In a move to address the concerns of the Indian pharma exporters to Nigeria, Pharmaceuticals Export Promotion Council of India (Pharmexcil) recently made a representation to National Agency for Food and Drug Administration and Control (NAFDAC), urging them to issue registration of the product license in the name of the loan licensee rather than in the host manufacturer's names.

NAFDAC, the Nigerian regulatory body equivalent to India's CDSCO, has been granting registration license only in the name of host manufacturers rather than the loan licensee, creating problem to the loan license manufacturers of India.  They have been citing regulatory concerns on this issue on whether granting registration in the name loan licensee will be legally acceptable in India or not.

Over some time now, Indian exporters to African countries especially Nigeria have been facing a lot of heat and uncertainty due to this policy of NAFDAC, rendering them in a state of confusion and distrust. This initiative was taken by the council with a view to address this issues, especially in the wake of increased incidence of problems faced by the Indian exporters over the lack of recognition of the loan licensee in Nigeria, leading to lot of chaos within the pharma exporting community.

Giving a detailed clarification on the ongoing confusion over the acceptability and recognition of the concept of loan license by the Indian regulators, Dr P V Appaji, director general of Pharmexcil stressed that loan license for manufacturing pharma products is both permitted and legally acceptable under the Indian law. In the representation that was made to the chief of the Nigerian regulatory body, during the two-day buyer seller meet (BSM) concluded in Gujarat recently, Dr Appaji requested and suggested them that whenever NAFDAC grants a registration, they should kindly consider and look into this matter by endorsing and ensuring registration to the Indian loan licensee rather than the host company.

“Our meeting with the regulators was basically aimed at addressing these issues and clarifying their doubts, so as to encourage and give confidence to the Indian exporters to continue exporting to these countries. We have already given them the required clarification that  they have been asking for and have got positive reply from them on addressing this issue,” informed Dr Appaji.