TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY

PUBLIC NOTICE

21^st August, 2019

CLARIFICATION ON EXISTENCE OF A PRODUCT NAMELY P-500® (PARACETAMOL) ON THE MARKET PURPOTED TO BE MANUFACTURED BY APEX LABORATORIES PRIVATE, INDIA

1. Tanzania Medicines and Medical Devices Authority (TMDA) is a regulatory body under the Ministry of Health, Community Development, Gender, Elderly and Children (MoHCDGEC) responsible for regulation of quality, safety and effictiveness of medicines, medical devices and diagnostics.
2. The Authority has set up a robust system for assessment and registration of products, inspection, laboratory analysis, post marketing surveillance, pharmacovigilance as well as import and export control which together provides assurance on the quality, safety and efficacy of medicines, medical devices and diagnostics.
3. The Authority has recently noted through social media rumours widely circulated purpoting to suggest that a product namely P-500® (Paracetamol) manufactured by Apex Laboratories Private Limited, Tamil Nadu, India (as depicted on the pictorial presentation below) contains a virus ‘Machupo’ which is falsely claimed to cause Bolivian Hemorrhagic Fever (BHF).
4. The public is alerted to note that there is no such virus known as Machupo and no virus can survive on tablets.
5. The product P-500® (Paracetamol) manufactured by Apex Laboratories Private Limited, India is not registered in Tanzania and the Authority has never issued any permit for importation of such product.
6. Different brands of Paracetamol have been registered in Tanzania after undergoing pre-authorization assessement processes which confirmed their quality, safety and efficacy.
7. The Authority through the existing regulatory systems and as per its mandate continues to protect public health by ensuring unregistered medicines and prohibited products are neither imported into nor circulating on our market.
8. We call upon the public to notify the TMDA when they suspect any Adverse Drug Reaction (ADR) associated to the use of medicines. The suspected ADRs can be sent to TMDA electronically through Adverse Reaction Reporting tool or by filling in and submitting ADR forms available at health facilities to nearby TMDA zone offices located in Mwanza, Arusha, Mbeya, Dodoma, Dar es salaam, Mtwara, Tabora and Simiyu or to offices of Regional and District Medical Officers. These pre-paid ADR forms can also be sent to TMDA through post offices.
9. The public is further urged to stop circulating misleading, irrational, unconfirmed or inauthentic information relating to medicines, medical devices and diagnostics prior to official communication from the Authority, to avoid unnecessary panic and chaos in the community.

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