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By Ally Jamah
Kenya: Quacks caught dishing out drugs in private and public pharmacies will part with Sh1 million in fines if a proposed law is approved.
The draft amendments to the Pharmacy and Poisons Board Act will also see unlicensed and unregistered pharmacies attracting a fine of Sh500,00 up from the current Sh30,000.
The proposed amendments are being considered by the Health Committee of Parliament led by Dr Rachael Nyamai.
A new requirement in the draft bill reads in part: “No person shall operate a pharmacy without the presence of a registered pharmacist and pharmaceutical technologist in the premises where such business is being carried out.”
Pharmacies and pharmaceutical technologists that don’t prominently display their certificate of registration and annual licenses in their pharmacies will be fined Sh200,000 up from Sh20,000.
The proposed changes come amid rising concerns over the high number of quacks operating with impunity across the country.
According to the amendments, a person who sells any counterfeit, illegally imported or unregistered pharmaceutical substances and medicinal devices will be fined Sh1 million or serve a maximum of ten years in prison or both.
Counterfeit drugs
The Act further proposes to have manufacturers of counterfeit drugs and devices to pay a fine of Sh3 million and/or three years imprisonment.
Those who manufacture drugs or medical devices without a licence will be fined Sh10 million or face five years in prison or both.
Should the proposed amendments be passed, the Pharmacy and Poisons Board will be transformed into the Pharmacy and Poisons Authority.
But sections of the bill have already caused uproar from other regulatory bodies who feel that the proposed powers of the Authority encroaches on their statutory mandates.
Section 3 of the draft bill gives the new authority powers to not only oversee drugs and the practice of pharmacy in the country, but also regulate medical devices and diagnostics.
Currently diagnostics such as lab test kits, reagents and equipment are handled by the Kenya Medical Laboratories Technicians and Technologists Board.
The board also handles medical devices such testing kits for HIV, malaria and diabetes.
Other medical devices such as x-rays are handed by the Radiation Protection Board. Such devices as X-rays are under the ambit of Medical Engineers.
The Nursing Council of Kenya is also not happy that the new authority will have a supervisory role over medical devices used by nurses.
Incessant accusations
The new authority shall be managed by a board that will include pharmacists and pharmaceutical technologists, representatives from the pharmaceutical industry, consumers as well as universities teaching pharmacy.
It will be headed by a Director-General who will be the Secretary of the board.
The Pharmacy and Poisons Board has faced incessant criticism over inability to effectively police the pharmaceutical sector leading to mushrooming of unregistered pharmacies run by quacks.
They have been accused of allowing unlicensed drugs in the local market.
The bill says that the Director-General to head the board will be appointed after a competitive recruitment process.
Currently the board is headed by a chief pharmacist.
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