Perfomance of the Inspectorate Department, Year review June 2009 - June 2010

NDA inspects manufacturing facilities that intend to market their products in Uganda to ensure that they comply with NDA requirements and World Health Organization standards for current Good Manufacturing Practice (cGMP). This is carried out annually for local manufacturers and once every three years for foreign manufacturers.  The medical products for which GMP inspections are conducted include pharmaceuticals (human and veterinary), biologicals, vaccines (human and veterinary), food fortificants and herbal medicines.
During the period under review, NDA inspected 120 foreign facilities and 13 local manufacturers, out of  which 11 were followed up for corrective action and, 26 were found not to be compliant with cGMP standards and therefore disqualified from supplying medicines to our population.

• Controlled import and export of medicines through issuance of verification certificates; 5,602 verification certificates were issued.

• Inspected drugs at the ports of  entry (All the imports of  medicines into Uganda must come through the following designated ports of  entry; Nakawa inland port, Entebbe Airport, Busia/Malaba, Mutukula and Katuna).

• Nakawa – approved 515, queried 31 and rejected 05

• Entebbe - approved 1,123, queried 21 and rejected 02

• Busia  - approved 197, queried 24 and rejected 06

• Total approved: 1,835

• Total queried: 76

• Total rejected: 13

• There must be a separate lockable store for quarantine of  the products.

• The responsible person (Pharmacist) should establish a documented procedure for quarantine of the drugs.

• The importer should have an import permit issued by the NDA.

• Application for conditional release should be made per consignment where need arises.

• The consignment must be accompanied by a verification certificate.

• Conditional Release will be granted after sampling of  the consignment for mandatory analysis where applicable and conformation to required standards.

NDA conducted operation “Mamba II”. Interpol in collaboration with IMPACT together with national enforcement agencies of Police, NDA and URA joined hands to execute Mamba II operation from 3rd – 31st August, 2009. The operation entailed; gathering and using intelligence on targets identified, cordoning and searching of premises identified to seize the counterfeit drugs, carrying out investigations to identify perpetrators, seizing counterfeits and prosecution of culprits.

The operation covered areas in Central region (Kampala, Mukono, Masaka and Lugazi), South Eastern region (Jinja and Iganga) and Eastern region (Tororo, Busia, Malaba and Mbale). As a result of the operation:-

• A total of 200 cartons of drugs were impounded in al the areas affected by the operation and those that were suspected to be counterfeits were submitted to NDQCL for quality assessment

• A number of unregistered drug outlets were uncovered

• A total of 38 cases were registered, 19 were taken to Court and the rest are still under investigation. Among those in Court 4 convictions have been registered.

• NDA issued a press release banning further use of Metakelfin after the intelligence gathering findings revealed that most of  the Metakelfin on market was found to be counterfeit.

• A post-operation press conference was held in which the findings of Operation Mamba II were jointly communicated by all the participating agencies to the public in a bid to raise public awareness and vigilance towards fight against counterfeits.

• Gmp inspection application form
• Recalls
• Guidelines for destruction
• Procedure for establishing a pharmaceutical enterprise
• Procedure for establishing a pharmaceutical and medical devices manufacturing company
• Guidelines on donations
• Guide to developing a site master file
• Sampling plan for medicines
• Guidelines for importation and export of pharmaceuticals
• Guidelines for importation and use of hormones in commercial fish production
• Guidelines on gmp inspection of foreign pharmaceutical plants
• Guidelines for the conduct of ectoparasiticides field trials in Uganda