New Kenya Health Law Amendment Establishes Quality Control Lab

Health law amends'

The Health Laws (Amendment) Bill of 2018 and the Assumption of the Office of County Governors Bill was signed into law by His Excellency President Uhuru Kenyatta on Monday 13th in a ceremony held at State House.

The new health law amends the Pharmacy and Poisons Act (Cap 244), the Medical Practitioners and Dentists Act (Cap 244), the Nurses Act (Cap 257), and the Kenya Medical Training College Act (Cap 261).

Others include the Nutritionists and Dieticians Act, the Kenya Medical Supplies Authority Act, the Counselors and Psychologists Act, the Physiotherapists Act, the Health Records and Information Managers Act and the Clinical Officers (Training, Registration and Licensing) Act.

In the 12th Parliament Second Session held in October last year, the Leader of the Majority Party, presented a bill to withdraw amendments in the Pharmacy and Poisons Act (CAP 244), relating to granting marketing authorization and the establishment of National Quality Control Laboratory as a corporate body.

According to section 35A of CAP 244, No person shall manufacture any medicinal substance for sale unless he has applied for and obtained a licence from the Board in respect of each substance intended to be manufactured.
Each manufacturing licence shall expire on the 31st December of every year and the renewal thereof shall be subject to compliance with conditions prescribed by the Board.

On the establishment of the National Quality Control Laboratory,  section 35D of CAP 244 ofHealth Laws (Amendment) Bill, 2018 states that the laboratory shall be used as a facility for the examination and testing of drugs and any material or substance from or with which and the manner in which drugs may be manufactured,
processed or treated and ensuring the quality control of drugs and medicinal substances.

The lab will also be performing chemical, biological, hie-chemical,  physiological analysis, pharmaceutical evaluation; and testing, at the request of the Board and on behalf of the Government, of locally manufactured and imported drugs or medicinal substances with a view to determining whether such drugs or medicinal substances comply with this Act.

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