NAFDAC, FCCPC helpless as unregistered drugs take over internet markets | Dailytrust

NAFDAC, FCCPC helpless as unregistered drugs take over internet markets

Lokoja resident, Hassan, 41, was hospitalised after taking few tablets from a pack of food supplements he had ordered via the internet....

Lokoja resident, Hassan, 41, was hospitalised after taking few tablets from a pack of food supplements he had ordered via the internet.

He purchased it following adverts he had seen on the social media that the food supplement helped in managing blood pressure.

The supplement was manufactured outside the country and had no National Agency for Food and Drug Administration and Control (NAFDAC) registration number.

Recalling the incident which occured two years ago, Hassan said he started vomiting and stooling after taking the drug. It continued for so many hours that he became very weak and was rushed to the emergency ward of a hospital.

“I was confused. I didn’t know if it was the real supplement or the fake one that I ordered. The foreign phone number on the product was not connecting for me to follow up with the reactions or ask for a refund.  I just threw the rest away,” he lamented.

He had bought the supplement at N150,000 but ended up spending a lot more in treating himself at the hospital.

Mojisola Adeyeye

However, the NAFDAC, which is supposed to be responsible for policing the online advertising of prescription drugs and devices, has no regulation tailored specifically to drug and device promotion on the internet, a fact that concerns many, especially in light of the explosion of medical use of the internet.

Like Hassan, many Nigerians have fallen victim of scams while purchasing medicines and drug-related products online.

A search for ‘manpower drug’ on the Google machine propped up multiple lists of links, directing to online adverts showing a horde of such drugs. But visits to many of the links show that they are just baits to scam unsuspected Nigerians as they market products that are either unregulated or those who have veiled health risks.  

One of the recent adverts for one of such drugs, Cardiovax, on Facebook presented Dr Olubukola Abubakar Saraki as a renowned cardiologist who retired at the age of 70 about 39 years ago “but feels as if he were 60.”

The advertiser claimed the drug helped in cleansing blood veins and cured hypertension with other nine incurable diseases.

The advert carried the picture of former Senate President Bukola Saraki, who is just 59 years old.

Another advert of the same drug on the purported Facebook page of Pastor Paul Enenche presented Dr Faisal Shuaib as a renowned cardiologist who retired at the age of 62 about 19 years ago but remained young in heart and body.

The name is synonymous with that of the executive director of the National Primarily Health Care Development Agency (NPHCDA).

Curiously, the marketers did not indicate side effects of the drugs, which, according to findings, range from swelling of body parts, shortness of breath and fainting.

In the comment section, a social media user, Vincent Okeke stated, “This whole thing is just a big fraud. I wanted to buy just two cans to try but they convinced me into buying the full dose, which didn’t do jack at the end of the day. When I complained, you need to see how they dribbled me on the phone. Don’t waste your money and precious time people, it is a scam. I even got scared of what I introduced into my body.”

Samuel Kunlere, who also raised concerns, said, “The government should have a way to check all these vagabonds advertising some unverified products on the net to keep the people safe.”

One Magili Samuel said he used two packs for 20 days but the only change he noticed was that he could sleep well, unlike before.

“I mean I can sleep for 8 hours like a baby at 55 years. I advise everyone to follow the instructions; it may work for you,” he said.

But another commentator, Enobong Ebitu, who tagged Samuel, asked, “Was it meant for sleep?”   

Online advertising involves the delivery of advertorial contents to internet/online users via web, e-mail, ad-supported software and internet-enabled smart-phones.

This mode of advertising differs majorly from terrestrial or offline advertising in that its reach is not limited by space or time – everyone across the world with access to the internet could be a recipient.

Apart from its expansive reach, online advertising has become increasingly important to business owners and service providers across the world because in comparison to offline advertising; it is cheaper and more cost-efficient. It offers measurability (the advertisers ability to keep empirical data of the reach and impact of the campaigns) and delivers an unmatched speed of dissemination.

Sections 5 and 30 of the NAFDAC Act stipulate that no person shall advertise any drug or related product unless it has been registered by the agency. No person shall advertise any drug product unless the advertisement has the pre-clearance and approval of the agency.

It stated that the advertisement of any drug or related product shall be accurate, complete, clear and designed to promote credibility and trust by the general public and health care practitioners.  It added that advertisement materials on the drug product shall be authenticated by the superintendent pharmacist and the chief executive of the drug product company sponsoring the drug product advertisement.

It also noted that drug products that have special safety warnings, particularly those that may lead to death or serious injury, shall have this warning information displayed within a box in the advertisement. 

It stated that no drug product shall state or imply in absolute terms or by quotations taken out of context, that any drug product is “safe” or has “guaranteed efficacy” or special status. Any statement claiming or implying a superlative function, such as “most effective, least toxic, best tolerated,” or special status, such as “the drug product of choice,” or any such statements for a drug product, shall not be used unless it can be adequately substantiated, and shall not imply superior efficacy to other products in same category.

It added that where an advertisement portrays a drug product as “fast, immediate, instant or rapid” in action, or any similar descriptions, such claims must be substantiated using studies based on the rate of absorption of the drug product.

It further stated that any person who contravenes any of the provisions of the regulations shall be guilty of an offence and liable on conviction.

“In the case of  an individual, he or she is liable to imprisonment for a term not exceeding one year, or to a fine not exceeding N50,000, or both. For a corporate body, to a fine not exceeding N100, 000.

Where an offence, under these regulations, is committed by a corporate body, firm or association of individuals, the director, manager, secretary, or other similar officers of the body, partner or officer of the firm or trustee of the body concerned, or the person concerned in the management of the affairs of the association, or person who was purporting to act in a capacity referred to in paragraphs (a) to (d) of this regulation, they are severally guilty of that offence and liable to be proceeded and punished in the same manner as if he had himself committed the offence, unless he proves that the act or omission constituting the offence took place without his knowledge, consent or connivance.

Also, a person convicted of an offence under these regulations shall forfeit to the federal government, any asset or property constituting proceeds derived from or obtained, directly or indirectly, as a result of the offence; any of the person’s property or instrumentalities used in any manner to commit or facilitate the commission of the offence.

When contacted, the director-general of the NAFDAC, Prof Mojisola Adeyeye, said the agency was aware that some people were advertising unregistered drugs online.

She said, “The agency is aware and officials of our investigation and enforcement directorate are not resting on their oars until the merchant of unregistered regulated products, including drugs, are brought to book.”

Asked what the agency is doing to address the menace, she said it had been enlightening members of the public to desist from patronising such products through radio and television programmes, such as ‘NAFDAC and Your Health’  on Radio Nigeria, Nigeria Television Authority (NTA) and TVC. 

She said the agency had made a lot of arrests and prosecutions, adding, “We are not relenting until the market is completely rid of unregistered drugs. Our efforts in this regard have led to sanity in the system.

“It could have been worse.  Recently, our officials stormed some warehouses at the Lagos Trade Fair complex, where N3billion worth of unregistered and banned drugs, as well as falsified medicines, amongst other items, were seized from the merchants of death who trade in unwholesome drugs to make money at the expense of innocent consumers,” she added.

Outdated advertising law and challenge of regulating online advertising

Given that the reach of digital advertising transcends jurisdictional boundaries, analysts said it was difficult to define the extent to which local laws and regulations of any specific country can regulate it. The principal law governing advertising in Nigeria is the Advertising Practitioners’ (Registration, Etc.) Act No. 55 of 1988, CAP A7 Laws of the Federation of Nigeria 2004 (the “Act”).

The Act, which was promulgated about 34 years ago, provides the statutory framework for the regulation of advertisements and practitioners. The Act further established the Advertising Practitioners Council of Nigeria (APCON) as the apex regulatory body for advertising in Nigeria with powers to monitor and ensure ethical advertising practices in the country. Section 23 empowers the APCON to establish the Advertising Standards Panel (ASP) charged with the duty of ensuring that advertorial contents conform with the prevailing laws of the federation, as well as the codes of ethics of the advertising profession.

Attempts by one of our reporters to seek reaction to this story from the APCON did not yield any positive result as its spokesperson, Mrs Comfort Nor, did not respond to enquiries.

But according to information on APCON’s website, its Governing Council approved and issued the 5th Nigerian Code of Advertising Practice & Sales Promotion (the “Code”) in January 2013. The code requires that all advertising contents be vetted by the ASP prior to being exposed to the public. But this rule makes no distinction between online and offline advertising.

In furtherance of its extensive regulatory powers, the APCON, in a recent memo to registered advertising practitioners, reinforced the need for advertising practitioners to submit exposure drafts of all advertisements required to be published online and on other social media platforms for prior approval by the ASP in compliance with Article 21 and 80(a) of the Nigerian code.

But it must be noted that the APCON vetting process is only open and applicable to advertising practitioners (Article 6.2 and 7.1, APCON vetting guidelines, effective March 1, 2017); suggesting that non-practitioners, who make up a critical mass of online advertisers, are exempted from this regulation.

An advert practitioner based in Lagos, Liadi Ilori, said even where the APCON has the power to vet all online advertisements, it lacked the capacity and personnel strength to do so.

Ilori said APCON’s advertising panel is comprised of just 24 members who meet twice each month. According to him, where applications require urgent attention, same would have to be accelerated at an additional cost to the applicant.

“This is not to mention the impracticality of establishing a geographical jurisdiction for the APCON as it relates to online advertisements. When will an advertorial content be said to be under APCON’s jurisdiction? Is it when the content originates from a licensed advertising practitioner, when it originates from the creation of a Nigerian citizen, when the advertorial content is created within Nigeria or when the advertorial content has been viewed by the Nigerian audience?’’

Writing in the Tropical Journal of Pharmaceutical Research of March 2015, Maxwell Ogochukwu Adibe and co stated that advertising materials used in promoting drugs in Nigeria had incomplete information and the physical characteristics of the materials were not adequate.

“It seems that drug industries at present mainly aim at increasing sales rather than promoting health care. Information in some pharmaceutical brochures exaggerated the benefits of the drug and downplayed risks associated with the drugs,” they stated.

They noted that the World Health Organisation (WHO) and some non-governmental organisations were becoming worried about the unethical and inappropriate approach to the promotion of drugs, devices and other pharmaceutical products.

They also sttaed, “As at 1997, in a seminar on WHO’s Ethical Criteria for Medicinal Drug Promotion, there was a firm agreement that inappropriate promotion of medicinal drugs is still a problem, both in developing and developed countries.

“Promotional materials, according to WHO’s Ethical Criteria for Medicinal drug Promotion, should include the name of the active ingredient, brand name, content of active ingredient per dosage form or regimen, other ingredients known to cause problems, approved therapeutic uses, dosage form or regimen, side effects, contraindications, major interactions, management in case of overdose or toxicity, storage conditions, pharmacokinetic profile, use in pregnancy and lactation, name and address of manufacturers or distributor, and reference to scientific literature.’’

When contacted, a top official of the Federal Competition Consumer Protection Commission (FCCPC), who did not want his name in print because he was not cleared to speak on the issue, said the commission had not recorded any complaint regarding the purchase of drugs that were not effective.

“We have not received any case regarding online drug scamming,” he said.

He, however, noted that in the past, the commission had received complaints over the marketing of the products rather than their efficacy. He advised Nigerians to be wary of who they purchase goods from online. 

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