JOB CREATION

Pharmacy and Poisons board roots for local manufacture of drugs

CEO wants Parliament to enact a law mandating healthcare workers to report any suspected adverse drug events

In Summary
  • Data shows that so far, there are 36 licensed manufacturers of medical products in Kenya.
  • Currently, the local manufacturers supply about 30 per cent of all the medicines consumed in Kenya.
The Kenya Pharmacy and Poisons Board CEO Fred Siyoi
SAFETY FIRST: The Kenya Pharmacy and Poisons Board CEO Fred Siyoi
Image: MAGDALINE SAYA

The Pharmacy and Poisons Board wants incentives put in place to promote local manufacture of healthcare products and technologies.

Speaking when he appeared before the departmental committee on Health, CEO Fred Siyoi noted that local manufacturers have the capacity to manufacture the most commonly used generic medicines in Kenya.

Data show that so far, there are 36 licensed manufacturers of medical products in Kenya, while four others are in various stages of certification to start manufacturing medical products.

Currently, the local manufacturers supply about 30 per cent of all the medicines consumed in Kenya.

“These local manufacturers of medical products play a key role in job creation in Kenya. VAT Zero-rating of HPTs to ensure manufacturers are able to claim back their input,” Dr Siyoi told the committee.

He said some of the licensed local manufacturers have achieved the World Health Organisation pre-qualification status and are among the very few facilities in Africa to attain such certification and thus manufacture products of very high quality.

“However, there is a need for incentives to promote further investment in local manufacturing of HPTs, including investments to attain the stringent international standards,” Siyoi added.

He further wants Parliament to enact a law mandating healthcare workers to report any suspected adverse drug events experienced by patients under their care.

Siyoi expressed concern that despite mechanisms put in place by the board to promote the collection and analysis of data on health products and technology quality and safety, the rate of reporting is relatively low.

This has been attributed to fear by the healthcare workers of being blamed for adverse reactions experienced by their patients.

Siyoi said the legislation should include an indemnity clause that protects any health care worker who reports a suspected adverse event, from unwarranted blame. 

“One best practice approach is legislation on mandatory reporting of adverse events by health workers, with a complementary indemnity clause,” Siyoi said.

An adverse drug event is an injury resulting from medical intervention related to a drug and they might include rashes, jaundice, anemia, a decrease in the white blood cell count, kidney damage, and nerve injury that may impair vision or hearing.

These reactions tend to be more serious but typically occur in a very small number of people.

Before marketing authorisation is granted for generic drugs, the board conducts a full assessment of pharmaceutical product data and information on safety, efficacy and quality submitted by the manufacturer, including product formulation, manufacture and test data and results.

It also conducts a full inspection of finished pharmaceutical product manufacturing sites to verify compliance with WHO Good Manufacturing Practices.

“The PPB also assures the quality of all medicines by ensuring that Good Distribution Practices are adhered to and transportation of these medicines are according to the prescribed guidelines,” he added.

“Reactive market surveillance is informed by market complaints and reports on suspected poor-quality HPTs from healthcare workers and the general public.”

Most of the reports are obtained through the Pharmacovigilance Electronic Reporting System platform.

-Edited by SKanyara