FDA Officer Blows Cover On Fake Medicines Cabal At Ministry
Acting Head of the Pharmaceutical Industrial Support Department of the Food and Drugs Authority (FDA), has taken on the Ministry of Health, over its decision to setup a ministerial committee to investigate its action against pharmaceutical importer, Tobinco Ghana Limited.
Mr. Samuel Asante Boateng, who is a trained pharmacist, asked the Ministry of Health (MoH) to rather probe how officials of the Ghana Health Service imported 130 million pieces of substandard condoms called “Be Safe Condoms” worth US$6 million of Global Fund money into its Central Medical stores to fight HIV/AIDS and other sexually transmitted diseases.
“Who are the people in-charge of procurement at the Ghana Health Service and the MoH?” Mr. Asante Boateng questioned in an opinion piece he released and distributed to the media, yesterday.
The statement also recalled how the FDA through a Post-market Surveillance uncovered the importation of substandard psychiatric medicines for mental patients by the same Health Ministry in 2010, and ordered the immediate re-exportation of these substandard psychiatry medicines.
This he said happened during that time the current President of the Pharmaceutical Society of Ghana (PSG), Mr. Oheming Kyei, who recently issued a statement condemning the FDA in the matter of the Tobinco and FDA, was the Chief Pharmacist of the MoH.
In the case of the US$6 million fake condoms, Mr. Asante Boateng revealed that “The FDA confiscated and quarantined in the Central Medical stores of the MoH 130 million pieces of substandard condoms(Be safe Condoms) imported by the Ghana Health Service, worth 6 million U.S. Dollars of Global Fund money”.
The Ministry should recall that it is this same Post-market Surveillance system of the FDA that uncovered the importation of substandard psychiatric medicines by the Ministry of Health in 2010 and the FDA ordered the immediate re-exportation of these substandard psychiatry
According to Mr. Asante Boateng, “It came as a shock to me when I saw the press release from the Ministry of Health titled Press Statement On FDA and Tobinco Pharmaceuticals Ltd”.
As a professional Pharmacist and a Principal Regulatory Officer of the FDA, Mr. Asante Boateng said “I had expected that rather than issuing this statement, the MoH would have supported the FDA by condemning the importation of fake/substandard/ unregistered medicines into the country”.
He insisted that “the FDA was an institution mandated by Law to ensure public health and safety and by this mandate the FDA was to ensure that medicines that enter into the country have been duly evaluated and approved prior to its importation and distribution”.
“Currently, the Medicine Registration processes put in place by the FDA is as per the format prescribed by the WHO and is in consonance with international best practices. The FDA cannot afford to use primitive methods to register medicines”, he asserted.
“The registration process of medicines is not for toddlers in Nursery school and it is not the same as dispensing of medicines in Pharmacies and chemical shops” adding, “this process involves manufacturing site verification, dossier evaluation, quality assessment of samples the medicines and this is carried out by experts who are well trained in this field”.
“For example I have specialised in Pharmaceutical technology and Medicine regulation at the University of Bradford, U.K. Most of my other Colleagues at the FDA have also been trained in various fields of medicines regulation”, Mr. Asante Boateng, disclosed.
He said “It is therefore, ridiculous and embarrassing to read a press release by the MoH talking about review of the processes of medicines registration of the FDA. By whom? Our medicines registration guidelines are WHO guidelines and we shall always go by international best Practice”.
“The question now is whether this intervention is to reduce the standards to suit some individuals who are uncomfortable with the processes due to their selfish gains at the detriment of public health and safety. Why are some people uncomfortable whenever the FDA exposes counterfeit medicines”, Mr. Asante Boateng, queried.
“It may be recalled that in 2009, the PSG accused the FDA of destroying the businesses of Pharmacists after the FDA through its post-market surveillance/Intelligence activities uncovered fake anti-malarial drug on the Ghanaian market and issued a public alert to that effect”.
But “through the efforts of the FDA the incidence of Substandard and fake Anti-malaria drugs on the Ghanaian market has reduced from 36 per cent in 2008 to less than 5 per cent as at 2011”.
Mr. Asante Boateng, questioned “why are some of my colleagues Pharmacists at the MoH, some of whom are Directors are uncomfortable with the stringent regulatory activities of the FDA?
“Concerning the Tobinco Pharmaceutical company matter, I am aware the case is in court at the instance of Tobinco Pharmaceutical company ltd and also the State Security Agencies are investigating same. I will, therefore, not waste my time to talk about it”.
He asked that the “MoH should rather be proud that we have a stringent medicines regulatory body like FDA”.
“I urge the MoH to support the FDA to fight against Substandard, Spurious, Falsified, Falsely Labelled, Counterfeit (SSFFC) Medical products, since this is the biggest threat to Global Public Health and it is one of the biggest concerns of the WHO” Mr. Asante Boateng, concluded.
The Health Ministry on Monday, said that it has set up a Committee to review the process of medicines registration following recent media row between Tobinco Pharmaceuticals Limited and FDA.
The Committee, headed by Deputy Health Minister, Dr. Alfred Tia Sugri, would also investigate the cause of the recent dispute between the FDA and Tobinco. Tony Goodman, Public Relations Officer (PRO) for the Health Ministry said, the Committee was also set up in response to reports from other pharmaceutical companies in the country about FDA’s conduct.
“The Committee will come out with some clear roadmaps…so that in the future, we will not have the situation we have at hand [Tobinco-FDA saga]”, he said.
He indicated that the Committee was likely to submit a report within a month. Mr Goodman also disclosed that post market surveillance report by FDA would also be made public.
The FDA and Tobinco Pharmaceuticals were involved in a row over the latter’s sale of fake malarial drug, GSUNATE Plus.
The drug was supplied by Bliss GVS Pharma Limited.
The FDA subsequently blacklisted all drugs from the Bliss GVS Pharma, an Indian company over the same incident.