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Saturday Nation 23/07/2011

P U B L I C  N O T I C E

RESPONSE TO HEADLINE ARTICLE “HOW UNSAFE DRUGS ARE CLEARED FOR USE” PUBLISHED ON SATURDAY NATION NEWSPAPER OF 23RD JULY 2011

The Board takes great exception with the Headline ‘How unsafe drugs are cleared for use’ on Saturday Nation July 23, 2011. The Board wishes to clarify the false and alarmist information published there in.

The Pharmacy and Poisons Board is mandated to make better provision for the control of the profession of Pharmacy and the trade in drugs and poisons and has never been a supplier of any Pharmaceutical products as alleged.
There are 13,850 registered medicinal products registered in Kenya for treatment of various diseases and ailments in this country and for export.
The National Quality Control Laboratory (NQCL) is one of the laboratories among others that the board recommends in line with World Health Organisation (WHO) guidelines to carry out analytical aspects of drug registration. Quality assurance is continuous process carried through pre-registration analysis and post market surveillance.

The following drugs were reported to be allegedly in the market despite failing laboratory analysis :

1. Malmed-Fed(jr/enfant) tablets
2. Lavina Rebetabs tablets
3. Fluxate Dry powder
4. Pecilllin 250mg B.P capsules
5. Kamox Clav 1000mg tablets

We wish to state the true position of the products as follows:

Product

Form

Manufacturer

Location

Status

Availability

 

Malmed – Fed

(Jr/Enfant)

Tablets

The Madras Pharmaceuticals

India

Failed analysis

Not registered

Not in the market

Lavina Repetabs

Tablets

SGMA Pharmaceutical Industries

Egypt

Failed analysis

Not registered

Not in the market

 

Fluxate Dry powder

Syrup

Sphinx Pharmaceuticals Ltd

Kenya

Passed NQCLanalysis

Registered

Product in the market

Pcillin 250mg B.P.

Capsules

Zest Pharma

India

Passed NQCLanalysis

Registered

Product in the market

Kamox Clav 1000mg

Tablets

Flamingo Pharmaceuticals

India

Failed analysis

Not registered

Not in the market

 

It was also alleged that a Company “Aglowmed E.A. Ltd- India” brought in a huge quantity of medicines despite the manufacturer failing Good Manufacturing Practice (GMP) inspection. The mentioned products were as follows;


a. Panacef Injection 1 gm
b. Cifomed 500 mg
c. Levomed 500 mg
d. Lizomed 600
e. Becoryl Syrup
f. Lizomed Syrup
g. Pancef-o- dry syrup

We wish to inform the Public; that this company was inspected by the Pharmacy and Poisons Board on 23/24th November 2009. The company failed to comply with the minimum GMP requirements and hence the stopping of any importation. The said products are not in the market.


The verification of Pharmaceutical Imports at Kilindini is done by the Board inspectors and we are not aware of the alleged 235 pharmaceutical import entries through Kilindini captured by the Kenya Ports Authority.
We further take great exception to the allegation that TELMI 40H and OVACARE are not registered, according to our records these medicines are registered under No. H2010/21980/565 and H/2010/20502/093 respectively after they met the necessary registration requirements.
The publication of the said article may have been ill intended with a view to create unwarranted panic and alarm to the public as it contains a lot of inaccuracies.

In conclusion we wish to state that the Board is a Public institution and open to any persons wishing to verify any information pertaining to medicines within the Republic of Kenya, which in this case the authors of the said publication never sought. The Board wishes to assure the Public that the medicines available within the country are of good Quality, safe and efficacious and the Board endevours to undertake its Mandate and ensure the quality of drugs is safe for Public use.

 

KIPKERICH CHUMO KOSKEI, OGW
REGISTRAR

Ensuring the provision of Quality, Safe and efficacious Pharmaceutical Products and Services.

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Saturday Nation 23/07/2011