The Nation’s prominent Civil Rights Advocacy group:- HUMAN RIGHTS WRITERS ASSOCIATION OF NIGERIA (HURIWA) has cautioned the Nigerian authorities against the deployment of foreign manufactured vaccines against Covid-19 without total compliance with the pharmaceutical laws of Nigeria.
The Rights group said it will amount to encouraging the meaningless conspiracy theories being spinned by pessimists should the Nigerian government not follow due process before the Nation-wide deployment of Covid-19 vaccines.
HUMAN RIGHTS WRITERS ASSOCIATION OF NIGERIA (HURIWA) which faulted any move to deny indigenous scientists and pharmacists of participation in the verification processes, stated that allowing local scientists to be part of the team of experts to authenticate the validity, functionality and efficacy of the vaccines will generate the needed National momentum for the greatest percentage of the Nigerian citizens to embrace the Covid-19 vaccines and accept to present themselves for vaccination.
“It must be noted that a lot of ignorance around the Covid-19 vaccines are already becoming widespread and being actively peddled in the Country including the conspiracy theory lacking logic and justification which was spinned by the governor of kogi state alleging that Covid-19 vaccines are meant to kill blacks.
“This empty and untrue allegation against Covid-19 vaccines as made by the Kogi state governor Yahaya Bello and publicized in the media, can only grow a life of its own, should the foreign-made vaccines imported into Nigeria not be subjected to scientific processes of verification and authentication by trusted and tested Nigerian pharmacists and scientists.”
The Rights group stated that under the extant law establishing National Agency For Drugs And Foods Control (NAFDAC) which is also identified as the provisions of Decree 19 of 1993 and the accompanying guidelines for pharmaceutical registration requirement in Nigeria, vaccines made abroad and imported into Nigeria must first be shown to have met the global best practices and passed the thresholds set by the local legislative frameworks.
HURIWA cited these Guidelines Are For the Interest of the General Public and in Particular, Pharmaceutical Industries in Nigeria.
It is Necessary To Emphasise That, no Drug Product Shall Be Manufactured, Imported, Exported Advertised, Sold or Distributed In Nigeria Unless It Has Been Registered In Accordance With The Provisions Of Decree 19 Of 1993 And The Accompanying Guidelines
B. Applications/ Manufacturer
1. (a) An application for registration of a drug product shall be made by the manufacturer
(b) Incase of a manufacturer outside Nigeria such shall be represented in Nigeria by a duly registered Pharmaceutical Company.
(c) An applicant for a manufacturer outside Nigeria, must file an evidence of Power of Attorney from the manufacturer, which authorizes him to speak for his principal on all matters relating to the latter’s specialties The original Power of Attorney is to be notarized and submitted to NAFDAC.
Other aspects of the local requirements for registration of pharmaceutical products are that the representative in Nigeria, whether a corporate body or an individual with the Power of Attorney, will be held responsible for ensuring that the competent authority in the country is informed of any serious hazard newly associated with a product imported under the provisions of the decree or of any criminal abuse of the certificate in particular to the importation of falsely labeled, spurious, counterfeited for sub-standard medicinal product.
(d) The manufacturer, in the case of imported products, must show evidence that he or she licensed to manufacture drugs for sale in the country of origin (Manufacturer’s Certificate). Such evidence must be by the competent Health Authority of the country of manufacture, and shall be authenticated by the Nigerian Mission in that country.
2. (a) The applicant must submit to the Registration Division, NAFDAC, a written application, stating name of manufacturer, generic name (brand name, where applicable), strength, indications and obtain the prescribed application form which must be properly filled with all information required. This form, labeled “FORM D-REG/001” shall be obtained on payment of N500.00 per product in Bank, Draft (MICR) issued in favour of NAFDAC, Lagos.
2. A separate application form shall be submitted for each drug product. In this context, a drug product means a separate drug formulation. However, the Application for registration of one dosage form with different strengths may be made on the same application form.
C. PRODUCT
1 . A drug product shall not be manufactured in Nigeria, unless the factory is inspected and Certificate of Recognition is issued by NAFDAC.
2. In case of imported products:-
– a) There must be evidence of registration of such products by the competent Health Authority of the country of manufacturer i.e., Product Licence/Certificate of Registration.
– b) There must be evidence by the competent Health Authority, that the sale of the product does not constitute a contravention of the drug laws of that country, i.e., Free Sale Certificate.
– c) The documents in respect of (a) and (b) shall be authenticated by the Nigerian Mission in that country.
3 . In the case of an imported new drug substance, there must be evidence that limited local clinical trials have been undertaken, and that such product is registered in the country of origin and also, in at least 2 or more developed countries.
The National Primary Health Care Development Agency (NPHCDA), says it is expecting the final confirmation for coronavirus vaccine from Covax Initiative backed by Gavi Vaccine Alliance, World Health Organisation and Coalition for Epidemic Preparedness Innovations.
The Executive Director, NPHCDA, Dr Faisal Shuaib, said this in an interview with the News Agency of Nigeria (NAN), on Friday in Abuja.
“We are expecting final confirmation soon from Covax on when our first doses will arrive through the programme.
“In parallel, we are speaking to both the African Union and manufacturers to get the doses we need,” he said.
Shuaib noted that the country was expected to take delivery of its first coronavirus vaccine doses in February, with health workers, top government officials and vulnerable people to be given priority.
He said the country targeted to vaccinate 70 per cent of its population in the country.
