Lagos, March 5, 2023 – The National Agency for Food and Drug Administration and Control (NAFDAC) has called for synergy between Nigeria and India Pharmaceutical sectors to provide unhindered access to safe, efficacious, and affordable medicines.
Prof Mojisola Adeyeye, it’s Director-General, made the call at the India-Nigeria Pharmaceuticals and Health Industry forum in Lagos on Thursday, March 2, 2023.
The forum aims to provide concrete steps towards birthing, actualizing, and strengthening mutual benefits for pharmaceutical business in both countries.
Adeyeye said that the prognosis for the Pharma business in Nigeria and India, the population dynamics and associated health indices provide a common baseline for strong synergy between both countries.
She said that these indicators were the reasons the regulatory landscape between both countries must of necessity be explored for the good of their citizens.
According to a statement issued by Sayo Akintola, the Resident Media Consultant to NAFDAC in Lagos on Sunday, Adeyeye also said the strong correlation in economic indices in both countries provided a common baseline for strong synergy between both countries.
She said that no country, no matter how well endowed, could meet all of its national drug needs and achieve the universal health coverage within the context of the sustainable development goals.
Adeyeye said that a fast means for meeting essential drug needs was through a proposition for mutually beneficial cooperation between regulatory agencies.
According to her, Nigeria was a huge beneficiary of this during the last global pandemic when substantial quantity of COVID-19 vaccines were obtained from Serum Institute India, adding that this was typically made possible through the active intervening role of the India National Regulatory Authority NRA (The Central Drugs Standard Control Organization (CDSCO).
Adeyeye said that NAFDAC, as a responsible national regulatory agency, would continue to forge meaningful alliances within the confines of its mandate, relevant legislation and in line with global best practice.
“As a ML3 Agency, NAFDAC was strongly averse to unethical practices and would not fail to protect public health through enforcement of appropriate sanctions when and where the need arose”.
She warned that a situation where unscrupulous persons or manufacturers, under the guise of convergence and cooperation, knowingly or unknowingly, engage in clandestine practices that violate extant regulations and constitutes significant risks to public health will not be treated with kid gloves.
“NAFDAC’s mandate is to safeguard public health and we are not in any way about to give up on this obligation,” she said, adding that some local and foreign manufacturers were being sanctioned for bad practices and post marketing failures.
She said that her transformative agenda in NAFDAC, which included, but not limited to attainment of WHO Maturity Level 4 status, attainment of vaccine lot release, supply chain monitoring and expanded post marketing surveillance, continual pharmacovigilance activities, were enough justification for promotion of strong synergy between the India-Nigeria Pharma sector.
According to the NAFDAC boss, India is the largest trading partner of Nigeria and Nigeria is India’s largest trading partner in Africa with bilateral trade in the region of over 13.89 billion USD as of 2019.
She said that Indian owned or operated companies were the second largest employer of labour in Nigeria with huge foreign direct investment in engineering, electrical machinery and equipment, plastics, chemicals, and the pharmaceutical sector.
To further enhance local production of pharmaceuticals and innovation in Nigeria, Adeyeye said that the Agency set up the Five Plus Five-Year Validity policy in 2019 for products that were sufficiently produced in the country.
“For such a product, during the registration license renewal period of 5 years, by the end of the 4th year of license validity, the importer/manufacturer is required to submit draft migration blueprints for local manufacturing or proposed partnership with a Nigerian company.
“If there is no progress on migration to local manufacturing as detailed in the blueprint, an alert for de-registration will be sent to the company at the end of the 4th year in the five-year validity,” she said.
The director-general said the Five-Plus-Five Validity policy was working because many companies were now embracing this migration either through building quality focused
The director general said the Five-Plus-Five Validity policy was working because many companies were now embracing this migration either through building quality focused facilities locally or partnership with existing local companies for their manufacturing needs.
Responding, Mr Verkay Verghese, the President of India Pharmaceutical Manufacturers and Importers of Nigeria (IPMIN), pledged the association’s cooperation with NAFDAC to ensure that only wholesome medicines would be produced in Nigeria or imported into the country to safeguard the health of Nigerians.
He commended NAFDAC for instilling professionalism in the Nigeria pharma sector through what he described as pragmatic regulatory activity of the Agency under Prof. Adeyeye, stressing that with her at the helm of affairs, attaining WHO Maturity Level 4 would not be too difficult for NAFDAC. (GBN)
