Pharma manufacturers urge NAFDAC to quicken approval

Local pharmaceutical manufacturers are urging the National Agency for Food and Drug Administration and Control to speed up the approval process for their products to enable them to address the gap created by the recent exit of multinational pharmaceutical companies from Nigeria.

The Pharmaceutical Manufacturers Group of the Manufacturers Association of Nigeria said local manufacturers could produce essential medicines but need timely regulatory support to ensure continuous supply.

The Chairman of PMG-MAN, Oluwatosin Jolayemi, stressed that NAFDAC’s accelerated registration for local companies was critical as they seek to replace products previously manufactured by departing multinationals.

Some multinational pharmaceutical manufacturers recently exited Nigeria, citing challenges such as high operational costs, regulatory complexities, foreign exchange shortages, and a tough operating environment.

Companies like GlaxoSmithKline and Novartis have either scaled back operations or fully withdrawn, impacting the availability of certain essential drugs.

The PUNCH reports how the exit of these multinationals has opened a gap in the healthcare sector, particularly for medicines they produced, whose prices have since skyrocketed, including the antibiotic Augmentin and asthma medication Seretide.

“NAFDAC has accepted to give local manufacturers priority,” Jolayemi noted, describing the agency’s support as essential for positioning Nigerian companies to make the most of a temporary zero VAT policy on pharmaceutical inputs.

“We are working with NAFDAC to ensure local manufacturers are properly positioned,” he said, adding that Nigerian firms could quickly scale up production if the registration process was streamlined.

Jolayemi emphasised the potential of local companies to produce high-demand items, including antibiotics, without compromising standards.

He added, “We are not asking (NAFDAC) to lower their requirements; instead, we are asking them to guide us on how to accelerate the production of these products locally.

‘“It is just for NAFDAC to say, ‘Come, as nationals, as companies, as a country, that wants to be able to be independent and not dependent on imports. How do we do this within a short period? To get our own companies producing this product that are no more under patent so that our population will be able to get this product at a reasonable cost.’”

Jolayemi, the Executive Director of Daily Need Group, a pharmaceutical company based in Lagos, noted that countries like India have become pharmaceutical hubs by establishing standards that support local manufacturing instead of strictly adhering to international benchmarks.

“If we sit down and say we want to begin to look at international standards, these companies that are asking us to meet their standard have been operating for over 200 years as a manufacturing concern.

“If you are using a 200-year-old factory that has emerged over time to emerge as a standard for a 60 (plus) year-old country, then you can see that there is a big mismatch,” the PMG-MAN chairman remarked.

He noted that Nigeria could shift from being a largely import-dependent pharmaceutical market to one that meets much of its demand.

NAFDAC’s Deputy Director of Public Affairs, Christina Obiazikwor, told The PUNCH the agency was committed to prioritising Nigerian pharmaceutical manufacturers.

Obiazikwor stated that NAFDAC’s Director General, Prof Mojisola Adeyeye, had made it her mission to boost the local pharmaceutical industry, stressing, “She is not playing with it at all. She’s doing everything she can to ensure that everything works fast for them.”

In a 2021 report assessing Adeyeye’s tenure, she outlined a strategy aimed at reducing Nigeria’s dependence on imported pharmaceuticals from 70 per cent to about 30 per cent by 2025.

Part of her initiative included an updated Five Plus Five-Year Validity policy, which requires foreign companies to either partner with Nigerian firms or establish local manufacturing plants to maintain their licenses.