Pharmacy and Poisons Board

MEDIA BRIEF ON OPERATION MAMBA III TO COMBAT COUNTERFEIT MEDICAL PRODUCTS
PHARMACY AND POISONS BOARD, 10.00AM, AUGUST 25, 2010

Counterfeit medicines are those drugs that are deliberately and fraudulently mislabelled with respect to identity or source. Counterfeiting occurs both with branded and generic products and counterfeit medicines may include products with the correct ingredients but fake packaging, with the wrong ingredients, without active ingredients or with insufficient active ingredients. 

The government recognizes the dangers posed by counterfeit/substandard and spurious medicines and is fully committed to the fight against counterfeit medical products. We recognize that counterfeiting of medicines is the result of deliberate criminal activity and is a global problem where organized criminals are crossing the borders to smuggle counterfeit medical products and illicit medicines.  

There are many measures put in place and being improved upon to combat trade in counterfeited medical products and to ensure provision of safe and efficacious medicines, including:

• Gazettement of ports of entry for medical products

• Posting and training more pharmaceutical inspectors

• Training of other government officials from agencies such as the police and customs on matters of counterfeit drugs

• Regular post market surveillance and pharmacovigilance for early detection

• The use of mini- labs at the ports of entry

In addition to these measures, and owing to the international nature of the problem of counterfeit medicinal products, Kenya associates itself with the efforts in the frame of WHO-IMPACT Project with the support of INTERPOL to carry out joint operations against counterfeit medicines. 

So far we have carried out two joint operations – “Operation Mamba II” was carried out in 2009 and “Operation Mamba III” has just been concluded in August 2010. 

These operations recognize the need for great inter-agency collaboration in the fight against counterfeit drugs to tap the expected benefits from the different areas of expertise and jurisdictional competence. In Kenya the joint operations were conducted by Pharmacy and Poisons Board, Police and Customs and supported by Interpol General Secretariat through the WHO International Medical Products Anti-Counterfeiting Taskforce (IMPACT). Mamba II was conducted simultaneously in three EAC states i.e. Kenya, Tanzania and Uganda.  Following the success of Mamba II, Mamba III was expanded to include Rwanda, Burundi and Zanzibar.

In Mamba II, a total of 127 premises, majority being pharmaceutical distribution outlets were visited. Ports of entry were also inspected. Four (4) suspected counterfeits were seized. Following this operation, 3 court cases have been concluded and 1 case is still going on. Out of the suspected products,

• The 65 packets of Zithromax seized at Malibu Pharmacy were confirmed genuine by the company representing Pfizer.

• Suspected Duo-Cotecxin being offered at a very low price in august 2009. The manufacturer confirmed the donation through their country office. The product is genuine.

In Mamba III, a total of 74 pharmaceutical distribution outlets were targeted and inspected based on risk profiles, previous experience and intelligence. Targeted inspections were also conducted at ports of entry. 17 different suspect products were seized, including suspected diverted products and stolen government drugs. This operation also netted drugs being imported illegally at Eldoret International Airport and another case at Lungalunga. Verification process and further investigation is still going on. Out of the eight cases, four (4) have been concluded and

• the accused persons were fined Kshs. 10,000 each in two cases,

• Kshs 15,000 on the third case, and

• Kshs 30,000 each on the fourth case.

The suspected counterfeits are still being evaluated based on the physical features and laboratory analysis. Some of the unregistered/ diverted products will also be analyzed to ascertain their true character. 

To support our direct regulatory activities and efforts, the Board is pushing for stakeholders to play a bigger role and has initiated regular consultations with the stakeholders as a means of encouraging better communication, collaboration and compliance.

• Manufacturers and distributors found handling dubious medicines will be named and shamed to lose image, and necessary legal and regulatory actions taken to ensure the public are protected from such persons.

• Licensed persons should adhere to Good Distribution Practices for pharmaceuticals, and particularly to ensure proper record keeping and batch tracing.

• Manufacturers are encouraged to register trademarks and other intellectual property

• The inspectorate activities are being strengthened for better regulation of the supply chain and to uproot illegal pharmacies/chemists

• Destruction of expired drugs will always be supervised to avoid unscrupulous people who may repackage. High awareness has resulted in a very significant rise in the number of those currently notifying the inspectorate to verify and supervise the disposal of expired drugs

• Self-regulation among professionals is encouraged. The Pharmaceutical Society of Kenya (PSK) and Kenya Pharmaceutical Association (KPA) should sensitize members on this so that information flow is adequate for appropriate actions. A  sensitive supply chain will ensure early reporting of suspicious products for quick action and make it more difficult for counterfeiters to penetrate the legitimate channel of distribution

The government appreciates the role of stakeholders and members of the public for the goodwill and tremendous support in fighting counterfeits. Accurate and timely information is a key success factor to perform and improve this type of complex enforcement activities.