Food and Drug Dept. aims to regularise pharmaceutical industry

Apr 11, 2014 News

The possibility exists that close to 50 per cent of malaria drugs on the local market do not conform to quality specifications, a daunting state of affairs that is compounded by the fact that the Government Analyst Food and Drug Department (GA-FDD) is currently not in a position to speak to the status of a number of other drugs currently

From left: GA-FDD Director, Marlan Cole; Communicable Diseases Director, Dr Morris Edwards and other GA-FDD officials Fabiola Robertson and Alison Hinds-Semple.

available here.
At least this was the assertion of GA-FDD Director Marlan Cole yesterday, as he addressed participants at a training seminar organised for importers and distributors of pharmaceuticals. The venue was Cara Lodge, Quamina Street, Georgetown,.
The seminar, according to Cole, was designed to garner the support of key stakeholders in the pharmaceutical industry to ensure that activities intended to cater to the needs of the consuming public are harmonised.
The GA-FDD has the legally mandated responsibility, among others, to regulate and register all pharmaceuticals on the market, but has not been able to efficiently carry out this function for a number of years.
Moreover, the GA-FDD is on a belated mission to ensure that pharmaceuticals currently available on the local market are not only efficacious and safe, but of the best quality which can contribute to the quality of life and health care of citizens. This ambitious move was prompted by indications that the World Health Organisation (WHO) will soon be making moves to closely scrutinise pharmaceuticals in a number of countries.
Cole disclosed that the WHO had in fact previously conducted assessments of the regulatory processes and systems of a number of countries and there is a likelihood that further assessments are looming.
“My suspicion is that the next thing they are going to do is to come into our territories and take the (pharmaceutical) samples and if they should come now and take the samples and discover what percentage do not conform, the cannon will be turned to the Food and Drug Department, and they will be asking us what we are doing,” Cole stated.
He said that between the period 2005 and 2010, the United States Agency for International Development (USAID) had conducted a study of 1,663 malaria medicines available in the public sector which revealed that 1,445 or 86.9 per cent did not meet the required quality specification. Samples of these drugs, Cole said, were taken to facilitate basic quality control tests of pharmaceuticals that were available in Bolivia, Brazil, Colombia, Ecuador, Suriname, Venezuela and Guyana.
That study, according to Cole, was able to deduce that 193 (11.6 per cent) of the pharmaceuticals never met the quality specification.
“Over 60 odd per cent failed the test,” said Cole, who noted that it is believed that quite a high percentage of the malaria drugs available on the local market are a cause for concern.

Some of the representatives of the local pharmaceutical industry attending the seminar yesterday.

He admitted that even after the findings of the study was disaggregated, “I didn’t look at the data, I didn’t want to look at it to verify it, but I am suspecting that over 50 per cent at least, of those drugs that were sampled, might not have passed.”
And while this is the situation that obtains for malaria drugs, Cole said, “what is going on with the other pharmaceuticals we don’t know…”
In fact he said that the Food and Drug Department is not even in a position to ascertain how many of the pharmaceuticals on the local market are registered.
“Is it less than 15 per cent, less than 20 per cent, less than 30 per cent? We don’t know; we’re supposed to know,”Cole emphasised. He went on to disclose that in some cases the GA-FDD is unable to authenticate even the address of some suppliers.
“If we Google the addresses, sometimes the addresses don’t exist… What percentage of registered and/or registered drugs on our local market that are in conformity, that is, of good quality, safe and efficacious we don’t know, and since we don’t know, the public is at risk. We cannot continue to do business as usual,” Cole said.
In fact, it was in light of such disturbing developments that USAID had some time ago suggested that confirmatory testing must be an area to be strengthened. “…That is why we are working on the Food and Drug Department to ensure that by October of this year we are accredited, but some things as it relates to accreditation are in our way.”
Although Cole has been in the Food and Drug Department for a number of years it was only about six months ago that he assumed the position of Director. And according to him, since taking office, he was tempted to question his officers and those who function in the laboratory “how often do we send (pharmaceutical) samples to the CRDTL (the Caribbean Regional Drug Testing Laboratory)?”
The CRDTL, headquartered in Jamaica, is recognised by Caricom and established to ensure that drugs in the Region conform to appropriate standards of purity, strength and quality.
Even as he highlighted what obtains in a number of territories including: Jamaica, Barbados and Trinidad, Cole emphasised the importance of confirming to the WHO Pre-qualification process. This, according to him, means that pharmaceuticals and their suppliers would have gone through a rigorous registration process with the WHO, something that the GA-FDD is looking to embrace in the near future.
“WHO has in place, and we will pursue this aggressively, a provision for representatives of developing countries to go to the WHO to spend about three months, and go through the prequalification process, so that they can learn and return to their countries to practice drug registration and regulation.”
And according to Cole, the regulatory body will fervently work to protect the consuming public with the support of Government, through the Ministry of Health, the business community and the general public.
Also speaking at yesterday’s forum was Director of Communicable Diseases, Dr Morris Edwards, who disclosed that the Health Ministry has in place its Health Vision 2020 which has as a stated goal “citizens of Guyana are among the healthiest in the Caribbean and South America.” Moreover, Dr Edwards said that the key to achieving that goal is the delivery of quality health
services, even as he added that a major component of quality health services “is ensuring that we have safe medicines that are efficacious and that are of good quality.”
In alluding to the fact that “the pharmaceutical industry is big business,” Dr Edwards highlighted that in 2011 the profits made amounted to some US$930 billion and it is projected that the profits will rise to US$1.1 trillion this year.
“We don’t know what the total market is in Guyana, but I will be bold enough to say that it is a substantial contributor to our economy…and with the policy of the Government being one of free market, then we expect the private sector to tap into that pie,” Dr Edwards said.
He however emphasised the notion that this profit-making venture should not be allowed to occur at the expense of consumers.