Substandard Drugs for Pediatric Cancer Imported into Armenia

The British Bureau of Investigative Journalism published an investigation in January 2023 regarding drugs used for the treatment of pediatric cancer, which also mentions Armenia. According to the report from Hetq, the investigation revealed that substandard medications containing asparaginase have been imported into over 90 countries.

Asparaginase is a key drug used in treating the most common type of pediatric cancer, acute lymphoblastic leukemia.

Journalists around the world monitored the distribution of substandard asparaginase brands using the Panjiva shipping data database. The investigation specified that in 2021, Onconase and Aspatero medications were imported from India to Armenia. It was found that these drugs are ineffective, have side effects, and have been banned in many countries.

On October 3, 2020, the Armenian government approved the importation of unregistered drugs with decision No. 1632-N regarding the special procedure for selling, acquiring, and circulating food, pharmaceutical, and essential goods during military operations. The mentioned medications were brought to Armenia just after this decision, in March, May, and December 2021.

According to data provided by our partners, the drugs were imported by two businesses, one of which is known as Violeta Medical Center LLC, while data about the other one could not be established.

Arkadi Dashyan, a representative of Violeta Medical Center LLC, stated in an interview with Hetq that Onconase was brought to Armenia in a small batch of 50 units in 2021. According to Dashyan, the drugs were never sold, became expired, and are set to be destroyed.

"We brought the medicine in 2021, and in 2023, it was found that it has side effects. However, it may not pertain specifically to that batch. In any case, they are long out of circulation and not a single unit has been sold. We have separated them from the warehouse and are supposed to destroy them," said Arkadi Dashyan.

Violeta Medical Center LLC provided the media with an import certificate for medications and pharmaceutical materials issued by the Ministry of Health and the destruction act of the batch. The documents indicate that the company received permission to import 50 units of the drug. According to the act regarding the expired medications, the entire batch was separated from the wholesale warehouse in March 2023 and was subject to destruction.

Arkadi Dashyan mentioned that the issue does not only relate to the Onconase brand; no medication containing L-asparaginase is used in Armenia at all. He states that there was no demand, and they understood that importing the drug was pointless.

The Ministry of Health responded to the media's inquiry regarding the import and consumption of unregistered drugs, stating that in 2021, the ministry provided an import certificate only for the unregistered drug Onconase produced by the Indian company United Biotech (P) Limited. The importing company has also informed the ministry that the entire batch of Onconase imported has "expired and been documented for destruction."

According to the Ministry of Health, no pharmaceutical company has applied for an import permit for the Aspatero drug. It has not been possible to clarify which operator imported the Aspatero drug into Armenia, in what quantity, and whether these medications were used for treatment purposes. The ministry reported that they have no information regarding the sale of the drugs brought to Armenia if they are not on the list of medications supplied by government order.