Onyebuchi Ezigbo in Ezigbo
The National Agency for Food and Drug Administration and Control (NAFDAC) has canvassed for stronger synergy between the Nigerian and Indian pharmaceutical sector.
In line with its resolve to check unethical practices, the agency said it has sanctioned some local and foreign manufacturers over unethical practices and post-marketing failures.
NAFDAC’s Director General, Prof. Mojisola Adeyeye, who made the assertion at the India-Nigeria Pharmaceuticals and Health Industry forum organised in Lagos, recently, said the collaboration with India would provide unhindered access to medicines that are safe, efficacious, affordable and of required quality.
As a responsible National Regulatory Agency, Adeyeye, said NAFDAC would continue to forge meaningful alliance with relevant bodies within the confines of its mandate and in line with global best practice.
A statement by NAFDAC’s Resident Media Consultant, Sanya Akintola quoted the NAFDAC boss as having said the agency’s attainment of World Health Organisation (WHO) Maturity Level 4 status, on vaccine lot release, supply chain monitoring and expanded post-marketing surveillance, and continual pharmacovigilance activities were enough justification for promotion of strong synergy between the India-Nigeria Pharma sector.
According to the NAFDAC boss, India remains 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 as of 2019.”
She added that Indian-owned and operated companies are 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.
Adeyeye said the agency had set up the Five Plus Five-Year Validity policy in 2019, for products that are 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 migration either through building quality focused facilities locally or partnership with existing local companies for their manufacturing needs.
As a ML3 Agency, she said the Agency was strongly averse to unethical practices, noting that NAFDAC would not fail to protect public health through enforcement of appropriate sanctions when and where the need arises.
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 which constitutes significant risks to public health would not be treated with kid gloves.
“NAFDACs 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 are currently sanctioned for unreputable practices and post marketing failures,” she added.
Speaking in the same vein, the President of India Pharmaceutical Manufacturers and Importers of Nigeria (IPMIN), Mr. Verkay Verghese, pledged the association’s cooperation with NAFDAC to ensure that only wholesome medicines are 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 Adeyeye, stressing that with her at the helm of affairs, attaining WHO Maturity Level 4 would not be too difficult for NAFDAC.
