Balwant Singh Hospital moves for contempt against Food and Drugs Chief

Oct 14, 2018 News

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A city hospital is battling the Government Analyst – Food and Drug Department (GA-FDD) over pharmaceuticals being imported.
Dr. Balwant Singh’s Hospital is seeking jail time for GA-FDD’s head, Marlan Cole.

The hospital claimed that the official refused to cooperate with supplying a list of drugs imported and the suppliers. The list is critical to treatment of the hospital’s patients, the hospital’s administrator, Dr. Madhu Singh is contending.
The hospital is seeking “an order that the Respondent do stand committed to the Georgetown Prison or such place of confinement or such place of confinement as the Court may direct for a period of one month”.
Cole, as head of GA-FDD, failed to comply with the order of Chief Justice Roxane George-Wiltshire, to provide a current list of all new drugs, as defined by Section 46 of the Food and Drug Regulations, which are currently licensed for import or sale by the department.
Dr. Singh said that Cole failed also to provide a list of corresponding suppliers licensed to import and/or resell those new drugs.
Dr. Singh is represented by Attorney-at-law Devindra Kissoon of the London House Chambers.
In an affidavit dated May 14, 2018, Dr. Singh alleged that as of the date of that affidavit, Cole had not complied with the court’s order.
She complained that as of that date Cole “has failed to provide the Applicant with an accurate, up to date and comprehensive list of registered drugs containing the identities of the licensed importers of drugs, the dates of registration and the manufacturer of those drugs.”
She stated that, “without knowing the identity of the registered importers of the drugs available in Guyana, the Applicant is unable to effectively render treatment to its patients. For example, drug Naloxone, which is on page 5 of the provided list, has no name of a local supplier, we being unable to know where to obtain this drug.
“Naloxone is used to save the lives of babies, which are born with little or no vitals. To be unable to know where to obtain that drug in Guyana is simply absurd.”
Dr. Singh had previously complained that the FDD has not provided transparent information as to who has been issued drug import permits, and who has been issued drug import waivers.

Cole had previously stated that he had complied with the court’s order by providing a comprehensive list to the hospital and had lamented to the Court that to the extent there was missing information, such information was unavailable due to staffing problems.
But the hospital acting on permission from the court, personally inspected the Food and Drugs records and over the last few days submitted a supplemental affidavit to the Court stating that after inspection “to my surprise, contrary to Mr. Cole’s representations to this Court, the FDD has meticulously maintained an accurate record of new registered drugs, but also recorded the corresponding licensees, and has done so continuously since at least 1995… It is clear that Mr. Cole is impeding with the administration of justice and must be held in contempt.”
The department has indeed submitted records to the hospital and its counsel, which are being reviewed to ensure their integrity.
In a scathing ruling issued on January 30, 2018, the Chief Justice deemed Cole’s refusal to grant registration of several life-saving drugs to the hospital arbitrary and unlawful.
This was after an application was filed to quash Cole’s refusal to issue an import licence for 18 lifesaving drugs. The application was also to compel the regulator to reconsider those licence applications and for him to provide a list of all new drugs currently being sold in Guyana along with the names of those persons authorised to sell those drugs.
Cole, according to court documents filed by the hospital last August, refused to register the drugs.
The director, the court documents said, indicated he would not register any drugs manufactured in India. He had also initially failed to provide the hospital with the requested list of drugs.
Kissoon had argued that Cole’s failure to approve the licences or provide the applicant (the hospital) with the list, created an untenable situation.
This is because as a major public health provider, it is unable to import drugs necessary for the treatment of its patients.
Worse yet, by its refusal of a list that may be available for sale by licensed importers, the Food and Drug Analyst endangered the well-being of its patients and the applicant’s business operation.

Cole had argued that the Food and Drug Administration entered into a Memorandum of Understanding (MoU) with Caribbean Public Health Agency (CARPHA), which implemented a new Caribbean Regulatory System in Guyana, and since those drugs for which applications were submitted were not registered with CARPHA, licences could not be issued.
Cole also argued that he was concerned about consumer safety and stated that he had provided the hospital with the requested list of drugs.
However, in response, Kissoon argued that Cole was deliberately misleading the Court, stating that the “list supplied by Mr. Cole is woefully incomplete, in not containing the name of the local suppliers, registration numbers, date of registration, and manufacturer of the registered drugs.”
Kissoon demonstrated to the court not only that the drugs sought, to be registered manufactured by two of India’s largest and well established pharmaceutical companies (Bharat Serums and VHB Medisciences Limited, and Merck Serono, a multinational company established in 1668 and headquartered in Germany focused on bio pharmaceuticals), but all of the applications contained evidence of safety to human beings and evidence that certification was issued only after documentation was produced about bio availability, bio equivalence and stability.
Kissoon argued that, “the Applicant is simply applying for registration of drugs that have already been developed and approved in other various countries. Clinical trials of these drugs have already been completed and approved in the development stage, which may take up to 12 to 15 years for development.
The contempt matter is currently scheduled to be heard again on October 29, 2018 where the hospital said it will ask for Cole to be committed.
Pharmaceuticals and its importation and supply to hospitals, health centres and pharmacies are big business involving billions of dollars annually for Guyana.
There has been a battle for control with the previous government, under the People’s Progressive Party/Civic accused of manipulating supplies to a few companies that were closed to them.

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