FAKE VACCINES: NDA’s warnings a blunder?

NDA Executive Director Dr. Medard Bitekyerezo

The National Drug Authority’s recent move in which top executives of the organization warned the general public about the existence of fake Hepatitis ‘B’ Vaccination at some private health facilities in the country has attracted the public’s scrutiny into the running of the organization than perhaps intended.

But even more worrying perhaps, is that the NDA’s highly publicised warning against the health facilities, may in fact have far reaching negative implications on the overall immunization programme in the country.

Following last week’s press conference in which the drug regulatory body together with minister Sarah Opendi came out to ‘warn’ the public, the NDA has come under increased scrutiny from Parliament, the pharmaceutical industry as well as private health operators.

Besides the apparent long-running fire from pharmacy owners over the management of the drugs body, several stakeholders have stepped into the limelight to criticize the NDA for ‘crying fire in a crowded theater’.

One of the leading stakeholders has gone as far as suggesting that NDA could have responded to the crisis in a less publicized way to avoid harming the overall vaccination programme.

Nazeem Muhammed, the Chairman of Kampala Pharmaceutical Industries (KPI) and one of the leading producers of medicines in the country warned NDA to tread carefully on the matter saying that any rushed statements about the quality of vaccines may have far reaching negative effects on the public regarding vaccination in the future.

“This is a very sensitive subject that needs to be discussed behind closed doors because most of the questions being asked don’t have clear answers and yet any statement that can be made erroneously may attract regrettable consequences,” said mr. Muhammed.

He also urged government officials to exercise caution while addressing the subject of ‘counterfeit’ pharmaceutical products saying it is mostly a legal rather than a quality issue especially when it comes to drugs locally produced under generic arrangement. Muhammed noted that nearly 16% of all medicines sold in the country are produced locally under generic labels but could be endangered by rushed conclusions that they are sub-standard.

In a related event, representatives of the Uganda Pharmacy Owners Association (UPOA) this week criticised the NDA Executive Director Dr. Medard Bitekyerezo the former Mbarara Municipality Member of Parliament, for violating rules, and conflict of interest by allegedly operating pharmacies that don’t meet standards.

They said that under such conflicted and lax leadership, the NDA has allowed unscrupulous individuals to sell contraband medicines to the public.

Appearing before the Parliamentary Committee on Health, members of (UPOA) led by their Secretary General Deo Kalikumutima attacked NDA for allegedly approving both fake and genuine drugs to enter the country.

“NDA has no capacity to test vaccines, including the fake hepatitis B vaccine,” Kalikumutima, told the Parliamentary committee investigating the NDA.

NDA’s Director for Product Safety Helen Byomire Ndagire claimed that the drugs body was forced to publicly announce the existence of fake vaccines following an operation in which they impounded counterfeit Hepatitis B vaccines from immunization camps at Mbale Central Market, Mbarara University camp being run by Sanyu Medical Center and Katabi Entebbe among others.

Former Member of Parliament for Buikwe South in Buikwe district Dr. Lulume Bayiga has also come out to charge the NDA for alleged incompetence and callousness in the execution of their mandate.

Bayiga has tasked the Authority to explain the circumstances under which the alleged drugs entered the country in the first place when NDA has offices at all border posts to check control the importation of unlicensed drugs.

“This is an indictment on the part of NDA because as far as I know they have offices on all border post where they are supposed to verify the quality and efficacy of every batch of drugs before entry into the country. Nevertheless, this is only helping to remind Ugandans that they (referring to NDA officials) are not in those offices to do their job explaining why exactly this is happening,” Bayiga said

The anti-counterfeit network has also added pressure on the drugs body by saying the Hepatitis B vaccine scandal highlights an old problem that has failed to be cured.

“We have also noted that there have been previous reports of fake cancer drugs, HIV and other medicines in Uganda. To this end, we require the full investigation reports which detail action taken by NDA in the past five years,” partly reads a letter written this week to NDA by the Anti Counterfeit Network (ACN) a private sector multi-stakeholder organization.

Our lawyers M/S Muwema and Company Advocates and M/S KSMO Advocates are notified to make the necessary follow up. Please treat this matter with the urgency and importance it deserves,” said a copy of the letter signed by ACN’ Company Secretary Damalie Tibugwisa Ntende.

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