Import Qalsody (Tofersen) from USA / EU to India for Individual Patients

Tofersen ( Qalsody ) 100 mg injection available online in India

This article mainly deals with the safe importation of Qalsody (Tofersen) to India from the approved/registered countries like the United States of America and Europe. 

Import Qalsody from USA/ EU

1. Legal access

The safe and legal way to get the access from USA or European countries is through the Named Patient Program (NPP). It is the pathway to buy Qalsody in India to the limited patients with medical need. The Drugs and Cosmetics Rules facilitates the import process for specialty medicines. 

NPP extends its helping hand in the following conditions:

1. The medicines which are approved but not approved and available in patient’s country
2. The medicines discontinued in the patient’s country but not in another country
3. Limited availability of medicines in patient’s country

Make sure to reach out to genuine pharma product providers like 24/7QualityMeds to avoid the risk of counterfeit medicines.

2. Determining the authenticity of international drug distributor

Check for the documents whether it is from the location of the original source and the manufacturer. Whether they include the submission of Certificate of Origin (COO). some details like batch number of the drug, its dosage, administration and presence of the tamper-proof sealing.

Since Qalsody is stored between 2°C to 8°C (36°F to 46°F), make sure to check the arrangements of the refrigerator with power backup. Make sure to maintain the constant temperature and if needed, it can be kept outside and returned back to the refrigerator but not more than 6 hours per day at or below 30°C (86°F) for a maximum of 6 days (36 hours).  

3. Confirmatory tests by doctor

All the confirmatory tests advised by the doctor are made to diagnose the medical condition of the patient. The diagnosis of amyotrophic lateral sclerosis (ALS) with a mutation in the superoxide dismutase 1 (SOD1) gene is finalised after the necessary tests like genetic testing, electromyography and blood tests.

4. Clinical aspect

Qalsody is an antisense oligonucleotide (a genetic material) indicated for the treatment of amyotrophic lateral sclerosis (ALS) in adults who have a mutation in the superoxide dismutase 1 (SOD1) gene. This abnormal SOD1 protein causes death of healthy cells. The main element in Qalsody i.e., Tofersen binds to the abnormal protein and eventually reduces its further growth.

The recommended dose of Qalsody is 100milligrams (15mL) per administration. Begin it with 3 loading doses administered at 14-day intervals. The maintenance dose is done for every 28 days thereafter. The cost of Qalsody in India is determined by the location, taxes and storage arrangements and it fluctuates based on availability.

5. Mandatory prescription

The prescription plays a key role in NPP in order to buy Qalsody in India. The licensed doctor provides the prescription which consists of the critical information such as:

Patient information: Name, age, diagnosis and treatment plan

Drug information: Name, strength, dosage, risk and benefits

Doctor’s information: Doctor’s name 

6. Form submission

Enter the official website of Central Drug Standard Control Organisation (CDSCO), fill the form no.12A and upload the patient's details through prescription. It is followed by issuing the form no.12B automatically on the website. The criterias like health condition, other alternative treatment options and how well it works on the patient’s body are evaluated by the CDSCO and if it matches with the patient’s condition, they agree to import from approved countries.

7. Customs clearance

As soon as the product reaches the border of the country, the regulatory authorities approve for the safety of the patient. The temperature must be put into observation for preserving the therapeutic effect of the medicine during its waiting period at the port. The compliance-based product will be finally delivered to the patient when the protocols are fulfilled.

Take the expert advice and guidance on 24/7QualityMeds website.