Saturday, 19 September 2015

PMGMAN boss chides pharmaceutical companies defaulting in producing sickle cell drugs

The Chairman, Pharmaceutical Manufacturing Group of Manufacturers Association of Nigeria, (PMG-MAN), Pharm. Okey Akpa (FPSN), has taken to the cleaners some drug-producing companies who demonstrate nonchalant attitude towards products they classified as “Orphan drugs.”

Akpa, spoke at the at the opening ceremony of a three-day Nigeria Pharma Manufacturers Expo 2015 in Lagos, which concluded yesterday and was staged for stakeholders in the health sector to exchange information, products, services and ideas.

In his key note address at the exhibition, with the theme: ‘The Nigerian Pharmaceutical Manufacturing Industry & International Competitiveness,’ PMG-MAN Chairman lamented that a major challenge in Africa is that many International Pharmaceutical Companies are not interested in research and development investments for conditions such as sickle cell anaemia and malaria that are peculiar to the African continent.
The three-day programme was declared opened by the Director-General of the National Agency for Food, Drugs Administration and Control, NAFDAC, Dr. Paul Orhii in Ikeja, Lagos.

The PMG-MAN boss highlighted the achievements recorded by the Nigerian pharmaceutical companies, which he said included the manufacturing of drugs for neglected tropical diseases.

L-R Director General, National Agency for Food and Drug Administration and Control
(NAFDAC, Dr. Paul Orhii; Chairman, PMGMAN and MD/CEO, SKG Pharmaceutical Limited,
Mr. Okey Akpa; Operations Director, Fidson Healthcare Plc, Mr. Biola Adetayo and
Managing Director/CEO, May & Baker Nigeria Plc, Mr. Nnamdi Okafor and other
dignitaries at the opening of the Nigeria Pharma Manufacturers EXPO
in Lagos…Monday. Photo: Bode Agbede
“The Nigerian pharmaceutical industry has paid adequate attention to the manufacturing of drugs for diseases prevailing in Africa, which international companies are not interested in, such as anti-malaria, sickle cell disease medicines,” he said.

According to him, “Nigeria is currently the biggest pharmaceutical manufacturing country in West Africa. It accounts for more than 65 per cent of the local manufacture of medicines relevant to the people and diseases of our nation and region. They are anti-malaria medicines, anti-retroviral medicines for HIV/AIDS, herbal medicines and medicines for sickle cell diseases and many others.

The chairman stated that to make impact on the global stage, many manufacturers in Nigeria have processed Expression of Interest (EOI) with the World Health Organization (WHO) for Pre-qualification of Products-Manufacturers processing WHO Pre-qualification and have invested over $50 million in the last five years.
“Manufacturers processing WHO prequalification have invested over 50 million dollars in the last five years,” he said.

He further noted that they have also developed manufactured and registered products for The UN Commission on Life-Saving Commodities for Women’s and Children’s Health (UNCoLs) such as: Zinc Sulphate/Oral Rehydration Solutions to manage Diarrhoea, Chlorhexidine gel to manage Cord care and Amoxicillin Dispersible Tablets.

He acknowledged the Support of NAFDAC, Federal Government of Nigeria an Organization (WAHO), the WHO Pre-qualification of Medicine Team and finally the Boards of these companies for their patriotism and commitment to the Nigerian Project.

He however said the newly introduced Common External Tariffs (CET) in West Africa cast a shadow on the industry in Nigeria.

“ECOWAS External Tariffs (CET) is the single factor threatening the industry today. Before its introduction finished pharmaceutical products under the Import HS codes, 3003 and 3004 attracted up to 20 per cent duty. But CET does not allow this. Rather, it attracts zero percent on finished products into countries.
“It is individual countries that are allowed to use protection tax on products which it has capacity for, and that is what we are asking for in the industry,” the PMGMAN chairman explained.

To improve the sector, the Akpa recommended that “an Import Adjustment Tax of 20 per cent on imported Finished Pharmaceutical Products of HS Codes 3003 & 3004 should be imposed immediately as applied to other sectors where Nigeria has capacity as allowed by the CET; input into pharmaceutical manufacturing should be allowed to be imported at zero per cent by bonafide Pharmaceutical Manufacturers” as well as support from Government, Pharmaceutical Innovators, International Suppliers and Partners.

Akpa also urged the Federal Government to give the drug manufacturers some incentives such as tax holidays to support the extra investment for quality upgrades and new factories.

He also appealed to the government, pharmaceutical innovators, international suppliers and partners to sustain the gains made so far by the pharmaceutical industry.

NAFDAC is currently leading other countries in the West African region towards the harmonization of regulatory activities in a 3-year convergence period.

In his speech, Orhii corroborated that NAFDAC has keyed into the United Nations Commission Life Saving Commodities for Women and Children (UNCoLSC) program which seeks to improve access to the thirteen life saving commodities and has worked with several partners such as the Clinton Health Access Initiative (CHAI) to build systems and pathways to facilitate access to these products.

“In order to increase efficiency, application pathways have been streamlined. A documentation-based pathway for the evaluation of Medical Devices registered by Stringent Regulatory Authorities has been introduced as well as a documentation-based renewal process for applications pending ratification after satisfactory laboratory report,” the DG said.

“Timelines for registration have been reduced and processes put in place to track applications. We have deployed the NAFDAC Products Administration and Monitoring System (NAPAMS), which allows for an electronic submission (e-Registration) and a robust database,” he added.

The expo was a joint venture of the PMG-MAN, and GPE Expo Pvt Limited, and this year’s event attracted over 130 exhibitors and at least 2,500 participants.


This story was published in Newswatch Times on September 10, 2015.

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