Shortage of life-saving drug Desferal puts thalassemia patients at risk

While patients say Novartis has reduced production of the drug, whose patent expired recently, the company says it is a logistics and supply issue

Thalassemia is a blood disorder in which the haemoglobin levels fall. Due to this, a patient needs regular blood transfusion, which results in iron overload in the body. Pic: iStock

For the past couple of weeks, a number of thalassemia patients across the country are facing a shortage of the life-saving drug, Desferal, which is administered to clear accumulated iron in the body. While the patients allege that the manufacturer of the drug, Novartis, has decreased the production, Novartis claims that the shortage is due to logistics.

The Swiss-based Novartis is the only company which manufactures this drug.

Thalassemia is a blood disorder in which the haemoglobin levels fall low. Due to this, a patient needs regular blood transfusion, which results in iron overload in the body. Over the years, the accumulated iron affects vital organs like liver, heart and kidneys. The human body doesn’t have a mechanism to clear the accumulated iron and the Desferal vial is used to do this.

“The process of taking this injection is long and torturous one. The vial has to be slowly infused and it takes 10 to 12 hours. Depending on the iron overload, patients need to take this drug 10-15 days a month. A single vial costs about Rs 170,” Utpal Panda, secretary of the Thalassemia Society of India, West Bengal, told The Federal. “The shortage in the drug adds more burden on the patients,” he said. Thalassemia Society is India’s oldest organisation to be engaged in the management of this blood disorder.

Effective medicine

Desferal has been in the market since the 1980s. In mid-2000s, oral drugs were introduced, thanks to which many patients did not need the injection any more.

“Unfortunately, for some of the patients, the oral drug has not worked. So, they again became dependent on the injection. Probably, the oral drugs manufactured by other companies could have pushed Novartis to reduce the manufacture of Desferal. However, Desferal still is the most effective medicine and is now being prescribed in combination with  oral drugs” Panda added.

Meanwhile, it is claimed that the patent on Desferal has expired.

Namitha Rao Malur, a thalassemia activist, tweeted that the drug has been out of supply in Bengaluru since February 2022. She also alleged that a large set of patients had severe side effects with oral drugs.

“Novartis has not been telling us the real reason. This happened in 2016 as well. Probably (there are) production issues. Patent on Desferal (deferoxamine) has run out. Time for Indian pharma to locally make this drug used by more than 1 lakh thalassemia patients in India,” she said in a series of tweets.

Shortage is recent

A Chennai-based activist, who is trying to organise logistics support to get the medicine, told The Federal on condition of anonymity that though India has the largest number of thalassemia patients – around 1-1.5 lakh in addition to 10,000-15,000 children being born every year with the disorder – the actual number of patients seeking Desferal could be minimal.

“Firstly, the shortage of this drug is a recent phenomenon. The production of this drug doesn’t bring much profit to Novartis. That’s why though the patent has expired, no other company has shown interest in making this drug. Secondly, though Novartis has its offices in India, this particular drug is manufactured in Switzerland. Naturally there are some logistic issues. Moreover, the ongoing Ukraine war has also shaken up the pharma industry just like any other industry. Once the drug hits Indian shores, the custom clearance and quality tests take more time. These are the reasons why we are facing a shortage of this drug currently,” he said.

He also added that Tamil Nadu is the only state in the country which gives financial aid of Rs 7,500 per month for thalassemia patients under the Chief Minister’s Medical Insurance Scheme to cover the cost of medicines like Desferal.

Logistics issue

The Federal had sent queries regarding this issue to Novartis India, but has not received any official reply till now. However, an official from the company, in an informal chat with The Federal, said the company has been taking steps to address this issue for the last 10 days.

“Definitely this is a logistics and supply issue. We are also in touch with patient leaders and explaining our situation. When we enquired about the drug stock with the stockists and hospitals, they said that the drug is in sufficient numbers. But still there is a problem. We are trying to figure out what went wrong and where. Within a week everything would be sorted out. A proper statement on this will be issued later,” the official said.