Gemtuzumab ozogamicin is an antibody-drug conjugate that is recommended in the treatment of Haematological disorders. It is specifically indicated in the management of AML - acute myeloid leukemia. Mylotarg is the brand or trade name of this drug which is now commercially promoted by Pfizer. It was originally developed by Celltech and Wyeth, a collaboration that also developed other significant drugs. Mylotarg is used both in adult and paediatric patients. Gemtuzumab in India has to be imported for specific patient usage purpose.
Mylotarg in India is a treatment option recommended by Haematologists who also have BMT expertise. In several cases, BMT is the ultimate treatment modality recommended and drugs like Gemtuzumab are given prior to it. As per the initial FDA approval in 2000, it was approved for the patients over sixty years. It was specific in relapsed AML. It was also approved for the usage in patients that are not fit or eligible for the standard chemotherapy. This was an accelerated approval. This drug was commercially withdrawn in 2010, due the data pointing towards increasing VOD risk in the patients on therapy. However, it was reapproved in 2017 both by the US FDA and EMA.
Gemtuzumab ozogamicin is a monoclonal antibody which is an advanced type of targeted therapy agent. It is prescribed both as a single agent as well as in combination with other chemotherapy agents. Mylotarg 4.5mg vials are commercially available in the US and Europe. Import channels are possible for Indian patients.
The import of Mylotarg in India can be done based on the recommendation by a Haematologist. Based on the certified prescription by your treating physician, you can initiate the process. It is better to be aware of the complete quantity requirement before proceeding any further.
Procuring the legal import permit would be the next important thing to do. This can be done online without much of a hassle. But, you should make yourself aware of the process how it is done on CDSCO portal. You can consider professional help here.
It is equally important for you to locate reliable international suppliers who also understand how the Indian regulatory works. It will be an added advantage if they have prior experience of delivering for Indian patients. When it comes to making the payments, ensure you do it only through a reliable bank.
Once you are sure about the availability of the drug at your supplier’s location, you should complete the customs related formalities. You can engage a reputed clearance agent in your city for the same.
It is easy to get the medicines delivered to your preferred location by planning every aspect of the import process well. There are several challenges associated with cold chain medicines. You must specify your shipments accordingly at the time of booking.
1. Anything and everything you come across online is not essentially trustworthy. You must verify the authenticity of everything your supplier puts forth. There are many dubious industry practices that are not good for your health.
2. Advice for only patient specific legal import. There are no provisions for bulk imports and unauthorized stocking for Gemtuzumab India. It’s an import process that has to be fulfilled with all due procedures.
3. You must receive a commercial invoice with all the necessary information that includes shipment details, drug batch numbers and manufacturer’s information with expiry details. You should also get the Bill of entry from the customs.
Synergy Drugs works with professional networks that understand every intricacy of importing medicines. The limitations with patient specific import can be accommodated well. There are legal and ethical ways of working around to assist patients. When you reach us for Mylotarg India import, you can be assured of reaching the most authentic sources. We will assist you with information and access.