DODOMA: THE government has directed the Tanzania Medicines and Medical Devices Authority (TMDA) to intensify the crackdown on counterfeit and substandard medicines through expanded market surveillance, wider regulatory coverage and closer cooperation with law enforcement agencies to protect public health.
Health Minister Mohamed Mchengerwa issued the directives in Dodoma recently while inaugurating the Ministry of Health Advisory Board for TMDA, warning that fake and poor quality medicines pose a serious threat to public health and require firm regulatory action.
“Counterfeit and substandard medicines are a crime against innocent people,” he said.
He cited World Health Organisation (WHO) estimates that one in every 10 medical products in lowand middle-income countries is substandard or falsified.
Mr Mchengerwa directed the board to oversee the establishment of TMDA regional offices across the country to strengthen inspections and enforcement at borders, ports and markets, instead of concentrating regulatory operations in Dodoma and Dar es Salaam.
He also called for stronger post-market surveillance and the use of technology to track medical products from manufacturing facilities to patients.
The minister urged TMDA to strengthen cooperation with the Tanzania Revenue Authority (TRA), Police Force, port authorities, Immigration Department and local government authorities to prevent counterfeit medicines from entering and circulating in the country.
He further directed the authority to integrate its information technology systems with those of the National Health Insurance Fund (NHIF) to ensure health insurance does not cover medicines that have not been registered by TMDA.
“With the government having introduced Universal Health Insurance, a medicine that has not been registered by TMDA should not be paid for by anyone’s health insurance. That is an additional weapon in this fight,” he said.
Mr Mchengerwa stressed that effective medicines regulation requires independence and the courage to reject products that fail to meet safety standards, regardless of pressure from influential individuals, investors or government officials.
“I want TMDA to have that courage. The courage to say ‘no’ when ‘no’ is the right answer, even to a major investor, a powerful person or the government itself. A regulator that is afraid is not a regulator; it is a rubber stamp,” he said.
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The minister said a credible regulatory system was also essential for attracting investment in pharmaceutical manufacturing and enabling locally produced medicines to compete in international markets.
The government aims to produce 80 per cent of the country’s medicines and health products locally by 2030, a target that requires efficient product registration, professional factory inspections and internationally recognised certification without compromising quality, he said.
He urged the board to align TMDA’s strategic plan with Development Vision 2050 and the government’s pharmaceutical industrialisation agenda. Mr Mchengerwa called on board members to provide independent advice and hold the authority’s management accountable rather than simply endorsing its decisions.
“Do not seek to please the management. Do not seek to please me. Tell me the truth, even when it hurts,” he said.
He directed TMDA to maintain its World Health Organisation Maturity Level 3 status and lead efforts to achieve Level 4, which would strengthen Tanzania’s position as a leading medicines regulator in Africa.
He also instructed the board to oversee efforts to secure ISO/IEC 17025 accreditation and WHO prequalification for TMDA laboratories in Mwanza and Dodoma, following the status achieved by the Dar es Salaam laboratory.
Additionally, he called for continued clean audit reports from the Controller and Auditor General (CAG), improved revenue collection and disciplined expenditure, while ensuring the authority continues paying dividends to the government’s Consolidated Fund in accordance with the law.