THE government has unveiled a comprehensive pharmaceutical standards acceleration strategy as the country moves from substantive dependency on imported drugs.
Mohamed Mchengerwa, the Health minister, launched the initiative at a high-level engagement with local manufacturers in Dar es Salaam yesterday, noting that the plan ties investment incentives directly to achieving World Health Organization (WHO) quality standards.
A ministerial task force to monitor implementation and supervise attainment of time-bound targets was being formed to steer implementation of the strategy, he said, underlining that government protection and market access for local pharmaceuticals will no longer be unconditional.
"Any manufacturer seeking incentives, protection or guaranteed market access needs to meet WHO standards or present a clear, time-bound roadmap to achieve the specific standards,” he declared/
While the local industry has grown, the lack of WHO certification remains a bottleneck that prevents Tanzanian-made drugs from competing in regional or wider markets, thus companies need to consider mergers and consolidations to build the financial and technical capacity required to meet global benchmarks, he further noted.
Tanzania trails its neighbors in pharmaceutical exports, a disparity the new strategy seeks to rectify, as without WHO authorization the products cannot enter international markets. “We risk remaining spectators while others advance,” he said, describing pharmaceutical industrialization as a matter of national security.
Dr. Seif Shekalaghe, the permanent secretary, said that to support this transition, the government has already begun streamlining regulatory hurdles, where the Tanzania Medicines and Medical Devices Authority (TMDA) has slashed drug registration timelines from 180 days to 60 days.
Local manufacturers welcomed the focus on the sector but highlighted the steep challenges ahead, with Bashiru Haroun, chairman of the Tanzania Pharmaceutical Manufacturers Association (TPMA), pointing out that local producers currently supply only 10 percent of the domestic demand.
“Importing products such as intravenous (IV) drips is inefficient when most raw materials are locally available,” he said, appealing for stronger protectionist measures in public procurement for firms that show progress.
Winna Shango, chairman of the Medical Devices Manufacturers Association (MDMA), cited high startup costs as a barrier for firms producing hospital consumables and reagents, urging the government to look into fiscal policies that favor local production.
Officials said that the strategy marks a decisive move toward self-reliance, to secure the sector’s future while boosting pharmaceutical exports, on the basis of the strategy highlights to 2030
A mandatory roadmap demands that local firms draw up a documented path towards WHO certification, while fast-tracked regulation in TMDA registration is reduced to 60 days for local products.
Consolidation is likely to be attained by encouraging small firms to merge for better capitalization while procurement priority linking public tenders to quality and safety standards rather than just prices could work, they said.
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