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 coming shortly after the
destruction of N1 million worth of fake and sub-standard drugs in the
drug market by the agency.
This 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.
“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 said.
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.
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