business compliance.
• Ikris has a well-experienced team of Therapy Specialists with sound domain knowledge.
• Ikris so far achieved access to the treatment for rare diseases such as Duchenne Muscular Dystrophy, Lysosomal Disorders, Organic Acidemias, Urea Cycle Disorders, Acute Intermittent Porphyria, MPS IV A, MPS VI, Hypophosphatasia, PKU, BH4 Deficiency, Batten Disease and many.