Kidney drugs seized over improper storage, sanctions against manufacturers
– GPHC says decision rash
A significant quantity of Erythropoietin injections made in India and purchased for use by kidney disease patients, was seized by the Government Analyst, Food and Drug Department (GA-FDD), as the Indian manufacturers have reportedly been banned in the United States, but the Georgetown Public Hospital Corporation (GPHC) has since said that the entity acted rashly.
Both the GA-FDD Director Marlan Cole and the GPHC Director of Medical and Professional Services Dr Sheik Amir have confirmed the seizure which occurred on September 30 at the GPHC’s bond.
In a letter written to then Chief Executive Officer (CEO) Michael Khan days after the seizure, the GAFDD said it was observed that Vintor-Erythropietin injection manufactured by Gennova Biopharmaceuticals Ltd, India and WepoxRecombinant Human Erythropoietin injection manufactured by Wockhardt Limited, India were present in the bond.
The two injections serve the same purpose but are manufactured by different companies. The seized injections are used to stimulate bone marrow to produce blood. This production process is heavily dependent on hormones produced by the kidneys. Patients who have renal failure are unable to produce enough of this needed hormone and as such are given the hormone in the form of an injection.
The letter said it was found that the drugs were being stored at temperatures between 17 and 25 degrees Celsius and not the recommended 2 to 8 degrees Celsius storage conditions recommended by the manufacturers; a situation which could adversely affect the efficacy and potency of the product’s intended therapeutic use.
According to the letter neither brand of injection was fit for use. In the case of the Vintor-Erythropietin injection, the plant where it was manufactured was “banned” by the United States Food and Drug Administration (FDA) for violating good manufacturing (GMP) standards and this resulted from the company “manipulating results of analysis for batches tested to derive desired (favourable) results of analysis,” the letter said. With regard to the second one, the GA-FDD stated that its use had also been banned for a similar reason and its sale was stopped in the United States because the FDA discovered “that results of the analysis were linked between “trial drugs” and official use.”
When contacted late last week, Cole said investigations were being conducted. When asked by this newspaper to provide details on the matter he declined to do so.
Sources have revealed to Sunday Stabroek that the issue was brought to the attention of the GA-FDD and two drug inspectors visited the hospital’s drug storage facility at New Market Street, South Cummingsburg to investigate. It was then that the seizure took place.
While noting that he was aware of the seizure, Permanent Secretary (PS) in the Ministry of Public Health, Trevor Thomas could offer no informed comment on the matter.
“I heard but …I have no details nor do I need to have the details because it does not fall under me. GPHC has a Board and a CEO,” he said.
Thomas told Sunday Stabroek that GPHC is a public corporation and the PS does not get involved in the procurement of drugs. The Food and Drug Department would have to be asked about that, he said.
The GA-FDD has since written to Dr Amir who was acting CEO when the drug was seized. Amir was told in the letter that the GA-FDD was in the process of retrieving additional information regarding the manufacture, registration, use, sale and distribution of the Erythropoietin Vintor and Wepox brands through the World Health Organization.
In the letter, it was indicated that in order to continue and complete the investigation, the Department urgently needed the exact name and address of the companies that supplied the drug to the hospital; the exact quantities that were supplied and the period of time the drug was supplied to the hospital prior to the September 30 seizure.
It was noted that the information was being requested in accordance with the Food and Drugs Act Chapter 34:03 Part (1) section (111) and the Food and Drugs Regulation of 1977.
Sunday Stabroek has also learnt that Minister of Public Health Dr George Norton was made aware of the matter. He was told in a letter dispatched to his office early last week that the Food and Drug Department has no records to suggest that the Vintor and Wepox brands were registered. “The only evidence of this class of drug being registered with the Department is the Epoetin Binocrit brand [for] which Ansa McAl was issued with a marketing authorization …in 2011,” the letter said.
Another letter sent to the minister stated that the Department has been able to “decisively conclude” via the WHO-India National Regulatory Authority that the Vintor and Wepox brands were not registered. It said that a quick search of the authority’s website for clinical trials revealed that “no clinical trials [were] done on biosimilar (Erythropoietin Vintor and Wepox brands).”
Disappointed
Amir last Friday expressed disappointment with the way the Food and Drug Department handled the matter, stating that there was no public recall of the drug. He opined that if it was indeed found that there was a problem with the drug, an advisory should have been sent out thereby giving the hospital an opportunity to source a replacement drug and avoid a possible wastage of money.
Speaking to this newspaper in his office, Amir said the hospital has been using this drug for some time now and it is not the only medical institution doing so. According to him, when the GPHC goes to collect its drugs the company would be delivering the same product to others.
He stated that the seized drug had entered the country legally and would have been cleared by both Customs and the Food and Drug Department before it ended up in the hospital’s bond.
He questioned why the drug was allowed into the country in the first place if there was a problem with its use.
He said that this particular drug with a similar name and manufactured by a similar company was used by the hospital previously but it was brought in by a different importer.
“We have been bringing it in all the time. It could be true that now there is an issue with the drug but there was none in the past,” he stressed.
This newspaper was made to understand that the seized drug was imported by the International Pharmaceutical Agency (IPA).
According to Amir, the seized injections were not removed from the premises but were sealed off by officials of the GA-FDD and left in the bond.
Amir told Sunday Stabroek that he did in fact receive a letter from Food and Drug Department last Thursday regarding the seized drugs. Asked specifically to address the claim about the wrong temperature he said that this could have been possible given that storage space in the bond was minimal and “we had a lot of shifting.”
He was unable to say exactly how much was seized or the exact value but knew it was a large quantity worth several million dollars.
Given the seizure, he said, the GPHC has had to secure a replacement from Ansa McAl and this is now being administered to the hospital’s kidney patients.
He informed that this was the second time, the Food and Drug Department had moved in on the hospital and seized drugs stored in its bond.