Procurement of low quality IVIG: Medical experts in a dilemma as govt. continues to procure low quality medicines

Health authorities are back in hot water for procuring a low quality intravenous medicine prescribed for patients with severe neurological disorders. IVIG, also known as Human Immunoglobulin is manufactured using antibodies collected from human blood samples. When a group of neurologists questioned the Health Ministry and the medicines regulator, the National Medicines Regulatory Authority (NMRA) on the procurement of this questionable medicine, a shocking response was issued by the latter to the effect that the said medicines were purchased using forged documents. 

A drug procured with forged documents ?

The tender includes procuring as many as 22,000 vials totaling over a billion of rupees, but only 3000 vials had been dispatched in the first batch. 
The procurement of a medicine follows a set of stringent procedures that the manufacturer has to comply with. A Cabinet Approval too should be sought for procurements that exceed Rs. 500 million. 

A letter issued by the NMRA on October 3 states that the drug in question is neither registered in the NMRA database and that the Authority hasn’t received any official correspondence requesting for a Waiver of Registration. 
The letter states that the documents submitted for approvals too have been forged with a fake signature of the NMRA’s Chief Executive Officer and his official seal. “While steps have been taken to suspend the batch of drugs with effect from September 21, a complaint has been lodged at the Criminal Investigations Department (CID) to conduct further investigations regarding the matter,” the letter reads. 

Complications in patients

Neurologists have observed shocking complications in several patients on whom they administered this drug and the authorities are perhaps in a position to suspend the procurement or tender altogether. The patients are now receiving treatments at the Intensive Care Units.
“IVIG is mainly prescribed for patients with severe neurological disorders but is also used to treat rheumatic and heart diseases as well,” said Dr. Piyara Ratnayaka – President, Association of Sri Lankan Neurologists at a press briefing organized by the Sri Lanka Medical Association (SLMA). 

“If not administered properly patients are at risk of developing various side effects which would be lethal. For instance, myasthenia gravis is a severe autoimmune, neuromuscular disease which causes weakening of skeletal muscles. With proper medication people can live with this disease but there are some patients who come to us with breathing difficulties as a result of this condition. In such situations the recommended medication to treat them is IVIG.”

“But several neurologists complained about the issue with regards to IVIG medication,” she continued. They observed several complications in patients once the medication had been administered with symptoms such as low blood pressure and unconsciousness and eventually the patients had to be admitted to the Intensive Care Units for further treatments. 
“As such we neurologists faced a severe inconvenience when we realized that a medication that we could prescribe for emergency treatments to prevent patients from becoming permanently disabled cannot be used anymore due to complications that arose. This is not only an essential medicine but also a medication that could prevent various complications in patients with autoimmune diseases.” 

“Since this medication is produced using human blood samples it is important to conduct a proper screening prior to obtaining samples. If samples are obtained from a person with sexually transmitted diseases such as AIDS or Hepatitis B another person will also be infected with the same diseases. Therefore we study the entire manufacturing procedure of this medication prior to administering them on patients,” Dr. Ratnayaka underscored.

Stringent procedures ignored?

“When procuring any type of medicine there is a stringent procedure that should be followed,” said Dr. Dharshana Sirisena, Neuro-physician and President of the Government Medical Officers Association. 
“Usually when there is a shortage of a particular medicine the first step in the process is to setup a Technical Evaluation Committee. Since IVIG is a medication used in neurological disorders I too have been involved in several technical evaluation committees. This committee usually comprise of five members often presided by an official appointed by the Health Ministry, two neurosurgeons, an official representing State Pharmaceutical Corporation and an official from the Finance Ministry. 

“This committee would firstly approve the medication. But according to my knowledge a TEC was not setup to check the quality of IVIG. As such this medication was procured sans a TEC report. The next step is to get the approval from the Tender Board. 

“The cost of 22,000 vials procured was close to a billion of rupees and therefore a Cabinet Approval is required for any procurement done above Rs. 500 million. Out of the entire lot, 3,000

vials have been procured in the first phase. 
“Once the Tender Board approves the procurement and the tender is awarded to a particular company, copies of these letters are sent to all stakeholders including the Chief Executive Officer of the NMRA. But the NMRA now says that they haven’t given approval for such a medication and that the said letter is a forged document. 

“We indeed suspect this entire process as it looks like a daylight robbery. Doctors in government hospitals are now facing a dilemma as they cannot use this medication on patients due to the complications that arose. For over one and a half years medical experts have been raising concerns regarding the discrepancies that exist in the procurement of medicines and the role played by the NMRA. 
“Both medical specialists and the public have lost their trust on the government health sector. We also suspect the actions taken by the government including the Health Ministry once this revelation was made. The matter was identified with the first 3,000 vials that were brought down. But the situation would have been much worse if the entire tender was procured.”

Playing fiddles to deaf elephants 

Dr. Asoka Gunaratne, Media Spokesman of the Association of Medical Specialists reiterated how all leading medical associations questioned the State regarding the procurement of unregistered medicines. 
“The main reason to bring down substandard drugs was the introduction of Waivers of Registration. Usually a WoR was issued during an emergency situation but over the past few months, WoRs were issued for almost all drug purchases. 

“Even though the Health Minister recently said that he would take a decision regarding WoRs, nothing has been implemented as yet. 10 days after the matter regarding IVIG has been exposed, where the authorities including the Health Ministry and the NMRA confirmed that the medicines have been purchased with forged documents, we don’t see any law enforcement authority launching a probe on the incident. 

“We didn’t see the CID questioning any health ministry officials or obtaining any statements despite the gravity of the situation. Therefore we suspect whether any higher officials are also linked in drafting the forged documents. We are also unaware of how many of these vials have been administered on patients. Hence the Health Ministry has to launch an investigation on how many of these vials have been distributed to hospitals and conduct a thorough follow up so as to prevent patients from developing complications. As doctors we are now in a dilemma when it comes to prescribing medicines for patients because we recommend what has been given to us by the state. We are not in a position to check for their quality inside hospitals. But in the end we too are responsible for any fatalities that happen thereafter. We have in fact reached the pinnacle of this problem,” he added.

IVIG was reportedly manufactured by Livealth Biopharmas Pvt. Ltd., India and was distributed by Isolez Biotech Pharma AG Limited. However, the NMRA letter further states that Livealth Biopharmas has denied manufacturing the drug in question, raising further doubts on the manufacturer itself and the entire procurement process.