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Africa: EAC harmonising human drugs registration to allow free flow


(Source: The Guardian 2014-3-17)

East African Community (EAC) member states are in the process of harmonising the registration of human drugs to allow their free movement and increase availability of safe, efficacious and good quality essential medicines in the region.

The move comes amid complaints by pharmaceutical importers in the country that the registration process is slow and involves several procedures compared to some neighbouring countries.

Speaking in Dar es Salaam yesterday during the India-Tanzania Pharmaceuticals Buyer Seller meeting, Tanzania Food and Drugs Authority, (TFDA) Director of Drugs and Cosmetics, Dr Adam Fimbo said the project’s guidelines are ready and awaiting approval.

“The project will start with free movement of some few drugs not all kinds of drugs…we may decide to start with malaria drugs and some few other medicines,” he said. He noted that the project will contain some rules and standards to be adhered to by member states.

Pharmaceutical importers in the country applauded the project, but expressed fear that it may lead to foreign drugs flooding the pharmaceutical sector in the country.

“I think this is a good idea. It will enable us to do business in five countries instead of depending on one and will also speed up the registration process…but it could be a disaster as it will pave way to flooding of drugs from our neighbours,” said one of the importers, Neelay Jani during in an exclusive interview with The Guardian.

Jani urged local importers in the country to brace for competition with their East African counterparts. He noted that through the free movement of drugs between the states, prices are expected to be lower.

According to the importers, it takes more than a year for TFDA to process the registration process while in neighbouring countries the process takes only 100 days.

However, according to Dr Fimbo, the delay is due to the fact that there are more than 1,000 registration applicants per year while each application takes at least 5 days to be processed.

He said the registration process needs comprehensive scientific analysis including traveling abroad to inspect the drugs’ manufacturer industries.

The Permanent Secretary Ministry of Health and Social Welfare, Charles Pallangyo said analysis of drug supply in the country shows that 70 percent of them are imported from India.

“This meeting has been organised at a time when the East African Community is implementing the EAC Regional Pharmaceutical Manufacturing Plan of Action, 2011-2016 which guides the EAC Secretariat and EAC Partner states towards evolving an efficient and effective pharmaceutical manufacturing industry,’’ he said.

The Chairman for Tanzania Association of Pharmaceutical Industry (TAPI) Dr Yusuph Sinare said local pharmaceutical importers are ready to work and do business with their counterparts from India. During their visit to Tanzania, PHARMEXCIL will hold a business meeting to promote the Indian generics.