India is studying pharmaceutical regulations in several countries, including those in Africa to ease trade while controlling quality of drugs and medical supplies before shipments.
Export and import of pharma-products is undergoing a number of checks and approval including drug registration and manufacturer certification prior to any shipping. The move comes due to the fact that most African regulatory bodies, including Tanzania, take between one and three years to register a drug and certify firms under Good Manufacturing Practice (GMP), hence constraining the process.
According to Pharmexcil, the organiser of Mumbai’s International Exhibition for Pharma and Healthcare (iPHEX) 2013, over 20 food and drug authorities are expected to make their country’s showcase on laws and regulations governing importations. T
he Director General Pharmexcil Dr P. V. Appaji said during the opening ceremony yesterday that drug regulators would attend technical conferences for their presentations and one to one meetings with exhibitors.
“The invited drug regulators (over 40 senior regulators) are to make presentations on regulatory procedures in their respected countries,” Dr Appaji said. Regulators scheduled to make their presentation include Tanzania, Ghana, Senegal, Uganda, Zimbabwe, Benin, Botswana, Burkina Faso, Niger, Nigeria, Egypt, Taiwan, Philippine, Mongolia, Cuba, Seychelles and Haiti.
Some of the (iPHEX) 2013 delegates, have it that the longer it takes to approve the drug leaves a room for substandard products to filter into the markets. It is estimated that 30 per cent of medicines in circulations, globally, are counterfeit.
The meeting, the DG said, would have immensely benefits as over 400 genuine pharma buyers would meet exhibitors – drugs manufacturers under the same roof to iron. And the bureaucrats have the chance to visit the producers premises as most are in Mumbai – the capital of Maharashtra State.
India’s Ministry of Commerce and Industry, Additional Secretary, Mr Rajiv Kher, said the quality control of medicine has paramount importance should Delhi want to enhance its international pharma markets. The Secretary, who is also India’s chief WTO negotiator, said the country could not afford to compromise quality of the medicines exported.
Currently, India produces 15 per cent of US total generics by volume. “Concept Senior Consultant, Mr Partha Pratim Mallik, said that through two-dimension (2D) barcode system, they have developed a software that once scanned to retail level identified if the product is genuine or sub-standard in less than 30 seconds.
“Already 14 countries in Asia are using this system which uses smartphone cameras to scan. “Once the barcode is scanned the originality of the packing consignment by reading the longitude and latitude is detected,” Mr Mallik told the ‘Daily News’ at their pavilion. Uganda’s Joint Clinical Research Centre, Chief Pharmacist Ocitti Paul Labeja said it took between six and 12 months to complete drug registration and obtained GMP certificate.
“This is time consuming,” Mr Labeja said “it also increases the cost of a drug.” Tanzania Association of Pharmaceutical Industry (TAPI) Chairman, Mr Sinare Yusuph Sinare, said to register a drug and get GMP takes between two and three years. In Rwanda and Kenya the whole process takes six months.
“Éby the time you get the approval the manufacturer has stopped producing the drug and pass the molecule (the formula) to other firm – its real a challenge,” Mr Sinare said. “Phex is mandated to help over 3,800 of its members to achieve excellence in export, where 250 are exhibitors at the ongoing show. To do so it has invited 104 countries worldwide that bring in over 500 delegates.
By ABDUEL ELINAZA, Tanzania Daily News
