Over 350 medicines approved by Medicines Council

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WINDHOEK – A total of 354 medicines were approved by the Namibia Medicines Regulatory Council and subsequently registered during the 2016/17 financial year.

They include 265 human and 89 veterinary medicines. A total of 1 701 section 27 permits (compassionate clearance certificate) and 371 post-registration amendment applications were processed. These statistics are contained in the Namibia Medicines Regulatory Council annual report for 2016/17 financial year, which was tabled in the National Assembly recently. 

The report shows that the council received N$10.7 million as the annual budget from the ministerial allocation. This shows an increase of 15.9 percent from the previous financial years’ total budget amount. However, it reveals the budget cuts that took place in every quarter made it difficult to keep track of the actual allocation. The main contributor to the budget increase was mainly the remuneration.

In total, the council received N$3.4 million from its clients for the various services rendered.
This represents an increase of 17.9 percent in revenue generated from the previous financial year.
The report further shows the quality surveillance laboratory analysed a total of 314 samples, of which 133 (42.35 percent) were Antiretroviral (ARVs), 35 (11.15 percent) generics and 20 (3.36 percent) anti-tuberculous medicines.  The inspectorate conducted inspections at 51 facilities including nurse clinics, private pharmacies, dispensing doctors consulting rooms, veterinary practices, public hospital pharmacies, pharmaceutical wholesalers, local and foreign pharmaceutical manufacturers. A total of 129 licenses and permits in terms of section 31 of the Medicines and Related Substances Control Act, 13 of 2003, were issued to amongst other medical doctors, veterinarian, nurses and complimentary medicines practitioners.

In line with international requirements, the report shows that 361 permits were issued for the import of internationally controlled substances for medicinal use. As part of the World Health Organisation (WHO) prequalification requirement, the quality surveillance laboratory participated in external quality assurance assessment scheme organised by WHO phase 6 procedure 1. Equally, the Therapeutic Information and Pharmacovigilance Centre (TIPC) continued with its advocacy work to improve safety of medicines used in Namibia. Moreover, it indicates that 19 products were reviewed through the SADC harmonisation initiative during the period under review.

In addition, 16 of these products were recommended for registration, and 13 products were eventually registered.
Three products did not have applications submitted in Namibia, while six pharmaceutical manufacturing facilities were inspected through the SADC harmonisation during that period, while four of these facilities were recommended for Good Manufacturing Practices (GMP) compliance and two are still being reviewed.

TIPC received a total of 234 adverse event reports through the passive surveillance system-being the voluntary reporting of health workers and the public at large.