By Chuks Okocha
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 would 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.
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.
According to a statement by the National Coordinator of the group, Emmanuel Onwubiko, “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 concocted by the Governor of Kogi State, Yahaya Bello, 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 publicised 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 Food and Drug Administration and 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 frame works.
HURIWA said that these guidelines “are for the interest of the general public and in particular, pharmaceutical industries in Nigeria.”
It said that 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 seven accompanying guidelines.”
It stated further that 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 labelled, spurious, counterfeited for sub-standard medicinal product.
It stated that the manufacturer, in the case of imported products, must show evidence that he or she is licensed to manufacture drugs for sale in the country of origin (Manufacturer’s Certificate), explaining that “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.”
It further stated that 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 from which must be properly filled with all information required.
“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,” Huriwa declared