NAFDAC DG: Agency Subjected Indian Anti-Leprosy Drugs to Regulatory Standards

Onyebuchi Ezigbo in Abuja

The National Agency for Food and Drugs Administration and Control (NAFDAC) has assured of the quality and efficacy of Rifampicin, anti-leprosy drug billed to arrive the country from India.

It said the quality assurance has become necessary following reports by British Broadcasting Corporation alleging pressures from the World Health Organization (WHO) to abandon its new testing policy and grant permission to import anti-leprosy medicines for patients who needed the medicines.

In the statement signed by the Director General of NAFDAC, Prof. Mojisola Adeyeye, the agency said its attention was drawn to a publication by the British Broadcasting Corporation titled vital leprosy drugs due in Nigeria after year delay.

The report stated the World Health Organization (WHO) had requested that NAFDAC lifts it new testing policy and grant permission to import anti-leprosy medicines for patients who needed the medicines.

However, NAFDAC’s DG said that a certificate of Pharmaceutical Products (CoPP) was issued based on the WHO guideline which requires that the issuing authority takes responsibility for assuring the receiving country that the certified data is authentic; that the manufacturing process of all batches of the medical products conform to GMP standards based on inspections conducted by the issuing authority.

She said: “Unfortunately, due process was not followed in ensuring that the manufacturer of the said consignment of anti-leprosy drugs (Rifampicin) obtained this quality assurance document from the Indian Regulatory Authority.

“To remedy the situation, the WHO requested a waiver of this important documentation requirement.  NAFDAC upon receipt of the appeal from the WHO, requested for the laboratory evaluation report of the consignment of Rifampicin from one of the NAFDAC approved CRIA Laboratories in India.

“This was to ensure that the said products had satisfactory quality, safety, and efficacy results before they can be shipped to Nigeria”.

Explaining further Adeyeye said that, “based on the strength of the satisfactory laboratory result and based on appeals, assurances, and the need to replenish stock out of the product for patients who need them, approval was granted for the release of the shipment of Rifampicin for export to Nigeria”.

She said that NAFDAC is currently working with local industry to reduce the over dependence on imported finished pharmaceutical products through regulatory systems strengthening and capacity building for local pharma manufacturers in Nigeria.

“This is therefore to assure the public that NAFDAC will continue to ensure that only quality, safe and efficacious medicines are available for distribution, sale and use within Nigeria,” she added.

Adeyeye said that her response was to provide clear and accurate details on what transpired and to dispel the misinformation in circulation that NAFDAC prevented/delayed the entry of the medicines into Nigeria.