The Ministry of Public Health (MoPH) bypassed local regulations in granting approval to a Non-Governmental Organisation (NGO) called the Guyana Medical Relief (GMR) to donate some $4 billion worth of drugs to Guyana, a source says.
As a result, the quality of the pharmaceuticals are now being questioned as the regulatory oversight body was not afforded the opportunity to scrutinise the various manufacturers from which the drugs were sourced.
A new system for the importation of drugs was recently introduced whereby all importers were obligated to submit their dossiers to a regional regulatory hub that would review and recommend whether the pharmaceuticals were safe for importation.
This publication understands that commercial importers as well as NGOs are both subjected to the same checks and balances in the interest of public health.
According to the MoPH source, “These are public health issues to ensure the drugs are safe and efficacious and of the requisite quality.” Suppose the NGO brings in substandard drugs?”
The recommendation from the regional entity would subsequently be sent to the Government Analyst-Food and Drug Department (GA-FDD) of Guyana, which would then approve the drugs for importation.
With regard to the NGO, this procedure was not followed, this publication was informed.
However, Inews understands that in its absence, the MoPH can apply for a waiver on behalf of the NGO, but this too was reportedly not done in this case.
Therefore, the $4 billion in drugs which were donated to the MoPH were not checked and approved by the country’s chief regulatory body, the source outlined.
Following reports of drug shortages in Guyana, the GMR said it approached the MoPH with a proposal to provide assistance.
The GMR is a Los Angeles, California-based NGO that has been providing support to the local health sector through various donations over the years.
The NGO’s Chief Operations Officer (COO), Sharir Chan told sections of the media that he met with a team from the Ministry’s procurement department and they accepted his proposal and provided a list of all the drugs they needed.
Chan said the list was sent to a larger charity organisation called Direct Relief, which has a network of manufacturers that would supply the drugs.
“After that, we flew it in because these were some stuff that had limited dates on them and so they needed to be used and distributed ASAP,” he stated, noting that the drugs arrived on April 20, 2017.
Chan also noted that this transaction only cost the Government the transportation cost to move the drugs from the airport to the storage bonds.
The drugs included asthma medication, Albuterol Sulfate, ibuprofen, acetaminophen, simvastatin, niacin, carvedilol, amlodipine, lovastatin, azithromycin, glipizide, Lisinopril, and metformin.
Furthermore, when asked, Chan indicated that he had no interaction with personnel from the GA-FDD.
“Everything went through with the Ministry of (Public) Health…But we are aware of the drug formulary and I think that the drug formulary is in line with Caricom. But we don’t go through Food and Drug, we go through the Ministry of (Public) Health,” he explained.
Efforts to contact the Public Health Minister, Volda Lawrence and the Junior Public Health Minister, Dr Karen Cummings for comments and clarifications on the issue proved futile.
However, the source at the Public Health Ministry questioned the donation pointing to the fact that such a large gift raises suspicion.
According to the source, $4B in donation is twice the yearly budget of the Ministry. Additionally, the source noted that some of the drugs supplied have short expiry dates, highlighting the fact that Guyana is being used as a dumping ground for a large corporation.
But more suspiciously, the source noted, is the fact that the Ministry maybe colluding to have the company gain a large tax write off in the United States.
The source added that when large companies make significant donations to developing countries, itself and parent company, in return applies for tax-write off in the home country.
The source pointed to the fact that proper assessment needs to be carried out to determine whether or not the drugs donated is part of the national formulary.