Professor Christianah Mojisola Adeyeye, Director General, National Agency for Food and Drug Administration and Control (NAFDAC), has emphasized that a strong regulatory framework and intentional government policies are essential for a virile pharmaceutical sector. She made the remarks at the commissioning of a new ultra-modern facility of SAM Pharmaceuticals Limited, Sango-Ota, Ogun State.

In attendance at the event were notable individuals from industry, government, and international organizations: Ogun State deputy governor, Her Excellency Noimot Adedeji; Minister of State for Health and Social Welfare, Hon. Isiaka Salako; Consul General of India, Mr. Kannan Chockalingham; former Minister of Trade and Industry, Hon. Adeniyi Adebayo; Chairman, FIDSON Healthcare Plc, Dr. Fidelis Ayebae, Commissioner of Health, Ogun State, Dr. Tomi Coker, and many others.

Prof Adeyeye informed the gathering that what was being witnessed was a culmination of deliberate government policies and a dogged regulatory system. Specifically, she remarked that the effectiveness of the agency’s ‘five plus five’ policy and the ‘ceiling list’ has now made it possible for local manufacturers to expand and fully utilize their capacities. The NAFDAC DG stated that having been successfully re-benchmarked for the World Health Organization Maturity Level 3 (ML3) status – the first National Regulatory Agency in Sub-Saharan Africa to scale through the re-benchmarking exercise, the next goal for the agency is attaining the WHO ML4 status, and ultimately, the WLA (World Listed Authority) status, which invariably confers on our manufacturers, the opportunity of marketing their products anywhere in the world.

According to Prof Adeyeye, ‘quality is synonymous with trade. When quality is built into the product, trade will be enhanced.’ Similarly, she said contract manufacturing has witnessed about six folds increase. ‘We insisted that you must migrate to local manufacturing or if you don’t have the capacity, you should partner with a local manufacturer. We now have sixfold increase in local manufacturers. No investor would like to invest where the regulatory system is weak.’

Also speaking at the occasion, the Consul General of India to the country, Mr. Kannan Chockalingham said Pharmaceutical manufacturers have ascribed the growth in the Nigeria Pharma sector to a strong regulatory system and deliberate government policies to enhance ease of doing business in the country.

Giving the exponential growth in the sector, Mr. Kannan Chockalingam, pledged India’s commitment to supporting Nigeria, not only in the area of finished pharmaceutical products, but in strengthening local capabilities and technology capacity building.

In his goodwill message, Dr. Fidelis Ayebae, Chairman, FIDSON Healthcare Plc said, ‘What we are witnessing would not have been possible without the NAFDAC-DG, Prof. Mojisola Adeyeye,’ adding that industries are not self-driven – policies drive industries. He said the policies that are supposed to anchor the industry and be pivotal to the success of the industry must be right.

‘Thank you for making the industry what it is today. Before you came it was a big industry. By the time you exit, you must have tripled the capacity of the big industry that you met, operating in compliance with international best practices,’ he said.

Sequel to the enunciation of the policy, he said the ratio of imported pharmaceutical products to the locally manufactured medicines has moved from 70 -30 to 50-50.

Dr Ayebae noted that the industry has grown threefold, stressing that ‘I am a witness to this. I know this because I’m well entrenched in the industry.’

He said, ‘things are happening. New factories are springing up. Old factories are getting retooled for higher capacity, creating employment for our people.’ The strange thing is that most of them are in Ogun State,’ he said jocularly.

The host of the commissioning event and the Chairman of SAM Pharmaceutical Limited, Mr Amit Bhojwani disclosed that ‘in this journey, our regulator has been our partners. I want to specifically thank NAFDAC and its DG for pushing us towards high standards. You have helped us prove to the world that made-in Nigeria is synonymous to world-class.’

Also, by maintaining ML3 and soon to achieve ML4, he said ‘you have led by example by raising the standard of accountability and regulations.’ He however, commended President Tinubu for supporting the pharma industry with the Executive Order. He thanked all those who attended the event and pledged the company’s commitment to producing quality, safe, and affordable medicines for the benefit of Nigerians.

The Deputy Governor of Ogun State, Engr. Mrs. Noimot Salako- Oyedele, described her state as the hotbed of industrial revolution in Nigeria. She stated that the state government would stop at nothing to enhance the ease of doing business to grow the nation’s economy and create employment opportunities for the teeming youths of the country,

She pledged the state’s continued support for the pharmaceutical manufacturers to enable them produce affordable medicines for Nigerians in line with the president Tinubu’s efforts to energize the sector with the Executive Order.

The Minister of State for Health, Dr. Isiaka Salako emphasised that the ongoing transformation of the nation’s pharma industry cannot be over-emphasized especially at this time of our national circumstance and the renewed commitment to unlock healthcare value chain not just for economic reason but also as a key enabler of medicine sovereignty.

Before now, the minister said a number of factors including some suboptimal prioritisation and a lack of requisite political will prevented the nation’s contextual system from harnessing the immense benefits associated with pharma and related value chan.

He however, stressed that the present administration has now rightly positioned the sector to not only meet Nigeria’s teeming population healthcare needs, but to also drag growth and development in many other auxiliary sectors.

‘’This expansive pharmaceutical manufacturing facility strongly aligns with the Nigeria First philosophy of Mr. President’s Renewed Hope Agenda,’ he said, adding that the Federal Government has developed several bold initiatives to drive reforms in the pharmaceutical manufacturing space.

Key amongst them, he said, are the presidential initiatives to unlock the healthcare value chain and the Presidential Executive Order for pharmaceutical and allied sectors targeted at revitalising local manufacturing as a driving force for Nigeria’s health sector reforms. The aim is to catalyse health security and economic growth and employment by accelerating value chain transformation through cross-institutional coordination and collaboration.

Dr Salako said that the Presidential Executive Order works in tandem by directly incentivising local manufacturing concerns and other commodities such as syringes and rapid diagnostics test kits, adding that these novel interventions leverage diverse drivers such as contextual funding mechanisms as well as research and innovation to build resilient systems.

As a result of the implementation of the Presidential Order on zero tariff on pharmaceutical machinery, APIs and other items, he disclosed that 87 local manufacturing companies are directly benefiting from incentives spread across a total of about 1000 harmonised system codes.

He said that the proactive approach mandated by President Tinubu is significantly helping to boost local production of healthcare products and must have contributed to the state-of-art factory by SAM Pharmaceutical Limited.

The minister, however, pointed out that the new factory was not an isolated case as two Nigerian products recently attained the highly regarded WHO Pre-qualification Status– the first of its kind in the Sub-Sahara Africa and Central Africa; and the commissioning of a world-class factory also in Ogun State for the manufacturing of Rapid Diagnostics Test (RDT) kits, a second such contextual specifications in Sub-Sahara Africa.

He added that the first Active Pharmaceutical Ingredients manufacturing in Sub-Sahara Africa by a local manufacturer would soon commence operations in Nigeria.

To support the industry, Dr Salako further explained that the Nigeria Institute for Pharmaceutical Research and Development is working assiduously to set up an API Capacity Building and Concept Production Centre – an entity facilitated by AFRIEXIM bank grant with implementation now at about 85 per cent, to be commissioned soon.

The Minister urged the pharmaceutical manufacturers to always put the Nigerian patient at the centre of all the progress already made by ensuring that government waivers and exemptions translate into a meaningful relief for the people.

He however, reaffirmed the commitment of the Federal Government to promoting local manufacturing of pharmaceuticals through policy enablement, investment mobilisation, regulatory improvement, local research facilitation and the ease of doing business.

•PHOTO, L-R: Chairman, FIDSON Healthcare Plc Dr. Fidelis Ayebae, Director General, National Agency for Food and Drug Administration and Control, NAFDAC, Professor Christianah Mojisola Adeyeye, and Chairman of SAM Pharmaceutical Limited, Mr Amit Bhojwani at the official commissioning of the ultramodern factory plant of SAM Pharmaceutical Limited, Sango-Ota, Ogun State.