By Chioma Obinna
Lagos—National Agency for Food and Drugs Administration and Control, NAFDAC, said yesterday it would shut down open drug market in Kano State before the end of this year.
This is coming on the heels of recent destruction of N1 million worth of fake and sub-standard drugs in the drug market in Kano drug market by the agency.
These came as the agency released a new guidelines and guidance documents for the registration of biopharmaceuticals (Biosimilars) in the country.
Biosimilars are complex drugs used in the treatment and management of terminal diseases, including complex cases of cancer, hepatitis, leukemia, among others.
Disclosing this at a dissemination workshop on the guidelines and guidance for the registration of Biosimilars in Lagos, Director General of NAFDAC, Dr Paul Orhii, affirmed that the Kano market had been a haven for the circulation of fake and counterfeit drugs.
Orhii said: “We are shutting down the Kano open drug market before December 31 because recent investigations show that many of the counterfeit drugs are being pushed into the Nigeria market through the Kano open drug market.
“We have observed that the market habours a large percentage of fake and counterfeit products, especially drugs.”
Orhii advised genuine drug manufacturers who have their products in the market to withdraw them before the closure.
He further warned drug manufacturers to comply with the Mobile Authentic Service, MAS, technology before January 2013 as defaulters would be sanctioned.
“The SMS authentication system has put the power of detection in the hands of over 80 million Nigerians. Only last week, we have over three million text verifications using this system.
“Manufacturers must buy into this technology because any of the selected products manufactured this December that is supposed to have the SMS verification system and is not doing so will be mopped up from the market,” he added. Selected drugs according to him include anti-malarials and antibiotics,” he said.
Speaking on the newly released guidelines, Orhii said the document would provide both the regulated industry and agency with adequate information and proper direction on how to handle biosimilars.
He added that Nigeria would be the first country in Sub-Sahara Africa to release a guidelines document on biosimilars.
“The recent upsurge in biosimilars, following the expiration of patency of several innovators products has created an urgent need for the global development of new regulatory processes for this class of products,” Orhii said.
On her part, the Director, Regulatory and Registration, Dr. Monica Eimunjeze, said although the World Health Organisation, WHO, had provided basic principles regarding these products, it had not resolved all issues.
To address the shortcomings in the global document, the agency had to domesticate a guideline to suit the needs of Nigerians.